Robotic Hysterectomy

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Robotic Hysterectomy

Since the first published report of a robotic hysterectomy appeared in 2001, we have gained enough experience to know that next to vaginal hysterectomy, which I believe is still the preferred approach whenever possible, the robotic approach is the next-best technique that gynecologic surgeons can offer patients.

The robotic system we use today—the da Vinci surgical system—was designed to overcome the surgical limitations of conventional laparoscopy. Indeed, it has.

My colleagues and I at the Mayo Clinic, and others elsewhere, have seen similar operating times, reduced blood loss, and shorter hospitalization for both simple and radical hysterectomies as compared with the laparotomy approach. We have experienced firsthand the increased accuracy and precision that robotics promised. Suturing is easier with robotics than with laparoscopy. The advantages of robotics—from instrument articulation to the steady three-dimensional vision—have been more than expected, surpassing the advantages of conventional laparoscopy. Our operating time for robotic radical hysterectomy, in fact, is significantly shorter than that of laparoscopy.

The learning curve for performing robotic hysterectomy, moreover, seems surprisingly short. In a case-series analysis of robotic simple hysterectomies, we found it interesting that the time spent in the operating room flattened after 20-25 cases.

A prospective, randomized study comparing robotic hysterectomy with conventional laparoscopic surgery should be completed at the Mayo Clinic by the end of this year. In the meantime, robotic hysterectomy is generally offered to patients at Mayo as an alternative whenever a laparoscopic hysterectomy is being considered.

Patients are beginning to ask for it, and indeed, there are instances when we strongly prefer the robotic approach regardless of patient demand—for example, when patients have a history of adhesions, advanced endometriosis, gynecologic cancer, or genitourinary fistula, or when we have to perform pelvic floor repair procedures or other additional procedures that require extensive suturing. Obesity is an excellent application for robotic technology, which is something we have learned as our operating time has not been influenced by a patient's body mass index.

Evolution of Robotics

We started performing hysterectomies with the Zeus MicroWrist surgical system in 2003. The system, which was approved by the Food and Drug Administration in 2002 for general and laparoscopic surgery, enabled the surgeon to operate three robotic arms while sitting a distance away from the operating table.

This Zeus system was an advance over the Aesop robotic device, a voice-activated robotic arm designed to operate the laparoscope. Released in 1994, Aesop was the first robotic system approved to assist in laparoscopic procedures. With Aesop, the surgeon would direct the robotic movement of the laparoscope through voice commands while working manually with regular instruments. Video quality thus improved, and the need for an assistant was obviated when only two instruments were needed.

With the development of the Zeus system, surgeons gained two more robotic arms (in addition to the laparoscope-operating arm) as well as some of the other advantages afforded by robotics, such as articulating tips and a downscaling of movement.

The da Vinci surgical system that we use currently is an improvement over Zeus. It was originally approved for procedures in the abdominal and pelvic cavity, but in 2005 it received special approval for the performance of robotic hysterectomy. At this point, because of various changes in the industry's structure, it is the only robotic system manufactured for laparoscopic procedures.

In an evolution that reflects likely future changes as well, a second generation of the da Vinci system, released in 2006, has longer instruments, lighter arms, and increased flexion-extension and lateral excursion, among other improvements.

Instrumentation and Process

We now refer to the approach as “robotic” hysterectomy rather than “robotic-assisted” laparoscopic hysterectomy because—although a surgical assistant is still needed for several key functions, such as suction and irrigation—the procedure is, with these latest advancements, largely robotic in nature.

With most hysterectomies, as with most pelvic operations, four trocar sites are used: three for the robotic arms (one of which is for the laparoscope) and one for the assistant, who will manually perform suction, irrigation, vessel sealing, tissue retraction, and specimen retrieval. When we have a patient with cancer, obesity, a large uterus, advanced endometriosis, or adhesions, we add a fourth robotic arm. This additional arm allows for the added retraction of tissues.

We use the open Hasson technique to place a 12-mm robotic trocar (the first of the three main trocars) in the umbilical area for the laparoscope. Two 8-mm robotic trocars are then placed bilaterally, 10 cm to the right and left of the umbilicus. This placement provides an operative field that extends, in most patients, from the lower pelvis up to the inferior mesenteric artery.

 

 

For the assistant, a 10-mm trocar is placed 3 cm cranial and right between the umbilicus and the left robotic trocar. Through this port, the assistant performs the functions that are not yet available robotically: vessel sealing, suction, irrigation, tissue retraction, specimen retrieval, and the introduction and retrieval of sutures and needles. When a fourth robotic arm is used, that trocar is placed 10 cm lateral and 10 cm caudal to the right robotic trocar.

The robotic tower with three arms is situated between the patient's legs. We have noticed that if the column is parked very close to the patient's perineum, there is inadequate space for the scrub nurse to mobilize and manipulate a vaginal probe, maintain the pneumoperitoneum during vaginal incision, and retrieve specimens vaginally. Ideally, the robotic column should rest at about the level of the patient's feet and not any closer.

The middle robotic arm is attached to the umbilical trocar where the laparoscope has been inserted. A monopolar spatula, or scissors, is inserted through the right lateral trocar, and a plasma-kinetic dissecting forceps is inserted through the left lateral trocar. When needed for suturing, a needle-holder replaces the spatula. When a fourth robotic arm is needed, a robotic instrument called a Prograsp is used.

The surgeon sits, unscrubbed, on a console that in our operating suite is about 12 feet away from the patient. Here the surgeon can manipulate the robotic arms that maneuver the instruments and the laparoscopic camera, as well as communicate verbally with the assistant. When the surgeon is playing the role of assistant and the trainee is at the console, the surgeon can direct the trainee by means of telestration to pinpoint anatomical structures and planes of dissection, or to indicate areas of potential visceral damage by drawing circles, arrows, or dots.

When the ovaries are to be removed, which in our practice is more common than not, our first step with robotic simple hysterectomy is to incise the pelvic peritoneum at the level of the pelvic brim to identify the ureters and the points at which they cross the ovarian vessels. We then coagulate and divide the infundibulopelvic ligament that contains the ovarian vessels.

The ureters are then traced and followed to the point where they cross the uterine arteries. Because we cannot palpate the tissues in robotic surgery and therefore need to see, we dissect the ureters anytime they appear close to the cervix or if there is parametrial pathology. Doing so prevents injury.

After this, the bladder must be dissected from the cervix and upper vagina, and at least 2 cm caudal to the anterior vaginal fornix. A vaginal probe that is inserted into the vagina by the scrub nurse is used to identify where the vagina joins the cervix and to define the level of incision on the vagina.

A vessel-sealing device is used to coagulate and transect the uterine arteries and the cardinal ligaments. At that point—and not any sooner—the vagina is transected immediately distal to the cervix and the uterus is detached and removed, along with the ovaries in most cases, through the vaginal opening. (When the ovaries are not removed, they are left attached to the ipsilateral round ligament.) The scrub nurse holds the labia majora to the midline over the surgical instrument used to remove the uterus, and that is enough to maintain the pneumoperitoneum.

Inflation of a sterile occluding balloon with 60 mL of saline is used to maintain the pneumoperitoneum after removal of the specimen vaginally.

The right monopolar spatula is then removed and replaced with a needle-holder, and the vaginal cuff is closed with a 15-cm precut 0 continuous polyglyconate absorbable suture starting at the right angle and going toward the midline. A similar 15-cm suture is applied from the left to the midline until it meets the other suture. The uterosacral ligaments are incorporated at each vaginal angle and at the midline in order to support the vagina. We use a LapraTy suture clip at each end of the sutures to eliminate the need for intracorporeal knot tying.

Using these small precut sutures is most helpful. A suture that is 30 cm long simply takes too long to pull through the tissues. In general, the use of smaller, shorter sutures is essential in robotic surgery.

For robotic hysterectomies as well as any other robotic gynecologic surgery, I also advise using slow, deliberate, precise movements. Such pacing alleviates the risk of bleeding, which dramatically slows the procedure down when it occurs.

 

 

At the end of the procedure, the robotic arms are disengaged from the trocars, the robotic column is moved away, and the fascia at the umbilical site is closed. The other trocar sites require closure of only the skin. We always perform a cystoscopy after injection of intravenous indigo carmine to ensure that there are bilateral ureteral jets and no injury to the bladder.

When we plan to send the patient home on the day of the robotic hysterectomy—something we started doing when we observed how well patients were faring with this approach—we modify the anesthesia regimen somewhat.

We give each patient dexamethasone preoperatively, apply an antinausea patch behind her ear, and administer two additional medications to prevent nausea: Zofran (ondansetron) and aprepitant. Then, at the end of the hysterectomy, we inject both the right and the left pelvic plexus (sympathetic and parasympathetic) with a cocktail of morphine, vasopressin, and Marcaine (bupivacaine). We also infiltrate the trocar sites with Marcaine, and before the patient is awakened from anesthesia, we administer intravenous ketorolac. When she is awake, the patient will then have minimal discomfort.

Additionally, normal saline (200 mL) is left in the bladder at the end of the cystoscopy so that the patient will have the urge to empty her bladder in the next hour rather than the need to wait up to 5 hours to empty her bladder before being able to go home.

In our preoperative discussions with patients, we do inform them that the incisions are placed a little higher than with conventional laparoscopy. Only once has one of our patients expressed cosmetic concern and opted for a laparoscopic approach with suprapubic trocar placement.

Hysterectomy has been a natural beginning application for robotic technology in gynecologic surgery. Experience with the approach has applications, in turn, for other gynecologic procedures because the same instrumentation and usually the same port placement are used.

Patient Outcomes

In a series of 91 consecutive patients who underwent robotic simple hysterectomy at Mayo (with or without salpingo-oophorectomy or concomitant appendectomy) between March 2004 and December 2005, we had no conversions to conventional laparoscopy or laparotomy, no bladder or ureteral injuries, and few intraoperative and postoperative complications (Am. J. Obstet. Gynecol. 2007;197:113.e1-4).

Our one intraoperative complication was an enterotomy that was repaired robotically in a patient with extensive pelvic adhesions. (We have learned that complications can be repaired robotically without having to convert to laparotomy.)

Postoperatively, one patient with cardiomyopathy required admission to intensive care for 24 hours for exacerbation of heart failure, and another patient required admission for vaginal cuff abscess. Three patients were readmitted for ileus, pneumonia, and colitis. The mean estimated blood loss was 79 mL, and the mean hospital stay was 1.3 days. (Indications in the patients, whose mean age was 50 years, included menometrorrhagia in 43% and ovarian neoplasm in 20%.)

In the evaluation of robotic surgery and analysis of the experience, it is important to break down the total process into several components: docking time (the time required to attach the robotic arms to the trocars), console time (the surgeon's time dedicated exclusively to performing the hysterectomy), and total operating time (from incision to closure).

For surgeons who haven't used the robotic system, a common misperception is that it takes a long time to set up for each procedure. In our series, however, the mean docking time was only 2.9 minutes.

The mean console time was 79 minutes, and the total mean operating time was 122 minutes, which was 14 minutes shorter than conventional laparoscopy. A mean of 43 minutes was required for setup and close, which included trocar placement, exploration, and the removal of trocars, closure, and cystoscopy. (The time for setup and close has not been reported before in laparoscopic surgery.)

Our surgical time was minimized by having a dedicated robotic team and by using certain surgical strategies, such as the use of only three instruments (monopolar spatula, bipolar grasper, and needle-holder) for the entire procedure—a practice that also reduces cost—and the use of precut, short sutures and suture clips. The optimal robotic team can comprise two surgeons or one surgeon and one assistant, as well as at least two nurses who are well versed in the robotic instrumentation and system. The assistant also plays a major role in fixing any malfunctions of the robotic instruments or arms, and in switching robotic instruments.

Console time clearly decreased over time as we performed more simple hysterectomies. It was not significantly affected by the performance of an appendectomy, but it was affected by uterine weight and the lysis of adhesions. In our practice, we prefer a vaginal approach for the larger uterus that requires more morcellation. In general, our threshold for the robotic approach is a uterus of 12-14 weeks' gestational size.

 

 

All of these findings—from reduced operating times to shorter hospitalizations and fewer complications—have applied to our experience with robotic radical hysterectomy as well. In one analysis of 16 patients undergoing robotic radical hysterectomy, we found that total operating time was 66 minutes shorter than it had been for laparoscopic radical hysterectomy.

An increased body mass index did not prolong operating times in any of our patient groups. In fact, we have noticed that for patients who are obese, surgical time is longer with laparoscopy than with robotics. This reflects one of the advantages of the robotic approach: It bypasses the fulcrum effect, which is inherent to conventional laparoscopy and which is especially challenging in patients with a thick abdominal wall. Surgeons using the articulated instrumentation of a robotic system will use the same manual effort regardless of how thick the abdominal wall is.

The lack of tactile feedback is viewed by some as a limitation of robotics, but after a short time of practice, it is easily compensated for by the depth of perception that three-dimensional vision affords.

In addition, the articulation of the instruments facilitates dissection of the tissues and suturing, such as closure of the vaginal cuff in hysterectomies. And as with other gynecologic surgeries, the downscaling of the surgeon's movements in a 3:1 or 5:1 ratio leads to increased accuracy and precision. (In such downscaling, when the surgeon's hand moves 3 cm or 5 cm, the tip of the instrument moves only 1 cm.)

We still believe that when the hysterectomy can be performed vaginally, the vaginal approach is preferable to robotics or to laparoscopy. This is because any study that has compared vaginal hysterectomy with another approach has demonstrated a faster operating time with the vaginal procedure, as well as lower cost.

When a patient is not a candidate for a vaginal hysterectomy, or when the gynecologist is not comfortable with the approach, however, then the robotic approach is indeed preferable to conventional laparoscopy.

Four robotic trocars are placed in preparation for pelvic surgery with the da Vinci robotic system.

The da Vinci robotic system is shown in operation, with the assistant sitting to the left of the patient.

The Zeus robotic system consists of two working arms and another to hold the laparoscope. Photos courtesy Dr. Javier Magrina

Robotics: Enabling Technology for the Gyn.

The first proponents of robotics in surgery were the cardiac surgeons, but it was the urologists who truly popularized robotic surgery. Hospitals around the country have purchased the da Vinci surgical system mainly for urologists who wanted to perform robot-assisted radical prostatectomies. Interestingly enough, the robot has enabled physicians who were virtually untrained in laparoscopic surgery to feel comfortable with a laparoscopic approach.

Even though gynecologists were the first surgical specialists to perform laparoscopic surgery on a routine basis, the acceptance of minimally invasive gynecologic surgery within our specialty remains dismally low. In a recent study submitted to the National Women's Health Resource Center by the Lewin Group, only 15% of more than 600,000 hysterectomies performed per annum in the United States are accomplished via a minimally invasive technique. This is especially sobering when one considers that 80% of the cholecystectomies are performed laparoscopically.

Given the above, it is interesting to speculate on the potential impact of robotic surgery in gynecology. Initially, it appears that gynecologists who were not previously performing advanced minimally invasive surgery are able to do so with this enabling technology.

I have put together a minisymposium on robotic surgery in gynecology that will be covered in the next four issues. With my esteemed faculty, I will discuss the topics of robotic-assisted laparoscopic hysterectomy, robotic-assisted laparoscopic myomectomy, robotic-assisted laparoscopic sacrocolpopexy, and robotic-assisted node dissection.

The first author is Dr. Javier Magrina, head of the division of gynecologic oncology, director of female pelvic medicine and reconstructive surgery, and professor of obstetrics and gynecology at the Mayo Clinic, Scottsdale, Ariz.

Dr. Magrina has written extensively and lectured throughout the world on robotic surgery, from a standpoint of both benign as well as malignant disease. For the past 2 years, he has served on the board of trustees of the AAGL and remains very active in the Society of Gynecologic Oncologists and the Society of Laparoendoscopic Surgeons.

It is a pleasure to have Dr. Magrina as the author of our Master Class in Gynecologic Surgery on robotic-assisted laparoscopic hysterectomy.

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Since the first published report of a robotic hysterectomy appeared in 2001, we have gained enough experience to know that next to vaginal hysterectomy, which I believe is still the preferred approach whenever possible, the robotic approach is the next-best technique that gynecologic surgeons can offer patients.

The robotic system we use today—the da Vinci surgical system—was designed to overcome the surgical limitations of conventional laparoscopy. Indeed, it has.

My colleagues and I at the Mayo Clinic, and others elsewhere, have seen similar operating times, reduced blood loss, and shorter hospitalization for both simple and radical hysterectomies as compared with the laparotomy approach. We have experienced firsthand the increased accuracy and precision that robotics promised. Suturing is easier with robotics than with laparoscopy. The advantages of robotics—from instrument articulation to the steady three-dimensional vision—have been more than expected, surpassing the advantages of conventional laparoscopy. Our operating time for robotic radical hysterectomy, in fact, is significantly shorter than that of laparoscopy.

The learning curve for performing robotic hysterectomy, moreover, seems surprisingly short. In a case-series analysis of robotic simple hysterectomies, we found it interesting that the time spent in the operating room flattened after 20-25 cases.

A prospective, randomized study comparing robotic hysterectomy with conventional laparoscopic surgery should be completed at the Mayo Clinic by the end of this year. In the meantime, robotic hysterectomy is generally offered to patients at Mayo as an alternative whenever a laparoscopic hysterectomy is being considered.

Patients are beginning to ask for it, and indeed, there are instances when we strongly prefer the robotic approach regardless of patient demand—for example, when patients have a history of adhesions, advanced endometriosis, gynecologic cancer, or genitourinary fistula, or when we have to perform pelvic floor repair procedures or other additional procedures that require extensive suturing. Obesity is an excellent application for robotic technology, which is something we have learned as our operating time has not been influenced by a patient's body mass index.

Evolution of Robotics

We started performing hysterectomies with the Zeus MicroWrist surgical system in 2003. The system, which was approved by the Food and Drug Administration in 2002 for general and laparoscopic surgery, enabled the surgeon to operate three robotic arms while sitting a distance away from the operating table.

This Zeus system was an advance over the Aesop robotic device, a voice-activated robotic arm designed to operate the laparoscope. Released in 1994, Aesop was the first robotic system approved to assist in laparoscopic procedures. With Aesop, the surgeon would direct the robotic movement of the laparoscope through voice commands while working manually with regular instruments. Video quality thus improved, and the need for an assistant was obviated when only two instruments were needed.

With the development of the Zeus system, surgeons gained two more robotic arms (in addition to the laparoscope-operating arm) as well as some of the other advantages afforded by robotics, such as articulating tips and a downscaling of movement.

The da Vinci surgical system that we use currently is an improvement over Zeus. It was originally approved for procedures in the abdominal and pelvic cavity, but in 2005 it received special approval for the performance of robotic hysterectomy. At this point, because of various changes in the industry's structure, it is the only robotic system manufactured for laparoscopic procedures.

In an evolution that reflects likely future changes as well, a second generation of the da Vinci system, released in 2006, has longer instruments, lighter arms, and increased flexion-extension and lateral excursion, among other improvements.

Instrumentation and Process

We now refer to the approach as “robotic” hysterectomy rather than “robotic-assisted” laparoscopic hysterectomy because—although a surgical assistant is still needed for several key functions, such as suction and irrigation—the procedure is, with these latest advancements, largely robotic in nature.

With most hysterectomies, as with most pelvic operations, four trocar sites are used: three for the robotic arms (one of which is for the laparoscope) and one for the assistant, who will manually perform suction, irrigation, vessel sealing, tissue retraction, and specimen retrieval. When we have a patient with cancer, obesity, a large uterus, advanced endometriosis, or adhesions, we add a fourth robotic arm. This additional arm allows for the added retraction of tissues.

We use the open Hasson technique to place a 12-mm robotic trocar (the first of the three main trocars) in the umbilical area for the laparoscope. Two 8-mm robotic trocars are then placed bilaterally, 10 cm to the right and left of the umbilicus. This placement provides an operative field that extends, in most patients, from the lower pelvis up to the inferior mesenteric artery.

 

 

For the assistant, a 10-mm trocar is placed 3 cm cranial and right between the umbilicus and the left robotic trocar. Through this port, the assistant performs the functions that are not yet available robotically: vessel sealing, suction, irrigation, tissue retraction, specimen retrieval, and the introduction and retrieval of sutures and needles. When a fourth robotic arm is used, that trocar is placed 10 cm lateral and 10 cm caudal to the right robotic trocar.

The robotic tower with three arms is situated between the patient's legs. We have noticed that if the column is parked very close to the patient's perineum, there is inadequate space for the scrub nurse to mobilize and manipulate a vaginal probe, maintain the pneumoperitoneum during vaginal incision, and retrieve specimens vaginally. Ideally, the robotic column should rest at about the level of the patient's feet and not any closer.

The middle robotic arm is attached to the umbilical trocar where the laparoscope has been inserted. A monopolar spatula, or scissors, is inserted through the right lateral trocar, and a plasma-kinetic dissecting forceps is inserted through the left lateral trocar. When needed for suturing, a needle-holder replaces the spatula. When a fourth robotic arm is needed, a robotic instrument called a Prograsp is used.

The surgeon sits, unscrubbed, on a console that in our operating suite is about 12 feet away from the patient. Here the surgeon can manipulate the robotic arms that maneuver the instruments and the laparoscopic camera, as well as communicate verbally with the assistant. When the surgeon is playing the role of assistant and the trainee is at the console, the surgeon can direct the trainee by means of telestration to pinpoint anatomical structures and planes of dissection, or to indicate areas of potential visceral damage by drawing circles, arrows, or dots.

When the ovaries are to be removed, which in our practice is more common than not, our first step with robotic simple hysterectomy is to incise the pelvic peritoneum at the level of the pelvic brim to identify the ureters and the points at which they cross the ovarian vessels. We then coagulate and divide the infundibulopelvic ligament that contains the ovarian vessels.

The ureters are then traced and followed to the point where they cross the uterine arteries. Because we cannot palpate the tissues in robotic surgery and therefore need to see, we dissect the ureters anytime they appear close to the cervix or if there is parametrial pathology. Doing so prevents injury.

After this, the bladder must be dissected from the cervix and upper vagina, and at least 2 cm caudal to the anterior vaginal fornix. A vaginal probe that is inserted into the vagina by the scrub nurse is used to identify where the vagina joins the cervix and to define the level of incision on the vagina.

A vessel-sealing device is used to coagulate and transect the uterine arteries and the cardinal ligaments. At that point—and not any sooner—the vagina is transected immediately distal to the cervix and the uterus is detached and removed, along with the ovaries in most cases, through the vaginal opening. (When the ovaries are not removed, they are left attached to the ipsilateral round ligament.) The scrub nurse holds the labia majora to the midline over the surgical instrument used to remove the uterus, and that is enough to maintain the pneumoperitoneum.

Inflation of a sterile occluding balloon with 60 mL of saline is used to maintain the pneumoperitoneum after removal of the specimen vaginally.

The right monopolar spatula is then removed and replaced with a needle-holder, and the vaginal cuff is closed with a 15-cm precut 0 continuous polyglyconate absorbable suture starting at the right angle and going toward the midline. A similar 15-cm suture is applied from the left to the midline until it meets the other suture. The uterosacral ligaments are incorporated at each vaginal angle and at the midline in order to support the vagina. We use a LapraTy suture clip at each end of the sutures to eliminate the need for intracorporeal knot tying.

Using these small precut sutures is most helpful. A suture that is 30 cm long simply takes too long to pull through the tissues. In general, the use of smaller, shorter sutures is essential in robotic surgery.

For robotic hysterectomies as well as any other robotic gynecologic surgery, I also advise using slow, deliberate, precise movements. Such pacing alleviates the risk of bleeding, which dramatically slows the procedure down when it occurs.

 

 

At the end of the procedure, the robotic arms are disengaged from the trocars, the robotic column is moved away, and the fascia at the umbilical site is closed. The other trocar sites require closure of only the skin. We always perform a cystoscopy after injection of intravenous indigo carmine to ensure that there are bilateral ureteral jets and no injury to the bladder.

When we plan to send the patient home on the day of the robotic hysterectomy—something we started doing when we observed how well patients were faring with this approach—we modify the anesthesia regimen somewhat.

We give each patient dexamethasone preoperatively, apply an antinausea patch behind her ear, and administer two additional medications to prevent nausea: Zofran (ondansetron) and aprepitant. Then, at the end of the hysterectomy, we inject both the right and the left pelvic plexus (sympathetic and parasympathetic) with a cocktail of morphine, vasopressin, and Marcaine (bupivacaine). We also infiltrate the trocar sites with Marcaine, and before the patient is awakened from anesthesia, we administer intravenous ketorolac. When she is awake, the patient will then have minimal discomfort.

Additionally, normal saline (200 mL) is left in the bladder at the end of the cystoscopy so that the patient will have the urge to empty her bladder in the next hour rather than the need to wait up to 5 hours to empty her bladder before being able to go home.

In our preoperative discussions with patients, we do inform them that the incisions are placed a little higher than with conventional laparoscopy. Only once has one of our patients expressed cosmetic concern and opted for a laparoscopic approach with suprapubic trocar placement.

Hysterectomy has been a natural beginning application for robotic technology in gynecologic surgery. Experience with the approach has applications, in turn, for other gynecologic procedures because the same instrumentation and usually the same port placement are used.

Patient Outcomes

In a series of 91 consecutive patients who underwent robotic simple hysterectomy at Mayo (with or without salpingo-oophorectomy or concomitant appendectomy) between March 2004 and December 2005, we had no conversions to conventional laparoscopy or laparotomy, no bladder or ureteral injuries, and few intraoperative and postoperative complications (Am. J. Obstet. Gynecol. 2007;197:113.e1-4).

Our one intraoperative complication was an enterotomy that was repaired robotically in a patient with extensive pelvic adhesions. (We have learned that complications can be repaired robotically without having to convert to laparotomy.)

Postoperatively, one patient with cardiomyopathy required admission to intensive care for 24 hours for exacerbation of heart failure, and another patient required admission for vaginal cuff abscess. Three patients were readmitted for ileus, pneumonia, and colitis. The mean estimated blood loss was 79 mL, and the mean hospital stay was 1.3 days. (Indications in the patients, whose mean age was 50 years, included menometrorrhagia in 43% and ovarian neoplasm in 20%.)

In the evaluation of robotic surgery and analysis of the experience, it is important to break down the total process into several components: docking time (the time required to attach the robotic arms to the trocars), console time (the surgeon's time dedicated exclusively to performing the hysterectomy), and total operating time (from incision to closure).

For surgeons who haven't used the robotic system, a common misperception is that it takes a long time to set up for each procedure. In our series, however, the mean docking time was only 2.9 minutes.

The mean console time was 79 minutes, and the total mean operating time was 122 minutes, which was 14 minutes shorter than conventional laparoscopy. A mean of 43 minutes was required for setup and close, which included trocar placement, exploration, and the removal of trocars, closure, and cystoscopy. (The time for setup and close has not been reported before in laparoscopic surgery.)

Our surgical time was minimized by having a dedicated robotic team and by using certain surgical strategies, such as the use of only three instruments (monopolar spatula, bipolar grasper, and needle-holder) for the entire procedure—a practice that also reduces cost—and the use of precut, short sutures and suture clips. The optimal robotic team can comprise two surgeons or one surgeon and one assistant, as well as at least two nurses who are well versed in the robotic instrumentation and system. The assistant also plays a major role in fixing any malfunctions of the robotic instruments or arms, and in switching robotic instruments.

Console time clearly decreased over time as we performed more simple hysterectomies. It was not significantly affected by the performance of an appendectomy, but it was affected by uterine weight and the lysis of adhesions. In our practice, we prefer a vaginal approach for the larger uterus that requires more morcellation. In general, our threshold for the robotic approach is a uterus of 12-14 weeks' gestational size.

 

 

All of these findings—from reduced operating times to shorter hospitalizations and fewer complications—have applied to our experience with robotic radical hysterectomy as well. In one analysis of 16 patients undergoing robotic radical hysterectomy, we found that total operating time was 66 minutes shorter than it had been for laparoscopic radical hysterectomy.

An increased body mass index did not prolong operating times in any of our patient groups. In fact, we have noticed that for patients who are obese, surgical time is longer with laparoscopy than with robotics. This reflects one of the advantages of the robotic approach: It bypasses the fulcrum effect, which is inherent to conventional laparoscopy and which is especially challenging in patients with a thick abdominal wall. Surgeons using the articulated instrumentation of a robotic system will use the same manual effort regardless of how thick the abdominal wall is.

The lack of tactile feedback is viewed by some as a limitation of robotics, but after a short time of practice, it is easily compensated for by the depth of perception that three-dimensional vision affords.

In addition, the articulation of the instruments facilitates dissection of the tissues and suturing, such as closure of the vaginal cuff in hysterectomies. And as with other gynecologic surgeries, the downscaling of the surgeon's movements in a 3:1 or 5:1 ratio leads to increased accuracy and precision. (In such downscaling, when the surgeon's hand moves 3 cm or 5 cm, the tip of the instrument moves only 1 cm.)

We still believe that when the hysterectomy can be performed vaginally, the vaginal approach is preferable to robotics or to laparoscopy. This is because any study that has compared vaginal hysterectomy with another approach has demonstrated a faster operating time with the vaginal procedure, as well as lower cost.

When a patient is not a candidate for a vaginal hysterectomy, or when the gynecologist is not comfortable with the approach, however, then the robotic approach is indeed preferable to conventional laparoscopy.

Four robotic trocars are placed in preparation for pelvic surgery with the da Vinci robotic system.

The da Vinci robotic system is shown in operation, with the assistant sitting to the left of the patient.

The Zeus robotic system consists of two working arms and another to hold the laparoscope. Photos courtesy Dr. Javier Magrina

Robotics: Enabling Technology for the Gyn.

The first proponents of robotics in surgery were the cardiac surgeons, but it was the urologists who truly popularized robotic surgery. Hospitals around the country have purchased the da Vinci surgical system mainly for urologists who wanted to perform robot-assisted radical prostatectomies. Interestingly enough, the robot has enabled physicians who were virtually untrained in laparoscopic surgery to feel comfortable with a laparoscopic approach.

Even though gynecologists were the first surgical specialists to perform laparoscopic surgery on a routine basis, the acceptance of minimally invasive gynecologic surgery within our specialty remains dismally low. In a recent study submitted to the National Women's Health Resource Center by the Lewin Group, only 15% of more than 600,000 hysterectomies performed per annum in the United States are accomplished via a minimally invasive technique. This is especially sobering when one considers that 80% of the cholecystectomies are performed laparoscopically.

Given the above, it is interesting to speculate on the potential impact of robotic surgery in gynecology. Initially, it appears that gynecologists who were not previously performing advanced minimally invasive surgery are able to do so with this enabling technology.

I have put together a minisymposium on robotic surgery in gynecology that will be covered in the next four issues. With my esteemed faculty, I will discuss the topics of robotic-assisted laparoscopic hysterectomy, robotic-assisted laparoscopic myomectomy, robotic-assisted laparoscopic sacrocolpopexy, and robotic-assisted node dissection.

The first author is Dr. Javier Magrina, head of the division of gynecologic oncology, director of female pelvic medicine and reconstructive surgery, and professor of obstetrics and gynecology at the Mayo Clinic, Scottsdale, Ariz.

Dr. Magrina has written extensively and lectured throughout the world on robotic surgery, from a standpoint of both benign as well as malignant disease. For the past 2 years, he has served on the board of trustees of the AAGL and remains very active in the Society of Gynecologic Oncologists and the Society of Laparoendoscopic Surgeons.

It is a pleasure to have Dr. Magrina as the author of our Master Class in Gynecologic Surgery on robotic-assisted laparoscopic hysterectomy.

Since the first published report of a robotic hysterectomy appeared in 2001, we have gained enough experience to know that next to vaginal hysterectomy, which I believe is still the preferred approach whenever possible, the robotic approach is the next-best technique that gynecologic surgeons can offer patients.

The robotic system we use today—the da Vinci surgical system—was designed to overcome the surgical limitations of conventional laparoscopy. Indeed, it has.

My colleagues and I at the Mayo Clinic, and others elsewhere, have seen similar operating times, reduced blood loss, and shorter hospitalization for both simple and radical hysterectomies as compared with the laparotomy approach. We have experienced firsthand the increased accuracy and precision that robotics promised. Suturing is easier with robotics than with laparoscopy. The advantages of robotics—from instrument articulation to the steady three-dimensional vision—have been more than expected, surpassing the advantages of conventional laparoscopy. Our operating time for robotic radical hysterectomy, in fact, is significantly shorter than that of laparoscopy.

The learning curve for performing robotic hysterectomy, moreover, seems surprisingly short. In a case-series analysis of robotic simple hysterectomies, we found it interesting that the time spent in the operating room flattened after 20-25 cases.

A prospective, randomized study comparing robotic hysterectomy with conventional laparoscopic surgery should be completed at the Mayo Clinic by the end of this year. In the meantime, robotic hysterectomy is generally offered to patients at Mayo as an alternative whenever a laparoscopic hysterectomy is being considered.

Patients are beginning to ask for it, and indeed, there are instances when we strongly prefer the robotic approach regardless of patient demand—for example, when patients have a history of adhesions, advanced endometriosis, gynecologic cancer, or genitourinary fistula, or when we have to perform pelvic floor repair procedures or other additional procedures that require extensive suturing. Obesity is an excellent application for robotic technology, which is something we have learned as our operating time has not been influenced by a patient's body mass index.

Evolution of Robotics

We started performing hysterectomies with the Zeus MicroWrist surgical system in 2003. The system, which was approved by the Food and Drug Administration in 2002 for general and laparoscopic surgery, enabled the surgeon to operate three robotic arms while sitting a distance away from the operating table.

This Zeus system was an advance over the Aesop robotic device, a voice-activated robotic arm designed to operate the laparoscope. Released in 1994, Aesop was the first robotic system approved to assist in laparoscopic procedures. With Aesop, the surgeon would direct the robotic movement of the laparoscope through voice commands while working manually with regular instruments. Video quality thus improved, and the need for an assistant was obviated when only two instruments were needed.

With the development of the Zeus system, surgeons gained two more robotic arms (in addition to the laparoscope-operating arm) as well as some of the other advantages afforded by robotics, such as articulating tips and a downscaling of movement.

The da Vinci surgical system that we use currently is an improvement over Zeus. It was originally approved for procedures in the abdominal and pelvic cavity, but in 2005 it received special approval for the performance of robotic hysterectomy. At this point, because of various changes in the industry's structure, it is the only robotic system manufactured for laparoscopic procedures.

In an evolution that reflects likely future changes as well, a second generation of the da Vinci system, released in 2006, has longer instruments, lighter arms, and increased flexion-extension and lateral excursion, among other improvements.

Instrumentation and Process

We now refer to the approach as “robotic” hysterectomy rather than “robotic-assisted” laparoscopic hysterectomy because—although a surgical assistant is still needed for several key functions, such as suction and irrigation—the procedure is, with these latest advancements, largely robotic in nature.

With most hysterectomies, as with most pelvic operations, four trocar sites are used: three for the robotic arms (one of which is for the laparoscope) and one for the assistant, who will manually perform suction, irrigation, vessel sealing, tissue retraction, and specimen retrieval. When we have a patient with cancer, obesity, a large uterus, advanced endometriosis, or adhesions, we add a fourth robotic arm. This additional arm allows for the added retraction of tissues.

We use the open Hasson technique to place a 12-mm robotic trocar (the first of the three main trocars) in the umbilical area for the laparoscope. Two 8-mm robotic trocars are then placed bilaterally, 10 cm to the right and left of the umbilicus. This placement provides an operative field that extends, in most patients, from the lower pelvis up to the inferior mesenteric artery.

 

 

For the assistant, a 10-mm trocar is placed 3 cm cranial and right between the umbilicus and the left robotic trocar. Through this port, the assistant performs the functions that are not yet available robotically: vessel sealing, suction, irrigation, tissue retraction, specimen retrieval, and the introduction and retrieval of sutures and needles. When a fourth robotic arm is used, that trocar is placed 10 cm lateral and 10 cm caudal to the right robotic trocar.

The robotic tower with three arms is situated between the patient's legs. We have noticed that if the column is parked very close to the patient's perineum, there is inadequate space for the scrub nurse to mobilize and manipulate a vaginal probe, maintain the pneumoperitoneum during vaginal incision, and retrieve specimens vaginally. Ideally, the robotic column should rest at about the level of the patient's feet and not any closer.

The middle robotic arm is attached to the umbilical trocar where the laparoscope has been inserted. A monopolar spatula, or scissors, is inserted through the right lateral trocar, and a plasma-kinetic dissecting forceps is inserted through the left lateral trocar. When needed for suturing, a needle-holder replaces the spatula. When a fourth robotic arm is needed, a robotic instrument called a Prograsp is used.

The surgeon sits, unscrubbed, on a console that in our operating suite is about 12 feet away from the patient. Here the surgeon can manipulate the robotic arms that maneuver the instruments and the laparoscopic camera, as well as communicate verbally with the assistant. When the surgeon is playing the role of assistant and the trainee is at the console, the surgeon can direct the trainee by means of telestration to pinpoint anatomical structures and planes of dissection, or to indicate areas of potential visceral damage by drawing circles, arrows, or dots.

When the ovaries are to be removed, which in our practice is more common than not, our first step with robotic simple hysterectomy is to incise the pelvic peritoneum at the level of the pelvic brim to identify the ureters and the points at which they cross the ovarian vessels. We then coagulate and divide the infundibulopelvic ligament that contains the ovarian vessels.

The ureters are then traced and followed to the point where they cross the uterine arteries. Because we cannot palpate the tissues in robotic surgery and therefore need to see, we dissect the ureters anytime they appear close to the cervix or if there is parametrial pathology. Doing so prevents injury.

After this, the bladder must be dissected from the cervix and upper vagina, and at least 2 cm caudal to the anterior vaginal fornix. A vaginal probe that is inserted into the vagina by the scrub nurse is used to identify where the vagina joins the cervix and to define the level of incision on the vagina.

A vessel-sealing device is used to coagulate and transect the uterine arteries and the cardinal ligaments. At that point—and not any sooner—the vagina is transected immediately distal to the cervix and the uterus is detached and removed, along with the ovaries in most cases, through the vaginal opening. (When the ovaries are not removed, they are left attached to the ipsilateral round ligament.) The scrub nurse holds the labia majora to the midline over the surgical instrument used to remove the uterus, and that is enough to maintain the pneumoperitoneum.

Inflation of a sterile occluding balloon with 60 mL of saline is used to maintain the pneumoperitoneum after removal of the specimen vaginally.

The right monopolar spatula is then removed and replaced with a needle-holder, and the vaginal cuff is closed with a 15-cm precut 0 continuous polyglyconate absorbable suture starting at the right angle and going toward the midline. A similar 15-cm suture is applied from the left to the midline until it meets the other suture. The uterosacral ligaments are incorporated at each vaginal angle and at the midline in order to support the vagina. We use a LapraTy suture clip at each end of the sutures to eliminate the need for intracorporeal knot tying.

Using these small precut sutures is most helpful. A suture that is 30 cm long simply takes too long to pull through the tissues. In general, the use of smaller, shorter sutures is essential in robotic surgery.

For robotic hysterectomies as well as any other robotic gynecologic surgery, I also advise using slow, deliberate, precise movements. Such pacing alleviates the risk of bleeding, which dramatically slows the procedure down when it occurs.

 

 

At the end of the procedure, the robotic arms are disengaged from the trocars, the robotic column is moved away, and the fascia at the umbilical site is closed. The other trocar sites require closure of only the skin. We always perform a cystoscopy after injection of intravenous indigo carmine to ensure that there are bilateral ureteral jets and no injury to the bladder.

When we plan to send the patient home on the day of the robotic hysterectomy—something we started doing when we observed how well patients were faring with this approach—we modify the anesthesia regimen somewhat.

We give each patient dexamethasone preoperatively, apply an antinausea patch behind her ear, and administer two additional medications to prevent nausea: Zofran (ondansetron) and aprepitant. Then, at the end of the hysterectomy, we inject both the right and the left pelvic plexus (sympathetic and parasympathetic) with a cocktail of morphine, vasopressin, and Marcaine (bupivacaine). We also infiltrate the trocar sites with Marcaine, and before the patient is awakened from anesthesia, we administer intravenous ketorolac. When she is awake, the patient will then have minimal discomfort.

Additionally, normal saline (200 mL) is left in the bladder at the end of the cystoscopy so that the patient will have the urge to empty her bladder in the next hour rather than the need to wait up to 5 hours to empty her bladder before being able to go home.

In our preoperative discussions with patients, we do inform them that the incisions are placed a little higher than with conventional laparoscopy. Only once has one of our patients expressed cosmetic concern and opted for a laparoscopic approach with suprapubic trocar placement.

Hysterectomy has been a natural beginning application for robotic technology in gynecologic surgery. Experience with the approach has applications, in turn, for other gynecologic procedures because the same instrumentation and usually the same port placement are used.

Patient Outcomes

In a series of 91 consecutive patients who underwent robotic simple hysterectomy at Mayo (with or without salpingo-oophorectomy or concomitant appendectomy) between March 2004 and December 2005, we had no conversions to conventional laparoscopy or laparotomy, no bladder or ureteral injuries, and few intraoperative and postoperative complications (Am. J. Obstet. Gynecol. 2007;197:113.e1-4).

Our one intraoperative complication was an enterotomy that was repaired robotically in a patient with extensive pelvic adhesions. (We have learned that complications can be repaired robotically without having to convert to laparotomy.)

Postoperatively, one patient with cardiomyopathy required admission to intensive care for 24 hours for exacerbation of heart failure, and another patient required admission for vaginal cuff abscess. Three patients were readmitted for ileus, pneumonia, and colitis. The mean estimated blood loss was 79 mL, and the mean hospital stay was 1.3 days. (Indications in the patients, whose mean age was 50 years, included menometrorrhagia in 43% and ovarian neoplasm in 20%.)

In the evaluation of robotic surgery and analysis of the experience, it is important to break down the total process into several components: docking time (the time required to attach the robotic arms to the trocars), console time (the surgeon's time dedicated exclusively to performing the hysterectomy), and total operating time (from incision to closure).

For surgeons who haven't used the robotic system, a common misperception is that it takes a long time to set up for each procedure. In our series, however, the mean docking time was only 2.9 minutes.

The mean console time was 79 minutes, and the total mean operating time was 122 minutes, which was 14 minutes shorter than conventional laparoscopy. A mean of 43 minutes was required for setup and close, which included trocar placement, exploration, and the removal of trocars, closure, and cystoscopy. (The time for setup and close has not been reported before in laparoscopic surgery.)

Our surgical time was minimized by having a dedicated robotic team and by using certain surgical strategies, such as the use of only three instruments (monopolar spatula, bipolar grasper, and needle-holder) for the entire procedure—a practice that also reduces cost—and the use of precut, short sutures and suture clips. The optimal robotic team can comprise two surgeons or one surgeon and one assistant, as well as at least two nurses who are well versed in the robotic instrumentation and system. The assistant also plays a major role in fixing any malfunctions of the robotic instruments or arms, and in switching robotic instruments.

Console time clearly decreased over time as we performed more simple hysterectomies. It was not significantly affected by the performance of an appendectomy, but it was affected by uterine weight and the lysis of adhesions. In our practice, we prefer a vaginal approach for the larger uterus that requires more morcellation. In general, our threshold for the robotic approach is a uterus of 12-14 weeks' gestational size.

 

 

All of these findings—from reduced operating times to shorter hospitalizations and fewer complications—have applied to our experience with robotic radical hysterectomy as well. In one analysis of 16 patients undergoing robotic radical hysterectomy, we found that total operating time was 66 minutes shorter than it had been for laparoscopic radical hysterectomy.

An increased body mass index did not prolong operating times in any of our patient groups. In fact, we have noticed that for patients who are obese, surgical time is longer with laparoscopy than with robotics. This reflects one of the advantages of the robotic approach: It bypasses the fulcrum effect, which is inherent to conventional laparoscopy and which is especially challenging in patients with a thick abdominal wall. Surgeons using the articulated instrumentation of a robotic system will use the same manual effort regardless of how thick the abdominal wall is.

The lack of tactile feedback is viewed by some as a limitation of robotics, but after a short time of practice, it is easily compensated for by the depth of perception that three-dimensional vision affords.

In addition, the articulation of the instruments facilitates dissection of the tissues and suturing, such as closure of the vaginal cuff in hysterectomies. And as with other gynecologic surgeries, the downscaling of the surgeon's movements in a 3:1 or 5:1 ratio leads to increased accuracy and precision. (In such downscaling, when the surgeon's hand moves 3 cm or 5 cm, the tip of the instrument moves only 1 cm.)

We still believe that when the hysterectomy can be performed vaginally, the vaginal approach is preferable to robotics or to laparoscopy. This is because any study that has compared vaginal hysterectomy with another approach has demonstrated a faster operating time with the vaginal procedure, as well as lower cost.

When a patient is not a candidate for a vaginal hysterectomy, or when the gynecologist is not comfortable with the approach, however, then the robotic approach is indeed preferable to conventional laparoscopy.

Four robotic trocars are placed in preparation for pelvic surgery with the da Vinci robotic system.

The da Vinci robotic system is shown in operation, with the assistant sitting to the left of the patient.

The Zeus robotic system consists of two working arms and another to hold the laparoscope. Photos courtesy Dr. Javier Magrina

Robotics: Enabling Technology for the Gyn.

The first proponents of robotics in surgery were the cardiac surgeons, but it was the urologists who truly popularized robotic surgery. Hospitals around the country have purchased the da Vinci surgical system mainly for urologists who wanted to perform robot-assisted radical prostatectomies. Interestingly enough, the robot has enabled physicians who were virtually untrained in laparoscopic surgery to feel comfortable with a laparoscopic approach.

Even though gynecologists were the first surgical specialists to perform laparoscopic surgery on a routine basis, the acceptance of minimally invasive gynecologic surgery within our specialty remains dismally low. In a recent study submitted to the National Women's Health Resource Center by the Lewin Group, only 15% of more than 600,000 hysterectomies performed per annum in the United States are accomplished via a minimally invasive technique. This is especially sobering when one considers that 80% of the cholecystectomies are performed laparoscopically.

Given the above, it is interesting to speculate on the potential impact of robotic surgery in gynecology. Initially, it appears that gynecologists who were not previously performing advanced minimally invasive surgery are able to do so with this enabling technology.

I have put together a minisymposium on robotic surgery in gynecology that will be covered in the next four issues. With my esteemed faculty, I will discuss the topics of robotic-assisted laparoscopic hysterectomy, robotic-assisted laparoscopic myomectomy, robotic-assisted laparoscopic sacrocolpopexy, and robotic-assisted node dissection.

The first author is Dr. Javier Magrina, head of the division of gynecologic oncology, director of female pelvic medicine and reconstructive surgery, and professor of obstetrics and gynecology at the Mayo Clinic, Scottsdale, Ariz.

Dr. Magrina has written extensively and lectured throughout the world on robotic surgery, from a standpoint of both benign as well as malignant disease. For the past 2 years, he has served on the board of trustees of the AAGL and remains very active in the Society of Gynecologic Oncologists and the Society of Laparoendoscopic Surgeons.

It is a pleasure to have Dr. Magrina as the author of our Master Class in Gynecologic Surgery on robotic-assisted laparoscopic hysterectomy.

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Hysteroscopy and Ablation: Instrumentation, Setup, and Process

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Hysteroscopy and Ablation: Instrumentation, Setup, and Process

As Dr. James Presthus discussed, in-office hysteroscopy not only makes good economic sense, it is good patient care. The office hysteroscope is critical for thoroughly evaluating abnormal uterine bleeding (the most common indication) and for more accurately diagnosing its common causes while maintaining the valuable ability to “see and treat.” For the diagnosis of abnormal uterine bleeding, hysteroscopy is simply an essential, integral part of good patient care. Once you add the office hysteroscope to your diagnostic armamentarium, you will find it difficult to imagine practicing ambulatory gynecology without it.

Office hysteroscopy plays a much larger role beyond diagnosis, however, because it enables us to remove polyps and adhesions, to do biopsies, and to perform minor therapeutic and operative procedures—such as hysteroscopic sterilization using the Essure system and global endometrial ablation—in a setting where our patients are comfortable and relaxed.

Control of pain (or the perception that patients will not tolerate the procedure) seems to be the greatest concern of physicians who are considering adding in-office hysteroscopy to their practice. It need not be. Patients tolerate in-office hysteroscopy extremely well.

A small hysteroscope is no larger than a Pipelle endometrial suction curette. Showing the patient a picture of both instruments, side by side, is truly worth a thousand words. Add to that the reduction in anxiety thanks to familiar surroundings, the conversations with office staff who often know the patient on a first-name basis, and a visualization of the procedure, and the discomfort that would be experienced in an operating room quickly dissipates.

Diagnostic hysteroscopy with a 3-mm flexible hysteroscope, in fact, does not require any anesthesia. Nevertheless, because studies indicate that a minority of patients find distention of the uterus uncomfortable and because we take a “see and treat” approach to in-office hysteroscopy, we use a small paracervical block. This way, virtually 100% of our patients are completely comfortable, and we are ready to move on to treatment if needed.

This is exactly what we tell our patients: that the small injection of local anesthetic will help them to tolerate the procedure, especially if we find a polyp or other abnormal tissue and want to remove it on the spot rather than subject them to a second procedure at a later date.

Both the Essure procedure and global endometrial ablation—we use a thermal ablation device called the Hydro ThermAblator (HTA) system—can be performed under local anesthesia with oral premedication at home.

When you embark on in-office operative hysteroscopy, it is vital to be aware of state regulations regarding in-office surgery. Almost 20 states now have rules that differentiate procedures into level I surgery and level II surgery, depending largely on the types of anesthesia used.

The South Carolina Board of Medical Examiners, for instance, defines level I surgery as including minor procedures in which “[oral] preoperative medication and/or unsupplemented local anesthesia” is used in quantities no greater than the manufacturer's recommended dose, with “no drug-induced alteration of consciousness other than preoperative minimal [oral] anxiolysis of the patient.”

Level II office surgery includes procedures that “require the administration of minimal or moderate intravenous, intramuscular, or rectal sedation/analgesia, thus making postoperative monitoring necessary.” Offices performing level II surgery must receive certification and follow various regulations and standards aimed at ensuring patient safety. A significant amount of office-based surgery done today involves the use of parenteral narcotics and thus is considered level II surgery. The protocols we use for in-office hysteroscopy and hysteroscopic procedures, however, are all level I.

For ablation, the HTA system is ideally suited for office use under minimal or level I sedation because it operates at low pressure (50 mm Hg) and is a “no touch” technique. Many of the other nonhysteroscopic global ablation technologies have also been used in the office setting, but—in order to ensure patient comfort—they may require parenteral narcotics, which are considered moderate or level II sedation.

Instrumentation and Setup

For diagnostic hysteroscopy, I favor a 3-mm flexible hysteroscope. I also prefer using normal warmed saline as a distension medium, and I have found that hanging the saline in a 1,000-cc bag on a tall IV pole, with standard IV tubing and with a pressure cuff to maintain distention, is an ideal setup. We use the C-Fusor pressure infusor bag.

Injecting the saline with a 60-cc syringe is another option and is certainly adequate for a quick diagnostic procedure. The disadvantage to this approach, however, is the likelihood of needing to continually change syringes if polyp removal or another treatment is needed, or if the patient has a patulous cervix and transcervical fluid loss occurs.

 

 

Some physicians prefer not to purchase a flexible scope and instead choose a continuous-flow diagnostic/operative hysteroscope. For the physician who is just starting out and wants one piece of equipment with the most versatility, I would recommend a 5.5-mm continuous flow hysteroscope with a 5-Fr operating channel. The Bettocchi 4.5-mm continuous flow hysteroscope is another alternative.

In either case, the use of these rigid scopes demands the use of a tenaculum as well. Because application of a tenaculum is often uncomfortable for the patient, local anesthetic should be used at the tenaculum site, as well as a small paracervical block in case the cervix needs to be dilated.

When a rigid hysteroscope is used diagnostically, an open-sided speculum should be used, because a closed speculum will restrict the free movement of the scope. After the hysteroscope is inserted through the cervix, the open-sided speculum is removed to allow for free lateral movement of the scope. Such a choice is irrelevant when a flexible hysteroscope is used because the end of the scope moves freely and flexes up to 110 degrees, allowing for adequate visualization of the cornua and the tubal ostia.

[Note: Vaginoscopy, a new technique, popularized in Italy, entails the insertion of a small-diameter rigid or flexible scope directly into the vagina without the use of a speculum, and then right into the cervix and uterus without the use of a tenaculum. The procedure appears to be well tolerated by patients, but it may not work well in patients with a narrow cervical os.]

Insertion of the hysteroscope through the cervix should always be done under direct visualization with fluid running and a camera always at the 12:00 position. It rarely is necessary to dilate the cervix when using a 3-mm flexible hysteroscope, even in nulliparous or postmenopausal women. Once the scope passes the external os, fluid pressure will sufficiently dilate the cervical canal. Dilatation is more often necessary when a 5.5-mm operative hysteroscope is used, though rarely for multiparous women.

When a polyp is visualized during a diagnostic hysteroscopy performed with a 3-mm flexible hysteroscope, the cervix can then be dilated to 5 mm or 6 mm if necessary, and the polyp can be removed using a Randall stone forceps inserted to the area where the polyp was visualized. Alternatively, a 2- to 3-mm-long laryngeal polyp forceps can be placed into the uterus alongside the flexible hysteroscope and used to remove the polyp under direct visualization.

Other forceps that are useful for polyp removal are the Kelly, Sopher, and Javerts polyp forceps. These instruments are 7 mm in diameter and are easily inserted if the cervix is dilated using standard Hegar or Pratt dilators to 6–7 mm. This can be done without any patient discomfort if a paracervical block has been administered initially.

The use of a continuous flow operative scope with a 5-Fr to 7-Fr operative channel instead of the diagnostic scope is another option for polyp removal, foreign body removal, or directed biopsy. It is most important not to attempt to pull a biopsy out through the operative channel, but rather to move the entire scope from the cervix with the specimen in view.

Our basic instrument tray for diagnostic and operative hysteroscopy, therefore, consists of an open-sided speculum; a series of Hagar dilators; a single-tooth tenaculum; a stainless steel or glass medicine cup; polyp forceps and Randall stone forceps; 9-inch ring forceps; two surgical towels; a 10-cc control syringe; a 22-gauge spinal needle; and 10 4-by-4-inch sponges. (We buy nonsterile sponges in packages of 500 and put 10 on each instrument tray, and then we steam-autoclave each kit.)

We always have a second sterile tenaculum in case the patient has a patulous cervix. A Gimpleson four-prong tenaculum is also valuable for the control of transcervical leakage.

Other basic equipment includes a camera system, a monitor (the new flat-panel monitors available from scope manufacturers are lightweight and compact), a light source (preferably xenon), and if possible, a video printer. We do not sterilize our cameras because the cameras will last longer if they are not subject to soaking or steam autoclaving. Instead, we simply fold an 11-by-17-inch Steri-Drape with an adhesive edge over the nonsterile camera.

For the Essure procedure, we use a sterile under-buttock drape with a fluid collection pouch to keep track of inflow and outflow.

Every procedure room should also have basic safety equipment: an oxygen supply with a mask or nasal cannula; a positive pressure manual resuscitator (Ambu bag); and monitoring equipment for pulse and blood pressure. We use a Dinamap automatic blood pressure and pulse monitor, which frees the nurse to concentrate on talking with the patient.

 

 

An automatic electronic defibrillator is optional, but it certainly is a good piece of relatively inexpensive equipment for any medical office to have, and I encourage its inclusion in any in-office hysteroscopy setup. A pulse oximeter is mandatory only for level II procedures. With office hysteroscopy, you likely will never use one (we have not), but it is nice to know it's there to use if a patient has a change in consciousness.

When level II procedures are being performed using parenteral narcotics and/or sedatives, a fully stocked crash cart is required, and an ACLS (advanced cardiac life support)-certified staff member who is not performing the procedure must be present to monitor the patient.

Anesthesia and Patient Comfort

At the Kaiser Permanente San Rafael (Calif.) Medical Center, we have performed more than 12,000 gynecologic office procedures—from diagnostic hysteroscopies to hysteroscopic sterilizations and endometrial ablations—under local anesthesia with minimal oral sedation, over a 25-year period.

For diagnostic and minor operative hysteroscopy, we generally instruct patients to take 400–800 mg ibuprofen at home 1 hour before the procedure. We administer a paracervical block consisting of 5–10 mL of 1% lidocaine to the cervical vaginal junction superficially through the mucosa at 3:00 and 9:00.

Whenever a tenaculum is used, we also inject the anterior lip of the cervix with approximately 1–2 mL of local anesthetic before the tenaculum is applied, and then leave the room for 5–10 minutes to allow the block to set properly.

Remember, as with any office gynecologic procedure, it is important to use a “no-touch” technique, as the uterine wall is innervated by both sympathetic and parasympathetic fibers. It is unnecessary to sound the uterus; the old but still common practice of sounding is uncomfortable for the patient and may provoke uterine contractions that make distention of the uterus difficult. It may also cause perforation and is simply unnecessary.

Our oral premedication regimen for HTA and Essure procedures consists of 800 mg ibuprofen (Motrin), 10 mg diazepam (Valium), and two hydrocodone/acetaminophen (Vicodin) tablets taken at home 1–2 hours before the procedure. Patients are instructed to arrive 30 minutes prior to their scheduled appointment, at which time they are given an intramuscular injection of 30 mg ketorolac (Toradol) and 0.4 mg atropine.

Toradol is a prostaglandin synthetase inhibitor and has a peripheral effect as well. Atropine is used to prevent vasovagal reactions. The patient should be warned that she may experience dry mouth, but that this is preferable to the extreme discomfort felt during a vasovagal episode.

We then administer a paracervical/intracervical block with 1% mepivacaine (Carbocaine, Polocaine), which is longer acting than lidocaine. We inject 2 mL in the anterior lip of the cervix before it is grasped with a tenaculum; we place the needle against the cervix and ask the patient to cough, which results in self-injection. We then inject 10 mL in the cervicovaginal junction on each side at 3:00 and 9:00. These injections are given superficially, just under the mucosa, to raise a weal.

We inject an additional 5 mL intracervically about 1–2 cm deep at 8:00 and 4:00, and 5 mL submucosally at 6:00 between the uterosacrals. The total amount of mepivacaine given is 37 mL, or 370 mg (the recommended maximum dose is 400 mg).

Again, it is important to leave the room for 10–15 minutes to allow the block to set properly. We recommend that the physician leave while the nurse stays to monitor the patient and help her relax.

The Essure procedure can be done with less oral anesthesia and a smaller paracervical or intracervical block than endometrial ablation requires, but because our patients tolerate our ablation anesthesia regimen so well, we use it for both procedures.

In a study of 249 endometrial ablations performed at Kaiser Permanente San Rafael over 5.5 years using the HTA system, only one procedure was discontinued because of pain, and two patients were admitted overnight for cramping and nausea. The overall success rate was 90.6%, despite 40% of our patients having submucous myomas. The only complications were four cases of postoperative endometritis, with two of those patients requiring hospitalization for intravenous antibiotics, and two cases of procedure failure due to false passages.

We have not had any adverse anesthetic reactions in our patients who have undergone HTA over the years, or in any of the thousands of other women who were given similar paracervical blocks for office gynecologic procedures.

Postprocedure recovery is rarely necessary for these level I procedures. Our nurses monitor patients' blood pressure for 10–15 minutes after the procedures are completed and ensure that patients are feeling well and are ambulatory. This monitoring is done in the procedure room. Patients who don't feel well enough to leave in that time period are brought into another exam room and are discharged when they are ready. This is very rare.

 

 

Our patients also receive written postoperative instructions that tell them to report any increase in abdominal pain, any fever, any foul-smelling discharge, and—after endometrial ablation—the absence of any discharge.

Most of the time, patients will just wave good-bye, pleased to have had their procedure done in the office.

For level II procedures, the postrecovery protocol is much more complex.

The South Carolina rule, for instance, states that monitoring in the recovery area must include both pulse oximetry and noninvasive blood pressure measurement, and that the patient must be assessed for level of consciousness, pain relief, or any untoward complication.

Most states require that the patient be monitored for at least 30 minutes and, depending on which drugs were administered, for as long as 2 hours.

Again, it is important for physicians who plan to use anything but minimal sedation in the office to know their state requirements, if any. These can usually be obtained online from the state department of health services.

A photo of a 3-mm flexible hysteroscope with other commonly used office instruments reassures patients. Courtesy Dr. Mark Glasser

A 42-year-old patient with a 4-cm type 0 myoma was treated in the office with the HTA system (preoperative view at left). The patient has been amenorrheic for more than 6 years (postprocedure view at right). Photos courtesy Dr. Mark Glasser

The Medex C-Fusor is placed around a bag of normal saline, which is used to maintain distention pressure. Courtesy Dr. Mark Glasser

This image shows paracervical block injection sites (dots) and doses of 1% mepivicaine (arrows) injected at each site. Courtesy Dr. Mark Glasser

In-Office Gynecologic Surgery, Part 2

In the last Master Class in Gynecologic Surgery, Dr. James Presthus provided the reader with an overview on in-office gynecologic surgery. Hysteroscopy, the standard of care in the diagnosis and treatment of abnormal uterine bleeding, is a procedure that lends itself especially readily to an office environment.

Dr. Presthus pointed out that the physician “can provide more thorough and efficient care in a more comfortable, familiar, and cost-effective setting.” He emphasized that despite the use of less anesthesia, patients routinely tolerate the procedure well.

Dr. Presthus gave us the “why” behind his recommendation that the gynecologist commit to office-based surgery.

Now, Dr. Mark Glasser provides us with the “how and what” considerations of in-office gynecologic surgery, focusing on hysteroscopy, global endometrial ablation, and the Essure tubal occlusion procedure.

Not only does Dr. Glasser make recommendations on instrumentation, he also discusses the surgical technique of hysteroscopy and the anesthesia concerns that can arise. This article is an excellent primer for those considering in-office hysteroscopy.

From 1992 until 2006, Dr. Glasser was the director of advanced gynecologic laparoscopy training for the Kaiser Northern California Region. He is a past member of the board of trustees of the AAGL and continues to serve on the national advisory committee of the AAGL and the editorial board of the Journal of Minimally Invasive Gynecology.

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As Dr. James Presthus discussed, in-office hysteroscopy not only makes good economic sense, it is good patient care. The office hysteroscope is critical for thoroughly evaluating abnormal uterine bleeding (the most common indication) and for more accurately diagnosing its common causes while maintaining the valuable ability to “see and treat.” For the diagnosis of abnormal uterine bleeding, hysteroscopy is simply an essential, integral part of good patient care. Once you add the office hysteroscope to your diagnostic armamentarium, you will find it difficult to imagine practicing ambulatory gynecology without it.

Office hysteroscopy plays a much larger role beyond diagnosis, however, because it enables us to remove polyps and adhesions, to do biopsies, and to perform minor therapeutic and operative procedures—such as hysteroscopic sterilization using the Essure system and global endometrial ablation—in a setting where our patients are comfortable and relaxed.

Control of pain (or the perception that patients will not tolerate the procedure) seems to be the greatest concern of physicians who are considering adding in-office hysteroscopy to their practice. It need not be. Patients tolerate in-office hysteroscopy extremely well.

A small hysteroscope is no larger than a Pipelle endometrial suction curette. Showing the patient a picture of both instruments, side by side, is truly worth a thousand words. Add to that the reduction in anxiety thanks to familiar surroundings, the conversations with office staff who often know the patient on a first-name basis, and a visualization of the procedure, and the discomfort that would be experienced in an operating room quickly dissipates.

Diagnostic hysteroscopy with a 3-mm flexible hysteroscope, in fact, does not require any anesthesia. Nevertheless, because studies indicate that a minority of patients find distention of the uterus uncomfortable and because we take a “see and treat” approach to in-office hysteroscopy, we use a small paracervical block. This way, virtually 100% of our patients are completely comfortable, and we are ready to move on to treatment if needed.

This is exactly what we tell our patients: that the small injection of local anesthetic will help them to tolerate the procedure, especially if we find a polyp or other abnormal tissue and want to remove it on the spot rather than subject them to a second procedure at a later date.

Both the Essure procedure and global endometrial ablation—we use a thermal ablation device called the Hydro ThermAblator (HTA) system—can be performed under local anesthesia with oral premedication at home.

When you embark on in-office operative hysteroscopy, it is vital to be aware of state regulations regarding in-office surgery. Almost 20 states now have rules that differentiate procedures into level I surgery and level II surgery, depending largely on the types of anesthesia used.

The South Carolina Board of Medical Examiners, for instance, defines level I surgery as including minor procedures in which “[oral] preoperative medication and/or unsupplemented local anesthesia” is used in quantities no greater than the manufacturer's recommended dose, with “no drug-induced alteration of consciousness other than preoperative minimal [oral] anxiolysis of the patient.”

Level II office surgery includes procedures that “require the administration of minimal or moderate intravenous, intramuscular, or rectal sedation/analgesia, thus making postoperative monitoring necessary.” Offices performing level II surgery must receive certification and follow various regulations and standards aimed at ensuring patient safety. A significant amount of office-based surgery done today involves the use of parenteral narcotics and thus is considered level II surgery. The protocols we use for in-office hysteroscopy and hysteroscopic procedures, however, are all level I.

For ablation, the HTA system is ideally suited for office use under minimal or level I sedation because it operates at low pressure (50 mm Hg) and is a “no touch” technique. Many of the other nonhysteroscopic global ablation technologies have also been used in the office setting, but—in order to ensure patient comfort—they may require parenteral narcotics, which are considered moderate or level II sedation.

Instrumentation and Setup

For diagnostic hysteroscopy, I favor a 3-mm flexible hysteroscope. I also prefer using normal warmed saline as a distension medium, and I have found that hanging the saline in a 1,000-cc bag on a tall IV pole, with standard IV tubing and with a pressure cuff to maintain distention, is an ideal setup. We use the C-Fusor pressure infusor bag.

Injecting the saline with a 60-cc syringe is another option and is certainly adequate for a quick diagnostic procedure. The disadvantage to this approach, however, is the likelihood of needing to continually change syringes if polyp removal or another treatment is needed, or if the patient has a patulous cervix and transcervical fluid loss occurs.

 

 

Some physicians prefer not to purchase a flexible scope and instead choose a continuous-flow diagnostic/operative hysteroscope. For the physician who is just starting out and wants one piece of equipment with the most versatility, I would recommend a 5.5-mm continuous flow hysteroscope with a 5-Fr operating channel. The Bettocchi 4.5-mm continuous flow hysteroscope is another alternative.

In either case, the use of these rigid scopes demands the use of a tenaculum as well. Because application of a tenaculum is often uncomfortable for the patient, local anesthetic should be used at the tenaculum site, as well as a small paracervical block in case the cervix needs to be dilated.

When a rigid hysteroscope is used diagnostically, an open-sided speculum should be used, because a closed speculum will restrict the free movement of the scope. After the hysteroscope is inserted through the cervix, the open-sided speculum is removed to allow for free lateral movement of the scope. Such a choice is irrelevant when a flexible hysteroscope is used because the end of the scope moves freely and flexes up to 110 degrees, allowing for adequate visualization of the cornua and the tubal ostia.

[Note: Vaginoscopy, a new technique, popularized in Italy, entails the insertion of a small-diameter rigid or flexible scope directly into the vagina without the use of a speculum, and then right into the cervix and uterus without the use of a tenaculum. The procedure appears to be well tolerated by patients, but it may not work well in patients with a narrow cervical os.]

Insertion of the hysteroscope through the cervix should always be done under direct visualization with fluid running and a camera always at the 12:00 position. It rarely is necessary to dilate the cervix when using a 3-mm flexible hysteroscope, even in nulliparous or postmenopausal women. Once the scope passes the external os, fluid pressure will sufficiently dilate the cervical canal. Dilatation is more often necessary when a 5.5-mm operative hysteroscope is used, though rarely for multiparous women.

When a polyp is visualized during a diagnostic hysteroscopy performed with a 3-mm flexible hysteroscope, the cervix can then be dilated to 5 mm or 6 mm if necessary, and the polyp can be removed using a Randall stone forceps inserted to the area where the polyp was visualized. Alternatively, a 2- to 3-mm-long laryngeal polyp forceps can be placed into the uterus alongside the flexible hysteroscope and used to remove the polyp under direct visualization.

Other forceps that are useful for polyp removal are the Kelly, Sopher, and Javerts polyp forceps. These instruments are 7 mm in diameter and are easily inserted if the cervix is dilated using standard Hegar or Pratt dilators to 6–7 mm. This can be done without any patient discomfort if a paracervical block has been administered initially.

The use of a continuous flow operative scope with a 5-Fr to 7-Fr operative channel instead of the diagnostic scope is another option for polyp removal, foreign body removal, or directed biopsy. It is most important not to attempt to pull a biopsy out through the operative channel, but rather to move the entire scope from the cervix with the specimen in view.

Our basic instrument tray for diagnostic and operative hysteroscopy, therefore, consists of an open-sided speculum; a series of Hagar dilators; a single-tooth tenaculum; a stainless steel or glass medicine cup; polyp forceps and Randall stone forceps; 9-inch ring forceps; two surgical towels; a 10-cc control syringe; a 22-gauge spinal needle; and 10 4-by-4-inch sponges. (We buy nonsterile sponges in packages of 500 and put 10 on each instrument tray, and then we steam-autoclave each kit.)

We always have a second sterile tenaculum in case the patient has a patulous cervix. A Gimpleson four-prong tenaculum is also valuable for the control of transcervical leakage.

Other basic equipment includes a camera system, a monitor (the new flat-panel monitors available from scope manufacturers are lightweight and compact), a light source (preferably xenon), and if possible, a video printer. We do not sterilize our cameras because the cameras will last longer if they are not subject to soaking or steam autoclaving. Instead, we simply fold an 11-by-17-inch Steri-Drape with an adhesive edge over the nonsterile camera.

For the Essure procedure, we use a sterile under-buttock drape with a fluid collection pouch to keep track of inflow and outflow.

Every procedure room should also have basic safety equipment: an oxygen supply with a mask or nasal cannula; a positive pressure manual resuscitator (Ambu bag); and monitoring equipment for pulse and blood pressure. We use a Dinamap automatic blood pressure and pulse monitor, which frees the nurse to concentrate on talking with the patient.

 

 

An automatic electronic defibrillator is optional, but it certainly is a good piece of relatively inexpensive equipment for any medical office to have, and I encourage its inclusion in any in-office hysteroscopy setup. A pulse oximeter is mandatory only for level II procedures. With office hysteroscopy, you likely will never use one (we have not), but it is nice to know it's there to use if a patient has a change in consciousness.

When level II procedures are being performed using parenteral narcotics and/or sedatives, a fully stocked crash cart is required, and an ACLS (advanced cardiac life support)-certified staff member who is not performing the procedure must be present to monitor the patient.

Anesthesia and Patient Comfort

At the Kaiser Permanente San Rafael (Calif.) Medical Center, we have performed more than 12,000 gynecologic office procedures—from diagnostic hysteroscopies to hysteroscopic sterilizations and endometrial ablations—under local anesthesia with minimal oral sedation, over a 25-year period.

For diagnostic and minor operative hysteroscopy, we generally instruct patients to take 400–800 mg ibuprofen at home 1 hour before the procedure. We administer a paracervical block consisting of 5–10 mL of 1% lidocaine to the cervical vaginal junction superficially through the mucosa at 3:00 and 9:00.

Whenever a tenaculum is used, we also inject the anterior lip of the cervix with approximately 1–2 mL of local anesthetic before the tenaculum is applied, and then leave the room for 5–10 minutes to allow the block to set properly.

Remember, as with any office gynecologic procedure, it is important to use a “no-touch” technique, as the uterine wall is innervated by both sympathetic and parasympathetic fibers. It is unnecessary to sound the uterus; the old but still common practice of sounding is uncomfortable for the patient and may provoke uterine contractions that make distention of the uterus difficult. It may also cause perforation and is simply unnecessary.

Our oral premedication regimen for HTA and Essure procedures consists of 800 mg ibuprofen (Motrin), 10 mg diazepam (Valium), and two hydrocodone/acetaminophen (Vicodin) tablets taken at home 1–2 hours before the procedure. Patients are instructed to arrive 30 minutes prior to their scheduled appointment, at which time they are given an intramuscular injection of 30 mg ketorolac (Toradol) and 0.4 mg atropine.

Toradol is a prostaglandin synthetase inhibitor and has a peripheral effect as well. Atropine is used to prevent vasovagal reactions. The patient should be warned that she may experience dry mouth, but that this is preferable to the extreme discomfort felt during a vasovagal episode.

We then administer a paracervical/intracervical block with 1% mepivacaine (Carbocaine, Polocaine), which is longer acting than lidocaine. We inject 2 mL in the anterior lip of the cervix before it is grasped with a tenaculum; we place the needle against the cervix and ask the patient to cough, which results in self-injection. We then inject 10 mL in the cervicovaginal junction on each side at 3:00 and 9:00. These injections are given superficially, just under the mucosa, to raise a weal.

We inject an additional 5 mL intracervically about 1–2 cm deep at 8:00 and 4:00, and 5 mL submucosally at 6:00 between the uterosacrals. The total amount of mepivacaine given is 37 mL, or 370 mg (the recommended maximum dose is 400 mg).

Again, it is important to leave the room for 10–15 minutes to allow the block to set properly. We recommend that the physician leave while the nurse stays to monitor the patient and help her relax.

The Essure procedure can be done with less oral anesthesia and a smaller paracervical or intracervical block than endometrial ablation requires, but because our patients tolerate our ablation anesthesia regimen so well, we use it for both procedures.

In a study of 249 endometrial ablations performed at Kaiser Permanente San Rafael over 5.5 years using the HTA system, only one procedure was discontinued because of pain, and two patients were admitted overnight for cramping and nausea. The overall success rate was 90.6%, despite 40% of our patients having submucous myomas. The only complications were four cases of postoperative endometritis, with two of those patients requiring hospitalization for intravenous antibiotics, and two cases of procedure failure due to false passages.

We have not had any adverse anesthetic reactions in our patients who have undergone HTA over the years, or in any of the thousands of other women who were given similar paracervical blocks for office gynecologic procedures.

Postprocedure recovery is rarely necessary for these level I procedures. Our nurses monitor patients' blood pressure for 10–15 minutes after the procedures are completed and ensure that patients are feeling well and are ambulatory. This monitoring is done in the procedure room. Patients who don't feel well enough to leave in that time period are brought into another exam room and are discharged when they are ready. This is very rare.

 

 

Our patients also receive written postoperative instructions that tell them to report any increase in abdominal pain, any fever, any foul-smelling discharge, and—after endometrial ablation—the absence of any discharge.

Most of the time, patients will just wave good-bye, pleased to have had their procedure done in the office.

For level II procedures, the postrecovery protocol is much more complex.

The South Carolina rule, for instance, states that monitoring in the recovery area must include both pulse oximetry and noninvasive blood pressure measurement, and that the patient must be assessed for level of consciousness, pain relief, or any untoward complication.

Most states require that the patient be monitored for at least 30 minutes and, depending on which drugs were administered, for as long as 2 hours.

Again, it is important for physicians who plan to use anything but minimal sedation in the office to know their state requirements, if any. These can usually be obtained online from the state department of health services.

A photo of a 3-mm flexible hysteroscope with other commonly used office instruments reassures patients. Courtesy Dr. Mark Glasser

A 42-year-old patient with a 4-cm type 0 myoma was treated in the office with the HTA system (preoperative view at left). The patient has been amenorrheic for more than 6 years (postprocedure view at right). Photos courtesy Dr. Mark Glasser

The Medex C-Fusor is placed around a bag of normal saline, which is used to maintain distention pressure. Courtesy Dr. Mark Glasser

This image shows paracervical block injection sites (dots) and doses of 1% mepivicaine (arrows) injected at each site. Courtesy Dr. Mark Glasser

In-Office Gynecologic Surgery, Part 2

In the last Master Class in Gynecologic Surgery, Dr. James Presthus provided the reader with an overview on in-office gynecologic surgery. Hysteroscopy, the standard of care in the diagnosis and treatment of abnormal uterine bleeding, is a procedure that lends itself especially readily to an office environment.

Dr. Presthus pointed out that the physician “can provide more thorough and efficient care in a more comfortable, familiar, and cost-effective setting.” He emphasized that despite the use of less anesthesia, patients routinely tolerate the procedure well.

Dr. Presthus gave us the “why” behind his recommendation that the gynecologist commit to office-based surgery.

Now, Dr. Mark Glasser provides us with the “how and what” considerations of in-office gynecologic surgery, focusing on hysteroscopy, global endometrial ablation, and the Essure tubal occlusion procedure.

Not only does Dr. Glasser make recommendations on instrumentation, he also discusses the surgical technique of hysteroscopy and the anesthesia concerns that can arise. This article is an excellent primer for those considering in-office hysteroscopy.

From 1992 until 2006, Dr. Glasser was the director of advanced gynecologic laparoscopy training for the Kaiser Northern California Region. He is a past member of the board of trustees of the AAGL and continues to serve on the national advisory committee of the AAGL and the editorial board of the Journal of Minimally Invasive Gynecology.

As Dr. James Presthus discussed, in-office hysteroscopy not only makes good economic sense, it is good patient care. The office hysteroscope is critical for thoroughly evaluating abnormal uterine bleeding (the most common indication) and for more accurately diagnosing its common causes while maintaining the valuable ability to “see and treat.” For the diagnosis of abnormal uterine bleeding, hysteroscopy is simply an essential, integral part of good patient care. Once you add the office hysteroscope to your diagnostic armamentarium, you will find it difficult to imagine practicing ambulatory gynecology without it.

Office hysteroscopy plays a much larger role beyond diagnosis, however, because it enables us to remove polyps and adhesions, to do biopsies, and to perform minor therapeutic and operative procedures—such as hysteroscopic sterilization using the Essure system and global endometrial ablation—in a setting where our patients are comfortable and relaxed.

Control of pain (or the perception that patients will not tolerate the procedure) seems to be the greatest concern of physicians who are considering adding in-office hysteroscopy to their practice. It need not be. Patients tolerate in-office hysteroscopy extremely well.

A small hysteroscope is no larger than a Pipelle endometrial suction curette. Showing the patient a picture of both instruments, side by side, is truly worth a thousand words. Add to that the reduction in anxiety thanks to familiar surroundings, the conversations with office staff who often know the patient on a first-name basis, and a visualization of the procedure, and the discomfort that would be experienced in an operating room quickly dissipates.

Diagnostic hysteroscopy with a 3-mm flexible hysteroscope, in fact, does not require any anesthesia. Nevertheless, because studies indicate that a minority of patients find distention of the uterus uncomfortable and because we take a “see and treat” approach to in-office hysteroscopy, we use a small paracervical block. This way, virtually 100% of our patients are completely comfortable, and we are ready to move on to treatment if needed.

This is exactly what we tell our patients: that the small injection of local anesthetic will help them to tolerate the procedure, especially if we find a polyp or other abnormal tissue and want to remove it on the spot rather than subject them to a second procedure at a later date.

Both the Essure procedure and global endometrial ablation—we use a thermal ablation device called the Hydro ThermAblator (HTA) system—can be performed under local anesthesia with oral premedication at home.

When you embark on in-office operative hysteroscopy, it is vital to be aware of state regulations regarding in-office surgery. Almost 20 states now have rules that differentiate procedures into level I surgery and level II surgery, depending largely on the types of anesthesia used.

The South Carolina Board of Medical Examiners, for instance, defines level I surgery as including minor procedures in which “[oral] preoperative medication and/or unsupplemented local anesthesia” is used in quantities no greater than the manufacturer's recommended dose, with “no drug-induced alteration of consciousness other than preoperative minimal [oral] anxiolysis of the patient.”

Level II office surgery includes procedures that “require the administration of minimal or moderate intravenous, intramuscular, or rectal sedation/analgesia, thus making postoperative monitoring necessary.” Offices performing level II surgery must receive certification and follow various regulations and standards aimed at ensuring patient safety. A significant amount of office-based surgery done today involves the use of parenteral narcotics and thus is considered level II surgery. The protocols we use for in-office hysteroscopy and hysteroscopic procedures, however, are all level I.

For ablation, the HTA system is ideally suited for office use under minimal or level I sedation because it operates at low pressure (50 mm Hg) and is a “no touch” technique. Many of the other nonhysteroscopic global ablation technologies have also been used in the office setting, but—in order to ensure patient comfort—they may require parenteral narcotics, which are considered moderate or level II sedation.

Instrumentation and Setup

For diagnostic hysteroscopy, I favor a 3-mm flexible hysteroscope. I also prefer using normal warmed saline as a distension medium, and I have found that hanging the saline in a 1,000-cc bag on a tall IV pole, with standard IV tubing and with a pressure cuff to maintain distention, is an ideal setup. We use the C-Fusor pressure infusor bag.

Injecting the saline with a 60-cc syringe is another option and is certainly adequate for a quick diagnostic procedure. The disadvantage to this approach, however, is the likelihood of needing to continually change syringes if polyp removal or another treatment is needed, or if the patient has a patulous cervix and transcervical fluid loss occurs.

 

 

Some physicians prefer not to purchase a flexible scope and instead choose a continuous-flow diagnostic/operative hysteroscope. For the physician who is just starting out and wants one piece of equipment with the most versatility, I would recommend a 5.5-mm continuous flow hysteroscope with a 5-Fr operating channel. The Bettocchi 4.5-mm continuous flow hysteroscope is another alternative.

In either case, the use of these rigid scopes demands the use of a tenaculum as well. Because application of a tenaculum is often uncomfortable for the patient, local anesthetic should be used at the tenaculum site, as well as a small paracervical block in case the cervix needs to be dilated.

When a rigid hysteroscope is used diagnostically, an open-sided speculum should be used, because a closed speculum will restrict the free movement of the scope. After the hysteroscope is inserted through the cervix, the open-sided speculum is removed to allow for free lateral movement of the scope. Such a choice is irrelevant when a flexible hysteroscope is used because the end of the scope moves freely and flexes up to 110 degrees, allowing for adequate visualization of the cornua and the tubal ostia.

[Note: Vaginoscopy, a new technique, popularized in Italy, entails the insertion of a small-diameter rigid or flexible scope directly into the vagina without the use of a speculum, and then right into the cervix and uterus without the use of a tenaculum. The procedure appears to be well tolerated by patients, but it may not work well in patients with a narrow cervical os.]

Insertion of the hysteroscope through the cervix should always be done under direct visualization with fluid running and a camera always at the 12:00 position. It rarely is necessary to dilate the cervix when using a 3-mm flexible hysteroscope, even in nulliparous or postmenopausal women. Once the scope passes the external os, fluid pressure will sufficiently dilate the cervical canal. Dilatation is more often necessary when a 5.5-mm operative hysteroscope is used, though rarely for multiparous women.

When a polyp is visualized during a diagnostic hysteroscopy performed with a 3-mm flexible hysteroscope, the cervix can then be dilated to 5 mm or 6 mm if necessary, and the polyp can be removed using a Randall stone forceps inserted to the area where the polyp was visualized. Alternatively, a 2- to 3-mm-long laryngeal polyp forceps can be placed into the uterus alongside the flexible hysteroscope and used to remove the polyp under direct visualization.

Other forceps that are useful for polyp removal are the Kelly, Sopher, and Javerts polyp forceps. These instruments are 7 mm in diameter and are easily inserted if the cervix is dilated using standard Hegar or Pratt dilators to 6–7 mm. This can be done without any patient discomfort if a paracervical block has been administered initially.

The use of a continuous flow operative scope with a 5-Fr to 7-Fr operative channel instead of the diagnostic scope is another option for polyp removal, foreign body removal, or directed biopsy. It is most important not to attempt to pull a biopsy out through the operative channel, but rather to move the entire scope from the cervix with the specimen in view.

Our basic instrument tray for diagnostic and operative hysteroscopy, therefore, consists of an open-sided speculum; a series of Hagar dilators; a single-tooth tenaculum; a stainless steel or glass medicine cup; polyp forceps and Randall stone forceps; 9-inch ring forceps; two surgical towels; a 10-cc control syringe; a 22-gauge spinal needle; and 10 4-by-4-inch sponges. (We buy nonsterile sponges in packages of 500 and put 10 on each instrument tray, and then we steam-autoclave each kit.)

We always have a second sterile tenaculum in case the patient has a patulous cervix. A Gimpleson four-prong tenaculum is also valuable for the control of transcervical leakage.

Other basic equipment includes a camera system, a monitor (the new flat-panel monitors available from scope manufacturers are lightweight and compact), a light source (preferably xenon), and if possible, a video printer. We do not sterilize our cameras because the cameras will last longer if they are not subject to soaking or steam autoclaving. Instead, we simply fold an 11-by-17-inch Steri-Drape with an adhesive edge over the nonsterile camera.

For the Essure procedure, we use a sterile under-buttock drape with a fluid collection pouch to keep track of inflow and outflow.

Every procedure room should also have basic safety equipment: an oxygen supply with a mask or nasal cannula; a positive pressure manual resuscitator (Ambu bag); and monitoring equipment for pulse and blood pressure. We use a Dinamap automatic blood pressure and pulse monitor, which frees the nurse to concentrate on talking with the patient.

 

 

An automatic electronic defibrillator is optional, but it certainly is a good piece of relatively inexpensive equipment for any medical office to have, and I encourage its inclusion in any in-office hysteroscopy setup. A pulse oximeter is mandatory only for level II procedures. With office hysteroscopy, you likely will never use one (we have not), but it is nice to know it's there to use if a patient has a change in consciousness.

When level II procedures are being performed using parenteral narcotics and/or sedatives, a fully stocked crash cart is required, and an ACLS (advanced cardiac life support)-certified staff member who is not performing the procedure must be present to monitor the patient.

Anesthesia and Patient Comfort

At the Kaiser Permanente San Rafael (Calif.) Medical Center, we have performed more than 12,000 gynecologic office procedures—from diagnostic hysteroscopies to hysteroscopic sterilizations and endometrial ablations—under local anesthesia with minimal oral sedation, over a 25-year period.

For diagnostic and minor operative hysteroscopy, we generally instruct patients to take 400–800 mg ibuprofen at home 1 hour before the procedure. We administer a paracervical block consisting of 5–10 mL of 1% lidocaine to the cervical vaginal junction superficially through the mucosa at 3:00 and 9:00.

Whenever a tenaculum is used, we also inject the anterior lip of the cervix with approximately 1–2 mL of local anesthetic before the tenaculum is applied, and then leave the room for 5–10 minutes to allow the block to set properly.

Remember, as with any office gynecologic procedure, it is important to use a “no-touch” technique, as the uterine wall is innervated by both sympathetic and parasympathetic fibers. It is unnecessary to sound the uterus; the old but still common practice of sounding is uncomfortable for the patient and may provoke uterine contractions that make distention of the uterus difficult. It may also cause perforation and is simply unnecessary.

Our oral premedication regimen for HTA and Essure procedures consists of 800 mg ibuprofen (Motrin), 10 mg diazepam (Valium), and two hydrocodone/acetaminophen (Vicodin) tablets taken at home 1–2 hours before the procedure. Patients are instructed to arrive 30 minutes prior to their scheduled appointment, at which time they are given an intramuscular injection of 30 mg ketorolac (Toradol) and 0.4 mg atropine.

Toradol is a prostaglandin synthetase inhibitor and has a peripheral effect as well. Atropine is used to prevent vasovagal reactions. The patient should be warned that she may experience dry mouth, but that this is preferable to the extreme discomfort felt during a vasovagal episode.

We then administer a paracervical/intracervical block with 1% mepivacaine (Carbocaine, Polocaine), which is longer acting than lidocaine. We inject 2 mL in the anterior lip of the cervix before it is grasped with a tenaculum; we place the needle against the cervix and ask the patient to cough, which results in self-injection. We then inject 10 mL in the cervicovaginal junction on each side at 3:00 and 9:00. These injections are given superficially, just under the mucosa, to raise a weal.

We inject an additional 5 mL intracervically about 1–2 cm deep at 8:00 and 4:00, and 5 mL submucosally at 6:00 between the uterosacrals. The total amount of mepivacaine given is 37 mL, or 370 mg (the recommended maximum dose is 400 mg).

Again, it is important to leave the room for 10–15 minutes to allow the block to set properly. We recommend that the physician leave while the nurse stays to monitor the patient and help her relax.

The Essure procedure can be done with less oral anesthesia and a smaller paracervical or intracervical block than endometrial ablation requires, but because our patients tolerate our ablation anesthesia regimen so well, we use it for both procedures.

In a study of 249 endometrial ablations performed at Kaiser Permanente San Rafael over 5.5 years using the HTA system, only one procedure was discontinued because of pain, and two patients were admitted overnight for cramping and nausea. The overall success rate was 90.6%, despite 40% of our patients having submucous myomas. The only complications were four cases of postoperative endometritis, with two of those patients requiring hospitalization for intravenous antibiotics, and two cases of procedure failure due to false passages.

We have not had any adverse anesthetic reactions in our patients who have undergone HTA over the years, or in any of the thousands of other women who were given similar paracervical blocks for office gynecologic procedures.

Postprocedure recovery is rarely necessary for these level I procedures. Our nurses monitor patients' blood pressure for 10–15 minutes after the procedures are completed and ensure that patients are feeling well and are ambulatory. This monitoring is done in the procedure room. Patients who don't feel well enough to leave in that time period are brought into another exam room and are discharged when they are ready. This is very rare.

 

 

Our patients also receive written postoperative instructions that tell them to report any increase in abdominal pain, any fever, any foul-smelling discharge, and—after endometrial ablation—the absence of any discharge.

Most of the time, patients will just wave good-bye, pleased to have had their procedure done in the office.

For level II procedures, the postrecovery protocol is much more complex.

The South Carolina rule, for instance, states that monitoring in the recovery area must include both pulse oximetry and noninvasive blood pressure measurement, and that the patient must be assessed for level of consciousness, pain relief, or any untoward complication.

Most states require that the patient be monitored for at least 30 minutes and, depending on which drugs were administered, for as long as 2 hours.

Again, it is important for physicians who plan to use anything but minimal sedation in the office to know their state requirements, if any. These can usually be obtained online from the state department of health services.

A photo of a 3-mm flexible hysteroscope with other commonly used office instruments reassures patients. Courtesy Dr. Mark Glasser

A 42-year-old patient with a 4-cm type 0 myoma was treated in the office with the HTA system (preoperative view at left). The patient has been amenorrheic for more than 6 years (postprocedure view at right). Photos courtesy Dr. Mark Glasser

The Medex C-Fusor is placed around a bag of normal saline, which is used to maintain distention pressure. Courtesy Dr. Mark Glasser

This image shows paracervical block injection sites (dots) and doses of 1% mepivicaine (arrows) injected at each site. Courtesy Dr. Mark Glasser

In-Office Gynecologic Surgery, Part 2

In the last Master Class in Gynecologic Surgery, Dr. James Presthus provided the reader with an overview on in-office gynecologic surgery. Hysteroscopy, the standard of care in the diagnosis and treatment of abnormal uterine bleeding, is a procedure that lends itself especially readily to an office environment.

Dr. Presthus pointed out that the physician “can provide more thorough and efficient care in a more comfortable, familiar, and cost-effective setting.” He emphasized that despite the use of less anesthesia, patients routinely tolerate the procedure well.

Dr. Presthus gave us the “why” behind his recommendation that the gynecologist commit to office-based surgery.

Now, Dr. Mark Glasser provides us with the “how and what” considerations of in-office gynecologic surgery, focusing on hysteroscopy, global endometrial ablation, and the Essure tubal occlusion procedure.

Not only does Dr. Glasser make recommendations on instrumentation, he also discusses the surgical technique of hysteroscopy and the anesthesia concerns that can arise. This article is an excellent primer for those considering in-office hysteroscopy.

From 1992 until 2006, Dr. Glasser was the director of advanced gynecologic laparoscopy training for the Kaiser Northern California Region. He is a past member of the board of trustees of the AAGL and continues to serve on the national advisory committee of the AAGL and the editorial board of the Journal of Minimally Invasive Gynecology.

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Taking Gynecologic Procedures Out of the Hospital

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The levels of burnout in our specialty are increasing as too many of us—90% of the 42,000 ob.gyns in the United States—continue to pursue generalist careers.

We attempt to do it all, from primary care to obstetrics to surgery, and are being pulled in too many directions while losing any sense of control in our professional and personal lives.

There are alternatives to the model of being everything to every patient, however, and adopting office-based procedures can be a key component to making changes successfully.

Most of us perform in-office endometrial biopsies, colposcopy with biopsies, LEEP (loop electrosurgical excision procedures), and IUD insertions. Yet it is estimated that fewer than 30% of ob.gyns. do appreciable hysteroscopy in any setting, and fewer than 5%–10% do office hysteroscopy.

Many of us believe that office-based procedures are potentially dangerous and that they are painful and will not be tolerated by patients.

We argue against an increased level of office-based procedures on the premise that the equipment costs too much, the required skill level is too high, we don't see enough patients who are candidates for these procedures, we don't have procedure rooms, or the integration of more procedures into our existing schedules is just too complex or difficult.

Increasingly, these beliefs are countered by contrasting realities: more medical knowledge, more training opportunities, more reasonably priced equipment, and appropriate third-party reimbursement for office-based hysteroscopic procedures.

These realities have made hysteroscopy the base technology for a successful gynecology-focused office-based practice.

With commitment, those ob.gyns. who enjoy doing procedures can build successful office-based practices by offering a full spectrum of diagnostic and minor operative hysteroscopic procedures that are just as safe, tolerable, and effective as they are in the hospital.

In doing so, they can provide more thorough and efficient care in a more comfortable, familiar, and cost-effective setting.

Less Anesthesia, More Accuracy

The most significant misconception among ob.gyns.–and probably the largest barrier to wider use of in-office hysteroscopy—relates to pain.

The perceptions are fueled by the operating room experience, where intravenous sedation causes patients to lose inhibition and the ability to follow directions and control their actions.

Patients perceive touch and other stimuli as pain, and the loss of inhibition often escalates as the anesthesist applies even more IV sedation in an effort to make them more comfortable.

This is often perceived as intolerance for pain, and ob.gyns. leave the operating room thinking that if patients cannot tolerate hysteroscopy in that setting, they will certainly not tolerate it in the office.

In reality, patients can tolerate procedures very well—and with less anesthesia—if they know what to expect and if they're in control of their bodies and the overall situation. This happens more readily in the office environment, which is familiar, less intimidating, and more comfortable for patients.

In addition to the comfort that comes with familiarity, the office environment offers distractions that lessen the perception and feeling of pain, and the small-diameter hysteroscopes that are available to us today are no larger than a Pipelle curette and can usually be guided easily through the cervix without dilation, paracervical blocks, or the use of a tenaculum. A simple diagnostic hysteroscopy takes, on average, 5 minutes or less and is extremely well tolerated. It is less painful than an endometrial biopsy.

Patients are often interested in watching the video monitor during a hysteroscopic procedure. Their understanding and comfort level are greater when they can see the findings—can see in living color, for instance, what polyps, fibroids, or intrauterine adhesions are.

Of equal or more importance, hysteroscopy provides a focused view that has significant and measurable clinical benefits.

Ob.gyns. are more attuned to ultrasound; it's readily available, and the global view of the pelvis, uterus, and adnexa that it provides is often viewed as adequate. Saline infusion sonography has certainly improved diagnostic accuracy.

Hysteroscopy, however, offers a more focused view and gives us the ability to investigate and to do a targeted biopsy under direct vision. It simply provides for greater accuracy and more thorough care. Hysteroscopy should be viewed as complementary to ultrasound rather than as an alternative.

Hysteroscopy is the standard for evaluating abnormal uterine bleeding (AUB), a problem that affects more than 10 million women a year and is the reason for 25% of all gynecologic clinic visits.

Although endometrial biopsy is effective for diagnosing diffuse disease such as hyperplasia and carcinoma, it often misses focal lesions like endometrial polyps and fibroids, which are common causes of AUB.

Hysteroscopy should be considered in all patients who require an endometrial biopsy. It has been shown to have a sensitivity of 100% and a specificity of 95% in evaluating the uterine cavity.

 

 

It allows us both to diagnose more accurately and often to “see and treat” at the same time, avoiding the courses of unsuccessful hormonal therapy and multiple visits and procedures that too often result from a reliance on endometrial biopsy and ultrasound alone.

Office cystoscopy is a routine part of urologists' practice. With hysteroscopy, we have the technology and capability as ob.gyns. to similarly diagnose and treat common problems in a cost-effective, readily acceptable way. We must more seriously ask ourselves, why not?

Are our reasons not to embrace hysteroscopy really good enough?

Better Fits for a New Era

Ob.gyns. are often at a loss to explain why they seem to be working harder and harder while not getting anywhere, or while losing control, income, and/or the gratification of strong physician-patient relationships.

In a 2004 survey of approximately 830 District III ob.gyns., 64% reported symptoms of burnout; 16% wanted to quit medicine, and 40% said they planned to retire early. To maintain income or prevent a significant decrease in earnings, many had increased patient volume by 20%–30%.

Part of the challenge we face stems from declining reimbursement and the loss of entrepreneurship that often comes with larger group practices. But we also have an inefficient specialty. Many of us leave our offices for labor and delivery and for long OR cases that are unpredictable, that challenge the flow and efficiency of our office practices and the stability of our family lives, and that bring us reimbursement rates that do not account for waiting and time lost between cases. Often the reimbursement we receive when we are away from the office will not cover the cost of office overhead.

This is something we ought to analyze now. Depending on our professional interests, personal needs, and surgical and labor/delivery volumes, such a mix may be gratifying and completely acceptable, or it may be taxing, inefficient, and a cause of burnout.

An office-based ob.gyn. model of care can give us greater control of our practice, our scheduling, our patient relationships, and our lifestyle. Given the elimination of unproductive time, and the fact that professional fees remain the same regardless of setting and that facility fees go to the physician, we can also increase our reimbursement.

Substantial time and financial savings, moreover, are passed on to patients and payers. There is no wasted time: no separate office visits, for instance, for preoperative histories and physicals. When it comes to procedures, patients can arrive 10-30 minutes beforehand and leave in less than 30 minutes. In many cases a patient will be responsible for the cost of an office visit copay, compared with a large deductible and percentage of hospital costs.

I recently saw an interview with Warren Buffett in which he was asked why he is so successful in choosing investments. How was he able to predict the future? He replied that he could not predict the future, but he could recognize what was becoming obsolete. The era in which the model of care relied on a single ob.gyn. who could provide equally competent general primary care, obstetrical care, and the full spectrum of gynecologic surgery to the patient is rapidly becoming obsolete.

The specialty of ob.gyn. is destined to change. Many of us eventually will need to discover and carve out or fine-tune our roles. Today's generalist model of ob.gyn. will evolve into three components in the future: the office-based ob.gyn., the hospital laborist, and the pelvic surgeon.

Greatest in number will be the office-based ob.gyns. who provide well-woman primary care, office-based obstetrics (prenatal care), and a range of office-based procedures, from hysteroscopy and endometrial ablations to incontinence procedures, ultrasound, IUDs, cystoscopy, LEEP cones, and perhaps some “lifestyle” procedures such as laser hair reduction and varicose vein treatment. Considering the demand for such services, they likely will make up about 70% of the specialty.

The ability to have one office, fewer partners, no hospital responsibilities, and control over one's schedule can provide a career that is interesting and rewarding.

Ob.gyn. laborists will be modeled after internal medicine “hospitalists,” and will handle routine deliveries and inpatient obstetrical management. The laborist will work a certain number of shifts each month and will have enough time to be able to balance his or her personal and professional life.

Pelvic surgeons will perform laparoscopy, operative hysteroscopy, and abdominal, vaginal, and robotic surgery. They will provide women with state-of-the-art surgical care and will not have to balance surgery with primary care.

Skills and Set-Up

Ob.gyns. who are performing endometrial biopsies and inserting IUDs are more than capable of doing diagnostic and minor operative hysteroscopy in the office.

 

 

The average ob.gyn., in fact, will be competent with the basic hysteroscopic technique for diagnosis after just two to five cases, and the skills honed by doing office diagnostic hysteroscopy will often lay the foundation for adding operative procedures for which there is growing demand, such as hysteroscopic sterilization and global endometrial ablation.

A 2002 survey of women found that sterilization is the most popular method of contraception (favored by 28%), and that women today rarely favor a tubal ligation. Since it has been on the market, the Essure procedure has had successful placement rates of more than 96%.

Hysteroscopic sterilization and global endometrial ablation are both safe and effective for the general ob.gyn. to perform in the office—and just as capably as the best gynecologic surgeon—if he or she is credentialed in the procedure and first has experience and comfort with the procedure in the hospital setting. As a transition, the office setting can be simulated in the OR, with the office staff brought in to observe and prepare for assisting, for instance, and implementing various pain management strategies. The office staff can also learn how to clean and care for the equipment.

Many physicians wonder what will happen if they are unable to complete a procedure in the office. Attempts will inevitably sometimes fail because of access problems, patient intolerance, equipment failure, or a complication. But with experience and proper patient selection, this will rarely happen. And if it does—if you're having some difficulty with the ablation set-up, for instance—keep in mind that it is only an office visit, and that the patient can be rescheduled for the operating room.

It is not necessary to remodel your office or have a “procedure room.” A normal exam room will almost always suffice for diagnostic and simple operative hysteroscopic procedures. Increasingly, equipment is reasonably priced and companies are able to work with ob.gyns. on favorable leasing arrangements. This has taken away the hurdle of price; in fact, one hysteroscopy procedure a week will pay for the equipment.

The reimbursement issues are also favorable. Office hysteroscopy with biopsy is reimbursed at the same rate in the office as in the OR, and in 2005 global codes were approved for hysteroscopic sterilization and endometrial ablation—another development that makes the investment in hysteroscopy equipment a financially sound decision.

Preparing for office-based procedures takes initiative: Anesthesia guidelines and requirements for facility maintenance must be learned, for instance, and a policy and procedures manual that includes protocols for managing complications must be developed.

There is an unappreciated amount of training support, however—both for technical procedural training and for the range of logistical issues—to be had from experienced colleagues, professional societies, and industry. Ob.gyns. who enjoy procedures are better positioned than ever before to take advantage of it.

Diagnostic hysteroscopy with a small hysteroscope is less painful than an endometrial biopsy. Such a hysteroscope is smaller than an IUD (left).

A typical diagnostic hysteroscopy tray for in-office procedures includes a small hysteroscope and sheath, an os finder, and a single-tooth tenaculum. Photos courtesy Dr. James B. Presthus

It is not necessary to remodel your office. A normal exam room will almost always suffice for diagnostic and simple operative hysteroscopic procedures. Courtesy Dr. James B. Presthus

In-Office Surgery Can Boost Practice

Given the constant threat of falling reimbursement, ob.gyns. throughout the country are exercising options on how to maintain a successful practice. For some, introducing new treatments has proved successful. We are all well aware of gynecologists who get involved in various aesthetic techniques and plastic procedures. However, for others, this option represents a marked departure from their practice profile.

It would appear that the introduction of in-office gynecologic surgery will offer many ob.gyns. the opportunity to add value to their practice, yet stay within the limits of the procedures they were trained to perform while in residency—that is, within an ob.gyn.'s “comfort zone.”

A second advantage of in-office gynecologic surgery is that it allows the physician to maintain efficiency.

Let's face it: Operating rooms are fraught with delays. Performing surgery within the confines of the office allows the gynecologist to be free of the yoke of OR tardiness.

Finally, procedures may actually be compensated better in the office than in the operating room, whether that OR is in an outpatient surgery center or in a hospital. Examples are hysteroscopic tubal occlusion or endometrial ablation.

I have invited Dr. James B. Presthus, who is currently practicing gynecology at Minnesota Gynecology and Surgery in Edina, Minn., to lead this discussion on office-based surgery. Dr. Presthus is an active member of the American Association of Gynecologic Laparoscopists, the American Urogynecology Association, the International Pelvic Pain Society, and many other professional organizations. He is a clinical professor of obstetrics and gynecology at the University of Minnesota, Minneapolis.

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The levels of burnout in our specialty are increasing as too many of us—90% of the 42,000 ob.gyns in the United States—continue to pursue generalist careers.

We attempt to do it all, from primary care to obstetrics to surgery, and are being pulled in too many directions while losing any sense of control in our professional and personal lives.

There are alternatives to the model of being everything to every patient, however, and adopting office-based procedures can be a key component to making changes successfully.

Most of us perform in-office endometrial biopsies, colposcopy with biopsies, LEEP (loop electrosurgical excision procedures), and IUD insertions. Yet it is estimated that fewer than 30% of ob.gyns. do appreciable hysteroscopy in any setting, and fewer than 5%–10% do office hysteroscopy.

Many of us believe that office-based procedures are potentially dangerous and that they are painful and will not be tolerated by patients.

We argue against an increased level of office-based procedures on the premise that the equipment costs too much, the required skill level is too high, we don't see enough patients who are candidates for these procedures, we don't have procedure rooms, or the integration of more procedures into our existing schedules is just too complex or difficult.

Increasingly, these beliefs are countered by contrasting realities: more medical knowledge, more training opportunities, more reasonably priced equipment, and appropriate third-party reimbursement for office-based hysteroscopic procedures.

These realities have made hysteroscopy the base technology for a successful gynecology-focused office-based practice.

With commitment, those ob.gyns. who enjoy doing procedures can build successful office-based practices by offering a full spectrum of diagnostic and minor operative hysteroscopic procedures that are just as safe, tolerable, and effective as they are in the hospital.

In doing so, they can provide more thorough and efficient care in a more comfortable, familiar, and cost-effective setting.

Less Anesthesia, More Accuracy

The most significant misconception among ob.gyns.–and probably the largest barrier to wider use of in-office hysteroscopy—relates to pain.

The perceptions are fueled by the operating room experience, where intravenous sedation causes patients to lose inhibition and the ability to follow directions and control their actions.

Patients perceive touch and other stimuli as pain, and the loss of inhibition often escalates as the anesthesist applies even more IV sedation in an effort to make them more comfortable.

This is often perceived as intolerance for pain, and ob.gyns. leave the operating room thinking that if patients cannot tolerate hysteroscopy in that setting, they will certainly not tolerate it in the office.

In reality, patients can tolerate procedures very well—and with less anesthesia—if they know what to expect and if they're in control of their bodies and the overall situation. This happens more readily in the office environment, which is familiar, less intimidating, and more comfortable for patients.

In addition to the comfort that comes with familiarity, the office environment offers distractions that lessen the perception and feeling of pain, and the small-diameter hysteroscopes that are available to us today are no larger than a Pipelle curette and can usually be guided easily through the cervix without dilation, paracervical blocks, or the use of a tenaculum. A simple diagnostic hysteroscopy takes, on average, 5 minutes or less and is extremely well tolerated. It is less painful than an endometrial biopsy.

Patients are often interested in watching the video monitor during a hysteroscopic procedure. Their understanding and comfort level are greater when they can see the findings—can see in living color, for instance, what polyps, fibroids, or intrauterine adhesions are.

Of equal or more importance, hysteroscopy provides a focused view that has significant and measurable clinical benefits.

Ob.gyns. are more attuned to ultrasound; it's readily available, and the global view of the pelvis, uterus, and adnexa that it provides is often viewed as adequate. Saline infusion sonography has certainly improved diagnostic accuracy.

Hysteroscopy, however, offers a more focused view and gives us the ability to investigate and to do a targeted biopsy under direct vision. It simply provides for greater accuracy and more thorough care. Hysteroscopy should be viewed as complementary to ultrasound rather than as an alternative.

Hysteroscopy is the standard for evaluating abnormal uterine bleeding (AUB), a problem that affects more than 10 million women a year and is the reason for 25% of all gynecologic clinic visits.

Although endometrial biopsy is effective for diagnosing diffuse disease such as hyperplasia and carcinoma, it often misses focal lesions like endometrial polyps and fibroids, which are common causes of AUB.

Hysteroscopy should be considered in all patients who require an endometrial biopsy. It has been shown to have a sensitivity of 100% and a specificity of 95% in evaluating the uterine cavity.

 

 

It allows us both to diagnose more accurately and often to “see and treat” at the same time, avoiding the courses of unsuccessful hormonal therapy and multiple visits and procedures that too often result from a reliance on endometrial biopsy and ultrasound alone.

Office cystoscopy is a routine part of urologists' practice. With hysteroscopy, we have the technology and capability as ob.gyns. to similarly diagnose and treat common problems in a cost-effective, readily acceptable way. We must more seriously ask ourselves, why not?

Are our reasons not to embrace hysteroscopy really good enough?

Better Fits for a New Era

Ob.gyns. are often at a loss to explain why they seem to be working harder and harder while not getting anywhere, or while losing control, income, and/or the gratification of strong physician-patient relationships.

In a 2004 survey of approximately 830 District III ob.gyns., 64% reported symptoms of burnout; 16% wanted to quit medicine, and 40% said they planned to retire early. To maintain income or prevent a significant decrease in earnings, many had increased patient volume by 20%–30%.

Part of the challenge we face stems from declining reimbursement and the loss of entrepreneurship that often comes with larger group practices. But we also have an inefficient specialty. Many of us leave our offices for labor and delivery and for long OR cases that are unpredictable, that challenge the flow and efficiency of our office practices and the stability of our family lives, and that bring us reimbursement rates that do not account for waiting and time lost between cases. Often the reimbursement we receive when we are away from the office will not cover the cost of office overhead.

This is something we ought to analyze now. Depending on our professional interests, personal needs, and surgical and labor/delivery volumes, such a mix may be gratifying and completely acceptable, or it may be taxing, inefficient, and a cause of burnout.

An office-based ob.gyn. model of care can give us greater control of our practice, our scheduling, our patient relationships, and our lifestyle. Given the elimination of unproductive time, and the fact that professional fees remain the same regardless of setting and that facility fees go to the physician, we can also increase our reimbursement.

Substantial time and financial savings, moreover, are passed on to patients and payers. There is no wasted time: no separate office visits, for instance, for preoperative histories and physicals. When it comes to procedures, patients can arrive 10-30 minutes beforehand and leave in less than 30 minutes. In many cases a patient will be responsible for the cost of an office visit copay, compared with a large deductible and percentage of hospital costs.

I recently saw an interview with Warren Buffett in which he was asked why he is so successful in choosing investments. How was he able to predict the future? He replied that he could not predict the future, but he could recognize what was becoming obsolete. The era in which the model of care relied on a single ob.gyn. who could provide equally competent general primary care, obstetrical care, and the full spectrum of gynecologic surgery to the patient is rapidly becoming obsolete.

The specialty of ob.gyn. is destined to change. Many of us eventually will need to discover and carve out or fine-tune our roles. Today's generalist model of ob.gyn. will evolve into three components in the future: the office-based ob.gyn., the hospital laborist, and the pelvic surgeon.

Greatest in number will be the office-based ob.gyns. who provide well-woman primary care, office-based obstetrics (prenatal care), and a range of office-based procedures, from hysteroscopy and endometrial ablations to incontinence procedures, ultrasound, IUDs, cystoscopy, LEEP cones, and perhaps some “lifestyle” procedures such as laser hair reduction and varicose vein treatment. Considering the demand for such services, they likely will make up about 70% of the specialty.

The ability to have one office, fewer partners, no hospital responsibilities, and control over one's schedule can provide a career that is interesting and rewarding.

Ob.gyn. laborists will be modeled after internal medicine “hospitalists,” and will handle routine deliveries and inpatient obstetrical management. The laborist will work a certain number of shifts each month and will have enough time to be able to balance his or her personal and professional life.

Pelvic surgeons will perform laparoscopy, operative hysteroscopy, and abdominal, vaginal, and robotic surgery. They will provide women with state-of-the-art surgical care and will not have to balance surgery with primary care.

Skills and Set-Up

Ob.gyns. who are performing endometrial biopsies and inserting IUDs are more than capable of doing diagnostic and minor operative hysteroscopy in the office.

 

 

The average ob.gyn., in fact, will be competent with the basic hysteroscopic technique for diagnosis after just two to five cases, and the skills honed by doing office diagnostic hysteroscopy will often lay the foundation for adding operative procedures for which there is growing demand, such as hysteroscopic sterilization and global endometrial ablation.

A 2002 survey of women found that sterilization is the most popular method of contraception (favored by 28%), and that women today rarely favor a tubal ligation. Since it has been on the market, the Essure procedure has had successful placement rates of more than 96%.

Hysteroscopic sterilization and global endometrial ablation are both safe and effective for the general ob.gyn. to perform in the office—and just as capably as the best gynecologic surgeon—if he or she is credentialed in the procedure and first has experience and comfort with the procedure in the hospital setting. As a transition, the office setting can be simulated in the OR, with the office staff brought in to observe and prepare for assisting, for instance, and implementing various pain management strategies. The office staff can also learn how to clean and care for the equipment.

Many physicians wonder what will happen if they are unable to complete a procedure in the office. Attempts will inevitably sometimes fail because of access problems, patient intolerance, equipment failure, or a complication. But with experience and proper patient selection, this will rarely happen. And if it does—if you're having some difficulty with the ablation set-up, for instance—keep in mind that it is only an office visit, and that the patient can be rescheduled for the operating room.

It is not necessary to remodel your office or have a “procedure room.” A normal exam room will almost always suffice for diagnostic and simple operative hysteroscopic procedures. Increasingly, equipment is reasonably priced and companies are able to work with ob.gyns. on favorable leasing arrangements. This has taken away the hurdle of price; in fact, one hysteroscopy procedure a week will pay for the equipment.

The reimbursement issues are also favorable. Office hysteroscopy with biopsy is reimbursed at the same rate in the office as in the OR, and in 2005 global codes were approved for hysteroscopic sterilization and endometrial ablation—another development that makes the investment in hysteroscopy equipment a financially sound decision.

Preparing for office-based procedures takes initiative: Anesthesia guidelines and requirements for facility maintenance must be learned, for instance, and a policy and procedures manual that includes protocols for managing complications must be developed.

There is an unappreciated amount of training support, however—both for technical procedural training and for the range of logistical issues—to be had from experienced colleagues, professional societies, and industry. Ob.gyns. who enjoy procedures are better positioned than ever before to take advantage of it.

Diagnostic hysteroscopy with a small hysteroscope is less painful than an endometrial biopsy. Such a hysteroscope is smaller than an IUD (left).

A typical diagnostic hysteroscopy tray for in-office procedures includes a small hysteroscope and sheath, an os finder, and a single-tooth tenaculum. Photos courtesy Dr. James B. Presthus

It is not necessary to remodel your office. A normal exam room will almost always suffice for diagnostic and simple operative hysteroscopic procedures. Courtesy Dr. James B. Presthus

In-Office Surgery Can Boost Practice

Given the constant threat of falling reimbursement, ob.gyns. throughout the country are exercising options on how to maintain a successful practice. For some, introducing new treatments has proved successful. We are all well aware of gynecologists who get involved in various aesthetic techniques and plastic procedures. However, for others, this option represents a marked departure from their practice profile.

It would appear that the introduction of in-office gynecologic surgery will offer many ob.gyns. the opportunity to add value to their practice, yet stay within the limits of the procedures they were trained to perform while in residency—that is, within an ob.gyn.'s “comfort zone.”

A second advantage of in-office gynecologic surgery is that it allows the physician to maintain efficiency.

Let's face it: Operating rooms are fraught with delays. Performing surgery within the confines of the office allows the gynecologist to be free of the yoke of OR tardiness.

Finally, procedures may actually be compensated better in the office than in the operating room, whether that OR is in an outpatient surgery center or in a hospital. Examples are hysteroscopic tubal occlusion or endometrial ablation.

I have invited Dr. James B. Presthus, who is currently practicing gynecology at Minnesota Gynecology and Surgery in Edina, Minn., to lead this discussion on office-based surgery. Dr. Presthus is an active member of the American Association of Gynecologic Laparoscopists, the American Urogynecology Association, the International Pelvic Pain Society, and many other professional organizations. He is a clinical professor of obstetrics and gynecology at the University of Minnesota, Minneapolis.

The levels of burnout in our specialty are increasing as too many of us—90% of the 42,000 ob.gyns in the United States—continue to pursue generalist careers.

We attempt to do it all, from primary care to obstetrics to surgery, and are being pulled in too many directions while losing any sense of control in our professional and personal lives.

There are alternatives to the model of being everything to every patient, however, and adopting office-based procedures can be a key component to making changes successfully.

Most of us perform in-office endometrial biopsies, colposcopy with biopsies, LEEP (loop electrosurgical excision procedures), and IUD insertions. Yet it is estimated that fewer than 30% of ob.gyns. do appreciable hysteroscopy in any setting, and fewer than 5%–10% do office hysteroscopy.

Many of us believe that office-based procedures are potentially dangerous and that they are painful and will not be tolerated by patients.

We argue against an increased level of office-based procedures on the premise that the equipment costs too much, the required skill level is too high, we don't see enough patients who are candidates for these procedures, we don't have procedure rooms, or the integration of more procedures into our existing schedules is just too complex or difficult.

Increasingly, these beliefs are countered by contrasting realities: more medical knowledge, more training opportunities, more reasonably priced equipment, and appropriate third-party reimbursement for office-based hysteroscopic procedures.

These realities have made hysteroscopy the base technology for a successful gynecology-focused office-based practice.

With commitment, those ob.gyns. who enjoy doing procedures can build successful office-based practices by offering a full spectrum of diagnostic and minor operative hysteroscopic procedures that are just as safe, tolerable, and effective as they are in the hospital.

In doing so, they can provide more thorough and efficient care in a more comfortable, familiar, and cost-effective setting.

Less Anesthesia, More Accuracy

The most significant misconception among ob.gyns.–and probably the largest barrier to wider use of in-office hysteroscopy—relates to pain.

The perceptions are fueled by the operating room experience, where intravenous sedation causes patients to lose inhibition and the ability to follow directions and control their actions.

Patients perceive touch and other stimuli as pain, and the loss of inhibition often escalates as the anesthesist applies even more IV sedation in an effort to make them more comfortable.

This is often perceived as intolerance for pain, and ob.gyns. leave the operating room thinking that if patients cannot tolerate hysteroscopy in that setting, they will certainly not tolerate it in the office.

In reality, patients can tolerate procedures very well—and with less anesthesia—if they know what to expect and if they're in control of their bodies and the overall situation. This happens more readily in the office environment, which is familiar, less intimidating, and more comfortable for patients.

In addition to the comfort that comes with familiarity, the office environment offers distractions that lessen the perception and feeling of pain, and the small-diameter hysteroscopes that are available to us today are no larger than a Pipelle curette and can usually be guided easily through the cervix without dilation, paracervical blocks, or the use of a tenaculum. A simple diagnostic hysteroscopy takes, on average, 5 minutes or less and is extremely well tolerated. It is less painful than an endometrial biopsy.

Patients are often interested in watching the video monitor during a hysteroscopic procedure. Their understanding and comfort level are greater when they can see the findings—can see in living color, for instance, what polyps, fibroids, or intrauterine adhesions are.

Of equal or more importance, hysteroscopy provides a focused view that has significant and measurable clinical benefits.

Ob.gyns. are more attuned to ultrasound; it's readily available, and the global view of the pelvis, uterus, and adnexa that it provides is often viewed as adequate. Saline infusion sonography has certainly improved diagnostic accuracy.

Hysteroscopy, however, offers a more focused view and gives us the ability to investigate and to do a targeted biopsy under direct vision. It simply provides for greater accuracy and more thorough care. Hysteroscopy should be viewed as complementary to ultrasound rather than as an alternative.

Hysteroscopy is the standard for evaluating abnormal uterine bleeding (AUB), a problem that affects more than 10 million women a year and is the reason for 25% of all gynecologic clinic visits.

Although endometrial biopsy is effective for diagnosing diffuse disease such as hyperplasia and carcinoma, it often misses focal lesions like endometrial polyps and fibroids, which are common causes of AUB.

Hysteroscopy should be considered in all patients who require an endometrial biopsy. It has been shown to have a sensitivity of 100% and a specificity of 95% in evaluating the uterine cavity.

 

 

It allows us both to diagnose more accurately and often to “see and treat” at the same time, avoiding the courses of unsuccessful hormonal therapy and multiple visits and procedures that too often result from a reliance on endometrial biopsy and ultrasound alone.

Office cystoscopy is a routine part of urologists' practice. With hysteroscopy, we have the technology and capability as ob.gyns. to similarly diagnose and treat common problems in a cost-effective, readily acceptable way. We must more seriously ask ourselves, why not?

Are our reasons not to embrace hysteroscopy really good enough?

Better Fits for a New Era

Ob.gyns. are often at a loss to explain why they seem to be working harder and harder while not getting anywhere, or while losing control, income, and/or the gratification of strong physician-patient relationships.

In a 2004 survey of approximately 830 District III ob.gyns., 64% reported symptoms of burnout; 16% wanted to quit medicine, and 40% said they planned to retire early. To maintain income or prevent a significant decrease in earnings, many had increased patient volume by 20%–30%.

Part of the challenge we face stems from declining reimbursement and the loss of entrepreneurship that often comes with larger group practices. But we also have an inefficient specialty. Many of us leave our offices for labor and delivery and for long OR cases that are unpredictable, that challenge the flow and efficiency of our office practices and the stability of our family lives, and that bring us reimbursement rates that do not account for waiting and time lost between cases. Often the reimbursement we receive when we are away from the office will not cover the cost of office overhead.

This is something we ought to analyze now. Depending on our professional interests, personal needs, and surgical and labor/delivery volumes, such a mix may be gratifying and completely acceptable, or it may be taxing, inefficient, and a cause of burnout.

An office-based ob.gyn. model of care can give us greater control of our practice, our scheduling, our patient relationships, and our lifestyle. Given the elimination of unproductive time, and the fact that professional fees remain the same regardless of setting and that facility fees go to the physician, we can also increase our reimbursement.

Substantial time and financial savings, moreover, are passed on to patients and payers. There is no wasted time: no separate office visits, for instance, for preoperative histories and physicals. When it comes to procedures, patients can arrive 10-30 minutes beforehand and leave in less than 30 minutes. In many cases a patient will be responsible for the cost of an office visit copay, compared with a large deductible and percentage of hospital costs.

I recently saw an interview with Warren Buffett in which he was asked why he is so successful in choosing investments. How was he able to predict the future? He replied that he could not predict the future, but he could recognize what was becoming obsolete. The era in which the model of care relied on a single ob.gyn. who could provide equally competent general primary care, obstetrical care, and the full spectrum of gynecologic surgery to the patient is rapidly becoming obsolete.

The specialty of ob.gyn. is destined to change. Many of us eventually will need to discover and carve out or fine-tune our roles. Today's generalist model of ob.gyn. will evolve into three components in the future: the office-based ob.gyn., the hospital laborist, and the pelvic surgeon.

Greatest in number will be the office-based ob.gyns. who provide well-woman primary care, office-based obstetrics (prenatal care), and a range of office-based procedures, from hysteroscopy and endometrial ablations to incontinence procedures, ultrasound, IUDs, cystoscopy, LEEP cones, and perhaps some “lifestyle” procedures such as laser hair reduction and varicose vein treatment. Considering the demand for such services, they likely will make up about 70% of the specialty.

The ability to have one office, fewer partners, no hospital responsibilities, and control over one's schedule can provide a career that is interesting and rewarding.

Ob.gyn. laborists will be modeled after internal medicine “hospitalists,” and will handle routine deliveries and inpatient obstetrical management. The laborist will work a certain number of shifts each month and will have enough time to be able to balance his or her personal and professional life.

Pelvic surgeons will perform laparoscopy, operative hysteroscopy, and abdominal, vaginal, and robotic surgery. They will provide women with state-of-the-art surgical care and will not have to balance surgery with primary care.

Skills and Set-Up

Ob.gyns. who are performing endometrial biopsies and inserting IUDs are more than capable of doing diagnostic and minor operative hysteroscopy in the office.

 

 

The average ob.gyn., in fact, will be competent with the basic hysteroscopic technique for diagnosis after just two to five cases, and the skills honed by doing office diagnostic hysteroscopy will often lay the foundation for adding operative procedures for which there is growing demand, such as hysteroscopic sterilization and global endometrial ablation.

A 2002 survey of women found that sterilization is the most popular method of contraception (favored by 28%), and that women today rarely favor a tubal ligation. Since it has been on the market, the Essure procedure has had successful placement rates of more than 96%.

Hysteroscopic sterilization and global endometrial ablation are both safe and effective for the general ob.gyn. to perform in the office—and just as capably as the best gynecologic surgeon—if he or she is credentialed in the procedure and first has experience and comfort with the procedure in the hospital setting. As a transition, the office setting can be simulated in the OR, with the office staff brought in to observe and prepare for assisting, for instance, and implementing various pain management strategies. The office staff can also learn how to clean and care for the equipment.

Many physicians wonder what will happen if they are unable to complete a procedure in the office. Attempts will inevitably sometimes fail because of access problems, patient intolerance, equipment failure, or a complication. But with experience and proper patient selection, this will rarely happen. And if it does—if you're having some difficulty with the ablation set-up, for instance—keep in mind that it is only an office visit, and that the patient can be rescheduled for the operating room.

It is not necessary to remodel your office or have a “procedure room.” A normal exam room will almost always suffice for diagnostic and simple operative hysteroscopic procedures. Increasingly, equipment is reasonably priced and companies are able to work with ob.gyns. on favorable leasing arrangements. This has taken away the hurdle of price; in fact, one hysteroscopy procedure a week will pay for the equipment.

The reimbursement issues are also favorable. Office hysteroscopy with biopsy is reimbursed at the same rate in the office as in the OR, and in 2005 global codes were approved for hysteroscopic sterilization and endometrial ablation—another development that makes the investment in hysteroscopy equipment a financially sound decision.

Preparing for office-based procedures takes initiative: Anesthesia guidelines and requirements for facility maintenance must be learned, for instance, and a policy and procedures manual that includes protocols for managing complications must be developed.

There is an unappreciated amount of training support, however—both for technical procedural training and for the range of logistical issues—to be had from experienced colleagues, professional societies, and industry. Ob.gyns. who enjoy procedures are better positioned than ever before to take advantage of it.

Diagnostic hysteroscopy with a small hysteroscope is less painful than an endometrial biopsy. Such a hysteroscope is smaller than an IUD (left).

A typical diagnostic hysteroscopy tray for in-office procedures includes a small hysteroscope and sheath, an os finder, and a single-tooth tenaculum. Photos courtesy Dr. James B. Presthus

It is not necessary to remodel your office. A normal exam room will almost always suffice for diagnostic and simple operative hysteroscopic procedures. Courtesy Dr. James B. Presthus

In-Office Surgery Can Boost Practice

Given the constant threat of falling reimbursement, ob.gyns. throughout the country are exercising options on how to maintain a successful practice. For some, introducing new treatments has proved successful. We are all well aware of gynecologists who get involved in various aesthetic techniques and plastic procedures. However, for others, this option represents a marked departure from their practice profile.

It would appear that the introduction of in-office gynecologic surgery will offer many ob.gyns. the opportunity to add value to their practice, yet stay within the limits of the procedures they were trained to perform while in residency—that is, within an ob.gyn.'s “comfort zone.”

A second advantage of in-office gynecologic surgery is that it allows the physician to maintain efficiency.

Let's face it: Operating rooms are fraught with delays. Performing surgery within the confines of the office allows the gynecologist to be free of the yoke of OR tardiness.

Finally, procedures may actually be compensated better in the office than in the operating room, whether that OR is in an outpatient surgery center or in a hospital. Examples are hysteroscopic tubal occlusion or endometrial ablation.

I have invited Dr. James B. Presthus, who is currently practicing gynecology at Minnesota Gynecology and Surgery in Edina, Minn., to lead this discussion on office-based surgery. Dr. Presthus is an active member of the American Association of Gynecologic Laparoscopists, the American Urogynecology Association, the International Pelvic Pain Society, and many other professional organizations. He is a clinical professor of obstetrics and gynecology at the University of Minnesota, Minneapolis.

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Sacrospinous Vaginal Vault Suspension: Variations on a Theme

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Sacrospinous Vaginal Vault Suspension: Variations on a Theme

A variety of operations now exists for the treatment of vaginal vault prolapse and the reestablishment of apical support—from abdominal sacral colpopexy and abdominal uterus sacral suspensions, to sacrospinous vaginal vault suspensions, sacrospinous hysteropexies, and iliococcygeal vaginal vault suspensions.

All options have been described in the literature as being effective operations with minimal complications and varying degrees of success, but the optimal approach for vaginal vault prolapse remains a subject of debate. Unfortunately, many surgeons are not comfortable with vaginal surgery, despite the safety, speed, and effectiveness that sacrospinous vaginal vault suspension and its modifications can provide in experienced hands.

Sacrospinous vaginal vault suspension was originally described by Dr. Paul Zweifel in Germany in 1892. It was “rediscovered” in 1951 by Dr. I.A. Amreich in Austria, modified by Dr. J. Sederl, and then studied and described extensively in 1968 by fellow Austrian Dr. K. Richter.

The operation received more attention when Dr. C.L. Randall and Dr. D.H. Nichols reported on it (Obstet. Gynecol. 1971;38:327–32). Since then, the posterior approach to sacrospinous vaginal vault suspension that was described by Dr. Nichols has been modified, and an alternative approach through the anterior compartment of the vagina has been developed and described. Several newer devices, in the meantime, have offered improved safety and simplicity.

The Original Posterior Approach

The posterior approach to sacrospinous vaginal vault suspension involves a posterior vaginal incision, perforation of the rectal pillars, and blunt dissection of the pararectal space anterior to the ligament.

In the original posterior approach described by Dr. Nichols, two Allis clamps are placed at the level of the hymenal ring, approximately 1 cm from the midline, and a dilute vasopressin solution can be used to infiltrate underneath the posterior vaginal wall to within 1 cm of the apex of the vagina. The scalpel is used to make a transverse incision between the Allis clamps, and then the Metzenbaum scissors are used to dissect underneath the vaginal epithelium in the midline, vertically to within 1 cm of the apex of the vagina.

The Metzenbaum scissors can be used to spread beneath the vaginal epithelium and smooth muscle to free the underlying endopelvic connective tissue from its attachments on the undersurface of the vaginal epithelium and smooth muscle. (See photo.) The scissors can then be used to make a vertical incision in the posterior vaginal wall to about 1–2 cm away from the vaginal apex.

Placement of Allis clamps—or self-restraining retractor hooks—on the incised edges of the vaginal epithelium and smooth muscle can allow for exposure and resection of the endopelvic connective tissue from the undersurface of the vaginal epithelium and smooth muscle laterally to the level of the rectal pillars. This may be facilitated by countertraction from your assistant, using tissue forceps on the endopelvic connective tissue.

Once this dissection is complete, the ischial spine on the patient's right side may be palpated, and—with either sharp dissection with the tips of the Metzenbaum scissors or blunt dissection with the operator's right index finger—the endopelvic connective tissue can be swept from anterior-lateral to medial of the ischial spine across the coccygeus muscle to remove the fatty tissue that overlies the ischial spine and the sacrospinous ligament.

The entire coccygeus muscle with its anterior sacrospinous ligament should be palpated, and the rectum and pararectal attachments mobilized bluntly with the index finger from lateral to medial. This is a relatively blood-free plane, and such a maneuver is possible with minimal bleeding so long as the affecting finger remains anterior to the ischial spine and sacrospinous ligament.

A short Breisky-Navratil retractor can then be placed at the 10 o'clock position, resting on the ischial spine. By maintaining your right index finger against the ischial spine, you can then insert a long Breisky-Navratil retractor directly opposing the short retractor over the ventral surface of your finger, against the ischial spine with its posterior edge just anterior to the coccygeus muscle.

Sweeping this long retractor counterclockwise immediately across the coccygeus muscle, keeping its posterior blade in contact with the muscle throughout, will mobilize the rectal and pararectal fat medially and expose the coccygeus muscle and sacrospinous ligament. This retractor should be held at approximately the 2 o'clock position, creating a 60- to 90-degree angle with the other Breisky-Navratil retractor. (The exact angle will depend on the angle of the pubic arch.)

At this point, the right-angle Haney retractor can be placed at approximately the 7 o'clock position over the coccygeus muscle and then, with posterior traction, withdrawn distally until it pops down in front of the coccygeus muscle, exposing this muscle and sacrospinous ligament.

 

 

A Deschamps ligature carrier then can be inserted through the middle of the coccygeus muscle and rotated clockwise to expose its tip around the sacrospinous ligament. The initial bite should be placed 1 cm medial to the ischial spine to avoid the pudendal complex. A second suture can then be placed 1–2 cm medial to the first, again with care taken to place it through the middle of the coccygeus muscle and not posterior to this muscle, where it could injure the vessel and nerve of the pudendal complex.

When the Deschamps ligature carrier is brought through the muscle, a colpotomy or nerve hook can be used to mobilize one end of the suture and withdraw it back out into the operative field. Once this is mobilized, the Deschamps ligature carrier can be rotated counterclockwise—in an arc exactly opposite to that in which it was placed—to withdraw the posterior end of the suture.

Care should be taken to identify the posterior end of the suture and differentiate it from the anterior end. This may be accomplished through the use of a straight hemostat on one end and the placement of a curved hemostat across both ends of the suture.

(When we perform the surgery, we use a straight hemostat to identify the posterior end of suture on the patient's right side, or the lateral suture, and a straight Kocher clamp to identify the posterior end on the patient's left side.)

The Breisky-Navratil retractors can then be slowly withdrawn one at a time to allow for observation of the entire paravaginal space and assessment for any bleeders, which can be easily grasped and electrocoagulated or sutured.

The suture can then be placed on the undersurface of the apex of the vagina by use of a free Mayo needle. The anterior arm of the lateral suture can be placed approximately 1–2 cm away from the right apex of the vagina in a figure-eight fashion, and this one arm of the suture can be tied to itself with a loose surgeon's knot.

The same process can be followed with the left or medial anterior arm of the second sacrospinous suture, 1–2 cm away from the left apex of the vagina, and tied down in the same fashion. Care needs to be taken on the patient's left side to place the suture approximately 0.5 cm further away from the apical edge of the vagina, as this suture will traverse a longer distance to reach the sacrospinous ligament.

Now the sutures can be retracted anteriorly, and a rectocele repair and/or enterocele repair can be performed as needed.

After successful completion of such repairs, excess vaginal epithelium and smooth muscle can be resected as indicated and the posterior vaginal wall closed with either interrupted sutures or a running, locking suture approximately halfway down the posterior vaginal wall.

At this point, the sacrospinous sutures should be tied down, with the suture on the patient's right lateral side tied down first. The posterior arm of the sacrospinous suture should be taken in the nondominant hand, and slow traction should be applied while the apex of the vagina is guided back into position in the pelvis, toward the right sacrospinous ligament.

Once the excess slack is taken up by mobilization of this suture, the suture may be tied down, with care taken to leave no gap between the vaginal apex and the sacrospinous ligament. This suture is then held while the second suture is mobilized in the same fashion and then tied down similarly.

Retraction of the undersurface of the closed posterior vaginal wall will allow for visualization of the sacrospinous sutures, which can be cut approximately 1 cm above the knot. The posterior vaginal wall may be closed, and perineorrhaphy performed as indicated.

The choice of sutures is up to the individual operator. Although Dr. Nichols originally described using delayed-absorbable sutures, later in his career he changed to using one Gore-Tex suture and one polyglycolic acid suture. He informed me that his reason for this was that the permanent suture would offer longer-lasting strength, whereas the delayed-absorbable suture would create more inflammatory response and possibly elicit more scarring.

Variations of the Original Approach

Some surgeons have suggested that a bilateral attachment of the vaginal apex—or attachment of the cervix, when the uterus is preserved—may offer a superior anatomical reconstruction of the vaginal vault, and may avoid deviation of the vagina to the right or the left side.

Instead of placing two sutures on one sacrospinous ligament, a single suture can be placed on the right sacrospinous ligament at its midportion and on the left sacrospinous ligament at its midportion. These sutures are attached to the right and left apex of the vagina, respectively.

 

 

This approach, the thinking goes, allows for a wider width of the vaginal apex in the posthysterectomy patient, as well as good lateral support.

Often, a bilateral sacrospinous ligament suspension may be augmented by bilateral paravaginal defect repairs performed through the vagina, with or without the use of an adjuvant graft. The dissection for placement of these sutures is identical to the ipsilateral dissection for sacrospinous vaginal vault suspension, just described, on the patient's right side; it also can be performed on the patient's left side, with care taken to mobilize the rectum medially (which is often a more challenging task on the patient's left side).

Bilateral suspension to the sacrospinous ligament has not, however, been compared directly to unilateral sacrospinous vaginal vault suspension. Sometimes, when scarring exists in the midline from prior vaginal hysterectomy, or when an enterocele repair has been performed, there may be indentation in the midline of the vaginal vault, creating a somewhat Y-shaped vagina.

In a report published in 1997, Dr. J.F. Pohl and Dr. J.L. Frattarelli concluded that bilateral suspension is feasible in many patients, but that it requires significant intraoperative judgment both as to its feasibility and as to the width of the vaginal cuff that will allow a bilateral suspension without tension (Am. J. Obstet. Gynecol. 1997;177:1356–61).

In our practice, we tend to prefer right-sided vaginal vault suspensions in which we utilize either an anterior approach or a posterior approach, with a left-sided iliococcygeus vaginal vault suspension. This requires less dissection and less risk of bleeding, as the sutures are placed lateral to the ischial spine.

It also creates a vagina with further cephalad elevation of the right vaginal apex than the left vaginal apex, as well as an ample apical width.

Anterior sacrospinous suspension is an approach that we have pursued and described in order to address possible shortcomings or limitations of the conventional posterior approach—chiefly, recurrence of anterior vaginal wall prolapse and a deep posterior angle and narrowing of the upper one-third of the vaginal vault.

Whereas posterior suspension uses a posterior vaginal incision and pararectal dissection, anterior suspension uses an anterior vaginal incision, perforation into the right retropubic space, and dissection of the ipsilateral paravaginal space from the level of the bladder neck to the ischial spine, to create a wide space to accommodate the vaginal vault.

In our experience—Dr. Harvey A. Winkler, Dr. Janet E. Tomeszko, and I first reported on the technique in 2000—the anterior approach appears to reduce postoperative proximal vaginal narrowing and lateral deviation of the upper vagina by avoiding passage through the rectal pillars (Obstet. Gynecol. 2000;95:612–5).

The technique involves opening the anterior vaginal wall and separating the endopelvic connective tissue on the patient's right from the pubic ramus at the level of the bladder neck to the ischial spine, exposing the paravesical and pararectal space. The sacrospinous ligament is identified and isolated through this space.

Two permanent sutures are placed approximately 2 cm apart through the ligament, anchored with pulley stitches underneath the vaginal epithelium and smooth muscle, and tied down to the ligament.

An Evolution in Instrumentation

The Deschamps ligature carrier is the device originally used for applying sutures through the coccygeus muscle and sacrospinous ligament. However, because the ligature carrier is delivered posterior-laterally to anterior-medially, there always has been concern about potential damage to the pudendal artery, vein, and nerve.

With the advent of newer devices that deliver the suture in a limited arc from the anterior to posterior direction, the risk of damage to the pudendal complex has been significantly minimized and the need for extensive dissection is often unnecessary. The newer devices have thus improved not only the safety of the procedure but also its simplicity, and they have reduced the operative time required.

The first of these devices described for applying sutures in a defined arc from anterior to posterior was the Miya hook, described by Dr. F. Miyazaki.

Another new device, the Capio device, is a push-and-catch suture delivery system that allows the suture to be delivered over a defined arc into a catch device. The Capio device has enabled placement of sacrospinous sutures through palpation and without direct visualization of the ligament. This further limits the need for dissection of the perirectal space, potentially improving safety and reducing blood loss.

Other authors have described using the Schutt device, which also delivers a suture from anterior to posterior in a defined arc to improve the safety and speed of the procedure.

Evolving Research

 

 

At this time, there are relatively few studies that have compared vaginal sacrospinous colpopexy with abdominal sacral colpopexy for the treatment of upper vaginal prolapse.

The two prospective, randomized trials that appear to be most often cited and referred to—a study by Dr. Christopher F. Maher published in 2004 and a study by Dr. J. Thomas Benson published in 1996—were quite different in their scope and methodology (Am. J. Obstet. Gynecol. 2004;190:20–6; 1996;175:1418–21).

Dr. Benson's group reported data for 80 women with uterovaginal or vault prolapse and concluded that the abdominal approach was more effective, but this study involved the use of multiple concomitant procedures that may have confounded the outcomes.

Needle suspensions of the bladder neck were used in the vaginal surgery group, compared with retropubic urethropexies in the abdominal surgery group. Needle suspensions have been associated with a significant increased risk of subsequent recurrent cystocele and have affected the high recurrent prolapse rate for the vaginal surgery group.

The outcomes for both groups in the Benson study were very poor and markedly different from other results in the literature, which makes it difficult to generalize these outcomes to other populations.

Dr. Maher's study was better designed and has been more reflective of my experience and the experience of many other surgeons. His group reported on 95 women with posthysterectomy vaginal vault prolapse, and concluded that both surgeries are highly effective and significantly improve the patient's quality of life.

Similarly, in the same year of Dr. Benson's publication, Dr. P.J. Hardiman and Dr. H.P. Drutz reported that in a case series of 130 sacrospinous vaginal vault suspensions and 80 abdominal sacral colpopexies, the failure rate in terms of the recurrent vault prolapse was 2.4% with the vaginal approach and 1.3% with the abdominal approach (Am. J. Obstet. Gynecol. 1996;175[3, pt. 1]:612–6).

They concluded that both approaches were associated with a low incidence of complications and recurrent vault prolapse.

Although it was not a randomized trial, the Hardiman-Drutz study is noteworthy and the outcomes are more comparable with real-life experience. I believe that surgeons who are expert at performing both surgeries find them to be equally successful, with the vaginal approach having less morbidity.

Success, in most cases, has been defined through rates of recurrent apical or anterior vaginal prolapse, and few studies have addressed anatomical outcomes more directly relevant to vaginal function, such as length, axis, and sexual satisfaction.

We are challenged by the lack of universally accepted standards for quantifying such outcomes, but nevertheless, such outcomes should be pursued.

In a study reported in 2001 (with Dr. R. Goldberg as lead author), we found that sexual function was well preserved regardless of the sacrospinous suspension technique, with equally low rates of postoperative dyspareunia in both groups (Obstet. Gynecol. 2001;98:199–204).

Metzenbaum scissors are used to free the endopelvic connective tissue from the vaginal epithelium. Courtesy Dr. Peter Sand

The dissection finger is placed adjacent to the suture site.

The upper vaginal vault is sutured to the sacrospinous ligament.

Vaginal wall suturing is done at the upper portion of the vaginal apex. Images courtesy Dr. Peter Sand

A Vaginal Approach to Pelvic Floor Prolapse

In a recent Master Class (OB.GYN. NEWS, Aug. 1, 2007, p. 24), abdominal sacral colpopexy via a laparoscopic approach was featured for the treatment of vaginal vault prolapse. However, for the gynecologic surgeon who is more adroit with vaginal surgery, sacrospinous vaginal vault suspension also offers a safe and effective remedy for this disorder. As a review, the ischial spine is located approximately halfway between the pubic bones and the sacrum. Posterior to the spine is the sacrospinous ligament with the overlying coccygeus muscle. The sacrospinous ligament marks the posterior limit of the pelvic diaphragm.

Because he is a nationally recognized expert in the vaginal approach to pelvic floor prolapse, I have asked Dr. Peter Sand to discuss vaginal vault suspension, the evolution of the procedure, and the prevailing literature that compares this technique with abdominal sacral colpopexy.

Dr. Sand is currently a professor of ob.gyn. at Northwestern University, Chicago, and the director of urogynecology and reconstructive pelvic surgery at Evanston (Ill.) Northwestern Healthcare. Dr. Sand is a prolific researcher and much-sought-after lecturer. As this year's scientific program chairman of the American Association of Gynecologic Laparoscopists' Global Congress of Minimally Invasive Gynecology, I invited Dr. Sand to present a surgical tutorial on the vaginal approach to prolapse. Just as the participants found his discussion interesting and informative, I am sure our readers will feel the same.

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A variety of operations now exists for the treatment of vaginal vault prolapse and the reestablishment of apical support—from abdominal sacral colpopexy and abdominal uterus sacral suspensions, to sacrospinous vaginal vault suspensions, sacrospinous hysteropexies, and iliococcygeal vaginal vault suspensions.

All options have been described in the literature as being effective operations with minimal complications and varying degrees of success, but the optimal approach for vaginal vault prolapse remains a subject of debate. Unfortunately, many surgeons are not comfortable with vaginal surgery, despite the safety, speed, and effectiveness that sacrospinous vaginal vault suspension and its modifications can provide in experienced hands.

Sacrospinous vaginal vault suspension was originally described by Dr. Paul Zweifel in Germany in 1892. It was “rediscovered” in 1951 by Dr. I.A. Amreich in Austria, modified by Dr. J. Sederl, and then studied and described extensively in 1968 by fellow Austrian Dr. K. Richter.

The operation received more attention when Dr. C.L. Randall and Dr. D.H. Nichols reported on it (Obstet. Gynecol. 1971;38:327–32). Since then, the posterior approach to sacrospinous vaginal vault suspension that was described by Dr. Nichols has been modified, and an alternative approach through the anterior compartment of the vagina has been developed and described. Several newer devices, in the meantime, have offered improved safety and simplicity.

The Original Posterior Approach

The posterior approach to sacrospinous vaginal vault suspension involves a posterior vaginal incision, perforation of the rectal pillars, and blunt dissection of the pararectal space anterior to the ligament.

In the original posterior approach described by Dr. Nichols, two Allis clamps are placed at the level of the hymenal ring, approximately 1 cm from the midline, and a dilute vasopressin solution can be used to infiltrate underneath the posterior vaginal wall to within 1 cm of the apex of the vagina. The scalpel is used to make a transverse incision between the Allis clamps, and then the Metzenbaum scissors are used to dissect underneath the vaginal epithelium in the midline, vertically to within 1 cm of the apex of the vagina.

The Metzenbaum scissors can be used to spread beneath the vaginal epithelium and smooth muscle to free the underlying endopelvic connective tissue from its attachments on the undersurface of the vaginal epithelium and smooth muscle. (See photo.) The scissors can then be used to make a vertical incision in the posterior vaginal wall to about 1–2 cm away from the vaginal apex.

Placement of Allis clamps—or self-restraining retractor hooks—on the incised edges of the vaginal epithelium and smooth muscle can allow for exposure and resection of the endopelvic connective tissue from the undersurface of the vaginal epithelium and smooth muscle laterally to the level of the rectal pillars. This may be facilitated by countertraction from your assistant, using tissue forceps on the endopelvic connective tissue.

Once this dissection is complete, the ischial spine on the patient's right side may be palpated, and—with either sharp dissection with the tips of the Metzenbaum scissors or blunt dissection with the operator's right index finger—the endopelvic connective tissue can be swept from anterior-lateral to medial of the ischial spine across the coccygeus muscle to remove the fatty tissue that overlies the ischial spine and the sacrospinous ligament.

The entire coccygeus muscle with its anterior sacrospinous ligament should be palpated, and the rectum and pararectal attachments mobilized bluntly with the index finger from lateral to medial. This is a relatively blood-free plane, and such a maneuver is possible with minimal bleeding so long as the affecting finger remains anterior to the ischial spine and sacrospinous ligament.

A short Breisky-Navratil retractor can then be placed at the 10 o'clock position, resting on the ischial spine. By maintaining your right index finger against the ischial spine, you can then insert a long Breisky-Navratil retractor directly opposing the short retractor over the ventral surface of your finger, against the ischial spine with its posterior edge just anterior to the coccygeus muscle.

Sweeping this long retractor counterclockwise immediately across the coccygeus muscle, keeping its posterior blade in contact with the muscle throughout, will mobilize the rectal and pararectal fat medially and expose the coccygeus muscle and sacrospinous ligament. This retractor should be held at approximately the 2 o'clock position, creating a 60- to 90-degree angle with the other Breisky-Navratil retractor. (The exact angle will depend on the angle of the pubic arch.)

At this point, the right-angle Haney retractor can be placed at approximately the 7 o'clock position over the coccygeus muscle and then, with posterior traction, withdrawn distally until it pops down in front of the coccygeus muscle, exposing this muscle and sacrospinous ligament.

 

 

A Deschamps ligature carrier then can be inserted through the middle of the coccygeus muscle and rotated clockwise to expose its tip around the sacrospinous ligament. The initial bite should be placed 1 cm medial to the ischial spine to avoid the pudendal complex. A second suture can then be placed 1–2 cm medial to the first, again with care taken to place it through the middle of the coccygeus muscle and not posterior to this muscle, where it could injure the vessel and nerve of the pudendal complex.

When the Deschamps ligature carrier is brought through the muscle, a colpotomy or nerve hook can be used to mobilize one end of the suture and withdraw it back out into the operative field. Once this is mobilized, the Deschamps ligature carrier can be rotated counterclockwise—in an arc exactly opposite to that in which it was placed—to withdraw the posterior end of the suture.

Care should be taken to identify the posterior end of the suture and differentiate it from the anterior end. This may be accomplished through the use of a straight hemostat on one end and the placement of a curved hemostat across both ends of the suture.

(When we perform the surgery, we use a straight hemostat to identify the posterior end of suture on the patient's right side, or the lateral suture, and a straight Kocher clamp to identify the posterior end on the patient's left side.)

The Breisky-Navratil retractors can then be slowly withdrawn one at a time to allow for observation of the entire paravaginal space and assessment for any bleeders, which can be easily grasped and electrocoagulated or sutured.

The suture can then be placed on the undersurface of the apex of the vagina by use of a free Mayo needle. The anterior arm of the lateral suture can be placed approximately 1–2 cm away from the right apex of the vagina in a figure-eight fashion, and this one arm of the suture can be tied to itself with a loose surgeon's knot.

The same process can be followed with the left or medial anterior arm of the second sacrospinous suture, 1–2 cm away from the left apex of the vagina, and tied down in the same fashion. Care needs to be taken on the patient's left side to place the suture approximately 0.5 cm further away from the apical edge of the vagina, as this suture will traverse a longer distance to reach the sacrospinous ligament.

Now the sutures can be retracted anteriorly, and a rectocele repair and/or enterocele repair can be performed as needed.

After successful completion of such repairs, excess vaginal epithelium and smooth muscle can be resected as indicated and the posterior vaginal wall closed with either interrupted sutures or a running, locking suture approximately halfway down the posterior vaginal wall.

At this point, the sacrospinous sutures should be tied down, with the suture on the patient's right lateral side tied down first. The posterior arm of the sacrospinous suture should be taken in the nondominant hand, and slow traction should be applied while the apex of the vagina is guided back into position in the pelvis, toward the right sacrospinous ligament.

Once the excess slack is taken up by mobilization of this suture, the suture may be tied down, with care taken to leave no gap between the vaginal apex and the sacrospinous ligament. This suture is then held while the second suture is mobilized in the same fashion and then tied down similarly.

Retraction of the undersurface of the closed posterior vaginal wall will allow for visualization of the sacrospinous sutures, which can be cut approximately 1 cm above the knot. The posterior vaginal wall may be closed, and perineorrhaphy performed as indicated.

The choice of sutures is up to the individual operator. Although Dr. Nichols originally described using delayed-absorbable sutures, later in his career he changed to using one Gore-Tex suture and one polyglycolic acid suture. He informed me that his reason for this was that the permanent suture would offer longer-lasting strength, whereas the delayed-absorbable suture would create more inflammatory response and possibly elicit more scarring.

Variations of the Original Approach

Some surgeons have suggested that a bilateral attachment of the vaginal apex—or attachment of the cervix, when the uterus is preserved—may offer a superior anatomical reconstruction of the vaginal vault, and may avoid deviation of the vagina to the right or the left side.

Instead of placing two sutures on one sacrospinous ligament, a single suture can be placed on the right sacrospinous ligament at its midportion and on the left sacrospinous ligament at its midportion. These sutures are attached to the right and left apex of the vagina, respectively.

 

 

This approach, the thinking goes, allows for a wider width of the vaginal apex in the posthysterectomy patient, as well as good lateral support.

Often, a bilateral sacrospinous ligament suspension may be augmented by bilateral paravaginal defect repairs performed through the vagina, with or without the use of an adjuvant graft. The dissection for placement of these sutures is identical to the ipsilateral dissection for sacrospinous vaginal vault suspension, just described, on the patient's right side; it also can be performed on the patient's left side, with care taken to mobilize the rectum medially (which is often a more challenging task on the patient's left side).

Bilateral suspension to the sacrospinous ligament has not, however, been compared directly to unilateral sacrospinous vaginal vault suspension. Sometimes, when scarring exists in the midline from prior vaginal hysterectomy, or when an enterocele repair has been performed, there may be indentation in the midline of the vaginal vault, creating a somewhat Y-shaped vagina.

In a report published in 1997, Dr. J.F. Pohl and Dr. J.L. Frattarelli concluded that bilateral suspension is feasible in many patients, but that it requires significant intraoperative judgment both as to its feasibility and as to the width of the vaginal cuff that will allow a bilateral suspension without tension (Am. J. Obstet. Gynecol. 1997;177:1356–61).

In our practice, we tend to prefer right-sided vaginal vault suspensions in which we utilize either an anterior approach or a posterior approach, with a left-sided iliococcygeus vaginal vault suspension. This requires less dissection and less risk of bleeding, as the sutures are placed lateral to the ischial spine.

It also creates a vagina with further cephalad elevation of the right vaginal apex than the left vaginal apex, as well as an ample apical width.

Anterior sacrospinous suspension is an approach that we have pursued and described in order to address possible shortcomings or limitations of the conventional posterior approach—chiefly, recurrence of anterior vaginal wall prolapse and a deep posterior angle and narrowing of the upper one-third of the vaginal vault.

Whereas posterior suspension uses a posterior vaginal incision and pararectal dissection, anterior suspension uses an anterior vaginal incision, perforation into the right retropubic space, and dissection of the ipsilateral paravaginal space from the level of the bladder neck to the ischial spine, to create a wide space to accommodate the vaginal vault.

In our experience—Dr. Harvey A. Winkler, Dr. Janet E. Tomeszko, and I first reported on the technique in 2000—the anterior approach appears to reduce postoperative proximal vaginal narrowing and lateral deviation of the upper vagina by avoiding passage through the rectal pillars (Obstet. Gynecol. 2000;95:612–5).

The technique involves opening the anterior vaginal wall and separating the endopelvic connective tissue on the patient's right from the pubic ramus at the level of the bladder neck to the ischial spine, exposing the paravesical and pararectal space. The sacrospinous ligament is identified and isolated through this space.

Two permanent sutures are placed approximately 2 cm apart through the ligament, anchored with pulley stitches underneath the vaginal epithelium and smooth muscle, and tied down to the ligament.

An Evolution in Instrumentation

The Deschamps ligature carrier is the device originally used for applying sutures through the coccygeus muscle and sacrospinous ligament. However, because the ligature carrier is delivered posterior-laterally to anterior-medially, there always has been concern about potential damage to the pudendal artery, vein, and nerve.

With the advent of newer devices that deliver the suture in a limited arc from the anterior to posterior direction, the risk of damage to the pudendal complex has been significantly minimized and the need for extensive dissection is often unnecessary. The newer devices have thus improved not only the safety of the procedure but also its simplicity, and they have reduced the operative time required.

The first of these devices described for applying sutures in a defined arc from anterior to posterior was the Miya hook, described by Dr. F. Miyazaki.

Another new device, the Capio device, is a push-and-catch suture delivery system that allows the suture to be delivered over a defined arc into a catch device. The Capio device has enabled placement of sacrospinous sutures through palpation and without direct visualization of the ligament. This further limits the need for dissection of the perirectal space, potentially improving safety and reducing blood loss.

Other authors have described using the Schutt device, which also delivers a suture from anterior to posterior in a defined arc to improve the safety and speed of the procedure.

Evolving Research

 

 

At this time, there are relatively few studies that have compared vaginal sacrospinous colpopexy with abdominal sacral colpopexy for the treatment of upper vaginal prolapse.

The two prospective, randomized trials that appear to be most often cited and referred to—a study by Dr. Christopher F. Maher published in 2004 and a study by Dr. J. Thomas Benson published in 1996—were quite different in their scope and methodology (Am. J. Obstet. Gynecol. 2004;190:20–6; 1996;175:1418–21).

Dr. Benson's group reported data for 80 women with uterovaginal or vault prolapse and concluded that the abdominal approach was more effective, but this study involved the use of multiple concomitant procedures that may have confounded the outcomes.

Needle suspensions of the bladder neck were used in the vaginal surgery group, compared with retropubic urethropexies in the abdominal surgery group. Needle suspensions have been associated with a significant increased risk of subsequent recurrent cystocele and have affected the high recurrent prolapse rate for the vaginal surgery group.

The outcomes for both groups in the Benson study were very poor and markedly different from other results in the literature, which makes it difficult to generalize these outcomes to other populations.

Dr. Maher's study was better designed and has been more reflective of my experience and the experience of many other surgeons. His group reported on 95 women with posthysterectomy vaginal vault prolapse, and concluded that both surgeries are highly effective and significantly improve the patient's quality of life.

Similarly, in the same year of Dr. Benson's publication, Dr. P.J. Hardiman and Dr. H.P. Drutz reported that in a case series of 130 sacrospinous vaginal vault suspensions and 80 abdominal sacral colpopexies, the failure rate in terms of the recurrent vault prolapse was 2.4% with the vaginal approach and 1.3% with the abdominal approach (Am. J. Obstet. Gynecol. 1996;175[3, pt. 1]:612–6).

They concluded that both approaches were associated with a low incidence of complications and recurrent vault prolapse.

Although it was not a randomized trial, the Hardiman-Drutz study is noteworthy and the outcomes are more comparable with real-life experience. I believe that surgeons who are expert at performing both surgeries find them to be equally successful, with the vaginal approach having less morbidity.

Success, in most cases, has been defined through rates of recurrent apical or anterior vaginal prolapse, and few studies have addressed anatomical outcomes more directly relevant to vaginal function, such as length, axis, and sexual satisfaction.

We are challenged by the lack of universally accepted standards for quantifying such outcomes, but nevertheless, such outcomes should be pursued.

In a study reported in 2001 (with Dr. R. Goldberg as lead author), we found that sexual function was well preserved regardless of the sacrospinous suspension technique, with equally low rates of postoperative dyspareunia in both groups (Obstet. Gynecol. 2001;98:199–204).

Metzenbaum scissors are used to free the endopelvic connective tissue from the vaginal epithelium. Courtesy Dr. Peter Sand

The dissection finger is placed adjacent to the suture site.

The upper vaginal vault is sutured to the sacrospinous ligament.

Vaginal wall suturing is done at the upper portion of the vaginal apex. Images courtesy Dr. Peter Sand

A Vaginal Approach to Pelvic Floor Prolapse

In a recent Master Class (OB.GYN. NEWS, Aug. 1, 2007, p. 24), abdominal sacral colpopexy via a laparoscopic approach was featured for the treatment of vaginal vault prolapse. However, for the gynecologic surgeon who is more adroit with vaginal surgery, sacrospinous vaginal vault suspension also offers a safe and effective remedy for this disorder. As a review, the ischial spine is located approximately halfway between the pubic bones and the sacrum. Posterior to the spine is the sacrospinous ligament with the overlying coccygeus muscle. The sacrospinous ligament marks the posterior limit of the pelvic diaphragm.

Because he is a nationally recognized expert in the vaginal approach to pelvic floor prolapse, I have asked Dr. Peter Sand to discuss vaginal vault suspension, the evolution of the procedure, and the prevailing literature that compares this technique with abdominal sacral colpopexy.

Dr. Sand is currently a professor of ob.gyn. at Northwestern University, Chicago, and the director of urogynecology and reconstructive pelvic surgery at Evanston (Ill.) Northwestern Healthcare. Dr. Sand is a prolific researcher and much-sought-after lecturer. As this year's scientific program chairman of the American Association of Gynecologic Laparoscopists' Global Congress of Minimally Invasive Gynecology, I invited Dr. Sand to present a surgical tutorial on the vaginal approach to prolapse. Just as the participants found his discussion interesting and informative, I am sure our readers will feel the same.

A variety of operations now exists for the treatment of vaginal vault prolapse and the reestablishment of apical support—from abdominal sacral colpopexy and abdominal uterus sacral suspensions, to sacrospinous vaginal vault suspensions, sacrospinous hysteropexies, and iliococcygeal vaginal vault suspensions.

All options have been described in the literature as being effective operations with minimal complications and varying degrees of success, but the optimal approach for vaginal vault prolapse remains a subject of debate. Unfortunately, many surgeons are not comfortable with vaginal surgery, despite the safety, speed, and effectiveness that sacrospinous vaginal vault suspension and its modifications can provide in experienced hands.

Sacrospinous vaginal vault suspension was originally described by Dr. Paul Zweifel in Germany in 1892. It was “rediscovered” in 1951 by Dr. I.A. Amreich in Austria, modified by Dr. J. Sederl, and then studied and described extensively in 1968 by fellow Austrian Dr. K. Richter.

The operation received more attention when Dr. C.L. Randall and Dr. D.H. Nichols reported on it (Obstet. Gynecol. 1971;38:327–32). Since then, the posterior approach to sacrospinous vaginal vault suspension that was described by Dr. Nichols has been modified, and an alternative approach through the anterior compartment of the vagina has been developed and described. Several newer devices, in the meantime, have offered improved safety and simplicity.

The Original Posterior Approach

The posterior approach to sacrospinous vaginal vault suspension involves a posterior vaginal incision, perforation of the rectal pillars, and blunt dissection of the pararectal space anterior to the ligament.

In the original posterior approach described by Dr. Nichols, two Allis clamps are placed at the level of the hymenal ring, approximately 1 cm from the midline, and a dilute vasopressin solution can be used to infiltrate underneath the posterior vaginal wall to within 1 cm of the apex of the vagina. The scalpel is used to make a transverse incision between the Allis clamps, and then the Metzenbaum scissors are used to dissect underneath the vaginal epithelium in the midline, vertically to within 1 cm of the apex of the vagina.

The Metzenbaum scissors can be used to spread beneath the vaginal epithelium and smooth muscle to free the underlying endopelvic connective tissue from its attachments on the undersurface of the vaginal epithelium and smooth muscle. (See photo.) The scissors can then be used to make a vertical incision in the posterior vaginal wall to about 1–2 cm away from the vaginal apex.

Placement of Allis clamps—or self-restraining retractor hooks—on the incised edges of the vaginal epithelium and smooth muscle can allow for exposure and resection of the endopelvic connective tissue from the undersurface of the vaginal epithelium and smooth muscle laterally to the level of the rectal pillars. This may be facilitated by countertraction from your assistant, using tissue forceps on the endopelvic connective tissue.

Once this dissection is complete, the ischial spine on the patient's right side may be palpated, and—with either sharp dissection with the tips of the Metzenbaum scissors or blunt dissection with the operator's right index finger—the endopelvic connective tissue can be swept from anterior-lateral to medial of the ischial spine across the coccygeus muscle to remove the fatty tissue that overlies the ischial spine and the sacrospinous ligament.

The entire coccygeus muscle with its anterior sacrospinous ligament should be palpated, and the rectum and pararectal attachments mobilized bluntly with the index finger from lateral to medial. This is a relatively blood-free plane, and such a maneuver is possible with minimal bleeding so long as the affecting finger remains anterior to the ischial spine and sacrospinous ligament.

A short Breisky-Navratil retractor can then be placed at the 10 o'clock position, resting on the ischial spine. By maintaining your right index finger against the ischial spine, you can then insert a long Breisky-Navratil retractor directly opposing the short retractor over the ventral surface of your finger, against the ischial spine with its posterior edge just anterior to the coccygeus muscle.

Sweeping this long retractor counterclockwise immediately across the coccygeus muscle, keeping its posterior blade in contact with the muscle throughout, will mobilize the rectal and pararectal fat medially and expose the coccygeus muscle and sacrospinous ligament. This retractor should be held at approximately the 2 o'clock position, creating a 60- to 90-degree angle with the other Breisky-Navratil retractor. (The exact angle will depend on the angle of the pubic arch.)

At this point, the right-angle Haney retractor can be placed at approximately the 7 o'clock position over the coccygeus muscle and then, with posterior traction, withdrawn distally until it pops down in front of the coccygeus muscle, exposing this muscle and sacrospinous ligament.

 

 

A Deschamps ligature carrier then can be inserted through the middle of the coccygeus muscle and rotated clockwise to expose its tip around the sacrospinous ligament. The initial bite should be placed 1 cm medial to the ischial spine to avoid the pudendal complex. A second suture can then be placed 1–2 cm medial to the first, again with care taken to place it through the middle of the coccygeus muscle and not posterior to this muscle, where it could injure the vessel and nerve of the pudendal complex.

When the Deschamps ligature carrier is brought through the muscle, a colpotomy or nerve hook can be used to mobilize one end of the suture and withdraw it back out into the operative field. Once this is mobilized, the Deschamps ligature carrier can be rotated counterclockwise—in an arc exactly opposite to that in which it was placed—to withdraw the posterior end of the suture.

Care should be taken to identify the posterior end of the suture and differentiate it from the anterior end. This may be accomplished through the use of a straight hemostat on one end and the placement of a curved hemostat across both ends of the suture.

(When we perform the surgery, we use a straight hemostat to identify the posterior end of suture on the patient's right side, or the lateral suture, and a straight Kocher clamp to identify the posterior end on the patient's left side.)

The Breisky-Navratil retractors can then be slowly withdrawn one at a time to allow for observation of the entire paravaginal space and assessment for any bleeders, which can be easily grasped and electrocoagulated or sutured.

The suture can then be placed on the undersurface of the apex of the vagina by use of a free Mayo needle. The anterior arm of the lateral suture can be placed approximately 1–2 cm away from the right apex of the vagina in a figure-eight fashion, and this one arm of the suture can be tied to itself with a loose surgeon's knot.

The same process can be followed with the left or medial anterior arm of the second sacrospinous suture, 1–2 cm away from the left apex of the vagina, and tied down in the same fashion. Care needs to be taken on the patient's left side to place the suture approximately 0.5 cm further away from the apical edge of the vagina, as this suture will traverse a longer distance to reach the sacrospinous ligament.

Now the sutures can be retracted anteriorly, and a rectocele repair and/or enterocele repair can be performed as needed.

After successful completion of such repairs, excess vaginal epithelium and smooth muscle can be resected as indicated and the posterior vaginal wall closed with either interrupted sutures or a running, locking suture approximately halfway down the posterior vaginal wall.

At this point, the sacrospinous sutures should be tied down, with the suture on the patient's right lateral side tied down first. The posterior arm of the sacrospinous suture should be taken in the nondominant hand, and slow traction should be applied while the apex of the vagina is guided back into position in the pelvis, toward the right sacrospinous ligament.

Once the excess slack is taken up by mobilization of this suture, the suture may be tied down, with care taken to leave no gap between the vaginal apex and the sacrospinous ligament. This suture is then held while the second suture is mobilized in the same fashion and then tied down similarly.

Retraction of the undersurface of the closed posterior vaginal wall will allow for visualization of the sacrospinous sutures, which can be cut approximately 1 cm above the knot. The posterior vaginal wall may be closed, and perineorrhaphy performed as indicated.

The choice of sutures is up to the individual operator. Although Dr. Nichols originally described using delayed-absorbable sutures, later in his career he changed to using one Gore-Tex suture and one polyglycolic acid suture. He informed me that his reason for this was that the permanent suture would offer longer-lasting strength, whereas the delayed-absorbable suture would create more inflammatory response and possibly elicit more scarring.

Variations of the Original Approach

Some surgeons have suggested that a bilateral attachment of the vaginal apex—or attachment of the cervix, when the uterus is preserved—may offer a superior anatomical reconstruction of the vaginal vault, and may avoid deviation of the vagina to the right or the left side.

Instead of placing two sutures on one sacrospinous ligament, a single suture can be placed on the right sacrospinous ligament at its midportion and on the left sacrospinous ligament at its midportion. These sutures are attached to the right and left apex of the vagina, respectively.

 

 

This approach, the thinking goes, allows for a wider width of the vaginal apex in the posthysterectomy patient, as well as good lateral support.

Often, a bilateral sacrospinous ligament suspension may be augmented by bilateral paravaginal defect repairs performed through the vagina, with or without the use of an adjuvant graft. The dissection for placement of these sutures is identical to the ipsilateral dissection for sacrospinous vaginal vault suspension, just described, on the patient's right side; it also can be performed on the patient's left side, with care taken to mobilize the rectum medially (which is often a more challenging task on the patient's left side).

Bilateral suspension to the sacrospinous ligament has not, however, been compared directly to unilateral sacrospinous vaginal vault suspension. Sometimes, when scarring exists in the midline from prior vaginal hysterectomy, or when an enterocele repair has been performed, there may be indentation in the midline of the vaginal vault, creating a somewhat Y-shaped vagina.

In a report published in 1997, Dr. J.F. Pohl and Dr. J.L. Frattarelli concluded that bilateral suspension is feasible in many patients, but that it requires significant intraoperative judgment both as to its feasibility and as to the width of the vaginal cuff that will allow a bilateral suspension without tension (Am. J. Obstet. Gynecol. 1997;177:1356–61).

In our practice, we tend to prefer right-sided vaginal vault suspensions in which we utilize either an anterior approach or a posterior approach, with a left-sided iliococcygeus vaginal vault suspension. This requires less dissection and less risk of bleeding, as the sutures are placed lateral to the ischial spine.

It also creates a vagina with further cephalad elevation of the right vaginal apex than the left vaginal apex, as well as an ample apical width.

Anterior sacrospinous suspension is an approach that we have pursued and described in order to address possible shortcomings or limitations of the conventional posterior approach—chiefly, recurrence of anterior vaginal wall prolapse and a deep posterior angle and narrowing of the upper one-third of the vaginal vault.

Whereas posterior suspension uses a posterior vaginal incision and pararectal dissection, anterior suspension uses an anterior vaginal incision, perforation into the right retropubic space, and dissection of the ipsilateral paravaginal space from the level of the bladder neck to the ischial spine, to create a wide space to accommodate the vaginal vault.

In our experience—Dr. Harvey A. Winkler, Dr. Janet E. Tomeszko, and I first reported on the technique in 2000—the anterior approach appears to reduce postoperative proximal vaginal narrowing and lateral deviation of the upper vagina by avoiding passage through the rectal pillars (Obstet. Gynecol. 2000;95:612–5).

The technique involves opening the anterior vaginal wall and separating the endopelvic connective tissue on the patient's right from the pubic ramus at the level of the bladder neck to the ischial spine, exposing the paravesical and pararectal space. The sacrospinous ligament is identified and isolated through this space.

Two permanent sutures are placed approximately 2 cm apart through the ligament, anchored with pulley stitches underneath the vaginal epithelium and smooth muscle, and tied down to the ligament.

An Evolution in Instrumentation

The Deschamps ligature carrier is the device originally used for applying sutures through the coccygeus muscle and sacrospinous ligament. However, because the ligature carrier is delivered posterior-laterally to anterior-medially, there always has been concern about potential damage to the pudendal artery, vein, and nerve.

With the advent of newer devices that deliver the suture in a limited arc from the anterior to posterior direction, the risk of damage to the pudendal complex has been significantly minimized and the need for extensive dissection is often unnecessary. The newer devices have thus improved not only the safety of the procedure but also its simplicity, and they have reduced the operative time required.

The first of these devices described for applying sutures in a defined arc from anterior to posterior was the Miya hook, described by Dr. F. Miyazaki.

Another new device, the Capio device, is a push-and-catch suture delivery system that allows the suture to be delivered over a defined arc into a catch device. The Capio device has enabled placement of sacrospinous sutures through palpation and without direct visualization of the ligament. This further limits the need for dissection of the perirectal space, potentially improving safety and reducing blood loss.

Other authors have described using the Schutt device, which also delivers a suture from anterior to posterior in a defined arc to improve the safety and speed of the procedure.

Evolving Research

 

 

At this time, there are relatively few studies that have compared vaginal sacrospinous colpopexy with abdominal sacral colpopexy for the treatment of upper vaginal prolapse.

The two prospective, randomized trials that appear to be most often cited and referred to—a study by Dr. Christopher F. Maher published in 2004 and a study by Dr. J. Thomas Benson published in 1996—were quite different in their scope and methodology (Am. J. Obstet. Gynecol. 2004;190:20–6; 1996;175:1418–21).

Dr. Benson's group reported data for 80 women with uterovaginal or vault prolapse and concluded that the abdominal approach was more effective, but this study involved the use of multiple concomitant procedures that may have confounded the outcomes.

Needle suspensions of the bladder neck were used in the vaginal surgery group, compared with retropubic urethropexies in the abdominal surgery group. Needle suspensions have been associated with a significant increased risk of subsequent recurrent cystocele and have affected the high recurrent prolapse rate for the vaginal surgery group.

The outcomes for both groups in the Benson study were very poor and markedly different from other results in the literature, which makes it difficult to generalize these outcomes to other populations.

Dr. Maher's study was better designed and has been more reflective of my experience and the experience of many other surgeons. His group reported on 95 women with posthysterectomy vaginal vault prolapse, and concluded that both surgeries are highly effective and significantly improve the patient's quality of life.

Similarly, in the same year of Dr. Benson's publication, Dr. P.J. Hardiman and Dr. H.P. Drutz reported that in a case series of 130 sacrospinous vaginal vault suspensions and 80 abdominal sacral colpopexies, the failure rate in terms of the recurrent vault prolapse was 2.4% with the vaginal approach and 1.3% with the abdominal approach (Am. J. Obstet. Gynecol. 1996;175[3, pt. 1]:612–6).

They concluded that both approaches were associated with a low incidence of complications and recurrent vault prolapse.

Although it was not a randomized trial, the Hardiman-Drutz study is noteworthy and the outcomes are more comparable with real-life experience. I believe that surgeons who are expert at performing both surgeries find them to be equally successful, with the vaginal approach having less morbidity.

Success, in most cases, has been defined through rates of recurrent apical or anterior vaginal prolapse, and few studies have addressed anatomical outcomes more directly relevant to vaginal function, such as length, axis, and sexual satisfaction.

We are challenged by the lack of universally accepted standards for quantifying such outcomes, but nevertheless, such outcomes should be pursued.

In a study reported in 2001 (with Dr. R. Goldberg as lead author), we found that sexual function was well preserved regardless of the sacrospinous suspension technique, with equally low rates of postoperative dyspareunia in both groups (Obstet. Gynecol. 2001;98:199–204).

Metzenbaum scissors are used to free the endopelvic connective tissue from the vaginal epithelium. Courtesy Dr. Peter Sand

The dissection finger is placed adjacent to the suture site.

The upper vaginal vault is sutured to the sacrospinous ligament.

Vaginal wall suturing is done at the upper portion of the vaginal apex. Images courtesy Dr. Peter Sand

A Vaginal Approach to Pelvic Floor Prolapse

In a recent Master Class (OB.GYN. NEWS, Aug. 1, 2007, p. 24), abdominal sacral colpopexy via a laparoscopic approach was featured for the treatment of vaginal vault prolapse. However, for the gynecologic surgeon who is more adroit with vaginal surgery, sacrospinous vaginal vault suspension also offers a safe and effective remedy for this disorder. As a review, the ischial spine is located approximately halfway between the pubic bones and the sacrum. Posterior to the spine is the sacrospinous ligament with the overlying coccygeus muscle. The sacrospinous ligament marks the posterior limit of the pelvic diaphragm.

Because he is a nationally recognized expert in the vaginal approach to pelvic floor prolapse, I have asked Dr. Peter Sand to discuss vaginal vault suspension, the evolution of the procedure, and the prevailing literature that compares this technique with abdominal sacral colpopexy.

Dr. Sand is currently a professor of ob.gyn. at Northwestern University, Chicago, and the director of urogynecology and reconstructive pelvic surgery at Evanston (Ill.) Northwestern Healthcare. Dr. Sand is a prolific researcher and much-sought-after lecturer. As this year's scientific program chairman of the American Association of Gynecologic Laparoscopists' Global Congress of Minimally Invasive Gynecology, I invited Dr. Sand to present a surgical tutorial on the vaginal approach to prolapse. Just as the participants found his discussion interesting and informative, I am sure our readers will feel the same.

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A Gynecologist's Procedure

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A Gynecologist's Procedure

Urology has long claimed the procedure as one that belongs within its realm of care, but for hundreds of years, gynecologic surgeons have used the cystoscope to examine the bladder. In doing so, they have not only evaluated fistulas and other occurrences, but have also authored many of the medical literature's notable papers on cystoscopy.

Gynecologists have also used the instrumentation to examine the urethra as well as the bladder. Dr. J.R. Robertson, an ob.gyn., is in fact the father of the urethroscope, which consists of an external sheath and a 0-degree lens.

In recent years, gynecologists have become more involved in evaluating problems such as bladder and pelvic pain, including interstitial cystitis, as well as recurrent urinary tract infection and overactive bladder symptoms.

Moreover, they have been performing increasing numbers of pelvic reconstruction procedures—and they have increasingly turned to cystoscopy, both to aid them in office diagnosis and to ensure surgical safety.

The evaluation of hematuria is still mainly within the realm of urologists.

Gynecologists' use of cystoscopy has become less controversial over the past decade as the lines between urology and gynecology have blurred, with gynecologists addressing more traditionally urologic issues and performing more procedures that were previously considered urologic, and vice versa.

Many gynecologists are using hysteroscopy to evaluate fibroids, abnormal uterine bleeding, and other symptoms, and for them, learning cystoscopy is an especially natural fit.

Even without the hysteroscopy backdrop, embracing cystoscopy with proper training is a natural and logical evolution for the specialty. In fact, an American College of Obstetricians and Gynecologists' Committee Opinion, issued in July, stated that cystoscopy is an important diagnostic and therapeutic tool, and that practicing gynecologists, especially gynecologic surgeons, should become comfortable with the routine performance of the procedure.

Office Cystoscopy

Cystoscopy is but one of several diagnostic tools and methods available for evaluating a number of indications, but it is proving to be a useful one. It can readily be performed in the office without the need for sedation.

The equipment needed to perform office cystoscopy includes a good light source; an endoscopic video system; a suitable hookup for a sterile water bag and related tubing; a cystoscope—preferably a narrow-angle scope (0–12.5 degrees)—to examine the urethra; and a wider-angle scope (70 degrees) to examine the bladder itself.

The urethra should be visualized first, with attention given to its anatomy, tone, and vasculature. It will look pink and spongy in a patient who is well estrogenized but pale and flat in someone who is atrophic. In a patient who has had a previous sling, the urethra should be evaluated for evidence of erosion.

Openings in the urethral wall that suggest diverticula, evidence of infection, and any other abnormalities can be identified. In women with stress incontinence, the severity of sphincteric deficiency can be evaluated by assessing urethral tone; someone with intrinsic sphincteric deficiency will have a patulous urethra and bladder neck.

We can also then evaluate mobility of the bladder neck—an area at which fronds, polyps, and cysts are normal variants—and the appearance of the trigone, or the posterior wall of the bladder right above the bladder neck.

Cystoscopy enables us to visualize various degrees of inflammation and to detect chronic trigonitis, an inflammatory condition that can present in women who have symptoms of recurrent urinary tract infection but negative urine cultures. Confirmation of the condition can usually be achieved with vaginal palpation of the trigone.

In visualizing the ureters, which is the next step in the office evaluation, our goal is to thoroughly evaluate the anatomy of the lower urinary tract. We can then examine the rest of the bladder, looking for evidence of obvious abnormalities like stones, tumors, diverticula, and inflammation. A 70-degree scope allows visualization of the entire bladder wall, including the lateral walls where a sling/suture erosion could occur.

We can also look for trabeculations, which are thick ridges observed in the middle of the bladder wall. Such patterns are sometimes a result of normal aging but they are also often found in patients with detrusor overactivity. Diverticula of the bladder can also be visualized; such abnormalities can be responsible for urinary retention.

Bladder tumors can take on various appearances, from flat white areas to cauliflowerlike papillary lesions. Although some cancers are obvious, other low-grade cancers can be extremely subtle in appearance. Persistent hematuria, especially in a smoker, should prompt us to perform a careful cystoscopy to look for tumors. If there is any question of malignancy, a biopsy can be performed in the office or upon referral to a urologist.

 

 

In women with bladder pain, we should look out for inflammatory changes, including glomerulations, which can suggest interstitial cystitis.

We also have the option of performing cystoscopy under anesthesia for patients with bladder pain. This process enables us to hydrodistend the bladder—the bladder is filled with fluid to capacity, emptied, and refilled—for an examination both of bladder capacity and of abnormalities like bleeding from glomerulations, while eliminating the pain component. A bladder that holds less than 400 mL of fluid under anesthesia is a bladder that is chronically scarred.

Bladder biopsies can be performed at the time of hydrodistention. Unfortunately, there is no consensus on indications for biopsy or on criteria for diagnosing interstitial cystitis (indeed, much about interstitial cystitis is controversial), but I believe that the scope can be an important diagnostic tool.

There also often is a therapeutic benefit to performing a cystoscopy and hydrodistention under anesthesia: Many patients remain relatively free of pain for 6 months or longer after the procedure. The urethral pain and dysuria that sometimes occur with cystoscopy can be treated with a preprocedure intraurethral injection of lidocaine jelly or oral phenazopyridine (Pyridium). Prophylactic oral antibiotics should be given routinely either right before or right after the procedure.

Intraoperative Cystoscopy

With more advanced incontinence and prolapse surgeries being performed by both urologists and gynecologists, it has become ever more important to use intraoperative cystoscopy to ensure that the bladder and ureters remain undamaged and unobstructed. In fact, we have reached a point where cystoscopy should be performed routinely for most advanced pelvic reconstructive procedures, whether the procedures are done vaginally or abdominally.

It is absolutely imperative that cystoscopy be performed with every retropubic sling that uses the tension-free vaginal tape (TVT) procedure.

With transobturator tape (TOT), its necessity is more debatable because needles don't pass as close to the bladder. Surgeons who have comfortably and successfully performed a significant number of TOT procedures can probably forgo cystoscopy.

There is one exception, however: cases in which TOT is performed before the prolapse is repaired. In this case, cystoscopy remains imperative.

Intraoperative cystoscopy has a fringe benefit as well, in that it sometimes leads to the identification of pathology—bladder stones, for instance—that went undiagnosed during the preoperative work-up.

Cystoscopy can also be used to guide the placement of suprapubic catheters intraoperatively, although its most significant purpose is to document ureteral patency. When examining for patency, most surgeons inject indigo carmine intravenously and examine the bladder approximately 10 minutes later to document flow of the dye through both ureteral openings.

Instruments and Training

A urethroscope with a 0-degree lens allows appropriate examination of the urethra; however, a 70-degree lens is preferable for examination of the bladder because it enables visualization of the entire circumference of the bladder in more detail.

Some surgeons are using flexible cystoscopes—the optics of flexible cystoscopy have improved significantly in recent years—but the 70-degree rigid scope is sufficient in the vast majority of procedures.

Gynecologists who perform trans- or periurethral bulking agent injections for intrinsic sphincteric deficiency must be comfortable with using a 0-degree scope in the office. In this process, which typically is done under cystoscopic guidance, a needle is placed either through the cystoscope or lateral to the urethra, and the agent—collagen (Contigen), silicone (Macroplastique), carbon beads (Durasphere), or another agent—is injected to add bulk around the urethral lumen and to increase urethral resistance.

For many gynecologists, cystoscopy is a natural progression from hysteroscopy. The two procedures are very similar when used for diagnostic purposes. Others are starting to perform cystoscopy even without the background in hysteroscopy, however.

In any case, the main issue we face is the need for training. We must learn how to use the instrumentation and advance the scope safely, without causing bladder trauma or perforation; how to approach various indications; and how to judge abnormal and normal aspects of the images obtained.

Although there are no courses including certification at this time, ACOG and others do offer various training courses designed to allow ob.gyns. to develop an expertise in cystoscopy.

Bladder trabeculations are in a patient with overactive bladder.

Urethral changes reflecting different levels of estrogenation: Atrophic looks pale and flat (top), normal looks pink and spongy (bottom). Photos courtesy Dr. G. Willy Davila

Tension-free vaginal tape mesh is shown in the urethra.

Ureteral opening is shown via cystoscopy, after injection of indigo carmine dye to document ureteral integrity. Photos courtesy Dr. G. Willy Davila

Cystoscopy

As a physician on the teaching faculty of two different residency programs in metropolitan Chicago—and as one whose surgical practice is limited to minimally invasive techniques—I see residents rotating through my service routinely performing cystoscopy in conjunction with total laparoscopic hysterectomy, resection of deep endometriosis over the pelvic sidewall or bladder, placement of a sling for the treatment of stress urinary incontinence, or evaluation of the bladder for interstitial cystitis.

 

 

Unfortunately, less than a generation ago, most trainees in our field had virtually no exposure to cystoscopy. Generally, as in my own case, gynecologists interested in gaining cystoscopy skills had to be mentored by a friendly urologist.

With this in mind, I have enlisted Dr. G. Willy Davila to present cystoscopy for this Master Class in gynecologic surgery.

Dr. Davila not only chairs the department of gynecology at the Cleveland Clinic in Weston, Fla., he also heads the clinic's section of urogynecology and reconstructive pelvic surgery.

Dr. Davila serves on the editorial boards of the Journal of Female Urinary Incontinence, Revista Latinoamericana de Uroginecologia y Disfunciones Pelvianas, and the International Urogynecology Journal. He is a prolific writer and has edited three books on the specialty subject matter of urogynecology.

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Urology has long claimed the procedure as one that belongs within its realm of care, but for hundreds of years, gynecologic surgeons have used the cystoscope to examine the bladder. In doing so, they have not only evaluated fistulas and other occurrences, but have also authored many of the medical literature's notable papers on cystoscopy.

Gynecologists have also used the instrumentation to examine the urethra as well as the bladder. Dr. J.R. Robertson, an ob.gyn., is in fact the father of the urethroscope, which consists of an external sheath and a 0-degree lens.

In recent years, gynecologists have become more involved in evaluating problems such as bladder and pelvic pain, including interstitial cystitis, as well as recurrent urinary tract infection and overactive bladder symptoms.

Moreover, they have been performing increasing numbers of pelvic reconstruction procedures—and they have increasingly turned to cystoscopy, both to aid them in office diagnosis and to ensure surgical safety.

The evaluation of hematuria is still mainly within the realm of urologists.

Gynecologists' use of cystoscopy has become less controversial over the past decade as the lines between urology and gynecology have blurred, with gynecologists addressing more traditionally urologic issues and performing more procedures that were previously considered urologic, and vice versa.

Many gynecologists are using hysteroscopy to evaluate fibroids, abnormal uterine bleeding, and other symptoms, and for them, learning cystoscopy is an especially natural fit.

Even without the hysteroscopy backdrop, embracing cystoscopy with proper training is a natural and logical evolution for the specialty. In fact, an American College of Obstetricians and Gynecologists' Committee Opinion, issued in July, stated that cystoscopy is an important diagnostic and therapeutic tool, and that practicing gynecologists, especially gynecologic surgeons, should become comfortable with the routine performance of the procedure.

Office Cystoscopy

Cystoscopy is but one of several diagnostic tools and methods available for evaluating a number of indications, but it is proving to be a useful one. It can readily be performed in the office without the need for sedation.

The equipment needed to perform office cystoscopy includes a good light source; an endoscopic video system; a suitable hookup for a sterile water bag and related tubing; a cystoscope—preferably a narrow-angle scope (0–12.5 degrees)—to examine the urethra; and a wider-angle scope (70 degrees) to examine the bladder itself.

The urethra should be visualized first, with attention given to its anatomy, tone, and vasculature. It will look pink and spongy in a patient who is well estrogenized but pale and flat in someone who is atrophic. In a patient who has had a previous sling, the urethra should be evaluated for evidence of erosion.

Openings in the urethral wall that suggest diverticula, evidence of infection, and any other abnormalities can be identified. In women with stress incontinence, the severity of sphincteric deficiency can be evaluated by assessing urethral tone; someone with intrinsic sphincteric deficiency will have a patulous urethra and bladder neck.

We can also then evaluate mobility of the bladder neck—an area at which fronds, polyps, and cysts are normal variants—and the appearance of the trigone, or the posterior wall of the bladder right above the bladder neck.

Cystoscopy enables us to visualize various degrees of inflammation and to detect chronic trigonitis, an inflammatory condition that can present in women who have symptoms of recurrent urinary tract infection but negative urine cultures. Confirmation of the condition can usually be achieved with vaginal palpation of the trigone.

In visualizing the ureters, which is the next step in the office evaluation, our goal is to thoroughly evaluate the anatomy of the lower urinary tract. We can then examine the rest of the bladder, looking for evidence of obvious abnormalities like stones, tumors, diverticula, and inflammation. A 70-degree scope allows visualization of the entire bladder wall, including the lateral walls where a sling/suture erosion could occur.

We can also look for trabeculations, which are thick ridges observed in the middle of the bladder wall. Such patterns are sometimes a result of normal aging but they are also often found in patients with detrusor overactivity. Diverticula of the bladder can also be visualized; such abnormalities can be responsible for urinary retention.

Bladder tumors can take on various appearances, from flat white areas to cauliflowerlike papillary lesions. Although some cancers are obvious, other low-grade cancers can be extremely subtle in appearance. Persistent hematuria, especially in a smoker, should prompt us to perform a careful cystoscopy to look for tumors. If there is any question of malignancy, a biopsy can be performed in the office or upon referral to a urologist.

 

 

In women with bladder pain, we should look out for inflammatory changes, including glomerulations, which can suggest interstitial cystitis.

We also have the option of performing cystoscopy under anesthesia for patients with bladder pain. This process enables us to hydrodistend the bladder—the bladder is filled with fluid to capacity, emptied, and refilled—for an examination both of bladder capacity and of abnormalities like bleeding from glomerulations, while eliminating the pain component. A bladder that holds less than 400 mL of fluid under anesthesia is a bladder that is chronically scarred.

Bladder biopsies can be performed at the time of hydrodistention. Unfortunately, there is no consensus on indications for biopsy or on criteria for diagnosing interstitial cystitis (indeed, much about interstitial cystitis is controversial), but I believe that the scope can be an important diagnostic tool.

There also often is a therapeutic benefit to performing a cystoscopy and hydrodistention under anesthesia: Many patients remain relatively free of pain for 6 months or longer after the procedure. The urethral pain and dysuria that sometimes occur with cystoscopy can be treated with a preprocedure intraurethral injection of lidocaine jelly or oral phenazopyridine (Pyridium). Prophylactic oral antibiotics should be given routinely either right before or right after the procedure.

Intraoperative Cystoscopy

With more advanced incontinence and prolapse surgeries being performed by both urologists and gynecologists, it has become ever more important to use intraoperative cystoscopy to ensure that the bladder and ureters remain undamaged and unobstructed. In fact, we have reached a point where cystoscopy should be performed routinely for most advanced pelvic reconstructive procedures, whether the procedures are done vaginally or abdominally.

It is absolutely imperative that cystoscopy be performed with every retropubic sling that uses the tension-free vaginal tape (TVT) procedure.

With transobturator tape (TOT), its necessity is more debatable because needles don't pass as close to the bladder. Surgeons who have comfortably and successfully performed a significant number of TOT procedures can probably forgo cystoscopy.

There is one exception, however: cases in which TOT is performed before the prolapse is repaired. In this case, cystoscopy remains imperative.

Intraoperative cystoscopy has a fringe benefit as well, in that it sometimes leads to the identification of pathology—bladder stones, for instance—that went undiagnosed during the preoperative work-up.

Cystoscopy can also be used to guide the placement of suprapubic catheters intraoperatively, although its most significant purpose is to document ureteral patency. When examining for patency, most surgeons inject indigo carmine intravenously and examine the bladder approximately 10 minutes later to document flow of the dye through both ureteral openings.

Instruments and Training

A urethroscope with a 0-degree lens allows appropriate examination of the urethra; however, a 70-degree lens is preferable for examination of the bladder because it enables visualization of the entire circumference of the bladder in more detail.

Some surgeons are using flexible cystoscopes—the optics of flexible cystoscopy have improved significantly in recent years—but the 70-degree rigid scope is sufficient in the vast majority of procedures.

Gynecologists who perform trans- or periurethral bulking agent injections for intrinsic sphincteric deficiency must be comfortable with using a 0-degree scope in the office. In this process, which typically is done under cystoscopic guidance, a needle is placed either through the cystoscope or lateral to the urethra, and the agent—collagen (Contigen), silicone (Macroplastique), carbon beads (Durasphere), or another agent—is injected to add bulk around the urethral lumen and to increase urethral resistance.

For many gynecologists, cystoscopy is a natural progression from hysteroscopy. The two procedures are very similar when used for diagnostic purposes. Others are starting to perform cystoscopy even without the background in hysteroscopy, however.

In any case, the main issue we face is the need for training. We must learn how to use the instrumentation and advance the scope safely, without causing bladder trauma or perforation; how to approach various indications; and how to judge abnormal and normal aspects of the images obtained.

Although there are no courses including certification at this time, ACOG and others do offer various training courses designed to allow ob.gyns. to develop an expertise in cystoscopy.

Bladder trabeculations are in a patient with overactive bladder.

Urethral changes reflecting different levels of estrogenation: Atrophic looks pale and flat (top), normal looks pink and spongy (bottom). Photos courtesy Dr. G. Willy Davila

Tension-free vaginal tape mesh is shown in the urethra.

Ureteral opening is shown via cystoscopy, after injection of indigo carmine dye to document ureteral integrity. Photos courtesy Dr. G. Willy Davila

Cystoscopy

As a physician on the teaching faculty of two different residency programs in metropolitan Chicago—and as one whose surgical practice is limited to minimally invasive techniques—I see residents rotating through my service routinely performing cystoscopy in conjunction with total laparoscopic hysterectomy, resection of deep endometriosis over the pelvic sidewall or bladder, placement of a sling for the treatment of stress urinary incontinence, or evaluation of the bladder for interstitial cystitis.

 

 

Unfortunately, less than a generation ago, most trainees in our field had virtually no exposure to cystoscopy. Generally, as in my own case, gynecologists interested in gaining cystoscopy skills had to be mentored by a friendly urologist.

With this in mind, I have enlisted Dr. G. Willy Davila to present cystoscopy for this Master Class in gynecologic surgery.

Dr. Davila not only chairs the department of gynecology at the Cleveland Clinic in Weston, Fla., he also heads the clinic's section of urogynecology and reconstructive pelvic surgery.

Dr. Davila serves on the editorial boards of the Journal of Female Urinary Incontinence, Revista Latinoamericana de Uroginecologia y Disfunciones Pelvianas, and the International Urogynecology Journal. He is a prolific writer and has edited three books on the specialty subject matter of urogynecology.

Urology has long claimed the procedure as one that belongs within its realm of care, but for hundreds of years, gynecologic surgeons have used the cystoscope to examine the bladder. In doing so, they have not only evaluated fistulas and other occurrences, but have also authored many of the medical literature's notable papers on cystoscopy.

Gynecologists have also used the instrumentation to examine the urethra as well as the bladder. Dr. J.R. Robertson, an ob.gyn., is in fact the father of the urethroscope, which consists of an external sheath and a 0-degree lens.

In recent years, gynecologists have become more involved in evaluating problems such as bladder and pelvic pain, including interstitial cystitis, as well as recurrent urinary tract infection and overactive bladder symptoms.

Moreover, they have been performing increasing numbers of pelvic reconstruction procedures—and they have increasingly turned to cystoscopy, both to aid them in office diagnosis and to ensure surgical safety.

The evaluation of hematuria is still mainly within the realm of urologists.

Gynecologists' use of cystoscopy has become less controversial over the past decade as the lines between urology and gynecology have blurred, with gynecologists addressing more traditionally urologic issues and performing more procedures that were previously considered urologic, and vice versa.

Many gynecologists are using hysteroscopy to evaluate fibroids, abnormal uterine bleeding, and other symptoms, and for them, learning cystoscopy is an especially natural fit.

Even without the hysteroscopy backdrop, embracing cystoscopy with proper training is a natural and logical evolution for the specialty. In fact, an American College of Obstetricians and Gynecologists' Committee Opinion, issued in July, stated that cystoscopy is an important diagnostic and therapeutic tool, and that practicing gynecologists, especially gynecologic surgeons, should become comfortable with the routine performance of the procedure.

Office Cystoscopy

Cystoscopy is but one of several diagnostic tools and methods available for evaluating a number of indications, but it is proving to be a useful one. It can readily be performed in the office without the need for sedation.

The equipment needed to perform office cystoscopy includes a good light source; an endoscopic video system; a suitable hookup for a sterile water bag and related tubing; a cystoscope—preferably a narrow-angle scope (0–12.5 degrees)—to examine the urethra; and a wider-angle scope (70 degrees) to examine the bladder itself.

The urethra should be visualized first, with attention given to its anatomy, tone, and vasculature. It will look pink and spongy in a patient who is well estrogenized but pale and flat in someone who is atrophic. In a patient who has had a previous sling, the urethra should be evaluated for evidence of erosion.

Openings in the urethral wall that suggest diverticula, evidence of infection, and any other abnormalities can be identified. In women with stress incontinence, the severity of sphincteric deficiency can be evaluated by assessing urethral tone; someone with intrinsic sphincteric deficiency will have a patulous urethra and bladder neck.

We can also then evaluate mobility of the bladder neck—an area at which fronds, polyps, and cysts are normal variants—and the appearance of the trigone, or the posterior wall of the bladder right above the bladder neck.

Cystoscopy enables us to visualize various degrees of inflammation and to detect chronic trigonitis, an inflammatory condition that can present in women who have symptoms of recurrent urinary tract infection but negative urine cultures. Confirmation of the condition can usually be achieved with vaginal palpation of the trigone.

In visualizing the ureters, which is the next step in the office evaluation, our goal is to thoroughly evaluate the anatomy of the lower urinary tract. We can then examine the rest of the bladder, looking for evidence of obvious abnormalities like stones, tumors, diverticula, and inflammation. A 70-degree scope allows visualization of the entire bladder wall, including the lateral walls where a sling/suture erosion could occur.

We can also look for trabeculations, which are thick ridges observed in the middle of the bladder wall. Such patterns are sometimes a result of normal aging but they are also often found in patients with detrusor overactivity. Diverticula of the bladder can also be visualized; such abnormalities can be responsible for urinary retention.

Bladder tumors can take on various appearances, from flat white areas to cauliflowerlike papillary lesions. Although some cancers are obvious, other low-grade cancers can be extremely subtle in appearance. Persistent hematuria, especially in a smoker, should prompt us to perform a careful cystoscopy to look for tumors. If there is any question of malignancy, a biopsy can be performed in the office or upon referral to a urologist.

 

 

In women with bladder pain, we should look out for inflammatory changes, including glomerulations, which can suggest interstitial cystitis.

We also have the option of performing cystoscopy under anesthesia for patients with bladder pain. This process enables us to hydrodistend the bladder—the bladder is filled with fluid to capacity, emptied, and refilled—for an examination both of bladder capacity and of abnormalities like bleeding from glomerulations, while eliminating the pain component. A bladder that holds less than 400 mL of fluid under anesthesia is a bladder that is chronically scarred.

Bladder biopsies can be performed at the time of hydrodistention. Unfortunately, there is no consensus on indications for biopsy or on criteria for diagnosing interstitial cystitis (indeed, much about interstitial cystitis is controversial), but I believe that the scope can be an important diagnostic tool.

There also often is a therapeutic benefit to performing a cystoscopy and hydrodistention under anesthesia: Many patients remain relatively free of pain for 6 months or longer after the procedure. The urethral pain and dysuria that sometimes occur with cystoscopy can be treated with a preprocedure intraurethral injection of lidocaine jelly or oral phenazopyridine (Pyridium). Prophylactic oral antibiotics should be given routinely either right before or right after the procedure.

Intraoperative Cystoscopy

With more advanced incontinence and prolapse surgeries being performed by both urologists and gynecologists, it has become ever more important to use intraoperative cystoscopy to ensure that the bladder and ureters remain undamaged and unobstructed. In fact, we have reached a point where cystoscopy should be performed routinely for most advanced pelvic reconstructive procedures, whether the procedures are done vaginally or abdominally.

It is absolutely imperative that cystoscopy be performed with every retropubic sling that uses the tension-free vaginal tape (TVT) procedure.

With transobturator tape (TOT), its necessity is more debatable because needles don't pass as close to the bladder. Surgeons who have comfortably and successfully performed a significant number of TOT procedures can probably forgo cystoscopy.

There is one exception, however: cases in which TOT is performed before the prolapse is repaired. In this case, cystoscopy remains imperative.

Intraoperative cystoscopy has a fringe benefit as well, in that it sometimes leads to the identification of pathology—bladder stones, for instance—that went undiagnosed during the preoperative work-up.

Cystoscopy can also be used to guide the placement of suprapubic catheters intraoperatively, although its most significant purpose is to document ureteral patency. When examining for patency, most surgeons inject indigo carmine intravenously and examine the bladder approximately 10 minutes later to document flow of the dye through both ureteral openings.

Instruments and Training

A urethroscope with a 0-degree lens allows appropriate examination of the urethra; however, a 70-degree lens is preferable for examination of the bladder because it enables visualization of the entire circumference of the bladder in more detail.

Some surgeons are using flexible cystoscopes—the optics of flexible cystoscopy have improved significantly in recent years—but the 70-degree rigid scope is sufficient in the vast majority of procedures.

Gynecologists who perform trans- or periurethral bulking agent injections for intrinsic sphincteric deficiency must be comfortable with using a 0-degree scope in the office. In this process, which typically is done under cystoscopic guidance, a needle is placed either through the cystoscope or lateral to the urethra, and the agent—collagen (Contigen), silicone (Macroplastique), carbon beads (Durasphere), or another agent—is injected to add bulk around the urethral lumen and to increase urethral resistance.

For many gynecologists, cystoscopy is a natural progression from hysteroscopy. The two procedures are very similar when used for diagnostic purposes. Others are starting to perform cystoscopy even without the background in hysteroscopy, however.

In any case, the main issue we face is the need for training. We must learn how to use the instrumentation and advance the scope safely, without causing bladder trauma or perforation; how to approach various indications; and how to judge abnormal and normal aspects of the images obtained.

Although there are no courses including certification at this time, ACOG and others do offer various training courses designed to allow ob.gyns. to develop an expertise in cystoscopy.

Bladder trabeculations are in a patient with overactive bladder.

Urethral changes reflecting different levels of estrogenation: Atrophic looks pale and flat (top), normal looks pink and spongy (bottom). Photos courtesy Dr. G. Willy Davila

Tension-free vaginal tape mesh is shown in the urethra.

Ureteral opening is shown via cystoscopy, after injection of indigo carmine dye to document ureteral integrity. Photos courtesy Dr. G. Willy Davila

Cystoscopy

As a physician on the teaching faculty of two different residency programs in metropolitan Chicago—and as one whose surgical practice is limited to minimally invasive techniques—I see residents rotating through my service routinely performing cystoscopy in conjunction with total laparoscopic hysterectomy, resection of deep endometriosis over the pelvic sidewall or bladder, placement of a sling for the treatment of stress urinary incontinence, or evaluation of the bladder for interstitial cystitis.

 

 

Unfortunately, less than a generation ago, most trainees in our field had virtually no exposure to cystoscopy. Generally, as in my own case, gynecologists interested in gaining cystoscopy skills had to be mentored by a friendly urologist.

With this in mind, I have enlisted Dr. G. Willy Davila to present cystoscopy for this Master Class in gynecologic surgery.

Dr. Davila not only chairs the department of gynecology at the Cleveland Clinic in Weston, Fla., he also heads the clinic's section of urogynecology and reconstructive pelvic surgery.

Dr. Davila serves on the editorial boards of the Journal of Female Urinary Incontinence, Revista Latinoamericana de Uroginecologia y Disfunciones Pelvianas, and the International Urogynecology Journal. He is a prolific writer and has edited three books on the specialty subject matter of urogynecology.

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Still the Standard

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Vaginal prolapse repair kits have gained popularity, as has laparoscopic sacral colpopexy. The learning curve associated with laparoscopic suturing has also fostered an interest in robotic-assisted laparoscopic approaches. Behind this changing landscape, however, is a long history of experience with open abdominal sacral colpopexy.

It is an approach with a record of success that we should know, appreciate, and retain in our armamentarium of surgical options while at the same time continuing to investigate which procedures for vaginal apex prolapse provide optimal effectiveness and safety.

Key Studies on Cure Rates

The sacral colpopexy, introduced in 1957, is a procedure that bridges the support tissue of the anterior and posterior vaginal apex to the anterior longitudinal ligament of the sacrum. A modification of the procedure, called sacral colpoperineopexy, was developed later to treat patients with vaginal apex prolapse and perineal descent; it results in contiguous posterior vaginal wall support from the anterior longitudinal ligament to the perineum.

Indications for sacral colpopexy include a previously failed vaginal route apex suspension procedure, a foreshortened vagina, a weak or denervated pelvic floor, chronic increases in abdominal pressure related to medical comorbidities and/or heavy manual labor, collagen disorders, and the need for concomitant abdominal surgery. Some physicians argue that sacral colpopexy is undoubtedly indicated in young women with severe uterine or vaginal apex prolapse.

A literature review of over 90 articles with outcomes data on sacral colpopexy published in 2004 by Dr. Ingrid E. Nygaard and members of the Pelvic Floor Disorders Network showed anatomic cure rates of 78%-100% when cure was defined as lack of apical prolapse postoperatively, and cure rates of 58%-100% when cure was defined more broadly as lack of any postoperative prolapse (anterior, posterior, apical).

Of interest, the review showed that concomitant paravaginal defect repair or culdoplasty neither improved anatomic cure nor decreased the recurrence of prolapse.

The follow-up for most of the studies in Dr. Nygaard's review ranged from 6 months to 3 years. The longest follow-up duration was almost 14 years in a study conducted by Dr. W.S. Hilger and associates. This long-term outcomes analysis of abdominal sacral colopopexy showed a cure rate of 74%.

A few randomized clinical trials have compared abdominal sacral colpopexy to other vaginal apex suspension procedures for the treatment of vaginal prolapse, with variable outcomes but with an overriding message that abdominal sacral colpopexy is an effective procedure.

In 1996 Dr. J.T. Benson and associates reported an optimal anatomic cure rate of 58% in patients who underwent abdominal sacral colpopexy with concomitant vaginal reconstructive procedures, and 29% in patients who underwent bilateral sacrospinous ligament suspension with pelvic reconstruction. Because of the significant failure rate associated with vaginal surgery, however, this trial was aborted prior to reaching adequate power.

In 2004, Dr. C.F. Maher and associates compared abdominal sacral colpopexy and concomitant Burch procedure with vaginal sacrospinous colpopexy and concomitant Burch procedure. Anatomic cure was similar in both groups after a 2-year follow-up, but abdominal sacral colpopexy was associated with more posterior vaginal wall recurrences, and vaginal sacrospinous colpopexy was associated with more anterior vaginal wall recurrences.

Of recent importance for the future practice of abdominal sacral colpopexy are the results of a randomized, multicenter clinical trial conducted by the Pelvic Floor Disorders Network that compared open sacral colpopexy with or without concomitant Burch colposuspension in women without preoperative stress incontinence.

Investigators of the CARE trial (Colpopexy and Urinary Reduction Efforts) found that stress incontinence was prevalent 3 months postoperatively in almost twice as many women who did not undergo the Burch procedure as in those who did (approximately 44% vs. 24%).

The results, which were reported by Dr. L. Brubaker and associates in the New England Journal of Medicine, clearly support the value of performing a prophylactic retropubic suspension for potential urinary incontinence along with abdominal sacral colpopexy. (These data do not extrapolate to midurethral slings as prophylactic procedures concomitant with sacral colpopexies.)

Regarding the issue of laparoscopic versus open abdominal sacral colpopexies, my colleagues and I found through a chart review of 117 consecutive patients that the two approaches have comparable clinical outcomes. Laparoscopic sacral colpopexy was associated with both a significantly decreased hospital stay and a significantly longer operating room time.

Key Studies on Mesh

The use of various types of mesh material is an issue that has been addressed to some extent in the literature. Certainly there is no ideal biologic or synthetic mesh. But in general, outcomes data addressing any type of biologic graft in abdominal repair of apical prolapse are sparse and inconsistent, while there is good literature to support the use of nonabsorbable synthetic implants.

 

 

The overall rate of mesh erosion in Dr. Nygaard's review of abdominal sacral colpopexy (using various types of mesh) was 3.4%, with good evidence to support the use of polypropylene mesh.

Dr. A.G. Visco and associates published a series in 2001 evaluating the prevalence of synthetic mesh erosion (predominantly Mersilene mesh) between abdominal sacral colpopexy and various colpoperineopexy procedures. The erosion rate overall was 4.5%. Vaginally introduced mesh, however, was associated with an erosion rate of 40%, compared with an erosion rate of 16% when sutures were placed by the vaginal route and attached to abdominally placed mesh.

In a more recently published study, Dr. P. J. Culligan and associates randomized patients undergoing sacral colpopexy to receive polyprophylene mesh or solvent-dehydrated cadaveric fascia lata. Of the patients who returned for 1-year follow-up, 91% of the synthetic mesh group, and 68% of the fascia group, were classified as cured. Several case series have had similar results.

With the available data, I see little reason to use biologic tissue. One indication, though, may be sacral colpopexy with concomitant sigmoid resection rectopexy. I prefer a macroporous polypropylene mesh for sacral colpopexy.

The Surgery

Whether we perform abdominal sacral colpoplexy through an open, laparoscopic, or even robotic technique, we must always remember that when working within the presacral space there is a risk of life-threatening bleeding.

For this reason, I always dissect the presacral space first. I have learned to be prepared for many variables: Older women sometimes have undetected aneurysms of the blood vessels bordering this area, and the anatomy of the sacrum can vary.

Surgeons handle bleeding in various ways. Some surgeons prophylactically cauterize the middle sacral vessel. For venous bleeding, I have success when I am working laparoscopically with inserting a sponge through a port and holding pressure for 5 minutes. Sterile thumbtacks, bone wax, and hemostatic agents can also be of value.

Once I've made my presacral dissection, I proceed all the way down into the cul-de-sac, having already visualized or palpated both ureters. I make sure I am at least 4 cm medial to the right ureter when I make my incision in the peritoneum overlying the sacral promontory.

I dissect all the way down to the rectovaginal space in the cul-de-sac. Lately, in laparoscopic surgery, I have been making a tunnel between the sacrum and cul-de-sac, because the peritoneum easily lifts off the retroperitoneal structures.

I usually use end-to-end anastomosis sizers for vaginal manipulation, but others will use vaginal palpation or Lucite probes. I dissect into the rectovaginal space first, which consists of areolar tissue.

I believe that when we're treating vaginal apex prolapse, we must attach the graft over a significant portion of the posterior vaginal length and, in cases of perineal descent, all the way down to the perineum.

There's now a caveat to this procedural modification, however, in that there is a new colorectal procedure used for treatment of outlet dysfunction constipation called the STARR procedure (Stapling Transanal Rectocele Resection). Unfortunately, a patient with mesh running all the way down to her perineum may not be able to undergo this colorectal procedure because of the risk of rectovaginal fistula. I inform my colpopexy patients that this is a contraindication to the STARR procedure.

In laparoscopic and some open cases, I will retrograde fill the bladder in order to delineate the bladder and facilitate the anterior dissection. This may be difficult if a patient has undergone an anterior colporrhaphy in the past.

I like to attach the anterior graft all the way down to the bladder base. Often times, what are thought to be stage III or stage IV cystoceles are in fact high anterior apical prolapses. Aggressive anterior vaginal wall dissection results in a more extensive attachment of the anterior vaginal mesh and decreased need for a paravaginal defect repair. Obviously, keeping the bladder from harm is very important.

The beauty of this procedure is that once you've suspended the anterior and posterior vaginal apex to the anterior longitudinal ligament, you're home free.

Surgeons often use a Y-shaped graft for sacral colpopexy. I currently use two pieces of 4-by-15-cm type 1 polypropylene mesh–a macroporous, monofilament mesh. I tension the posterior and anterior straps separately so as to avoid excess tension on the mesh and hence the vagina, and subsequently attach them to the anterior longitudinal ligament of the sacrum at the level of S1 or S2.

Many believe that if you don't stitch (or tack) at the S3 level, you're not allowing the vagina to be in its normal axis–that by going up to S1, you risk exposing the vagina posteriorly to increases in pressure that change the axis and increase posterior vaginal wall recurrence.

 

 

There have not been any studies precisely comparing mesh placement sites and their effect on anatomic success, but after doing a large number of these procedures, it does seem clear to me that it may not be necessary to attach the graft at the level of S3.

There are several reasons: For one, the anterior longitudinal ligament of the sacrum has been shown to have the greatest tensile strength at the level of the sacral promontory. Secondly, attachment of the mesh without tension to S1 or S2 has the same resultant vaginal axis because of retroperitoneal scarring of the mesh in the right pararectal space aided by intraabdominal pressure. Lastly, we risk venous plexus bleeding at the level of S3.

Surgeons use different types of sutures to fix the mesh, and I think there is some literature to support the use of monofilament sutures. I tend to use a braided polyester suture when performing the procedure laparoscopically because it ties much better.

Tying the mesh fairly loosely without strangulating tissue may reduce the risk of mesh erosion. I also tend to treat my patients with vaginal estrogen preoperatively and postoperatively to prevent mesh erosion.

Finally, I always retroperitonealize the mesh in order to decrease the risk of bowel obstruction and bowel adherence to the mesh. This may not be necessary with Mersilene mesh, which is multifilament but possesses macroporous and microporous elements (Type III).

Where We Stand Today

The problem with our literature is that we do not have enough adequately powered comparative trials for any of our vaginal apex suspension procedures. Our lack of adequate outcomes data is of particular concern when it comes to vaginal surgeries for apical prolapse.

The lack of data designating a preferred vaginal-route apical suspension procedure leads most surgeons to argue that abdominal sacral colpopexy is the accepted standard procedure.

In all circumstances, surgeons should do what is best for their patients. Ideally, though, we should have at least one abdominal approach–whether it be open, laparoscopic, or robotic–and at least one vaginal route to offer our patients because no procedure is best for all complaints, anatomic variations, and medical conditions.

Clearly, the pendulum has swung toward minimally invasive approaches for vaginal apex prolapse, as it has for many other conditions, but there are many questions that will remain unanswered until further randomized trials comparing abdominal and vaginal approaches, and new variations of each, are completed. This does not mean, in the meantime, that we should throw out the old.

Two strips of polypropylene mesh are attached to the anterior and posterior vaginal muscularis and passed through a retroperitoneal tunnel. Courtesy Dr. Marie Paraiso

Dissection of the presacral space and rectovaginal space: “I always dissect the presacral space first. I have learned to be prepared for many variables.” Courtesy Dr. Marie Paraiso

Sacral Colpopexy

No area of gynecologic surgery has undergone greater transformation over the past decade than the treatment of pelvic floor prolapse. Among other innovative surgical therapies, vaginal prolapse repair kits are now available to essentially replace the patient's pelvic floor.

Although these approaches are both novel and exciting, studies to date are lacking. Unfortunately, these procedures are too new to have stood the test of time.

Given this situation, it is imperative that the gynecologic surgeon who is involved in the treatment of pelvic floor prolapse maintain within his/her surgical armamentarium “tried-and-true” surgical techniques.

Because of its long-standing use, with excellent long-term outcomes, as can be noted in this edition of the Master Class in gynecologic surgery, the accepted standard continues to be the sacral colpopexy.

It seems especially fitting that this procedure, now a half century old, be reviewed based on approach (laparotomy, laparoscopy, robot-assisted), use of mesh material (biologic versus synthetic), technique (fixation of mesh at S1 versus S3, use of split mesh anterior and posterior versus mesh sheet anterior and posterior), and use of concomitant procedures (paravaginal defect repair, culdoplasty, prophylactic retropubic suspension, prophylactic midurethral slings).

Our discussant is Dr. Marie Paraiso, codirector of the Center for Female Pelvic Medicine and Reconstructive Surgery at the Cleveland Clinic Foundation. Despite the fact that she completed her fellowship training only a little more than 10 years ago, Dr. Paraiso has authored/coauthored 60 peer-reviewed journal articles and 13 book chapters, all pertaining to pelvic floor prolapse and urinary incontinence.

She is a much sought-after lecturer, and is routinely an invited speaker at American Association of Gynecologic Laparoscopists, the American College of Obstetricians and Gynecologists, Society of Gynecologic Surgeons, and American Urological Association.

 

 

Currently Dr. Paraiso is senior investigator of a prospective trial of robot-assisted laparoscopic sacral colpopexy versus traditional laparoscopic sacral colpopexy and the principal investigator of a cohort study evaluating the implementation of synthetic mesh for pelvic organ prolapse.

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Vaginal prolapse repair kits have gained popularity, as has laparoscopic sacral colpopexy. The learning curve associated with laparoscopic suturing has also fostered an interest in robotic-assisted laparoscopic approaches. Behind this changing landscape, however, is a long history of experience with open abdominal sacral colpopexy.

It is an approach with a record of success that we should know, appreciate, and retain in our armamentarium of surgical options while at the same time continuing to investigate which procedures for vaginal apex prolapse provide optimal effectiveness and safety.

Key Studies on Cure Rates

The sacral colpopexy, introduced in 1957, is a procedure that bridges the support tissue of the anterior and posterior vaginal apex to the anterior longitudinal ligament of the sacrum. A modification of the procedure, called sacral colpoperineopexy, was developed later to treat patients with vaginal apex prolapse and perineal descent; it results in contiguous posterior vaginal wall support from the anterior longitudinal ligament to the perineum.

Indications for sacral colpopexy include a previously failed vaginal route apex suspension procedure, a foreshortened vagina, a weak or denervated pelvic floor, chronic increases in abdominal pressure related to medical comorbidities and/or heavy manual labor, collagen disorders, and the need for concomitant abdominal surgery. Some physicians argue that sacral colpopexy is undoubtedly indicated in young women with severe uterine or vaginal apex prolapse.

A literature review of over 90 articles with outcomes data on sacral colpopexy published in 2004 by Dr. Ingrid E. Nygaard and members of the Pelvic Floor Disorders Network showed anatomic cure rates of 78%-100% when cure was defined as lack of apical prolapse postoperatively, and cure rates of 58%-100% when cure was defined more broadly as lack of any postoperative prolapse (anterior, posterior, apical).

Of interest, the review showed that concomitant paravaginal defect repair or culdoplasty neither improved anatomic cure nor decreased the recurrence of prolapse.

The follow-up for most of the studies in Dr. Nygaard's review ranged from 6 months to 3 years. The longest follow-up duration was almost 14 years in a study conducted by Dr. W.S. Hilger and associates. This long-term outcomes analysis of abdominal sacral colopopexy showed a cure rate of 74%.

A few randomized clinical trials have compared abdominal sacral colpopexy to other vaginal apex suspension procedures for the treatment of vaginal prolapse, with variable outcomes but with an overriding message that abdominal sacral colpopexy is an effective procedure.

In 1996 Dr. J.T. Benson and associates reported an optimal anatomic cure rate of 58% in patients who underwent abdominal sacral colpopexy with concomitant vaginal reconstructive procedures, and 29% in patients who underwent bilateral sacrospinous ligament suspension with pelvic reconstruction. Because of the significant failure rate associated with vaginal surgery, however, this trial was aborted prior to reaching adequate power.

In 2004, Dr. C.F. Maher and associates compared abdominal sacral colpopexy and concomitant Burch procedure with vaginal sacrospinous colpopexy and concomitant Burch procedure. Anatomic cure was similar in both groups after a 2-year follow-up, but abdominal sacral colpopexy was associated with more posterior vaginal wall recurrences, and vaginal sacrospinous colpopexy was associated with more anterior vaginal wall recurrences.

Of recent importance for the future practice of abdominal sacral colpopexy are the results of a randomized, multicenter clinical trial conducted by the Pelvic Floor Disorders Network that compared open sacral colpopexy with or without concomitant Burch colposuspension in women without preoperative stress incontinence.

Investigators of the CARE trial (Colpopexy and Urinary Reduction Efforts) found that stress incontinence was prevalent 3 months postoperatively in almost twice as many women who did not undergo the Burch procedure as in those who did (approximately 44% vs. 24%).

The results, which were reported by Dr. L. Brubaker and associates in the New England Journal of Medicine, clearly support the value of performing a prophylactic retropubic suspension for potential urinary incontinence along with abdominal sacral colpopexy. (These data do not extrapolate to midurethral slings as prophylactic procedures concomitant with sacral colpopexies.)

Regarding the issue of laparoscopic versus open abdominal sacral colpopexies, my colleagues and I found through a chart review of 117 consecutive patients that the two approaches have comparable clinical outcomes. Laparoscopic sacral colpopexy was associated with both a significantly decreased hospital stay and a significantly longer operating room time.

Key Studies on Mesh

The use of various types of mesh material is an issue that has been addressed to some extent in the literature. Certainly there is no ideal biologic or synthetic mesh. But in general, outcomes data addressing any type of biologic graft in abdominal repair of apical prolapse are sparse and inconsistent, while there is good literature to support the use of nonabsorbable synthetic implants.

 

 

The overall rate of mesh erosion in Dr. Nygaard's review of abdominal sacral colpopexy (using various types of mesh) was 3.4%, with good evidence to support the use of polypropylene mesh.

Dr. A.G. Visco and associates published a series in 2001 evaluating the prevalence of synthetic mesh erosion (predominantly Mersilene mesh) between abdominal sacral colpopexy and various colpoperineopexy procedures. The erosion rate overall was 4.5%. Vaginally introduced mesh, however, was associated with an erosion rate of 40%, compared with an erosion rate of 16% when sutures were placed by the vaginal route and attached to abdominally placed mesh.

In a more recently published study, Dr. P. J. Culligan and associates randomized patients undergoing sacral colpopexy to receive polyprophylene mesh or solvent-dehydrated cadaveric fascia lata. Of the patients who returned for 1-year follow-up, 91% of the synthetic mesh group, and 68% of the fascia group, were classified as cured. Several case series have had similar results.

With the available data, I see little reason to use biologic tissue. One indication, though, may be sacral colpopexy with concomitant sigmoid resection rectopexy. I prefer a macroporous polypropylene mesh for sacral colpopexy.

The Surgery

Whether we perform abdominal sacral colpoplexy through an open, laparoscopic, or even robotic technique, we must always remember that when working within the presacral space there is a risk of life-threatening bleeding.

For this reason, I always dissect the presacral space first. I have learned to be prepared for many variables: Older women sometimes have undetected aneurysms of the blood vessels bordering this area, and the anatomy of the sacrum can vary.

Surgeons handle bleeding in various ways. Some surgeons prophylactically cauterize the middle sacral vessel. For venous bleeding, I have success when I am working laparoscopically with inserting a sponge through a port and holding pressure for 5 minutes. Sterile thumbtacks, bone wax, and hemostatic agents can also be of value.

Once I've made my presacral dissection, I proceed all the way down into the cul-de-sac, having already visualized or palpated both ureters. I make sure I am at least 4 cm medial to the right ureter when I make my incision in the peritoneum overlying the sacral promontory.

I dissect all the way down to the rectovaginal space in the cul-de-sac. Lately, in laparoscopic surgery, I have been making a tunnel between the sacrum and cul-de-sac, because the peritoneum easily lifts off the retroperitoneal structures.

I usually use end-to-end anastomosis sizers for vaginal manipulation, but others will use vaginal palpation or Lucite probes. I dissect into the rectovaginal space first, which consists of areolar tissue.

I believe that when we're treating vaginal apex prolapse, we must attach the graft over a significant portion of the posterior vaginal length and, in cases of perineal descent, all the way down to the perineum.

There's now a caveat to this procedural modification, however, in that there is a new colorectal procedure used for treatment of outlet dysfunction constipation called the STARR procedure (Stapling Transanal Rectocele Resection). Unfortunately, a patient with mesh running all the way down to her perineum may not be able to undergo this colorectal procedure because of the risk of rectovaginal fistula. I inform my colpopexy patients that this is a contraindication to the STARR procedure.

In laparoscopic and some open cases, I will retrograde fill the bladder in order to delineate the bladder and facilitate the anterior dissection. This may be difficult if a patient has undergone an anterior colporrhaphy in the past.

I like to attach the anterior graft all the way down to the bladder base. Often times, what are thought to be stage III or stage IV cystoceles are in fact high anterior apical prolapses. Aggressive anterior vaginal wall dissection results in a more extensive attachment of the anterior vaginal mesh and decreased need for a paravaginal defect repair. Obviously, keeping the bladder from harm is very important.

The beauty of this procedure is that once you've suspended the anterior and posterior vaginal apex to the anterior longitudinal ligament, you're home free.

Surgeons often use a Y-shaped graft for sacral colpopexy. I currently use two pieces of 4-by-15-cm type 1 polypropylene mesh–a macroporous, monofilament mesh. I tension the posterior and anterior straps separately so as to avoid excess tension on the mesh and hence the vagina, and subsequently attach them to the anterior longitudinal ligament of the sacrum at the level of S1 or S2.

Many believe that if you don't stitch (or tack) at the S3 level, you're not allowing the vagina to be in its normal axis–that by going up to S1, you risk exposing the vagina posteriorly to increases in pressure that change the axis and increase posterior vaginal wall recurrence.

 

 

There have not been any studies precisely comparing mesh placement sites and their effect on anatomic success, but after doing a large number of these procedures, it does seem clear to me that it may not be necessary to attach the graft at the level of S3.

There are several reasons: For one, the anterior longitudinal ligament of the sacrum has been shown to have the greatest tensile strength at the level of the sacral promontory. Secondly, attachment of the mesh without tension to S1 or S2 has the same resultant vaginal axis because of retroperitoneal scarring of the mesh in the right pararectal space aided by intraabdominal pressure. Lastly, we risk venous plexus bleeding at the level of S3.

Surgeons use different types of sutures to fix the mesh, and I think there is some literature to support the use of monofilament sutures. I tend to use a braided polyester suture when performing the procedure laparoscopically because it ties much better.

Tying the mesh fairly loosely without strangulating tissue may reduce the risk of mesh erosion. I also tend to treat my patients with vaginal estrogen preoperatively and postoperatively to prevent mesh erosion.

Finally, I always retroperitonealize the mesh in order to decrease the risk of bowel obstruction and bowel adherence to the mesh. This may not be necessary with Mersilene mesh, which is multifilament but possesses macroporous and microporous elements (Type III).

Where We Stand Today

The problem with our literature is that we do not have enough adequately powered comparative trials for any of our vaginal apex suspension procedures. Our lack of adequate outcomes data is of particular concern when it comes to vaginal surgeries for apical prolapse.

The lack of data designating a preferred vaginal-route apical suspension procedure leads most surgeons to argue that abdominal sacral colpopexy is the accepted standard procedure.

In all circumstances, surgeons should do what is best for their patients. Ideally, though, we should have at least one abdominal approach–whether it be open, laparoscopic, or robotic–and at least one vaginal route to offer our patients because no procedure is best for all complaints, anatomic variations, and medical conditions.

Clearly, the pendulum has swung toward minimally invasive approaches for vaginal apex prolapse, as it has for many other conditions, but there are many questions that will remain unanswered until further randomized trials comparing abdominal and vaginal approaches, and new variations of each, are completed. This does not mean, in the meantime, that we should throw out the old.

Two strips of polypropylene mesh are attached to the anterior and posterior vaginal muscularis and passed through a retroperitoneal tunnel. Courtesy Dr. Marie Paraiso

Dissection of the presacral space and rectovaginal space: “I always dissect the presacral space first. I have learned to be prepared for many variables.” Courtesy Dr. Marie Paraiso

Sacral Colpopexy

No area of gynecologic surgery has undergone greater transformation over the past decade than the treatment of pelvic floor prolapse. Among other innovative surgical therapies, vaginal prolapse repair kits are now available to essentially replace the patient's pelvic floor.

Although these approaches are both novel and exciting, studies to date are lacking. Unfortunately, these procedures are too new to have stood the test of time.

Given this situation, it is imperative that the gynecologic surgeon who is involved in the treatment of pelvic floor prolapse maintain within his/her surgical armamentarium “tried-and-true” surgical techniques.

Because of its long-standing use, with excellent long-term outcomes, as can be noted in this edition of the Master Class in gynecologic surgery, the accepted standard continues to be the sacral colpopexy.

It seems especially fitting that this procedure, now a half century old, be reviewed based on approach (laparotomy, laparoscopy, robot-assisted), use of mesh material (biologic versus synthetic), technique (fixation of mesh at S1 versus S3, use of split mesh anterior and posterior versus mesh sheet anterior and posterior), and use of concomitant procedures (paravaginal defect repair, culdoplasty, prophylactic retropubic suspension, prophylactic midurethral slings).

Our discussant is Dr. Marie Paraiso, codirector of the Center for Female Pelvic Medicine and Reconstructive Surgery at the Cleveland Clinic Foundation. Despite the fact that she completed her fellowship training only a little more than 10 years ago, Dr. Paraiso has authored/coauthored 60 peer-reviewed journal articles and 13 book chapters, all pertaining to pelvic floor prolapse and urinary incontinence.

She is a much sought-after lecturer, and is routinely an invited speaker at American Association of Gynecologic Laparoscopists, the American College of Obstetricians and Gynecologists, Society of Gynecologic Surgeons, and American Urological Association.

 

 

Currently Dr. Paraiso is senior investigator of a prospective trial of robot-assisted laparoscopic sacral colpopexy versus traditional laparoscopic sacral colpopexy and the principal investigator of a cohort study evaluating the implementation of synthetic mesh for pelvic organ prolapse.

Vaginal prolapse repair kits have gained popularity, as has laparoscopic sacral colpopexy. The learning curve associated with laparoscopic suturing has also fostered an interest in robotic-assisted laparoscopic approaches. Behind this changing landscape, however, is a long history of experience with open abdominal sacral colpopexy.

It is an approach with a record of success that we should know, appreciate, and retain in our armamentarium of surgical options while at the same time continuing to investigate which procedures for vaginal apex prolapse provide optimal effectiveness and safety.

Key Studies on Cure Rates

The sacral colpopexy, introduced in 1957, is a procedure that bridges the support tissue of the anterior and posterior vaginal apex to the anterior longitudinal ligament of the sacrum. A modification of the procedure, called sacral colpoperineopexy, was developed later to treat patients with vaginal apex prolapse and perineal descent; it results in contiguous posterior vaginal wall support from the anterior longitudinal ligament to the perineum.

Indications for sacral colpopexy include a previously failed vaginal route apex suspension procedure, a foreshortened vagina, a weak or denervated pelvic floor, chronic increases in abdominal pressure related to medical comorbidities and/or heavy manual labor, collagen disorders, and the need for concomitant abdominal surgery. Some physicians argue that sacral colpopexy is undoubtedly indicated in young women with severe uterine or vaginal apex prolapse.

A literature review of over 90 articles with outcomes data on sacral colpopexy published in 2004 by Dr. Ingrid E. Nygaard and members of the Pelvic Floor Disorders Network showed anatomic cure rates of 78%-100% when cure was defined as lack of apical prolapse postoperatively, and cure rates of 58%-100% when cure was defined more broadly as lack of any postoperative prolapse (anterior, posterior, apical).

Of interest, the review showed that concomitant paravaginal defect repair or culdoplasty neither improved anatomic cure nor decreased the recurrence of prolapse.

The follow-up for most of the studies in Dr. Nygaard's review ranged from 6 months to 3 years. The longest follow-up duration was almost 14 years in a study conducted by Dr. W.S. Hilger and associates. This long-term outcomes analysis of abdominal sacral colopopexy showed a cure rate of 74%.

A few randomized clinical trials have compared abdominal sacral colpopexy to other vaginal apex suspension procedures for the treatment of vaginal prolapse, with variable outcomes but with an overriding message that abdominal sacral colpopexy is an effective procedure.

In 1996 Dr. J.T. Benson and associates reported an optimal anatomic cure rate of 58% in patients who underwent abdominal sacral colpopexy with concomitant vaginal reconstructive procedures, and 29% in patients who underwent bilateral sacrospinous ligament suspension with pelvic reconstruction. Because of the significant failure rate associated with vaginal surgery, however, this trial was aborted prior to reaching adequate power.

In 2004, Dr. C.F. Maher and associates compared abdominal sacral colpopexy and concomitant Burch procedure with vaginal sacrospinous colpopexy and concomitant Burch procedure. Anatomic cure was similar in both groups after a 2-year follow-up, but abdominal sacral colpopexy was associated with more posterior vaginal wall recurrences, and vaginal sacrospinous colpopexy was associated with more anterior vaginal wall recurrences.

Of recent importance for the future practice of abdominal sacral colpopexy are the results of a randomized, multicenter clinical trial conducted by the Pelvic Floor Disorders Network that compared open sacral colpopexy with or without concomitant Burch colposuspension in women without preoperative stress incontinence.

Investigators of the CARE trial (Colpopexy and Urinary Reduction Efforts) found that stress incontinence was prevalent 3 months postoperatively in almost twice as many women who did not undergo the Burch procedure as in those who did (approximately 44% vs. 24%).

The results, which were reported by Dr. L. Brubaker and associates in the New England Journal of Medicine, clearly support the value of performing a prophylactic retropubic suspension for potential urinary incontinence along with abdominal sacral colpopexy. (These data do not extrapolate to midurethral slings as prophylactic procedures concomitant with sacral colpopexies.)

Regarding the issue of laparoscopic versus open abdominal sacral colpopexies, my colleagues and I found through a chart review of 117 consecutive patients that the two approaches have comparable clinical outcomes. Laparoscopic sacral colpopexy was associated with both a significantly decreased hospital stay and a significantly longer operating room time.

Key Studies on Mesh

The use of various types of mesh material is an issue that has been addressed to some extent in the literature. Certainly there is no ideal biologic or synthetic mesh. But in general, outcomes data addressing any type of biologic graft in abdominal repair of apical prolapse are sparse and inconsistent, while there is good literature to support the use of nonabsorbable synthetic implants.

 

 

The overall rate of mesh erosion in Dr. Nygaard's review of abdominal sacral colpopexy (using various types of mesh) was 3.4%, with good evidence to support the use of polypropylene mesh.

Dr. A.G. Visco and associates published a series in 2001 evaluating the prevalence of synthetic mesh erosion (predominantly Mersilene mesh) between abdominal sacral colpopexy and various colpoperineopexy procedures. The erosion rate overall was 4.5%. Vaginally introduced mesh, however, was associated with an erosion rate of 40%, compared with an erosion rate of 16% when sutures were placed by the vaginal route and attached to abdominally placed mesh.

In a more recently published study, Dr. P. J. Culligan and associates randomized patients undergoing sacral colpopexy to receive polyprophylene mesh or solvent-dehydrated cadaveric fascia lata. Of the patients who returned for 1-year follow-up, 91% of the synthetic mesh group, and 68% of the fascia group, were classified as cured. Several case series have had similar results.

With the available data, I see little reason to use biologic tissue. One indication, though, may be sacral colpopexy with concomitant sigmoid resection rectopexy. I prefer a macroporous polypropylene mesh for sacral colpopexy.

The Surgery

Whether we perform abdominal sacral colpoplexy through an open, laparoscopic, or even robotic technique, we must always remember that when working within the presacral space there is a risk of life-threatening bleeding.

For this reason, I always dissect the presacral space first. I have learned to be prepared for many variables: Older women sometimes have undetected aneurysms of the blood vessels bordering this area, and the anatomy of the sacrum can vary.

Surgeons handle bleeding in various ways. Some surgeons prophylactically cauterize the middle sacral vessel. For venous bleeding, I have success when I am working laparoscopically with inserting a sponge through a port and holding pressure for 5 minutes. Sterile thumbtacks, bone wax, and hemostatic agents can also be of value.

Once I've made my presacral dissection, I proceed all the way down into the cul-de-sac, having already visualized or palpated both ureters. I make sure I am at least 4 cm medial to the right ureter when I make my incision in the peritoneum overlying the sacral promontory.

I dissect all the way down to the rectovaginal space in the cul-de-sac. Lately, in laparoscopic surgery, I have been making a tunnel between the sacrum and cul-de-sac, because the peritoneum easily lifts off the retroperitoneal structures.

I usually use end-to-end anastomosis sizers for vaginal manipulation, but others will use vaginal palpation or Lucite probes. I dissect into the rectovaginal space first, which consists of areolar tissue.

I believe that when we're treating vaginal apex prolapse, we must attach the graft over a significant portion of the posterior vaginal length and, in cases of perineal descent, all the way down to the perineum.

There's now a caveat to this procedural modification, however, in that there is a new colorectal procedure used for treatment of outlet dysfunction constipation called the STARR procedure (Stapling Transanal Rectocele Resection). Unfortunately, a patient with mesh running all the way down to her perineum may not be able to undergo this colorectal procedure because of the risk of rectovaginal fistula. I inform my colpopexy patients that this is a contraindication to the STARR procedure.

In laparoscopic and some open cases, I will retrograde fill the bladder in order to delineate the bladder and facilitate the anterior dissection. This may be difficult if a patient has undergone an anterior colporrhaphy in the past.

I like to attach the anterior graft all the way down to the bladder base. Often times, what are thought to be stage III or stage IV cystoceles are in fact high anterior apical prolapses. Aggressive anterior vaginal wall dissection results in a more extensive attachment of the anterior vaginal mesh and decreased need for a paravaginal defect repair. Obviously, keeping the bladder from harm is very important.

The beauty of this procedure is that once you've suspended the anterior and posterior vaginal apex to the anterior longitudinal ligament, you're home free.

Surgeons often use a Y-shaped graft for sacral colpopexy. I currently use two pieces of 4-by-15-cm type 1 polypropylene mesh–a macroporous, monofilament mesh. I tension the posterior and anterior straps separately so as to avoid excess tension on the mesh and hence the vagina, and subsequently attach them to the anterior longitudinal ligament of the sacrum at the level of S1 or S2.

Many believe that if you don't stitch (or tack) at the S3 level, you're not allowing the vagina to be in its normal axis–that by going up to S1, you risk exposing the vagina posteriorly to increases in pressure that change the axis and increase posterior vaginal wall recurrence.

 

 

There have not been any studies precisely comparing mesh placement sites and their effect on anatomic success, but after doing a large number of these procedures, it does seem clear to me that it may not be necessary to attach the graft at the level of S3.

There are several reasons: For one, the anterior longitudinal ligament of the sacrum has been shown to have the greatest tensile strength at the level of the sacral promontory. Secondly, attachment of the mesh without tension to S1 or S2 has the same resultant vaginal axis because of retroperitoneal scarring of the mesh in the right pararectal space aided by intraabdominal pressure. Lastly, we risk venous plexus bleeding at the level of S3.

Surgeons use different types of sutures to fix the mesh, and I think there is some literature to support the use of monofilament sutures. I tend to use a braided polyester suture when performing the procedure laparoscopically because it ties much better.

Tying the mesh fairly loosely without strangulating tissue may reduce the risk of mesh erosion. I also tend to treat my patients with vaginal estrogen preoperatively and postoperatively to prevent mesh erosion.

Finally, I always retroperitonealize the mesh in order to decrease the risk of bowel obstruction and bowel adherence to the mesh. This may not be necessary with Mersilene mesh, which is multifilament but possesses macroporous and microporous elements (Type III).

Where We Stand Today

The problem with our literature is that we do not have enough adequately powered comparative trials for any of our vaginal apex suspension procedures. Our lack of adequate outcomes data is of particular concern when it comes to vaginal surgeries for apical prolapse.

The lack of data designating a preferred vaginal-route apical suspension procedure leads most surgeons to argue that abdominal sacral colpopexy is the accepted standard procedure.

In all circumstances, surgeons should do what is best for their patients. Ideally, though, we should have at least one abdominal approach–whether it be open, laparoscopic, or robotic–and at least one vaginal route to offer our patients because no procedure is best for all complaints, anatomic variations, and medical conditions.

Clearly, the pendulum has swung toward minimally invasive approaches for vaginal apex prolapse, as it has for many other conditions, but there are many questions that will remain unanswered until further randomized trials comparing abdominal and vaginal approaches, and new variations of each, are completed. This does not mean, in the meantime, that we should throw out the old.

Two strips of polypropylene mesh are attached to the anterior and posterior vaginal muscularis and passed through a retroperitoneal tunnel. Courtesy Dr. Marie Paraiso

Dissection of the presacral space and rectovaginal space: “I always dissect the presacral space first. I have learned to be prepared for many variables.” Courtesy Dr. Marie Paraiso

Sacral Colpopexy

No area of gynecologic surgery has undergone greater transformation over the past decade than the treatment of pelvic floor prolapse. Among other innovative surgical therapies, vaginal prolapse repair kits are now available to essentially replace the patient's pelvic floor.

Although these approaches are both novel and exciting, studies to date are lacking. Unfortunately, these procedures are too new to have stood the test of time.

Given this situation, it is imperative that the gynecologic surgeon who is involved in the treatment of pelvic floor prolapse maintain within his/her surgical armamentarium “tried-and-true” surgical techniques.

Because of its long-standing use, with excellent long-term outcomes, as can be noted in this edition of the Master Class in gynecologic surgery, the accepted standard continues to be the sacral colpopexy.

It seems especially fitting that this procedure, now a half century old, be reviewed based on approach (laparotomy, laparoscopy, robot-assisted), use of mesh material (biologic versus synthetic), technique (fixation of mesh at S1 versus S3, use of split mesh anterior and posterior versus mesh sheet anterior and posterior), and use of concomitant procedures (paravaginal defect repair, culdoplasty, prophylactic retropubic suspension, prophylactic midurethral slings).

Our discussant is Dr. Marie Paraiso, codirector of the Center for Female Pelvic Medicine and Reconstructive Surgery at the Cleveland Clinic Foundation. Despite the fact that she completed her fellowship training only a little more than 10 years ago, Dr. Paraiso has authored/coauthored 60 peer-reviewed journal articles and 13 book chapters, all pertaining to pelvic floor prolapse and urinary incontinence.

She is a much sought-after lecturer, and is routinely an invited speaker at American Association of Gynecologic Laparoscopists, the American College of Obstetricians and Gynecologists, Society of Gynecologic Surgeons, and American Urological Association.

 

 

Currently Dr. Paraiso is senior investigator of a prospective trial of robot-assisted laparoscopic sacral colpopexy versus traditional laparoscopic sacral colpopexy and the principal investigator of a cohort study evaluating the implementation of synthetic mesh for pelvic organ prolapse.

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An Ancillary Treatment for Midline Pelvic Pain

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An Ancillary Treatment for Midline Pelvic Pain

Presacral neurectomy—the resection of the hypogastric nervous plexus that innervates the uterus—is a safe and effective alternative for these women.

It can be done alone or concomitantly with any surgical treatment of coexisting endometriosis or other pelvic pathology.

Presacral neurectomy is not a simple procedure, however, and should not be attempted without appropriate training and preparation, or without careful patient selection.

The procedure does not alleviate adnexal pain or pelvic pain that is more lateral, and is indicated when medical management has failed.

Nonetheless, when patients are carefully selected, and when the procedure is performed by a skilled surgeon who follows the principles and technique described more than 80 years ago by Dr. M.G. Cotte, it can be effectively carried out with good long-term outcomes for the majority of patients who have disabling midline dysmenorrhea and deep central, chronic pelvic pain.

More and more, the procedure is being done laparoscopically with a lower rate of postoperative morbidity. Indeed, advances in minimally invasive surgery have renewed interest in the procedure after a period starting in the 1960s in which the introduction of nonsteroidal anti-inflammatory drugs and various regimens of hormonal suppression caused interest to wane.

Moreover, despite the fact that the data on presacral neurectomy historically have covered women with dysmenorrhea, nonetheless within modern medicine dyspareunia has become an additional indication for the procedure.

Cotte's Technique

Dr. M. Jaboulay first described the severance of sacral sympathetic afferent fibers for serious dysmenorrhea (using a posterior extraperitoneal approach) in 1899, and a variety of other procedures for nerve interruption subsequently evolved.

It took until 1937, however, for a description of presacral neurectomy to emerge.

Dr. M.G. Cotte is credited with performing the first presacral neurectomy in 1924, and 13 years later he reported 98% success after transection of the superior hypogastric plexus in 1,500 patients.

Dr. Cotte emphasized that the only nerve tissue that should be resected is that within what he called the interiliac triangle (now known as the “Triangle of Cotte”), and that resection of all nerve elements in the triangle is essential in order to maximize effectiveness and minimize complications.

This triangle is extremely important. Unfortunately, because of the perilous location of the sensitive plexus, there have been modifications made in the procedure throughout the years.

Results have thus been variable, and some groups have reported recurrence rates of pelvic pain after presacral neurectomy that are significantly higher than the rates achieved by Cotte and the rates that we—and others—are now achieving.

It is difficult to analyze these results and ascertain exactly what the problems were and why the procedures failed.

However, because those surgeons who follow Cotte's principles and technique are indeed achieving good long-term results, I suspect that patient selection in the other studies wasn't optimal, or that the procedure was performed in a manner different from that originally described by Cotte.

The Anatomy

The presacral nerve is actually almost always a plexus of nerves known as the superior hypogastric plexus. It is a direct extension of the aortic plexus below the aortic bifurcation.

The plexus spreads out behind the peritoneum in the loose areolar tissue lying over the fourth and fifth lumbar vertebrae.

Between the vertebrae and the presacral nerve lies the middle sacral artery. On the right of the presacral nerve lie the right ureter and the common iliac vein and artery. On the left lie the sigmoid colon, inferior mesenteric vessels, left iliac vessels, and the left ureter.

Within the Triangle of Cotte, then, the common iliac artery and ureter are on the right, and the common iliac vein is on the left. The inferior mesenteric, superior hemorrhoidal, and midsacral arteries are in the center of the prelumbar space.

The triangle is defined caudally by the sacral promontory and laterally by the common iliac arteries. The superior edge of the triangle is delineated by the aortic bifurcation.

Centrally and to the left, the multiple nerve fibers representing the presacral nerve—sometimes in bundles—run caudally from the aortic plexus above and through the interiliac triangle to form the superior hypogastric plexus. These fibers are buried in loose areolar tissue. They display no particular patterns and vary among individuals.

In fact, surgeons must be prepared to encounter variable anatomical findings, in addition to being prepared for potential bleeding problems that can result from the sensitive proximity to the aortic bifurcation, vena cava, and iliac vessels.

The Procedure

In our Cotte-based procedure, an operating laparoscope is inserted through a 10-mm cannula placed through an umbilical incision.

 

 

Two or three suprapubic 5-mm cannulas are inserted at about 5-cm midsuprapubic and at 7 cm to the left and right side for the introduction of a bipolar electrode, suction irrigator, and grasping forceps, respectively.

I place the patient in the steep Trendelenburg's position, tilt her slightly to the left, and hold the sigmoid colon away from the presacral area.

After the Triangle of Cotte is identified, the peritoneum overlying the sacral promontory is elevated with a grasping forceps. I use grasping forceps to elevate the peritoneum overlying the promontory and make a small opening. I have used the CO2 laser or scissors in the past. Currently, I use harmonic shears.

The suction irrigator is inserted through this opening, and the peritoneum is elevated. The peritoneum is incised horizontally and vertically, and the opening is extended cephalad to the aortic bifurcation. Any bleeding from the peritoneal vessels can be controlled with the bipolar electrocoagulator. If harmonic shears are used, this is rarely necessary.

After removing retroperitoneal lymphatic and fatty tissue, we reach the hypogastric plexus and can identify the presacral tissue.

The nerve plexus is grasped with an atraumatic forceps, and using blunt and sharp dissection, I skeletonize, desiccate, and excise the nerve fibers.

All the nerve fibers that lie within the boundaries of the interiliac triangle must be removed, including any fibers entering the area from under the common iliac artery and over the left common iliac vein.

I then irrigate the retroperitoneal space and coagulate bleeding points, if any. Sutures are not required to approximate the posterior peritoneum. The area heals completely on follow-up, and is covered by the peritoneum.

I send excised tissue for histologic examination to verify removal of nerve elements and ganglion.

The Outcomes

In 1992, we described a laparoscopic method of presacral neurectomy, based on Cotte's principles and technique, as part of a report on 52 patients with disabling midline dysmenorrhea and varying severity of endometriosis, all of whom had been unresponsive to medical treatment.

Of the 52 patients who were followed for more than a year, 48 (92%) reported relief of dysmenorrhea, and 27 (52%) reported complete pain relief (BJOG 1992:99;659–63).

In 1998, we reported even longer-term outcomes (up to 72 months) in 176 women with central pelvic pain who underwent laparoscopic presacral neurectomy and treatment of endometriosis. Pain was reduced substantially in 74% of the women, and just as notably, the degree of pain improvement was not directly related to the stage of endometriosis.

A reduction in pain of more than 50% was reported in 69.8% of women with stage I endometriosis (using the revised classification of the American Fertility Society), 77.3% of those with stage II, 71.4% of those with stage III, and 84.6% of those with stage IV endometriosis (Obstet. Gynecol. 1998;91:701–4).

We were discouraged from offering patients treatment in a blinded manner because a randomized trial conducted not long before this had been stopped in an early stage by a monitoring committee when the efficacy of presacral neurectomy became clear.

In this prematurely halted study, Dr. B. Tjaden, Dr. John A. Rock, and associates at Johns Hopkins University found that of 17 patients undergoing the procedure (all had moderate to severe dysmenorrhea and stage III-IV endometriosis), only two had recurrence of pain and the remainder remained pain free at 42 months of follow-up.

Of the nine patients who underwent resection of endometriosis but not presacral neurectomy, none had relief of midline pain (Obstet. Gynecol. 1990;76:89–91).

Although Dr. Rock and his team found that relief of dyspareunia was variable in both groups, we and others have had success in treating this manifestation of pelvic pain.

In our study published in 1998, a reduction in dyspareunia by more than 50% was seen in 32 of 60 patients followed for 24 months or longer.

More recently, Dr. F. Zullo and associates published the 2-year success of laparoscopic presacral neurectomy, reporting significant reduction in the frequency and severity not only of chronic pelvic pain and dysmenorrhea but of dyspareunia as well (J. Am. Assoc. Gynecol. Laparosc. 2004;11:23–8).

Laparoscopic uterosacral nerve ablation is an easier procedure to perform than laparoscopic presacral neurectomy, but it has been proved to provide only temporary relief and not the longer-term pain reduction that presacral neurectomy can achieve in most cases. I liken it to trimming a weed in your yard versus pulling the weed out by the roots.

The Complications

The most common and urgent intraoperative complication is bleeding, and we must be prepared, in the event of injury, to actively identify the anatomy and determine the feasibility of the repair laparoscopically, or to immediately convert to laparotomy.

 

 

We have not had any major complications, but the slight risk of vascular injury and the possible need to convert to laparotomy is something that patients should be informed of.

Long-term complications with presacral neurectomy are uncommon. Urinary urgency, poor bladder emptying, and constipation have been reported occasionally, as has vaginal dryness during sexual arousal.

We have not had any major complications such as vascular injury, gastrointestinal injury, or genitourinary injury in any of our presacral neurectomy procedures. Nor did any of these cases require conversion to laparotomy or transfusion.

Our initial (1992) study revealed no major intraoperative or immediate postoperative complications.

However, of the 52 women followed after 1 year, seven women reported either constipation (three patients), urinary urgency (one), vaginal dryness (one), or “painless labor” (two). These are all among the issues that we routinely cover in our patient counseling.

In conclusion, procedural failure, of course, is an important long-term complication, but the most common reasons for failure—poor patient selection and incomplete neurectomy because of neurologic variability or failure to remove all nerve tissue within the interiliac triangle—can, in most cases, be avoided with proper training and preparation.

Within the Triangle of Cotte, the common iliac artery is on the right; the common iliac vein is on the left. Courtesy Dr. Ceana Nezhat

The presacral tissue is identified, and the nerve plexus is grasped with an atraumatic forceps.

All the nerve fibers that lie within the boundaries of the interiliac triangle have been removed.

Presacral space on second look: The area heals completely on follow-up. Photos courtesy Dr. Ceana Nezhat

Presacral Neurectomy

In previous Master Class articles, we have explored the diagnosis and work-up of chronic pelvic pain (OB.GYN. NEWS, Feb. 1, 2007, p. 28; April 1, 2007, p. 25). Moreover, we presented an excellent technique in surgical extirpation of endometriosis (OB.GYN. NEWS, April 1, 2007, p. 38).

Despite a thorough evaluation and medical and surgical treatment, midline pelvic pain, dysmenorrhea, and/or dyspareunia may persist. Not only can this be caused by conditions such as primary dysmenorrhea or adenomyosis, but it may persist despite adequate surgical treatment of endometriosis and pelvic adhesions.

When midline pelvic pain, dysmenorrhea, and/or dyspareunia are not alleviated with treatment, ancillary surgical procedures should be considered. Unfortunately, the most commonly performed procedure—transection of the uterosacral nerves—has proved to be ineffective over time.

On the other hand, if performed by a skilled surgeon who understands the anatomy below the bifurcation of the aorta at the level of the sacral promontory, presacral neurectomy has proved quite effective long term.

I once performed this technique via laparotomy, but for nearly 20 years now I have used a purely laparoscopic technique. With the same indications, I have noted similar results to those explained here by Dr. Ceana Nezhat, the invited author of this Master Class article.

Dr. Ceana Nezhat is in private practice in Atlanta and is one of three brothers who are extraordinary gynecologic laparoscopic surgeons. Dr. Camran Nezhat, of Stanford (Calif.) University, has been an innovator in the laparoscopic treatment of endometriosis for a quarter of a century. Dr. Farr Nezhat, who is a gynecologist at Mount Sinai School of Medicine, New York, has been a leader in the use of laparoscopy to perform gynecologic oncology procedures. Dr. Ceana Nezhat is known not only for his laparoscopic treatment of endometriosis, but also for pelvic floor reconstruction. He is a prolific author and an international lecturer, and it is with great admiration that we bring you Dr. Ceana Nezhat, discussing the laparoscopic approach to presacral neurectomy.

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Presacral neurectomy—the resection of the hypogastric nervous plexus that innervates the uterus—is a safe and effective alternative for these women.

It can be done alone or concomitantly with any surgical treatment of coexisting endometriosis or other pelvic pathology.

Presacral neurectomy is not a simple procedure, however, and should not be attempted without appropriate training and preparation, or without careful patient selection.

The procedure does not alleviate adnexal pain or pelvic pain that is more lateral, and is indicated when medical management has failed.

Nonetheless, when patients are carefully selected, and when the procedure is performed by a skilled surgeon who follows the principles and technique described more than 80 years ago by Dr. M.G. Cotte, it can be effectively carried out with good long-term outcomes for the majority of patients who have disabling midline dysmenorrhea and deep central, chronic pelvic pain.

More and more, the procedure is being done laparoscopically with a lower rate of postoperative morbidity. Indeed, advances in minimally invasive surgery have renewed interest in the procedure after a period starting in the 1960s in which the introduction of nonsteroidal anti-inflammatory drugs and various regimens of hormonal suppression caused interest to wane.

Moreover, despite the fact that the data on presacral neurectomy historically have covered women with dysmenorrhea, nonetheless within modern medicine dyspareunia has become an additional indication for the procedure.

Cotte's Technique

Dr. M. Jaboulay first described the severance of sacral sympathetic afferent fibers for serious dysmenorrhea (using a posterior extraperitoneal approach) in 1899, and a variety of other procedures for nerve interruption subsequently evolved.

It took until 1937, however, for a description of presacral neurectomy to emerge.

Dr. M.G. Cotte is credited with performing the first presacral neurectomy in 1924, and 13 years later he reported 98% success after transection of the superior hypogastric plexus in 1,500 patients.

Dr. Cotte emphasized that the only nerve tissue that should be resected is that within what he called the interiliac triangle (now known as the “Triangle of Cotte”), and that resection of all nerve elements in the triangle is essential in order to maximize effectiveness and minimize complications.

This triangle is extremely important. Unfortunately, because of the perilous location of the sensitive plexus, there have been modifications made in the procedure throughout the years.

Results have thus been variable, and some groups have reported recurrence rates of pelvic pain after presacral neurectomy that are significantly higher than the rates achieved by Cotte and the rates that we—and others—are now achieving.

It is difficult to analyze these results and ascertain exactly what the problems were and why the procedures failed.

However, because those surgeons who follow Cotte's principles and technique are indeed achieving good long-term results, I suspect that patient selection in the other studies wasn't optimal, or that the procedure was performed in a manner different from that originally described by Cotte.

The Anatomy

The presacral nerve is actually almost always a plexus of nerves known as the superior hypogastric plexus. It is a direct extension of the aortic plexus below the aortic bifurcation.

The plexus spreads out behind the peritoneum in the loose areolar tissue lying over the fourth and fifth lumbar vertebrae.

Between the vertebrae and the presacral nerve lies the middle sacral artery. On the right of the presacral nerve lie the right ureter and the common iliac vein and artery. On the left lie the sigmoid colon, inferior mesenteric vessels, left iliac vessels, and the left ureter.

Within the Triangle of Cotte, then, the common iliac artery and ureter are on the right, and the common iliac vein is on the left. The inferior mesenteric, superior hemorrhoidal, and midsacral arteries are in the center of the prelumbar space.

The triangle is defined caudally by the sacral promontory and laterally by the common iliac arteries. The superior edge of the triangle is delineated by the aortic bifurcation.

Centrally and to the left, the multiple nerve fibers representing the presacral nerve—sometimes in bundles—run caudally from the aortic plexus above and through the interiliac triangle to form the superior hypogastric plexus. These fibers are buried in loose areolar tissue. They display no particular patterns and vary among individuals.

In fact, surgeons must be prepared to encounter variable anatomical findings, in addition to being prepared for potential bleeding problems that can result from the sensitive proximity to the aortic bifurcation, vena cava, and iliac vessels.

The Procedure

In our Cotte-based procedure, an operating laparoscope is inserted through a 10-mm cannula placed through an umbilical incision.

 

 

Two or three suprapubic 5-mm cannulas are inserted at about 5-cm midsuprapubic and at 7 cm to the left and right side for the introduction of a bipolar electrode, suction irrigator, and grasping forceps, respectively.

I place the patient in the steep Trendelenburg's position, tilt her slightly to the left, and hold the sigmoid colon away from the presacral area.

After the Triangle of Cotte is identified, the peritoneum overlying the sacral promontory is elevated with a grasping forceps. I use grasping forceps to elevate the peritoneum overlying the promontory and make a small opening. I have used the CO2 laser or scissors in the past. Currently, I use harmonic shears.

The suction irrigator is inserted through this opening, and the peritoneum is elevated. The peritoneum is incised horizontally and vertically, and the opening is extended cephalad to the aortic bifurcation. Any bleeding from the peritoneal vessels can be controlled with the bipolar electrocoagulator. If harmonic shears are used, this is rarely necessary.

After removing retroperitoneal lymphatic and fatty tissue, we reach the hypogastric plexus and can identify the presacral tissue.

The nerve plexus is grasped with an atraumatic forceps, and using blunt and sharp dissection, I skeletonize, desiccate, and excise the nerve fibers.

All the nerve fibers that lie within the boundaries of the interiliac triangle must be removed, including any fibers entering the area from under the common iliac artery and over the left common iliac vein.

I then irrigate the retroperitoneal space and coagulate bleeding points, if any. Sutures are not required to approximate the posterior peritoneum. The area heals completely on follow-up, and is covered by the peritoneum.

I send excised tissue for histologic examination to verify removal of nerve elements and ganglion.

The Outcomes

In 1992, we described a laparoscopic method of presacral neurectomy, based on Cotte's principles and technique, as part of a report on 52 patients with disabling midline dysmenorrhea and varying severity of endometriosis, all of whom had been unresponsive to medical treatment.

Of the 52 patients who were followed for more than a year, 48 (92%) reported relief of dysmenorrhea, and 27 (52%) reported complete pain relief (BJOG 1992:99;659–63).

In 1998, we reported even longer-term outcomes (up to 72 months) in 176 women with central pelvic pain who underwent laparoscopic presacral neurectomy and treatment of endometriosis. Pain was reduced substantially in 74% of the women, and just as notably, the degree of pain improvement was not directly related to the stage of endometriosis.

A reduction in pain of more than 50% was reported in 69.8% of women with stage I endometriosis (using the revised classification of the American Fertility Society), 77.3% of those with stage II, 71.4% of those with stage III, and 84.6% of those with stage IV endometriosis (Obstet. Gynecol. 1998;91:701–4).

We were discouraged from offering patients treatment in a blinded manner because a randomized trial conducted not long before this had been stopped in an early stage by a monitoring committee when the efficacy of presacral neurectomy became clear.

In this prematurely halted study, Dr. B. Tjaden, Dr. John A. Rock, and associates at Johns Hopkins University found that of 17 patients undergoing the procedure (all had moderate to severe dysmenorrhea and stage III-IV endometriosis), only two had recurrence of pain and the remainder remained pain free at 42 months of follow-up.

Of the nine patients who underwent resection of endometriosis but not presacral neurectomy, none had relief of midline pain (Obstet. Gynecol. 1990;76:89–91).

Although Dr. Rock and his team found that relief of dyspareunia was variable in both groups, we and others have had success in treating this manifestation of pelvic pain.

In our study published in 1998, a reduction in dyspareunia by more than 50% was seen in 32 of 60 patients followed for 24 months or longer.

More recently, Dr. F. Zullo and associates published the 2-year success of laparoscopic presacral neurectomy, reporting significant reduction in the frequency and severity not only of chronic pelvic pain and dysmenorrhea but of dyspareunia as well (J. Am. Assoc. Gynecol. Laparosc. 2004;11:23–8).

Laparoscopic uterosacral nerve ablation is an easier procedure to perform than laparoscopic presacral neurectomy, but it has been proved to provide only temporary relief and not the longer-term pain reduction that presacral neurectomy can achieve in most cases. I liken it to trimming a weed in your yard versus pulling the weed out by the roots.

The Complications

The most common and urgent intraoperative complication is bleeding, and we must be prepared, in the event of injury, to actively identify the anatomy and determine the feasibility of the repair laparoscopically, or to immediately convert to laparotomy.

 

 

We have not had any major complications, but the slight risk of vascular injury and the possible need to convert to laparotomy is something that patients should be informed of.

Long-term complications with presacral neurectomy are uncommon. Urinary urgency, poor bladder emptying, and constipation have been reported occasionally, as has vaginal dryness during sexual arousal.

We have not had any major complications such as vascular injury, gastrointestinal injury, or genitourinary injury in any of our presacral neurectomy procedures. Nor did any of these cases require conversion to laparotomy or transfusion.

Our initial (1992) study revealed no major intraoperative or immediate postoperative complications.

However, of the 52 women followed after 1 year, seven women reported either constipation (three patients), urinary urgency (one), vaginal dryness (one), or “painless labor” (two). These are all among the issues that we routinely cover in our patient counseling.

In conclusion, procedural failure, of course, is an important long-term complication, but the most common reasons for failure—poor patient selection and incomplete neurectomy because of neurologic variability or failure to remove all nerve tissue within the interiliac triangle—can, in most cases, be avoided with proper training and preparation.

Within the Triangle of Cotte, the common iliac artery is on the right; the common iliac vein is on the left. Courtesy Dr. Ceana Nezhat

The presacral tissue is identified, and the nerve plexus is grasped with an atraumatic forceps.

All the nerve fibers that lie within the boundaries of the interiliac triangle have been removed.

Presacral space on second look: The area heals completely on follow-up. Photos courtesy Dr. Ceana Nezhat

Presacral Neurectomy

In previous Master Class articles, we have explored the diagnosis and work-up of chronic pelvic pain (OB.GYN. NEWS, Feb. 1, 2007, p. 28; April 1, 2007, p. 25). Moreover, we presented an excellent technique in surgical extirpation of endometriosis (OB.GYN. NEWS, April 1, 2007, p. 38).

Despite a thorough evaluation and medical and surgical treatment, midline pelvic pain, dysmenorrhea, and/or dyspareunia may persist. Not only can this be caused by conditions such as primary dysmenorrhea or adenomyosis, but it may persist despite adequate surgical treatment of endometriosis and pelvic adhesions.

When midline pelvic pain, dysmenorrhea, and/or dyspareunia are not alleviated with treatment, ancillary surgical procedures should be considered. Unfortunately, the most commonly performed procedure—transection of the uterosacral nerves—has proved to be ineffective over time.

On the other hand, if performed by a skilled surgeon who understands the anatomy below the bifurcation of the aorta at the level of the sacral promontory, presacral neurectomy has proved quite effective long term.

I once performed this technique via laparotomy, but for nearly 20 years now I have used a purely laparoscopic technique. With the same indications, I have noted similar results to those explained here by Dr. Ceana Nezhat, the invited author of this Master Class article.

Dr. Ceana Nezhat is in private practice in Atlanta and is one of three brothers who are extraordinary gynecologic laparoscopic surgeons. Dr. Camran Nezhat, of Stanford (Calif.) University, has been an innovator in the laparoscopic treatment of endometriosis for a quarter of a century. Dr. Farr Nezhat, who is a gynecologist at Mount Sinai School of Medicine, New York, has been a leader in the use of laparoscopy to perform gynecologic oncology procedures. Dr. Ceana Nezhat is known not only for his laparoscopic treatment of endometriosis, but also for pelvic floor reconstruction. He is a prolific author and an international lecturer, and it is with great admiration that we bring you Dr. Ceana Nezhat, discussing the laparoscopic approach to presacral neurectomy.

Presacral neurectomy—the resection of the hypogastric nervous plexus that innervates the uterus—is a safe and effective alternative for these women.

It can be done alone or concomitantly with any surgical treatment of coexisting endometriosis or other pelvic pathology.

Presacral neurectomy is not a simple procedure, however, and should not be attempted without appropriate training and preparation, or without careful patient selection.

The procedure does not alleviate adnexal pain or pelvic pain that is more lateral, and is indicated when medical management has failed.

Nonetheless, when patients are carefully selected, and when the procedure is performed by a skilled surgeon who follows the principles and technique described more than 80 years ago by Dr. M.G. Cotte, it can be effectively carried out with good long-term outcomes for the majority of patients who have disabling midline dysmenorrhea and deep central, chronic pelvic pain.

More and more, the procedure is being done laparoscopically with a lower rate of postoperative morbidity. Indeed, advances in minimally invasive surgery have renewed interest in the procedure after a period starting in the 1960s in which the introduction of nonsteroidal anti-inflammatory drugs and various regimens of hormonal suppression caused interest to wane.

Moreover, despite the fact that the data on presacral neurectomy historically have covered women with dysmenorrhea, nonetheless within modern medicine dyspareunia has become an additional indication for the procedure.

Cotte's Technique

Dr. M. Jaboulay first described the severance of sacral sympathetic afferent fibers for serious dysmenorrhea (using a posterior extraperitoneal approach) in 1899, and a variety of other procedures for nerve interruption subsequently evolved.

It took until 1937, however, for a description of presacral neurectomy to emerge.

Dr. M.G. Cotte is credited with performing the first presacral neurectomy in 1924, and 13 years later he reported 98% success after transection of the superior hypogastric plexus in 1,500 patients.

Dr. Cotte emphasized that the only nerve tissue that should be resected is that within what he called the interiliac triangle (now known as the “Triangle of Cotte”), and that resection of all nerve elements in the triangle is essential in order to maximize effectiveness and minimize complications.

This triangle is extremely important. Unfortunately, because of the perilous location of the sensitive plexus, there have been modifications made in the procedure throughout the years.

Results have thus been variable, and some groups have reported recurrence rates of pelvic pain after presacral neurectomy that are significantly higher than the rates achieved by Cotte and the rates that we—and others—are now achieving.

It is difficult to analyze these results and ascertain exactly what the problems were and why the procedures failed.

However, because those surgeons who follow Cotte's principles and technique are indeed achieving good long-term results, I suspect that patient selection in the other studies wasn't optimal, or that the procedure was performed in a manner different from that originally described by Cotte.

The Anatomy

The presacral nerve is actually almost always a plexus of nerves known as the superior hypogastric plexus. It is a direct extension of the aortic plexus below the aortic bifurcation.

The plexus spreads out behind the peritoneum in the loose areolar tissue lying over the fourth and fifth lumbar vertebrae.

Between the vertebrae and the presacral nerve lies the middle sacral artery. On the right of the presacral nerve lie the right ureter and the common iliac vein and artery. On the left lie the sigmoid colon, inferior mesenteric vessels, left iliac vessels, and the left ureter.

Within the Triangle of Cotte, then, the common iliac artery and ureter are on the right, and the common iliac vein is on the left. The inferior mesenteric, superior hemorrhoidal, and midsacral arteries are in the center of the prelumbar space.

The triangle is defined caudally by the sacral promontory and laterally by the common iliac arteries. The superior edge of the triangle is delineated by the aortic bifurcation.

Centrally and to the left, the multiple nerve fibers representing the presacral nerve—sometimes in bundles—run caudally from the aortic plexus above and through the interiliac triangle to form the superior hypogastric plexus. These fibers are buried in loose areolar tissue. They display no particular patterns and vary among individuals.

In fact, surgeons must be prepared to encounter variable anatomical findings, in addition to being prepared for potential bleeding problems that can result from the sensitive proximity to the aortic bifurcation, vena cava, and iliac vessels.

The Procedure

In our Cotte-based procedure, an operating laparoscope is inserted through a 10-mm cannula placed through an umbilical incision.

 

 

Two or three suprapubic 5-mm cannulas are inserted at about 5-cm midsuprapubic and at 7 cm to the left and right side for the introduction of a bipolar electrode, suction irrigator, and grasping forceps, respectively.

I place the patient in the steep Trendelenburg's position, tilt her slightly to the left, and hold the sigmoid colon away from the presacral area.

After the Triangle of Cotte is identified, the peritoneum overlying the sacral promontory is elevated with a grasping forceps. I use grasping forceps to elevate the peritoneum overlying the promontory and make a small opening. I have used the CO2 laser or scissors in the past. Currently, I use harmonic shears.

The suction irrigator is inserted through this opening, and the peritoneum is elevated. The peritoneum is incised horizontally and vertically, and the opening is extended cephalad to the aortic bifurcation. Any bleeding from the peritoneal vessels can be controlled with the bipolar electrocoagulator. If harmonic shears are used, this is rarely necessary.

After removing retroperitoneal lymphatic and fatty tissue, we reach the hypogastric plexus and can identify the presacral tissue.

The nerve plexus is grasped with an atraumatic forceps, and using blunt and sharp dissection, I skeletonize, desiccate, and excise the nerve fibers.

All the nerve fibers that lie within the boundaries of the interiliac triangle must be removed, including any fibers entering the area from under the common iliac artery and over the left common iliac vein.

I then irrigate the retroperitoneal space and coagulate bleeding points, if any. Sutures are not required to approximate the posterior peritoneum. The area heals completely on follow-up, and is covered by the peritoneum.

I send excised tissue for histologic examination to verify removal of nerve elements and ganglion.

The Outcomes

In 1992, we described a laparoscopic method of presacral neurectomy, based on Cotte's principles and technique, as part of a report on 52 patients with disabling midline dysmenorrhea and varying severity of endometriosis, all of whom had been unresponsive to medical treatment.

Of the 52 patients who were followed for more than a year, 48 (92%) reported relief of dysmenorrhea, and 27 (52%) reported complete pain relief (BJOG 1992:99;659–63).

In 1998, we reported even longer-term outcomes (up to 72 months) in 176 women with central pelvic pain who underwent laparoscopic presacral neurectomy and treatment of endometriosis. Pain was reduced substantially in 74% of the women, and just as notably, the degree of pain improvement was not directly related to the stage of endometriosis.

A reduction in pain of more than 50% was reported in 69.8% of women with stage I endometriosis (using the revised classification of the American Fertility Society), 77.3% of those with stage II, 71.4% of those with stage III, and 84.6% of those with stage IV endometriosis (Obstet. Gynecol. 1998;91:701–4).

We were discouraged from offering patients treatment in a blinded manner because a randomized trial conducted not long before this had been stopped in an early stage by a monitoring committee when the efficacy of presacral neurectomy became clear.

In this prematurely halted study, Dr. B. Tjaden, Dr. John A. Rock, and associates at Johns Hopkins University found that of 17 patients undergoing the procedure (all had moderate to severe dysmenorrhea and stage III-IV endometriosis), only two had recurrence of pain and the remainder remained pain free at 42 months of follow-up.

Of the nine patients who underwent resection of endometriosis but not presacral neurectomy, none had relief of midline pain (Obstet. Gynecol. 1990;76:89–91).

Although Dr. Rock and his team found that relief of dyspareunia was variable in both groups, we and others have had success in treating this manifestation of pelvic pain.

In our study published in 1998, a reduction in dyspareunia by more than 50% was seen in 32 of 60 patients followed for 24 months or longer.

More recently, Dr. F. Zullo and associates published the 2-year success of laparoscopic presacral neurectomy, reporting significant reduction in the frequency and severity not only of chronic pelvic pain and dysmenorrhea but of dyspareunia as well (J. Am. Assoc. Gynecol. Laparosc. 2004;11:23–8).

Laparoscopic uterosacral nerve ablation is an easier procedure to perform than laparoscopic presacral neurectomy, but it has been proved to provide only temporary relief and not the longer-term pain reduction that presacral neurectomy can achieve in most cases. I liken it to trimming a weed in your yard versus pulling the weed out by the roots.

The Complications

The most common and urgent intraoperative complication is bleeding, and we must be prepared, in the event of injury, to actively identify the anatomy and determine the feasibility of the repair laparoscopically, or to immediately convert to laparotomy.

 

 

We have not had any major complications, but the slight risk of vascular injury and the possible need to convert to laparotomy is something that patients should be informed of.

Long-term complications with presacral neurectomy are uncommon. Urinary urgency, poor bladder emptying, and constipation have been reported occasionally, as has vaginal dryness during sexual arousal.

We have not had any major complications such as vascular injury, gastrointestinal injury, or genitourinary injury in any of our presacral neurectomy procedures. Nor did any of these cases require conversion to laparotomy or transfusion.

Our initial (1992) study revealed no major intraoperative or immediate postoperative complications.

However, of the 52 women followed after 1 year, seven women reported either constipation (three patients), urinary urgency (one), vaginal dryness (one), or “painless labor” (two). These are all among the issues that we routinely cover in our patient counseling.

In conclusion, procedural failure, of course, is an important long-term complication, but the most common reasons for failure—poor patient selection and incomplete neurectomy because of neurologic variability or failure to remove all nerve tissue within the interiliac triangle—can, in most cases, be avoided with proper training and preparation.

Within the Triangle of Cotte, the common iliac artery is on the right; the common iliac vein is on the left. Courtesy Dr. Ceana Nezhat

The presacral tissue is identified, and the nerve plexus is grasped with an atraumatic forceps.

All the nerve fibers that lie within the boundaries of the interiliac triangle have been removed.

Presacral space on second look: The area heals completely on follow-up. Photos courtesy Dr. Ceana Nezhat

Presacral Neurectomy

In previous Master Class articles, we have explored the diagnosis and work-up of chronic pelvic pain (OB.GYN. NEWS, Feb. 1, 2007, p. 28; April 1, 2007, p. 25). Moreover, we presented an excellent technique in surgical extirpation of endometriosis (OB.GYN. NEWS, April 1, 2007, p. 38).

Despite a thorough evaluation and medical and surgical treatment, midline pelvic pain, dysmenorrhea, and/or dyspareunia may persist. Not only can this be caused by conditions such as primary dysmenorrhea or adenomyosis, but it may persist despite adequate surgical treatment of endometriosis and pelvic adhesions.

When midline pelvic pain, dysmenorrhea, and/or dyspareunia are not alleviated with treatment, ancillary surgical procedures should be considered. Unfortunately, the most commonly performed procedure—transection of the uterosacral nerves—has proved to be ineffective over time.

On the other hand, if performed by a skilled surgeon who understands the anatomy below the bifurcation of the aorta at the level of the sacral promontory, presacral neurectomy has proved quite effective long term.

I once performed this technique via laparotomy, but for nearly 20 years now I have used a purely laparoscopic technique. With the same indications, I have noted similar results to those explained here by Dr. Ceana Nezhat, the invited author of this Master Class article.

Dr. Ceana Nezhat is in private practice in Atlanta and is one of three brothers who are extraordinary gynecologic laparoscopic surgeons. Dr. Camran Nezhat, of Stanford (Calif.) University, has been an innovator in the laparoscopic treatment of endometriosis for a quarter of a century. Dr. Farr Nezhat, who is a gynecologist at Mount Sinai School of Medicine, New York, has been a leader in the use of laparoscopy to perform gynecologic oncology procedures. Dr. Ceana Nezhat is known not only for his laparoscopic treatment of endometriosis, but also for pelvic floor reconstruction. He is a prolific author and an international lecturer, and it is with great admiration that we bring you Dr. Ceana Nezhat, discussing the laparoscopic approach to presacral neurectomy.

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This combination of disease-specific and pain-specific therapies reflects the complexity of chronic pelvic pain and the fact that there most often will be more than one diagnosis, as well as the fact that pain itself will more often than not be one of the diagnoses and not only a symptom.

Just as we should be guided in our differential diagnosis by seeking diagnoses for which we have the best evidence of casual or associative roles in chronic pelvic pain, we should begin with treatments for which there is good level I evidence of efficacy.

Surgery will help a subgroup of women with chronic pelvic pain, especially those with endometriosis and other reproductive tract disorders, but the majority of women with chronic pelvic pain will benefit most from medical, psychological, and physical therapy.

There are strong data from studies of the treatment of irritable bowel syndrome (IBS) and pelvic congestion syndrome that show that adding psychological treatment to medical treatment is more effective than providing either by itself. Physical therapy, moreover, can be helpful for the secondary pelvic floor muscle pain that many women develop regardless of what problems were pain generators in the first place.

Disease-Specific Therapy

In trying to help women with chronic pelvic pain, we will most often find ourselves treating the common diagnoses that have level A evidence of association with the pain: IBS, endometriosis, interstitial cystitis, myofascial trigger points, depression, and chronic pain syndrome.

Endometriosis and interstitial cystitis are particularly common in women with chronic pelvic pain, and there is good evidence that the disorders not only cause the pain but also tend to occur together. The literature suggests that 30%–80% of women with endometriosis also have interstitial cystitis, and we know that treating one but not the other will significantly lessen our chances of success in treating pelvic pain.

For endometriosis, there is good level I evidence of efficacy for the use of hormonal treatments like GnRH agonists, progestins, and continuous oral contraceptives. Additionally, two randomized trials have confirmed that conservative—or organ-sparing—surgical removal of endometriosis lesions is effective in decreasing pain.

Combining surgery and medical treatment for endometriosis may be more efficacious than providing either by itself. We don't yet have level I evidence to support this approach—just as we don't yet have any published studies directly comparing medical and surgical treatments—but some of the completed clinical studies suggest that we should consider a combined approach in patients who are not trying to conceive.

For interstitial cystitis, randomized trials have demonstrated the efficacy of intravesical dimethyl sulfoxide and of oral pentosan polysulfate sodium.

Symptoms of IBS are present in a majority of women with chronic pelvic pain, and treatment tends to be based on which symptoms are predominant. For example, a number of good randomized trials have shown efficacy for the use of antispasmodics in patients whose symptomatology is predominantly abdominal pain, and for loperamide (Imodium) in patients with diarrhea-predominant symptomatology. Interestingly, tricyclic antidepressants, which often are prescribed to control chronic pelvic pain, can be useful for diarrhea-predominant IBS because constipation tends to be a side effect of the drugs. For constipation-predominant IBS, the newer drug tegaserod (Zelnorm) is frequently used.

In general, for our patients clearly troubled by IBS, evaluation and treatment with a gastroenterologist who is well versed in IBS are definitely worthwhile.

When it comes to myofascial and musculoskeletal pain, we don't have as much good data from randomized clinical trials to help direct our treatment decisions, but it certainly appears, based on clinical experience, that physical therapy—and, when indicated, trigger-point injections—is effective.

It is important to realize that physical therapy is often an important adjunct to the treatment of chronic pelvic pain, as well as a specific treatment. Regardless of what the pain generators or specific diagnoses are, many of these women develop secondary pelvic floor muscle pain, or pelvic floor tension myalgia.

Secondary pelvic floor muscle pain often does not respond to treatments for the specific diagnoses we make in women with chronic pelvic pain, and evaluation and treatment by a women's health physical therapist can thus be most useful. For this, contact the women's health section of the American Physical Therapy Association.

When it comes to the issue of surgery for chronic pelvic pain, endometriosis is one of the few diagnoses for which surgery has a clear role.

The treatment of adhesions, which are diagnosed in about one-quarter of women with chronic pelvic pain, is still controversial. It is not clear whether lysis of adhesions is effective in reducing pelvic pain, and it appears that the majority of adhesions that are surgically lysed do reform. The role of adhesions as a cause of pelvic pain, of course, is also controversial.

 

 

Pain-Specific Therapy

Here we have many different treatments— pharmacologic, psychological, and neuroablative—that rest, to some extent, on acceptance of the notions that pain may not necessarily be cured but can be managed, and that patients can progress toward more normal lives that are not dominated by pain.

It is important that we not use psychological treatment as a last resort. If we do everything else, and then tell a patient that everything else has failed and we are recommending psychological treatment, we are in essence sending her the message that we think her pain is not real. There are two errors here that warrant correction: First, psychological pain is indeed real. Second, most of the time, the etiology of chronic pelvic pain is not psychological.

What we should do right away, with all of our patients, is explain that cognitive-behavioral therapy, relaxation therapy, and other psychological techniques are extremely useful in helping patients decrease and cope with pain.

I sometimes use the analogy of how our emotions and mind can cause us to turn beet red and make us sweat and become tachycardic when we are embarrassed about something we have said or done. If our emotions can cause that kind of physical reaction, might not relaxation therapy, for instance, cause physiologic changes that help decrease our pain? More often than not, it is financial issues and the relatively poor coverage of mental health care in this country—and not patient acceptance—that is the major impediment to including psychotherapy in the treatment of chronic pelvic pain.

In the neuroablative arena, there is some evidence that adding presacral neurectomy (excision of the superior hypogastric plexus, or presacral nerve) to other treatments for endometriosis is sometimes indicated, although it's not perfectly clear what those indications are. I tend to use the therapy in patients who have previously failed medical or surgical therapy. It is one of the neurolytic therapies that may be useful in decreasing pain centrally even when there is no specific nerve dysfunction.

Tricyclic antidepressants, particularly amitriptyline, have been shown to be effective in treating chronic pelvic pain and other chronic pain syndromes, and therefore are a part of the pharmacologic arm of pain-specific therapy. In addition to reducing depressive symptoms—which is often an aim anyway in patients with chronic pelvic pain, as depression occurs with increased frequency in these women—it is generally thought that the tricyclic antidepressants improve pain tolerance.

Analgesics, of course, are a mainstay of pharmacologic pain-specific treatment of chronic pelvic pain, and there is little controversy about the use of analgesics like acetaminophen, NSAIDs, tricyclic antidepressants, and other neuropathic medications, such as gabapentin and other anticonvulsants used for chronic pain.

The use of opioids in the treatment of chronic pain remains controversial, however. Several studies, as well as clinical experience in pain centers, suggest that opioids are effective for chronic—and not only acute—pain: that the analgesics improve function and quality of life in patients who have failed other treatments. There is, however, the well-known risk of addiction, which is estimated to occur in anywhere from 3% to 15% of chronic pain patients.

As gynecologists, we can consider providing opioid treatment ourselves, but only if we are attuned to looking for addictive behaviors and only if we are familiar with state regulations that address chronic opioid use. Federal codes are quite clear in stating that the federal government has no intention of preventing physicians from treating chronic pain with opioids if such treatment is indicated, but state regulations vary.

Treatment of Chronic Pelvic Pain

This is the second installment of the Master Class in Gynecologic Surgery on pelvic pain. In part 1, I drafted Dr. Fred Howard, who serves as associate chair for academic affairs, director of the division of gynecologic specialists, and professor of obstetrics and gynecology at the University of Rochester (N.Y.), to discuss the differential diagnosis and work-up of chronic pelvic pain. In part 2, he will turn from the diagnosis to the treatment of chronic pelvic pain.

I am certain that the reader will be immediately drawn to Dr. Howard's double-armed treatment regimen of both disease-specific therapy and pain-specific therapy. Although he recognizes the importance of surgical treatment—especially in cases of endometriosis, uterine fibroids, ovarian cysts, and other reproductive tract disorders—he is quick to point out that medical, psychological, or physical therapy will suffice in most women's cases. Moreover, as Dr. Howard recognizes, physicians as well as their patients must realize and accept that although a cure is the ultimate goal of treatment, pain management may be the reality.

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This combination of disease-specific and pain-specific therapies reflects the complexity of chronic pelvic pain and the fact that there most often will be more than one diagnosis, as well as the fact that pain itself will more often than not be one of the diagnoses and not only a symptom.

Just as we should be guided in our differential diagnosis by seeking diagnoses for which we have the best evidence of casual or associative roles in chronic pelvic pain, we should begin with treatments for which there is good level I evidence of efficacy.

Surgery will help a subgroup of women with chronic pelvic pain, especially those with endometriosis and other reproductive tract disorders, but the majority of women with chronic pelvic pain will benefit most from medical, psychological, and physical therapy.

There are strong data from studies of the treatment of irritable bowel syndrome (IBS) and pelvic congestion syndrome that show that adding psychological treatment to medical treatment is more effective than providing either by itself. Physical therapy, moreover, can be helpful for the secondary pelvic floor muscle pain that many women develop regardless of what problems were pain generators in the first place.

Disease-Specific Therapy

In trying to help women with chronic pelvic pain, we will most often find ourselves treating the common diagnoses that have level A evidence of association with the pain: IBS, endometriosis, interstitial cystitis, myofascial trigger points, depression, and chronic pain syndrome.

Endometriosis and interstitial cystitis are particularly common in women with chronic pelvic pain, and there is good evidence that the disorders not only cause the pain but also tend to occur together. The literature suggests that 30%–80% of women with endometriosis also have interstitial cystitis, and we know that treating one but not the other will significantly lessen our chances of success in treating pelvic pain.

For endometriosis, there is good level I evidence of efficacy for the use of hormonal treatments like GnRH agonists, progestins, and continuous oral contraceptives. Additionally, two randomized trials have confirmed that conservative—or organ-sparing—surgical removal of endometriosis lesions is effective in decreasing pain.

Combining surgery and medical treatment for endometriosis may be more efficacious than providing either by itself. We don't yet have level I evidence to support this approach—just as we don't yet have any published studies directly comparing medical and surgical treatments—but some of the completed clinical studies suggest that we should consider a combined approach in patients who are not trying to conceive.

For interstitial cystitis, randomized trials have demonstrated the efficacy of intravesical dimethyl sulfoxide and of oral pentosan polysulfate sodium.

Symptoms of IBS are present in a majority of women with chronic pelvic pain, and treatment tends to be based on which symptoms are predominant. For example, a number of good randomized trials have shown efficacy for the use of antispasmodics in patients whose symptomatology is predominantly abdominal pain, and for loperamide (Imodium) in patients with diarrhea-predominant symptomatology. Interestingly, tricyclic antidepressants, which often are prescribed to control chronic pelvic pain, can be useful for diarrhea-predominant IBS because constipation tends to be a side effect of the drugs. For constipation-predominant IBS, the newer drug tegaserod (Zelnorm) is frequently used.

In general, for our patients clearly troubled by IBS, evaluation and treatment with a gastroenterologist who is well versed in IBS are definitely worthwhile.

When it comes to myofascial and musculoskeletal pain, we don't have as much good data from randomized clinical trials to help direct our treatment decisions, but it certainly appears, based on clinical experience, that physical therapy—and, when indicated, trigger-point injections—is effective.

It is important to realize that physical therapy is often an important adjunct to the treatment of chronic pelvic pain, as well as a specific treatment. Regardless of what the pain generators or specific diagnoses are, many of these women develop secondary pelvic floor muscle pain, or pelvic floor tension myalgia.

Secondary pelvic floor muscle pain often does not respond to treatments for the specific diagnoses we make in women with chronic pelvic pain, and evaluation and treatment by a women's health physical therapist can thus be most useful. For this, contact the women's health section of the American Physical Therapy Association.

When it comes to the issue of surgery for chronic pelvic pain, endometriosis is one of the few diagnoses for which surgery has a clear role.

The treatment of adhesions, which are diagnosed in about one-quarter of women with chronic pelvic pain, is still controversial. It is not clear whether lysis of adhesions is effective in reducing pelvic pain, and it appears that the majority of adhesions that are surgically lysed do reform. The role of adhesions as a cause of pelvic pain, of course, is also controversial.

 

 

Pain-Specific Therapy

Here we have many different treatments— pharmacologic, psychological, and neuroablative—that rest, to some extent, on acceptance of the notions that pain may not necessarily be cured but can be managed, and that patients can progress toward more normal lives that are not dominated by pain.

It is important that we not use psychological treatment as a last resort. If we do everything else, and then tell a patient that everything else has failed and we are recommending psychological treatment, we are in essence sending her the message that we think her pain is not real. There are two errors here that warrant correction: First, psychological pain is indeed real. Second, most of the time, the etiology of chronic pelvic pain is not psychological.

What we should do right away, with all of our patients, is explain that cognitive-behavioral therapy, relaxation therapy, and other psychological techniques are extremely useful in helping patients decrease and cope with pain.

I sometimes use the analogy of how our emotions and mind can cause us to turn beet red and make us sweat and become tachycardic when we are embarrassed about something we have said or done. If our emotions can cause that kind of physical reaction, might not relaxation therapy, for instance, cause physiologic changes that help decrease our pain? More often than not, it is financial issues and the relatively poor coverage of mental health care in this country—and not patient acceptance—that is the major impediment to including psychotherapy in the treatment of chronic pelvic pain.

In the neuroablative arena, there is some evidence that adding presacral neurectomy (excision of the superior hypogastric plexus, or presacral nerve) to other treatments for endometriosis is sometimes indicated, although it's not perfectly clear what those indications are. I tend to use the therapy in patients who have previously failed medical or surgical therapy. It is one of the neurolytic therapies that may be useful in decreasing pain centrally even when there is no specific nerve dysfunction.

Tricyclic antidepressants, particularly amitriptyline, have been shown to be effective in treating chronic pelvic pain and other chronic pain syndromes, and therefore are a part of the pharmacologic arm of pain-specific therapy. In addition to reducing depressive symptoms—which is often an aim anyway in patients with chronic pelvic pain, as depression occurs with increased frequency in these women—it is generally thought that the tricyclic antidepressants improve pain tolerance.

Analgesics, of course, are a mainstay of pharmacologic pain-specific treatment of chronic pelvic pain, and there is little controversy about the use of analgesics like acetaminophen, NSAIDs, tricyclic antidepressants, and other neuropathic medications, such as gabapentin and other anticonvulsants used for chronic pain.

The use of opioids in the treatment of chronic pain remains controversial, however. Several studies, as well as clinical experience in pain centers, suggest that opioids are effective for chronic—and not only acute—pain: that the analgesics improve function and quality of life in patients who have failed other treatments. There is, however, the well-known risk of addiction, which is estimated to occur in anywhere from 3% to 15% of chronic pain patients.

As gynecologists, we can consider providing opioid treatment ourselves, but only if we are attuned to looking for addictive behaviors and only if we are familiar with state regulations that address chronic opioid use. Federal codes are quite clear in stating that the federal government has no intention of preventing physicians from treating chronic pain with opioids if such treatment is indicated, but state regulations vary.

Treatment of Chronic Pelvic Pain

This is the second installment of the Master Class in Gynecologic Surgery on pelvic pain. In part 1, I drafted Dr. Fred Howard, who serves as associate chair for academic affairs, director of the division of gynecologic specialists, and professor of obstetrics and gynecology at the University of Rochester (N.Y.), to discuss the differential diagnosis and work-up of chronic pelvic pain. In part 2, he will turn from the diagnosis to the treatment of chronic pelvic pain.

I am certain that the reader will be immediately drawn to Dr. Howard's double-armed treatment regimen of both disease-specific therapy and pain-specific therapy. Although he recognizes the importance of surgical treatment—especially in cases of endometriosis, uterine fibroids, ovarian cysts, and other reproductive tract disorders—he is quick to point out that medical, psychological, or physical therapy will suffice in most women's cases. Moreover, as Dr. Howard recognizes, physicians as well as their patients must realize and accept that although a cure is the ultimate goal of treatment, pain management may be the reality.

This combination of disease-specific and pain-specific therapies reflects the complexity of chronic pelvic pain and the fact that there most often will be more than one diagnosis, as well as the fact that pain itself will more often than not be one of the diagnoses and not only a symptom.

Just as we should be guided in our differential diagnosis by seeking diagnoses for which we have the best evidence of casual or associative roles in chronic pelvic pain, we should begin with treatments for which there is good level I evidence of efficacy.

Surgery will help a subgroup of women with chronic pelvic pain, especially those with endometriosis and other reproductive tract disorders, but the majority of women with chronic pelvic pain will benefit most from medical, psychological, and physical therapy.

There are strong data from studies of the treatment of irritable bowel syndrome (IBS) and pelvic congestion syndrome that show that adding psychological treatment to medical treatment is more effective than providing either by itself. Physical therapy, moreover, can be helpful for the secondary pelvic floor muscle pain that many women develop regardless of what problems were pain generators in the first place.

Disease-Specific Therapy

In trying to help women with chronic pelvic pain, we will most often find ourselves treating the common diagnoses that have level A evidence of association with the pain: IBS, endometriosis, interstitial cystitis, myofascial trigger points, depression, and chronic pain syndrome.

Endometriosis and interstitial cystitis are particularly common in women with chronic pelvic pain, and there is good evidence that the disorders not only cause the pain but also tend to occur together. The literature suggests that 30%–80% of women with endometriosis also have interstitial cystitis, and we know that treating one but not the other will significantly lessen our chances of success in treating pelvic pain.

For endometriosis, there is good level I evidence of efficacy for the use of hormonal treatments like GnRH agonists, progestins, and continuous oral contraceptives. Additionally, two randomized trials have confirmed that conservative—or organ-sparing—surgical removal of endometriosis lesions is effective in decreasing pain.

Combining surgery and medical treatment for endometriosis may be more efficacious than providing either by itself. We don't yet have level I evidence to support this approach—just as we don't yet have any published studies directly comparing medical and surgical treatments—but some of the completed clinical studies suggest that we should consider a combined approach in patients who are not trying to conceive.

For interstitial cystitis, randomized trials have demonstrated the efficacy of intravesical dimethyl sulfoxide and of oral pentosan polysulfate sodium.

Symptoms of IBS are present in a majority of women with chronic pelvic pain, and treatment tends to be based on which symptoms are predominant. For example, a number of good randomized trials have shown efficacy for the use of antispasmodics in patients whose symptomatology is predominantly abdominal pain, and for loperamide (Imodium) in patients with diarrhea-predominant symptomatology. Interestingly, tricyclic antidepressants, which often are prescribed to control chronic pelvic pain, can be useful for diarrhea-predominant IBS because constipation tends to be a side effect of the drugs. For constipation-predominant IBS, the newer drug tegaserod (Zelnorm) is frequently used.

In general, for our patients clearly troubled by IBS, evaluation and treatment with a gastroenterologist who is well versed in IBS are definitely worthwhile.

When it comes to myofascial and musculoskeletal pain, we don't have as much good data from randomized clinical trials to help direct our treatment decisions, but it certainly appears, based on clinical experience, that physical therapy—and, when indicated, trigger-point injections—is effective.

It is important to realize that physical therapy is often an important adjunct to the treatment of chronic pelvic pain, as well as a specific treatment. Regardless of what the pain generators or specific diagnoses are, many of these women develop secondary pelvic floor muscle pain, or pelvic floor tension myalgia.

Secondary pelvic floor muscle pain often does not respond to treatments for the specific diagnoses we make in women with chronic pelvic pain, and evaluation and treatment by a women's health physical therapist can thus be most useful. For this, contact the women's health section of the American Physical Therapy Association.

When it comes to the issue of surgery for chronic pelvic pain, endometriosis is one of the few diagnoses for which surgery has a clear role.

The treatment of adhesions, which are diagnosed in about one-quarter of women with chronic pelvic pain, is still controversial. It is not clear whether lysis of adhesions is effective in reducing pelvic pain, and it appears that the majority of adhesions that are surgically lysed do reform. The role of adhesions as a cause of pelvic pain, of course, is also controversial.

 

 

Pain-Specific Therapy

Here we have many different treatments— pharmacologic, psychological, and neuroablative—that rest, to some extent, on acceptance of the notions that pain may not necessarily be cured but can be managed, and that patients can progress toward more normal lives that are not dominated by pain.

It is important that we not use psychological treatment as a last resort. If we do everything else, and then tell a patient that everything else has failed and we are recommending psychological treatment, we are in essence sending her the message that we think her pain is not real. There are two errors here that warrant correction: First, psychological pain is indeed real. Second, most of the time, the etiology of chronic pelvic pain is not psychological.

What we should do right away, with all of our patients, is explain that cognitive-behavioral therapy, relaxation therapy, and other psychological techniques are extremely useful in helping patients decrease and cope with pain.

I sometimes use the analogy of how our emotions and mind can cause us to turn beet red and make us sweat and become tachycardic when we are embarrassed about something we have said or done. If our emotions can cause that kind of physical reaction, might not relaxation therapy, for instance, cause physiologic changes that help decrease our pain? More often than not, it is financial issues and the relatively poor coverage of mental health care in this country—and not patient acceptance—that is the major impediment to including psychotherapy in the treatment of chronic pelvic pain.

In the neuroablative arena, there is some evidence that adding presacral neurectomy (excision of the superior hypogastric plexus, or presacral nerve) to other treatments for endometriosis is sometimes indicated, although it's not perfectly clear what those indications are. I tend to use the therapy in patients who have previously failed medical or surgical therapy. It is one of the neurolytic therapies that may be useful in decreasing pain centrally even when there is no specific nerve dysfunction.

Tricyclic antidepressants, particularly amitriptyline, have been shown to be effective in treating chronic pelvic pain and other chronic pain syndromes, and therefore are a part of the pharmacologic arm of pain-specific therapy. In addition to reducing depressive symptoms—which is often an aim anyway in patients with chronic pelvic pain, as depression occurs with increased frequency in these women—it is generally thought that the tricyclic antidepressants improve pain tolerance.

Analgesics, of course, are a mainstay of pharmacologic pain-specific treatment of chronic pelvic pain, and there is little controversy about the use of analgesics like acetaminophen, NSAIDs, tricyclic antidepressants, and other neuropathic medications, such as gabapentin and other anticonvulsants used for chronic pain.

The use of opioids in the treatment of chronic pain remains controversial, however. Several studies, as well as clinical experience in pain centers, suggest that opioids are effective for chronic—and not only acute—pain: that the analgesics improve function and quality of life in patients who have failed other treatments. There is, however, the well-known risk of addiction, which is estimated to occur in anywhere from 3% to 15% of chronic pain patients.

As gynecologists, we can consider providing opioid treatment ourselves, but only if we are attuned to looking for addictive behaviors and only if we are familiar with state regulations that address chronic opioid use. Federal codes are quite clear in stating that the federal government has no intention of preventing physicians from treating chronic pain with opioids if such treatment is indicated, but state regulations vary.

Treatment of Chronic Pelvic Pain

This is the second installment of the Master Class in Gynecologic Surgery on pelvic pain. In part 1, I drafted Dr. Fred Howard, who serves as associate chair for academic affairs, director of the division of gynecologic specialists, and professor of obstetrics and gynecology at the University of Rochester (N.Y.), to discuss the differential diagnosis and work-up of chronic pelvic pain. In part 2, he will turn from the diagnosis to the treatment of chronic pelvic pain.

I am certain that the reader will be immediately drawn to Dr. Howard's double-armed treatment regimen of both disease-specific therapy and pain-specific therapy. Although he recognizes the importance of surgical treatment—especially in cases of endometriosis, uterine fibroids, ovarian cysts, and other reproductive tract disorders—he is quick to point out that medical, psychological, or physical therapy will suffice in most women's cases. Moreover, as Dr. Howard recognizes, physicians as well as their patients must realize and accept that although a cure is the ultimate goal of treatment, pain management may be the reality.

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Too often, women with chronic pelvic pain will have a barium enema to rule out a gastrointestinal cause, an intravenous pyelogram to rule out urinary tract disease, and a host of other diagnostic tests that are neither efficient nor effective because they have not been driven specifically by the findings of a history and physical exam. Most gastrointestinal causes of pelvic pain, in fact, cannot be diagnosed by a barium enema, and most urologic causes cannot be determined through an IVP. The same holds true for other tests.

Such a rule-out approach may seem appropriate up front, but it actually is much less efficient—and quite often less accurate—than a stepwise, deliberate approach to history-taking and physical examination.

With the correct approach, we can successfully evaluate most patients with chronic pelvic pain in a 45-minute visit—which is an achievement, considering that many disorders of the reproductive tract, gastrointestinal system, urologic organs, musculoskeletal system, and psychoneurologic system may be associated with the disorder.

Behind the Diagnostic Approach

After years of treating patients with chronic pelvic pain, I still am struck by the fact that among women of reproductive age, the disorder has about the same prevalence as do asthma, migraine headache, and low-back pain. It is a significant cause of all referrals to gynecologists, and the etiology is usually not immediately discernible. More often than not, chronic pelvic pain is caused by or associated with several diagnoses or disorders.

One woman, for instance, might have endometriosis, irritable bowel syndrome, and emotional stresses, all of which could be contributing to her chronic pelvic pain.

We lack a universally accepted definition of chronic pelvic pain, but we come closest, I believe, with a definition described in a practice bulletin published by the American College of Gynecologists and Obstetricians in 2004.

The definition is based primarily on the duration, location, and severity of the pain. It says that chronic pelvic pain is noncyclic pain of 6 or more months' duration that is localized to the true anatomical pelvis; the anterior abdominal wall at or below the umbilicus; the lumbosacral back; or the buttocks. The pain must be severe enough to cause functional disability or require medical care.

Some experts include chronic vulvar pain in their definition of chronic pelvic pain, but many do not—and the latter sentiment is reflected in ACOG's definition. According to the bulletin, approximately 15%–20% of women aged 18–50 years have chronic pelvic pain that lasts longer than 1 year.

It is less clear what proportions of women with chronic pelvic pain have specific diagnoses. We do know, however, that the gastrointestinal tract and urinary tract are just as important—if not more important—than the reproductive tract in its diagnosis. One study using a large, primary care database in the United Kingdom found that diagnoses related to the GI and urinary tracts were significantly more common than gynecologic diagnoses (approximately 38% GI, 31% urinary, and 20% gynecologic).

Again, the message for us is significant: We need to conduct a comprehensive review, through a history and physical exam, of all the systems—not only the reproductive tract—that are potentially involved in chronic pelvic pain.

The History and Exam

One of the fundamental components of the diagnostic approach is a pelvic pain intake questionnaire. Questionnaires are so commonly used in medicine today that they generally are well received by patients, and although they are not at all meant to take the place of listening to the patient tell her story, they can be quite helpful in securing details of your patient's obstetric and other medical and psychosocial history as well as the location, severity, quality, and timing of her pain. The International Pelvic Pain Society offers a useful form that can be downloaded free of charge.

It can also be useful to ask your patient to mark the location of her pain on a pain map, indicating whether it is external or internal, and whether it is sharp, dull, numb, or prickly. Other evaluation instruments, such as the visual analog scale, may also be used to assess pain severity. In addition, it can be useful to ask the patient how long the pain lasts when it occurs, how much it affects her daily life, and how the pain has changed over time.

When it comes to the physical exam of a patient with chronic pelvic pain, we need to think a little differently than we would in other scenarios and with other classic exam techniques. One of our major goals with chronic pelvic pain is to detect exact locations of tenderness and correlate these with areas of pain, so we need to think of our exam as an attempt to map the patient's pain.

 

 

This means that we must take a systematic, step-by-step approach to reproducing the pain through gentle palpations and physical positioning and maneuvering.

When I do an examination, I divide it into standing, sitting, supine, and lithotomy exams. The standing exam is mainly an evaluation for musculoskeletal problems, and should specifically seek evidence of abdominal, inguinal, or femoral hernias; fibromyalgia; lumbosacral disk disease; short leg syndrome; and postural abnormalities.

The supine exam consists of a series of maneuvers and tests, from active leg flexion and obturator and psoas sign testing, to abdominal palpation and groin and pubic symphysis evaluation. It is important to initially palpate the abdominal wall with a light touch—almost superficially at first—while you note hyperesthesias or hypersensitivity of the skin and check for superficial abdominal reflexes. Then use single-digit palpation to look for myofascial or trigger-point pain.

An abdominal wall-tenderness test (known as Carnett's test), in which the patient tenses her abdominal muscles while you palpate an area of tenderness, can be used to distinguish myofascial tenderness or trigger points from visceral tenderness. Pain that increases during the test is usually of myofascial origin, or comes from the abdominal wall itself. If the pain is decreased or unchanged, it likely is not myofascial.

Myofascial pain is most often related to trigger points and can be the result of hernias, hematomas, infections, or trauma.

It is important also to specifically evaluate any scars for abnormal tenderness.

Once you have moved through these components, you can finish the supine examination with a more classic approach aimed at detecting distention, masses, ascites, and other irregularities.

The most important thing to consider for the pelvic examination is that it should always be done with a single finger on a single hand. The objective is to identify focal areas of abnormal tenderness in any pelvic structure. This includes the pelvic floor muscles (levators, piriformis, obturators), rectovaginal septum, cul-de-sac, vulvar vestibule, urethra, bladder, Alcock's canal, uterosacral ligaments, cervix, lower uterine segment, uterine fundus, adnexae, pelvic ureters, anus, coccyx, and rectum.

Beyond the Physical Exam

It is then appropriate to perform laboratory and other diagnostic tests as indicated by the history and physical exam. Overall, such tests do not add much to the evaluation. They are important, however, for ruling out potentially life-threatening conditions or for verifying suspected diagnoses.

If you think your patient has interstitial cystitis, for example, you would probably move on to cystoscopy or potassium sensitivity testing. If you think your patient has endometriosis, you may perform a laparoscopy. If colorectal cancer is a concern, then referral for a colonoscopy might be the best option.

In general, we should be guided in our differential diagnosis by seeking those diagnoses for which we have the best evidence of causal or associative roles in chronic pelvic pain. These include interstitial cystitis, irritable bowel syndrome, endometriosis, depression, myofascial pain, and chronic pain syndrome. This does not mean we will never diagnose disorders for which the evidence of association with chronic pelvic pain is weak; it just means that these are not the diagnoses that we should seek initially.

We must not be surprised, moreover, when our patients have more than one diagnosis. In fact, we should anticipate and expect more than one. And more often than not, the pain itself will be a diagnosis and not just a symptom. Although it is frustrating to us and to our patients, in some cases chronic pain syndrome may be the only diagnosis that can be confirmed.

An Individual's Pain, Society's Pain

Chronic pelvic pain is a staggering problem. Medical costs have been estimated at $1–$2 billion per year. Missed work and decreased productivity are believed to affect business negatively at a cost of $15 billion per year. Chronic pelvic pain is responsible for 10% of ambulatory referrals to gynecologists, 20% of all hysterectomies for benign disease, and 40% of all laparoscopies. Moreover, 15% of women have reported chronic pelvic pain within the past 3 months.

Despite this, we as physicians do a poor job of diagnosing and managing chronic pelvic pain. Several reasons, including the following, account for this shortcoming:

▸ Chronic pelvic pain patients require a real time commitment. Because time is our greatest commodity, the lengthy process of reviewing voluminous records, taking a detailed history, and carrying out a meticulous examination can be quite exasperating for a busy practitioner.

▸ Evaluation and treatment generally reflect our training. That is, we tend to make gynecology-related diagnoses and to recommend treatment within our skill set, just as urologists and gastroenterologists would make GU- and GI-related diagnoses and treatment recommendations.

 

 

▸ Once a diagnosis has been made, physicians have a tendency to stay with the diagnosis; they do not reinvestigate for other causes. Unfortunately, chronic pelvic pain can have multiple etiologies.

▸ Physicians can be uncomfortable initiating a discussion of abuse issues with their patients, thus omitting the evaluation of a very real aspect of chronic pelvic pain.

I have asked Dr. Fred Howard to present the first of two articles for the Master Class in gynecologic surgery. In this article, he discusses the diagnostic approach to chronic pelvic pain; in April, he will present therapeutic options.

Dr. Howard, who is associate chair for academic affairs, director of the division of gynecologic specialists, and professor of ob.gyn. at the University of Rochester (N.Y.), is a world leader in the arena of chronic pelvic pain. Not only has he authored numerous peer-reviewed journal articles and book chapters on the condition, but he is also the coeditor of one of the essential authoritative resources on the subject, “Pelvic Pain: Diagnosis and Management” (Philadelphia: Lippincott Williams & Wilkins, 2000).

Main Concepts For Evaluations

▸ Obtain a thorough and complete history in the following areas:

Pain

Gynecologic

Gastrointestinal

Urinary

Musculoskeletal

Psychological

Neurologic

Prior evaluations

Prior treatments

▸ Use a questionnaire.

▸ Direct the physical examination to “pain mapping.”

▸ Do not expect laboratory and imaging studies to add much to your evaluation:

Order tests that are needed to rule out life-threatening diseases.

Order tests that will definitively confirm your clinical diagnoses.

▸ Expect common diagnoses that have level A evidence of association with CPP:

Irritable bowel syndrome

Interstitial cystitis

Myofascial trigger points

Depression

Endometriosis

Chronic pain syndrome

▸ Expect more than one diagnosis.

▸ Appreciate that chronic pain syndrome is often a diagnosis.

▸ Do not assume that laparoscopy is essential; it is usually not needed for a diagnosis.

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Too often, women with chronic pelvic pain will have a barium enema to rule out a gastrointestinal cause, an intravenous pyelogram to rule out urinary tract disease, and a host of other diagnostic tests that are neither efficient nor effective because they have not been driven specifically by the findings of a history and physical exam. Most gastrointestinal causes of pelvic pain, in fact, cannot be diagnosed by a barium enema, and most urologic causes cannot be determined through an IVP. The same holds true for other tests.

Such a rule-out approach may seem appropriate up front, but it actually is much less efficient—and quite often less accurate—than a stepwise, deliberate approach to history-taking and physical examination.

With the correct approach, we can successfully evaluate most patients with chronic pelvic pain in a 45-minute visit—which is an achievement, considering that many disorders of the reproductive tract, gastrointestinal system, urologic organs, musculoskeletal system, and psychoneurologic system may be associated with the disorder.

Behind the Diagnostic Approach

After years of treating patients with chronic pelvic pain, I still am struck by the fact that among women of reproductive age, the disorder has about the same prevalence as do asthma, migraine headache, and low-back pain. It is a significant cause of all referrals to gynecologists, and the etiology is usually not immediately discernible. More often than not, chronic pelvic pain is caused by or associated with several diagnoses or disorders.

One woman, for instance, might have endometriosis, irritable bowel syndrome, and emotional stresses, all of which could be contributing to her chronic pelvic pain.

We lack a universally accepted definition of chronic pelvic pain, but we come closest, I believe, with a definition described in a practice bulletin published by the American College of Gynecologists and Obstetricians in 2004.

The definition is based primarily on the duration, location, and severity of the pain. It says that chronic pelvic pain is noncyclic pain of 6 or more months' duration that is localized to the true anatomical pelvis; the anterior abdominal wall at or below the umbilicus; the lumbosacral back; or the buttocks. The pain must be severe enough to cause functional disability or require medical care.

Some experts include chronic vulvar pain in their definition of chronic pelvic pain, but many do not—and the latter sentiment is reflected in ACOG's definition. According to the bulletin, approximately 15%–20% of women aged 18–50 years have chronic pelvic pain that lasts longer than 1 year.

It is less clear what proportions of women with chronic pelvic pain have specific diagnoses. We do know, however, that the gastrointestinal tract and urinary tract are just as important—if not more important—than the reproductive tract in its diagnosis. One study using a large, primary care database in the United Kingdom found that diagnoses related to the GI and urinary tracts were significantly more common than gynecologic diagnoses (approximately 38% GI, 31% urinary, and 20% gynecologic).

Again, the message for us is significant: We need to conduct a comprehensive review, through a history and physical exam, of all the systems—not only the reproductive tract—that are potentially involved in chronic pelvic pain.

The History and Exam

One of the fundamental components of the diagnostic approach is a pelvic pain intake questionnaire. Questionnaires are so commonly used in medicine today that they generally are well received by patients, and although they are not at all meant to take the place of listening to the patient tell her story, they can be quite helpful in securing details of your patient's obstetric and other medical and psychosocial history as well as the location, severity, quality, and timing of her pain. The International Pelvic Pain Society offers a useful form that can be downloaded free of charge.

It can also be useful to ask your patient to mark the location of her pain on a pain map, indicating whether it is external or internal, and whether it is sharp, dull, numb, or prickly. Other evaluation instruments, such as the visual analog scale, may also be used to assess pain severity. In addition, it can be useful to ask the patient how long the pain lasts when it occurs, how much it affects her daily life, and how the pain has changed over time.

When it comes to the physical exam of a patient with chronic pelvic pain, we need to think a little differently than we would in other scenarios and with other classic exam techniques. One of our major goals with chronic pelvic pain is to detect exact locations of tenderness and correlate these with areas of pain, so we need to think of our exam as an attempt to map the patient's pain.

 

 

This means that we must take a systematic, step-by-step approach to reproducing the pain through gentle palpations and physical positioning and maneuvering.

When I do an examination, I divide it into standing, sitting, supine, and lithotomy exams. The standing exam is mainly an evaluation for musculoskeletal problems, and should specifically seek evidence of abdominal, inguinal, or femoral hernias; fibromyalgia; lumbosacral disk disease; short leg syndrome; and postural abnormalities.

The supine exam consists of a series of maneuvers and tests, from active leg flexion and obturator and psoas sign testing, to abdominal palpation and groin and pubic symphysis evaluation. It is important to initially palpate the abdominal wall with a light touch—almost superficially at first—while you note hyperesthesias or hypersensitivity of the skin and check for superficial abdominal reflexes. Then use single-digit palpation to look for myofascial or trigger-point pain.

An abdominal wall-tenderness test (known as Carnett's test), in which the patient tenses her abdominal muscles while you palpate an area of tenderness, can be used to distinguish myofascial tenderness or trigger points from visceral tenderness. Pain that increases during the test is usually of myofascial origin, or comes from the abdominal wall itself. If the pain is decreased or unchanged, it likely is not myofascial.

Myofascial pain is most often related to trigger points and can be the result of hernias, hematomas, infections, or trauma.

It is important also to specifically evaluate any scars for abnormal tenderness.

Once you have moved through these components, you can finish the supine examination with a more classic approach aimed at detecting distention, masses, ascites, and other irregularities.

The most important thing to consider for the pelvic examination is that it should always be done with a single finger on a single hand. The objective is to identify focal areas of abnormal tenderness in any pelvic structure. This includes the pelvic floor muscles (levators, piriformis, obturators), rectovaginal septum, cul-de-sac, vulvar vestibule, urethra, bladder, Alcock's canal, uterosacral ligaments, cervix, lower uterine segment, uterine fundus, adnexae, pelvic ureters, anus, coccyx, and rectum.

Beyond the Physical Exam

It is then appropriate to perform laboratory and other diagnostic tests as indicated by the history and physical exam. Overall, such tests do not add much to the evaluation. They are important, however, for ruling out potentially life-threatening conditions or for verifying suspected diagnoses.

If you think your patient has interstitial cystitis, for example, you would probably move on to cystoscopy or potassium sensitivity testing. If you think your patient has endometriosis, you may perform a laparoscopy. If colorectal cancer is a concern, then referral for a colonoscopy might be the best option.

In general, we should be guided in our differential diagnosis by seeking those diagnoses for which we have the best evidence of causal or associative roles in chronic pelvic pain. These include interstitial cystitis, irritable bowel syndrome, endometriosis, depression, myofascial pain, and chronic pain syndrome. This does not mean we will never diagnose disorders for which the evidence of association with chronic pelvic pain is weak; it just means that these are not the diagnoses that we should seek initially.

We must not be surprised, moreover, when our patients have more than one diagnosis. In fact, we should anticipate and expect more than one. And more often than not, the pain itself will be a diagnosis and not just a symptom. Although it is frustrating to us and to our patients, in some cases chronic pain syndrome may be the only diagnosis that can be confirmed.

An Individual's Pain, Society's Pain

Chronic pelvic pain is a staggering problem. Medical costs have been estimated at $1–$2 billion per year. Missed work and decreased productivity are believed to affect business negatively at a cost of $15 billion per year. Chronic pelvic pain is responsible for 10% of ambulatory referrals to gynecologists, 20% of all hysterectomies for benign disease, and 40% of all laparoscopies. Moreover, 15% of women have reported chronic pelvic pain within the past 3 months.

Despite this, we as physicians do a poor job of diagnosing and managing chronic pelvic pain. Several reasons, including the following, account for this shortcoming:

▸ Chronic pelvic pain patients require a real time commitment. Because time is our greatest commodity, the lengthy process of reviewing voluminous records, taking a detailed history, and carrying out a meticulous examination can be quite exasperating for a busy practitioner.

▸ Evaluation and treatment generally reflect our training. That is, we tend to make gynecology-related diagnoses and to recommend treatment within our skill set, just as urologists and gastroenterologists would make GU- and GI-related diagnoses and treatment recommendations.

 

 

▸ Once a diagnosis has been made, physicians have a tendency to stay with the diagnosis; they do not reinvestigate for other causes. Unfortunately, chronic pelvic pain can have multiple etiologies.

▸ Physicians can be uncomfortable initiating a discussion of abuse issues with their patients, thus omitting the evaluation of a very real aspect of chronic pelvic pain.

I have asked Dr. Fred Howard to present the first of two articles for the Master Class in gynecologic surgery. In this article, he discusses the diagnostic approach to chronic pelvic pain; in April, he will present therapeutic options.

Dr. Howard, who is associate chair for academic affairs, director of the division of gynecologic specialists, and professor of ob.gyn. at the University of Rochester (N.Y.), is a world leader in the arena of chronic pelvic pain. Not only has he authored numerous peer-reviewed journal articles and book chapters on the condition, but he is also the coeditor of one of the essential authoritative resources on the subject, “Pelvic Pain: Diagnosis and Management” (Philadelphia: Lippincott Williams & Wilkins, 2000).

Main Concepts For Evaluations

▸ Obtain a thorough and complete history in the following areas:

Pain

Gynecologic

Gastrointestinal

Urinary

Musculoskeletal

Psychological

Neurologic

Prior evaluations

Prior treatments

▸ Use a questionnaire.

▸ Direct the physical examination to “pain mapping.”

▸ Do not expect laboratory and imaging studies to add much to your evaluation:

Order tests that are needed to rule out life-threatening diseases.

Order tests that will definitively confirm your clinical diagnoses.

▸ Expect common diagnoses that have level A evidence of association with CPP:

Irritable bowel syndrome

Interstitial cystitis

Myofascial trigger points

Depression

Endometriosis

Chronic pain syndrome

▸ Expect more than one diagnosis.

▸ Appreciate that chronic pain syndrome is often a diagnosis.

▸ Do not assume that laparoscopy is essential; it is usually not needed for a diagnosis.

Too often, women with chronic pelvic pain will have a barium enema to rule out a gastrointestinal cause, an intravenous pyelogram to rule out urinary tract disease, and a host of other diagnostic tests that are neither efficient nor effective because they have not been driven specifically by the findings of a history and physical exam. Most gastrointestinal causes of pelvic pain, in fact, cannot be diagnosed by a barium enema, and most urologic causes cannot be determined through an IVP. The same holds true for other tests.

Such a rule-out approach may seem appropriate up front, but it actually is much less efficient—and quite often less accurate—than a stepwise, deliberate approach to history-taking and physical examination.

With the correct approach, we can successfully evaluate most patients with chronic pelvic pain in a 45-minute visit—which is an achievement, considering that many disorders of the reproductive tract, gastrointestinal system, urologic organs, musculoskeletal system, and psychoneurologic system may be associated with the disorder.

Behind the Diagnostic Approach

After years of treating patients with chronic pelvic pain, I still am struck by the fact that among women of reproductive age, the disorder has about the same prevalence as do asthma, migraine headache, and low-back pain. It is a significant cause of all referrals to gynecologists, and the etiology is usually not immediately discernible. More often than not, chronic pelvic pain is caused by or associated with several diagnoses or disorders.

One woman, for instance, might have endometriosis, irritable bowel syndrome, and emotional stresses, all of which could be contributing to her chronic pelvic pain.

We lack a universally accepted definition of chronic pelvic pain, but we come closest, I believe, with a definition described in a practice bulletin published by the American College of Gynecologists and Obstetricians in 2004.

The definition is based primarily on the duration, location, and severity of the pain. It says that chronic pelvic pain is noncyclic pain of 6 or more months' duration that is localized to the true anatomical pelvis; the anterior abdominal wall at or below the umbilicus; the lumbosacral back; or the buttocks. The pain must be severe enough to cause functional disability or require medical care.

Some experts include chronic vulvar pain in their definition of chronic pelvic pain, but many do not—and the latter sentiment is reflected in ACOG's definition. According to the bulletin, approximately 15%–20% of women aged 18–50 years have chronic pelvic pain that lasts longer than 1 year.

It is less clear what proportions of women with chronic pelvic pain have specific diagnoses. We do know, however, that the gastrointestinal tract and urinary tract are just as important—if not more important—than the reproductive tract in its diagnosis. One study using a large, primary care database in the United Kingdom found that diagnoses related to the GI and urinary tracts were significantly more common than gynecologic diagnoses (approximately 38% GI, 31% urinary, and 20% gynecologic).

Again, the message for us is significant: We need to conduct a comprehensive review, through a history and physical exam, of all the systems—not only the reproductive tract—that are potentially involved in chronic pelvic pain.

The History and Exam

One of the fundamental components of the diagnostic approach is a pelvic pain intake questionnaire. Questionnaires are so commonly used in medicine today that they generally are well received by patients, and although they are not at all meant to take the place of listening to the patient tell her story, they can be quite helpful in securing details of your patient's obstetric and other medical and psychosocial history as well as the location, severity, quality, and timing of her pain. The International Pelvic Pain Society offers a useful form that can be downloaded free of charge.

It can also be useful to ask your patient to mark the location of her pain on a pain map, indicating whether it is external or internal, and whether it is sharp, dull, numb, or prickly. Other evaluation instruments, such as the visual analog scale, may also be used to assess pain severity. In addition, it can be useful to ask the patient how long the pain lasts when it occurs, how much it affects her daily life, and how the pain has changed over time.

When it comes to the physical exam of a patient with chronic pelvic pain, we need to think a little differently than we would in other scenarios and with other classic exam techniques. One of our major goals with chronic pelvic pain is to detect exact locations of tenderness and correlate these with areas of pain, so we need to think of our exam as an attempt to map the patient's pain.

 

 

This means that we must take a systematic, step-by-step approach to reproducing the pain through gentle palpations and physical positioning and maneuvering.

When I do an examination, I divide it into standing, sitting, supine, and lithotomy exams. The standing exam is mainly an evaluation for musculoskeletal problems, and should specifically seek evidence of abdominal, inguinal, or femoral hernias; fibromyalgia; lumbosacral disk disease; short leg syndrome; and postural abnormalities.

The supine exam consists of a series of maneuvers and tests, from active leg flexion and obturator and psoas sign testing, to abdominal palpation and groin and pubic symphysis evaluation. It is important to initially palpate the abdominal wall with a light touch—almost superficially at first—while you note hyperesthesias or hypersensitivity of the skin and check for superficial abdominal reflexes. Then use single-digit palpation to look for myofascial or trigger-point pain.

An abdominal wall-tenderness test (known as Carnett's test), in which the patient tenses her abdominal muscles while you palpate an area of tenderness, can be used to distinguish myofascial tenderness or trigger points from visceral tenderness. Pain that increases during the test is usually of myofascial origin, or comes from the abdominal wall itself. If the pain is decreased or unchanged, it likely is not myofascial.

Myofascial pain is most often related to trigger points and can be the result of hernias, hematomas, infections, or trauma.

It is important also to specifically evaluate any scars for abnormal tenderness.

Once you have moved through these components, you can finish the supine examination with a more classic approach aimed at detecting distention, masses, ascites, and other irregularities.

The most important thing to consider for the pelvic examination is that it should always be done with a single finger on a single hand. The objective is to identify focal areas of abnormal tenderness in any pelvic structure. This includes the pelvic floor muscles (levators, piriformis, obturators), rectovaginal septum, cul-de-sac, vulvar vestibule, urethra, bladder, Alcock's canal, uterosacral ligaments, cervix, lower uterine segment, uterine fundus, adnexae, pelvic ureters, anus, coccyx, and rectum.

Beyond the Physical Exam

It is then appropriate to perform laboratory and other diagnostic tests as indicated by the history and physical exam. Overall, such tests do not add much to the evaluation. They are important, however, for ruling out potentially life-threatening conditions or for verifying suspected diagnoses.

If you think your patient has interstitial cystitis, for example, you would probably move on to cystoscopy or potassium sensitivity testing. If you think your patient has endometriosis, you may perform a laparoscopy. If colorectal cancer is a concern, then referral for a colonoscopy might be the best option.

In general, we should be guided in our differential diagnosis by seeking those diagnoses for which we have the best evidence of causal or associative roles in chronic pelvic pain. These include interstitial cystitis, irritable bowel syndrome, endometriosis, depression, myofascial pain, and chronic pain syndrome. This does not mean we will never diagnose disorders for which the evidence of association with chronic pelvic pain is weak; it just means that these are not the diagnoses that we should seek initially.

We must not be surprised, moreover, when our patients have more than one diagnosis. In fact, we should anticipate and expect more than one. And more often than not, the pain itself will be a diagnosis and not just a symptom. Although it is frustrating to us and to our patients, in some cases chronic pain syndrome may be the only diagnosis that can be confirmed.

An Individual's Pain, Society's Pain

Chronic pelvic pain is a staggering problem. Medical costs have been estimated at $1–$2 billion per year. Missed work and decreased productivity are believed to affect business negatively at a cost of $15 billion per year. Chronic pelvic pain is responsible for 10% of ambulatory referrals to gynecologists, 20% of all hysterectomies for benign disease, and 40% of all laparoscopies. Moreover, 15% of women have reported chronic pelvic pain within the past 3 months.

Despite this, we as physicians do a poor job of diagnosing and managing chronic pelvic pain. Several reasons, including the following, account for this shortcoming:

▸ Chronic pelvic pain patients require a real time commitment. Because time is our greatest commodity, the lengthy process of reviewing voluminous records, taking a detailed history, and carrying out a meticulous examination can be quite exasperating for a busy practitioner.

▸ Evaluation and treatment generally reflect our training. That is, we tend to make gynecology-related diagnoses and to recommend treatment within our skill set, just as urologists and gastroenterologists would make GU- and GI-related diagnoses and treatment recommendations.

 

 

▸ Once a diagnosis has been made, physicians have a tendency to stay with the diagnosis; they do not reinvestigate for other causes. Unfortunately, chronic pelvic pain can have multiple etiologies.

▸ Physicians can be uncomfortable initiating a discussion of abuse issues with their patients, thus omitting the evaluation of a very real aspect of chronic pelvic pain.

I have asked Dr. Fred Howard to present the first of two articles for the Master Class in gynecologic surgery. In this article, he discusses the diagnostic approach to chronic pelvic pain; in April, he will present therapeutic options.

Dr. Howard, who is associate chair for academic affairs, director of the division of gynecologic specialists, and professor of ob.gyn. at the University of Rochester (N.Y.), is a world leader in the arena of chronic pelvic pain. Not only has he authored numerous peer-reviewed journal articles and book chapters on the condition, but he is also the coeditor of one of the essential authoritative resources on the subject, “Pelvic Pain: Diagnosis and Management” (Philadelphia: Lippincott Williams & Wilkins, 2000).

Main Concepts For Evaluations

▸ Obtain a thorough and complete history in the following areas:

Pain

Gynecologic

Gastrointestinal

Urinary

Musculoskeletal

Psychological

Neurologic

Prior evaluations

Prior treatments

▸ Use a questionnaire.

▸ Direct the physical examination to “pain mapping.”

▸ Do not expect laboratory and imaging studies to add much to your evaluation:

Order tests that are needed to rule out life-threatening diseases.

Order tests that will definitively confirm your clinical diagnoses.

▸ Expect common diagnoses that have level A evidence of association with CPP:

Irritable bowel syndrome

Interstitial cystitis

Myofascial trigger points

Depression

Endometriosis

Chronic pain syndrome

▸ Expect more than one diagnosis.

▸ Appreciate that chronic pain syndrome is often a diagnosis.

▸ Do not assume that laparoscopy is essential; it is usually not needed for a diagnosis.

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Hysteroscopic Lysis of Intrauterine Adhesions

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Hysteroscopic Lysis of Intrauterine Adhesions

Asherman's syndrome can occur after any type of gynecologic surgery, and we must shift our thinking and heighten our index of suspicion to accommodate the growing body of data that supports this claim.

A literature review published in Fertility and Sterility 15 years ago reported that approximately 90% of all cases of Asherman's syndrome occurred after curettage, mainly after D&C for a spontaneous abortion or one performed to control a postpartum hemorrhage. Although these two antecedent factors remain the most common causes, there has been a significant increase in the number of patients who develop endometrial scarring after gynecologic surgery, particularly following abdominal and hysteroscopic myomectomy.

Women who have had myomectomy or other types of uterine surgery make up an increasing proportion of all patients with adhesion formation and a variant of Asherman's syndrome known as endometrial sclerosis.

Endometrial sclerosis, commonly called an “unstuck Asherman's,” is an end-stage disease in which the basalis layer of the endometrium has been severely damaged or even removed. In these women, the hysterosalpingography (HSG) may demonstrate a normal cavity or one of slightly reduced size, but with little or no scarring.

This change presents new challenges because the damage that follows gynecologic surgery other than curettage is a much less curable condition.

Our Index of Suspicion

Key to our role as gynecologists is suspecting the problem. Any change in menstrual flow and pattern—from amenorrhea to any decrease in the duration or amount of bleeding—that follows any type of uterine surgery, irrespective of how minimal that surgery might have been, must prompt us to suspect that this patient may have scarring in her uterus. All patients with a history of intrauterine trauma must be considered at risk.

In addition to endometrial trauma, pregnancy (or recent pregnancy) and hypoestrogenism are important keys. The pregnant or recently pregnant uterus appears to be more vulnerable to scar formation.

Concomitantly, breast-feeding increases the risk of adhesion formation because women who breast-feed remain estrogen deficient. Estrogen has a tremendous effect in promoting the healing of the uterus and regeneration of the endometrium. Women who breast-feed don't have that stimulus.

To a lesser extent, infection also can play a role. Decades ago, infection was viewed as critical, in that it was the “infected abortion” that was thought to cause Asherman's syndrome. Today, infections are an uncommon cause of the problem. I have treated more than 1,000 patients with Asherman's, and fewer than 5 had any clinical evidence of infection around the time of their original surgery. Still, the possibility of Asherman's resulting from infections still exists.

Pelvic tuberculosis by itself, without any surgical trauma, causes scarring in the uterus. Considering the diversity of our society and the rise in antibiotic-resistant TB, we ought to keep it in mind.

It is also important to appreciate the fact that the presence of normal menstrual flow does not rule out the presence of intrauterine adhesions. Approximately three-quarters of women with Asherman's syndrome have amenorrhea or hypomenorrhea, but the remainder have menses of normal flow and duration. Other symptoms of intrauterine adhesions include infertility, recurrent miscarriage, and placenta accreta or its more severe variants.

Methods of Diagnosis

The diagnosis will most frequently be made by either HSG or a saline-infusion sonogram. However, these methods provide us with only a presumptive diagnosis. Both will demonstrate irregular, lacunalike defects spaced throughout the cavity. Access to the oviducts may or may not be blocked. A definitive diagnosis comes only with hysteroscopy.

We should individualize our diagnostic methods depending on the patient's history and symptoms and our own index of suspicion. For instance, a patient who presents with amenorrhea and monthly cramping following a D&C would benefit from a pelvic ultrasound. This study is likely to demonstrate fluid in the uterus. Her hematometra is secondary to outflow tract obstruction. There is no reason in this case to do a saline-infusion sonogram or an HSG. The next appropriate step is hysteroscopy, which will allow the diagnosis to be made with certainty so that treatment can commence.

Consider another patient with postcurettage amenorrhea. She has little or no fluid in the uterus and her endometrium is thin and/or irregular. A pregnancy test is negative and a uterine sound cannot be passed into the cavity. In this case, it is wise to proceed to hysteroscopy because it would not be possible to pass the contrast material for HSG—or the saline for a saline-infusion sonogram—beyond the site that blocked passage of the sound.

Hysteroscopy provides us with absolute proof of intrauterine adhesions. It allows us to directly inspect the uterine cavity and assess the extent, nature, and location of the adhesions. This also allows us to classify the disease, which is critical because classification enables us to make meaningful comparisons among different types of treatment regimens or adjunctive therapies. Finally, adhesiolysis under hysteroscopic guidance is more efficacious and less traumatic to the adjacent normal tissue.

 

 

Scissors vs. Heat

Since the introduction of hysteroscopy to treat intrauterine adhesions, the prognosis has gone from dismal to excellent. Hysteroscopic management not only enables us to cut all the scar tissue, but it ensures that we will not damage adjacent normal endometrium. There is no justification today for treating Asherman's syndrome by a technique other than hysteroscopy.

Although comparative studies are not available, we advocate that only scissors be used to cut adhesions, and we use them in our own practice.

Adhesiolysis methods that use a resectoscope, an Nd:YAG laser, or a monopolar or bipolar electrode have their proponents. However, all of these modalities deliver energy to the endometrial surface and can cause further damage to the endometrium. Remember that these same instruments are used to cause endometrial ablation.

Years ago, it was demonstrated that—in contrast to what occurs after a scalpel has been used to make an incision—tissue damage is observed far from the operative site when electrodes or an Nd:YAG laser is used for the same purpose. These energy sources offer no advantage—neither speed nor improved hemostasis (intrauterine scars do not bleed, but myometrium does)—over scissor dissection. In a patient with a damaged endometrium, it is prudent to limit the risk of further injury.

Although I have performed surgery that was not successful, it was not because of the inability of the flexible or semirigid scissors to cut through dense scars.

For women with extensive scarring, we should use simultaneous laparoscopy to reduce the risk of uterine perforation. This group of patients is increasing in relative frequency. The main antecedent factors for severe disease are the postpartum curettage performed 2–4 weeks after delivery, and scarring after myomectomy or metroplasty.

After the cutting of all adhesions under direct vision using hysteroscopy, I advise the placement of a splint into the uterus to help reduce adhesion reformation, and the prescription of 1–2 months of high-dose estrogen treatment to promote healing of the tissue and overgrowth of the endometrium.

We use the Cook balloon uterine stent, which has a triangular shape and therefore conforms to the shape of the normal uterus. (See photo, page 36.) This configuration allows it to reduce the risk of reformation of adhesions that had been along the margins of the cavity.

If the adhesions are limited to the endocervical canal and lower uterine segment, a Foley catheter is used as a stent instead of the Cook device because the former has a much wider diameter.

If a Foley catheter is used, the portion distal to the balloon is removed prior to insertion. After insertion of the Foley and inflation of its balloon, ligatures of No. 1 silk are placed around the catheter close to the cervix. This step keeps the balloon inflated and allows the trailing edge to be removed, thereby reducing patient discomfort.

The stent remains in place for 5 days to 3 weeks, depending on the type of stent used and the location and density of the adhesions. During the time that the stent is in situ, a broad-spectrum antibiotic is prescribed.

Following surgery, high-dose estrogen therapy (usually 3–4 mg of micronized oral estradiol) is prescribed for 30–60 days in order to maximally stimulate the endometrium, especially those areas under and adjacent to the adhesions. On the last 5 days of estrogen treatment, 10 mg of medroxyprogesterone acetate is added.

After the menstrual period that follows cessation of the estrogen-progestin treatment, we must perform HSG, hysteroscopy, or a saline-infusion sonogram to assess thoroughly the structure and configuration of the uterus. The last step in postoperative surveillance is a midcycle ultrasound to check endometrial growth and development.

The importance of verifying the normalcy of the uterine cavity and the complete resolution of adhesions before permitting conception cannot be overemphasized. The prognosis for the patient whose problem has been only partially solved is not good.

Variable Success, Mitigating Risks

The rates of cure of Asherman's syndrome vary dramatically according to the antecedent factors involved. In women with Asherman's syndrome that occurs after a D&C for a first-trimester abortion, whether spontaneous or induced, we can achieve a 98% structural success rate (normal follow-up HSG and ultrasound). This rate drops to 50% for Asherman's that occurs after a D&C for postpartum hemorrhage that is performed 2–4 weeks after delivery. The success rate drops further—to 20%—for treatment of scarring that follows myomectomy.

The low success rate of treatment for Asherman's after myomectomy is especially disconcerting because these cases make up an increasing proportion of all those with intrauterine adhesions that we see today. As women delay childbearing, there are more who will develop myomas prior to seeking their first pregnancy at an age older than 35 years.

 

 

If one or more myomas were removed because of symptoms, or to improve the likelihood of a successful pregnancy, then attempts to achieve a successful implantation may be stymied by the resultant scarring.

The key to increasing the cure rates for postmyomectomy Asherman's syndrome—and to reducing the incidence and severity of postmyomectomy scarring—could lie in the approach to fibroid removal.

The best approach for a woman who may want to become pregnant in the future, and who has a myoma that occupies a fair amount of the endometrial surface, may be to extract it abdominally. This approach provides a better chance of sparing the endometrium because the fibroid can often be “peeled” away from the endometrial surface, thereby maintaining the basalis layer within the outer layer of the myoma's capsule.

If the hysteroscopic approach is used, all of the endometrium over the surface of the myoma will be removed in order to extract the tumor.

The European Society of Hysteroscopy's classification of myomas is a helpful guide to plan the ideal route of surgery based on the extent of the intracavitary component. I have found this system—coupled with the size and location of the tumor (or tumors) and the patient's desire for future fertility—to be very useful in planning the ideal surgical approach.

We also should be extremely selective in our use of GnRH agonists. These agents allow anemia to be reversed, cause endometrial atrophy, and can make myomectomy easier to perform. However, the atrophic, estrogen-depleted endometrium may be more prone to adhesion formation.

To prevent intrauterine scarring following a D&C performed for postpartum hemorrhage 2–4 weeks after delivery, when the uterus is most vulnerable to scarring, I would propose to the patient that she not breast-feed, that a splint be placed in her uterus, and that she receive estrogen therapy. Although there are no studies on the efficacy of this prophylactic approach, these measures may help prevent the development of intrauterine adhesions, which are quite difficult to cure.

Administering prophylactic antibiotics at the time of D&C is a common practice and may help prevent subclinical infection. For the pregnancy loss that occurs very early in gestation, medical rather than surgical termination may be considered as a method of reducing the risk of scar formation. If curettage is necessary, it is advisable to perform surgery shortly after the fetal demise has been diagnosed. Curettage performed long after fetal demise is associated with a higher risk of scar formation, probably because some degree of fibrosis has begun.

Subsequent Pregnancy

The overall pregnancy rate after successful treatment for intrauterine adhesions is approximately 75%. (Other causes of infertility prevent us from reaching 100%.) In patients who conceive, approximately 85% of the pregnancies are successful. During pregnancy, there are several potential complications that must be anticipated in patients who have been treated for Asherman's syndrome. One is an incompetent cervix. These patients often have had many cervical dilatations because of curettages and hysteroscopies before becoming pregnant. An ultrasound can be used to assess the shortening of the cervix and any funneling of the membranes.

We must also consider the possibility of placenta accreta, which can be easily diagnosed with either high-resolution ultrasound or MRI in late pregnancy.

The advantages of suspecting the problem are several. For example, a patient can bank her own blood because placenta accreta can be associated with significant blood loss at delivery, and she can plan the timing and/or site of her delivery to optimize hospital resources and ensure access to a large amount of blood products and consultants from various specialties.

Even if the placenta appears to have been delivered complete and intact, uterine exploration is advised to verify that there are no retained fragments. Placenta accreta occurs significantly more often in patients who become pregnant with only partially treated Asherman's syndrome than in patients whose uterine cavity is normal. The successful-pregnancy rate in patients with incompletely resolved intrauterine adhesions is only 20%, and 18%–28% of these patients will have placental complications.

This means that once a diagnosis of intrauterine adhesions has been made, the patient should be offered therapy if she wishes to conceive. The recommendation to “try to conceive and see how it works” is a recipe for a bad outcome.

About 20% of my patients have needed more than one procedure in order to restore the cavity to normalcy. The second—or, rarely, even a fifth—procedure may be considered extreme if the postoperative HSG and ultrasound that followed a prior hysteroscopic adhesiolysis were “pretty normal.” However, the poor outcome in those with partially treated disease speaks volumes, especially in women who are older and are less fertile than in the past.

 

 

An important resource for patients with this condition is Asherman's Syndrome International, which is accessible at

http://groups.yahoo.com/group/Ashermans

Intrauterine Adhesions

Intrauterine adhesions continue to plague gynecologists and reproductive endocrinologists. Approximately 70 years ago, Asherman and Toaff came out with their landmark paper on patients who present with intrauterine synechiae and amenorrhea: Asherman's syndrome. The scarring can affect not only menstrual flow, but implantation as well, even in the environment of apparently normal menstruation.

When these adhesions are removed, proper care must be taken to minimize damage to the normal intrauterine cavity. Moreover, strategies must be considered to reduce subsequent postoperative adhesions. This is especially problematic because the intrauterine cavity is a pseudospace. The removal of intrauterine synechiae places traumatized tissue against traumatized tissue. This situation would appear to enable subsequent postoperative adhesion formation.

For this Master Class in gynecologic surgery, I have elicited the help of Dr. Charles March. Dr. March spent 30 years in the department of obstetrics and gynecology at the University of Southern California, Los Angeles, where he became professor in 1987. During his tenure there, Dr. March was a prolific writer, especially in the area of operative hysteroscopy, and was the recipient of numerous awards including many resident-teaching awards. In 2000, Dr. March was given a Pioneer in Hysteroscopy award from the American Association of Gynecologic Laparoscopists.

Since 2003, Dr. March has been in private practice, where he specializes in infertility treatment and sees patients from across the country for operative hysteroscopy secondary to intrauterine synechiae. Even so, Dr. March continues to win teaching awards, now as a voluntary faculty member.

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Asherman's syndrome can occur after any type of gynecologic surgery, and we must shift our thinking and heighten our index of suspicion to accommodate the growing body of data that supports this claim.

A literature review published in Fertility and Sterility 15 years ago reported that approximately 90% of all cases of Asherman's syndrome occurred after curettage, mainly after D&C for a spontaneous abortion or one performed to control a postpartum hemorrhage. Although these two antecedent factors remain the most common causes, there has been a significant increase in the number of patients who develop endometrial scarring after gynecologic surgery, particularly following abdominal and hysteroscopic myomectomy.

Women who have had myomectomy or other types of uterine surgery make up an increasing proportion of all patients with adhesion formation and a variant of Asherman's syndrome known as endometrial sclerosis.

Endometrial sclerosis, commonly called an “unstuck Asherman's,” is an end-stage disease in which the basalis layer of the endometrium has been severely damaged or even removed. In these women, the hysterosalpingography (HSG) may demonstrate a normal cavity or one of slightly reduced size, but with little or no scarring.

This change presents new challenges because the damage that follows gynecologic surgery other than curettage is a much less curable condition.

Our Index of Suspicion

Key to our role as gynecologists is suspecting the problem. Any change in menstrual flow and pattern—from amenorrhea to any decrease in the duration or amount of bleeding—that follows any type of uterine surgery, irrespective of how minimal that surgery might have been, must prompt us to suspect that this patient may have scarring in her uterus. All patients with a history of intrauterine trauma must be considered at risk.

In addition to endometrial trauma, pregnancy (or recent pregnancy) and hypoestrogenism are important keys. The pregnant or recently pregnant uterus appears to be more vulnerable to scar formation.

Concomitantly, breast-feeding increases the risk of adhesion formation because women who breast-feed remain estrogen deficient. Estrogen has a tremendous effect in promoting the healing of the uterus and regeneration of the endometrium. Women who breast-feed don't have that stimulus.

To a lesser extent, infection also can play a role. Decades ago, infection was viewed as critical, in that it was the “infected abortion” that was thought to cause Asherman's syndrome. Today, infections are an uncommon cause of the problem. I have treated more than 1,000 patients with Asherman's, and fewer than 5 had any clinical evidence of infection around the time of their original surgery. Still, the possibility of Asherman's resulting from infections still exists.

Pelvic tuberculosis by itself, without any surgical trauma, causes scarring in the uterus. Considering the diversity of our society and the rise in antibiotic-resistant TB, we ought to keep it in mind.

It is also important to appreciate the fact that the presence of normal menstrual flow does not rule out the presence of intrauterine adhesions. Approximately three-quarters of women with Asherman's syndrome have amenorrhea or hypomenorrhea, but the remainder have menses of normal flow and duration. Other symptoms of intrauterine adhesions include infertility, recurrent miscarriage, and placenta accreta or its more severe variants.

Methods of Diagnosis

The diagnosis will most frequently be made by either HSG or a saline-infusion sonogram. However, these methods provide us with only a presumptive diagnosis. Both will demonstrate irregular, lacunalike defects spaced throughout the cavity. Access to the oviducts may or may not be blocked. A definitive diagnosis comes only with hysteroscopy.

We should individualize our diagnostic methods depending on the patient's history and symptoms and our own index of suspicion. For instance, a patient who presents with amenorrhea and monthly cramping following a D&C would benefit from a pelvic ultrasound. This study is likely to demonstrate fluid in the uterus. Her hematometra is secondary to outflow tract obstruction. There is no reason in this case to do a saline-infusion sonogram or an HSG. The next appropriate step is hysteroscopy, which will allow the diagnosis to be made with certainty so that treatment can commence.

Consider another patient with postcurettage amenorrhea. She has little or no fluid in the uterus and her endometrium is thin and/or irregular. A pregnancy test is negative and a uterine sound cannot be passed into the cavity. In this case, it is wise to proceed to hysteroscopy because it would not be possible to pass the contrast material for HSG—or the saline for a saline-infusion sonogram—beyond the site that blocked passage of the sound.

Hysteroscopy provides us with absolute proof of intrauterine adhesions. It allows us to directly inspect the uterine cavity and assess the extent, nature, and location of the adhesions. This also allows us to classify the disease, which is critical because classification enables us to make meaningful comparisons among different types of treatment regimens or adjunctive therapies. Finally, adhesiolysis under hysteroscopic guidance is more efficacious and less traumatic to the adjacent normal tissue.

 

 

Scissors vs. Heat

Since the introduction of hysteroscopy to treat intrauterine adhesions, the prognosis has gone from dismal to excellent. Hysteroscopic management not only enables us to cut all the scar tissue, but it ensures that we will not damage adjacent normal endometrium. There is no justification today for treating Asherman's syndrome by a technique other than hysteroscopy.

Although comparative studies are not available, we advocate that only scissors be used to cut adhesions, and we use them in our own practice.

Adhesiolysis methods that use a resectoscope, an Nd:YAG laser, or a monopolar or bipolar electrode have their proponents. However, all of these modalities deliver energy to the endometrial surface and can cause further damage to the endometrium. Remember that these same instruments are used to cause endometrial ablation.

Years ago, it was demonstrated that—in contrast to what occurs after a scalpel has been used to make an incision—tissue damage is observed far from the operative site when electrodes or an Nd:YAG laser is used for the same purpose. These energy sources offer no advantage—neither speed nor improved hemostasis (intrauterine scars do not bleed, but myometrium does)—over scissor dissection. In a patient with a damaged endometrium, it is prudent to limit the risk of further injury.

Although I have performed surgery that was not successful, it was not because of the inability of the flexible or semirigid scissors to cut through dense scars.

For women with extensive scarring, we should use simultaneous laparoscopy to reduce the risk of uterine perforation. This group of patients is increasing in relative frequency. The main antecedent factors for severe disease are the postpartum curettage performed 2–4 weeks after delivery, and scarring after myomectomy or metroplasty.

After the cutting of all adhesions under direct vision using hysteroscopy, I advise the placement of a splint into the uterus to help reduce adhesion reformation, and the prescription of 1–2 months of high-dose estrogen treatment to promote healing of the tissue and overgrowth of the endometrium.

We use the Cook balloon uterine stent, which has a triangular shape and therefore conforms to the shape of the normal uterus. (See photo, page 36.) This configuration allows it to reduce the risk of reformation of adhesions that had been along the margins of the cavity.

If the adhesions are limited to the endocervical canal and lower uterine segment, a Foley catheter is used as a stent instead of the Cook device because the former has a much wider diameter.

If a Foley catheter is used, the portion distal to the balloon is removed prior to insertion. After insertion of the Foley and inflation of its balloon, ligatures of No. 1 silk are placed around the catheter close to the cervix. This step keeps the balloon inflated and allows the trailing edge to be removed, thereby reducing patient discomfort.

The stent remains in place for 5 days to 3 weeks, depending on the type of stent used and the location and density of the adhesions. During the time that the stent is in situ, a broad-spectrum antibiotic is prescribed.

Following surgery, high-dose estrogen therapy (usually 3–4 mg of micronized oral estradiol) is prescribed for 30–60 days in order to maximally stimulate the endometrium, especially those areas under and adjacent to the adhesions. On the last 5 days of estrogen treatment, 10 mg of medroxyprogesterone acetate is added.

After the menstrual period that follows cessation of the estrogen-progestin treatment, we must perform HSG, hysteroscopy, or a saline-infusion sonogram to assess thoroughly the structure and configuration of the uterus. The last step in postoperative surveillance is a midcycle ultrasound to check endometrial growth and development.

The importance of verifying the normalcy of the uterine cavity and the complete resolution of adhesions before permitting conception cannot be overemphasized. The prognosis for the patient whose problem has been only partially solved is not good.

Variable Success, Mitigating Risks

The rates of cure of Asherman's syndrome vary dramatically according to the antecedent factors involved. In women with Asherman's syndrome that occurs after a D&C for a first-trimester abortion, whether spontaneous or induced, we can achieve a 98% structural success rate (normal follow-up HSG and ultrasound). This rate drops to 50% for Asherman's that occurs after a D&C for postpartum hemorrhage that is performed 2–4 weeks after delivery. The success rate drops further—to 20%—for treatment of scarring that follows myomectomy.

The low success rate of treatment for Asherman's after myomectomy is especially disconcerting because these cases make up an increasing proportion of all those with intrauterine adhesions that we see today. As women delay childbearing, there are more who will develop myomas prior to seeking their first pregnancy at an age older than 35 years.

 

 

If one or more myomas were removed because of symptoms, or to improve the likelihood of a successful pregnancy, then attempts to achieve a successful implantation may be stymied by the resultant scarring.

The key to increasing the cure rates for postmyomectomy Asherman's syndrome—and to reducing the incidence and severity of postmyomectomy scarring—could lie in the approach to fibroid removal.

The best approach for a woman who may want to become pregnant in the future, and who has a myoma that occupies a fair amount of the endometrial surface, may be to extract it abdominally. This approach provides a better chance of sparing the endometrium because the fibroid can often be “peeled” away from the endometrial surface, thereby maintaining the basalis layer within the outer layer of the myoma's capsule.

If the hysteroscopic approach is used, all of the endometrium over the surface of the myoma will be removed in order to extract the tumor.

The European Society of Hysteroscopy's classification of myomas is a helpful guide to plan the ideal route of surgery based on the extent of the intracavitary component. I have found this system—coupled with the size and location of the tumor (or tumors) and the patient's desire for future fertility—to be very useful in planning the ideal surgical approach.

We also should be extremely selective in our use of GnRH agonists. These agents allow anemia to be reversed, cause endometrial atrophy, and can make myomectomy easier to perform. However, the atrophic, estrogen-depleted endometrium may be more prone to adhesion formation.

To prevent intrauterine scarring following a D&C performed for postpartum hemorrhage 2–4 weeks after delivery, when the uterus is most vulnerable to scarring, I would propose to the patient that she not breast-feed, that a splint be placed in her uterus, and that she receive estrogen therapy. Although there are no studies on the efficacy of this prophylactic approach, these measures may help prevent the development of intrauterine adhesions, which are quite difficult to cure.

Administering prophylactic antibiotics at the time of D&C is a common practice and may help prevent subclinical infection. For the pregnancy loss that occurs very early in gestation, medical rather than surgical termination may be considered as a method of reducing the risk of scar formation. If curettage is necessary, it is advisable to perform surgery shortly after the fetal demise has been diagnosed. Curettage performed long after fetal demise is associated with a higher risk of scar formation, probably because some degree of fibrosis has begun.

Subsequent Pregnancy

The overall pregnancy rate after successful treatment for intrauterine adhesions is approximately 75%. (Other causes of infertility prevent us from reaching 100%.) In patients who conceive, approximately 85% of the pregnancies are successful. During pregnancy, there are several potential complications that must be anticipated in patients who have been treated for Asherman's syndrome. One is an incompetent cervix. These patients often have had many cervical dilatations because of curettages and hysteroscopies before becoming pregnant. An ultrasound can be used to assess the shortening of the cervix and any funneling of the membranes.

We must also consider the possibility of placenta accreta, which can be easily diagnosed with either high-resolution ultrasound or MRI in late pregnancy.

The advantages of suspecting the problem are several. For example, a patient can bank her own blood because placenta accreta can be associated with significant blood loss at delivery, and she can plan the timing and/or site of her delivery to optimize hospital resources and ensure access to a large amount of blood products and consultants from various specialties.

Even if the placenta appears to have been delivered complete and intact, uterine exploration is advised to verify that there are no retained fragments. Placenta accreta occurs significantly more often in patients who become pregnant with only partially treated Asherman's syndrome than in patients whose uterine cavity is normal. The successful-pregnancy rate in patients with incompletely resolved intrauterine adhesions is only 20%, and 18%–28% of these patients will have placental complications.

This means that once a diagnosis of intrauterine adhesions has been made, the patient should be offered therapy if she wishes to conceive. The recommendation to “try to conceive and see how it works” is a recipe for a bad outcome.

About 20% of my patients have needed more than one procedure in order to restore the cavity to normalcy. The second—or, rarely, even a fifth—procedure may be considered extreme if the postoperative HSG and ultrasound that followed a prior hysteroscopic adhesiolysis were “pretty normal.” However, the poor outcome in those with partially treated disease speaks volumes, especially in women who are older and are less fertile than in the past.

 

 

An important resource for patients with this condition is Asherman's Syndrome International, which is accessible at

http://groups.yahoo.com/group/Ashermans

Intrauterine Adhesions

Intrauterine adhesions continue to plague gynecologists and reproductive endocrinologists. Approximately 70 years ago, Asherman and Toaff came out with their landmark paper on patients who present with intrauterine synechiae and amenorrhea: Asherman's syndrome. The scarring can affect not only menstrual flow, but implantation as well, even in the environment of apparently normal menstruation.

When these adhesions are removed, proper care must be taken to minimize damage to the normal intrauterine cavity. Moreover, strategies must be considered to reduce subsequent postoperative adhesions. This is especially problematic because the intrauterine cavity is a pseudospace. The removal of intrauterine synechiae places traumatized tissue against traumatized tissue. This situation would appear to enable subsequent postoperative adhesion formation.

For this Master Class in gynecologic surgery, I have elicited the help of Dr. Charles March. Dr. March spent 30 years in the department of obstetrics and gynecology at the University of Southern California, Los Angeles, where he became professor in 1987. During his tenure there, Dr. March was a prolific writer, especially in the area of operative hysteroscopy, and was the recipient of numerous awards including many resident-teaching awards. In 2000, Dr. March was given a Pioneer in Hysteroscopy award from the American Association of Gynecologic Laparoscopists.

Since 2003, Dr. March has been in private practice, where he specializes in infertility treatment and sees patients from across the country for operative hysteroscopy secondary to intrauterine synechiae. Even so, Dr. March continues to win teaching awards, now as a voluntary faculty member.

Asherman's syndrome can occur after any type of gynecologic surgery, and we must shift our thinking and heighten our index of suspicion to accommodate the growing body of data that supports this claim.

A literature review published in Fertility and Sterility 15 years ago reported that approximately 90% of all cases of Asherman's syndrome occurred after curettage, mainly after D&C for a spontaneous abortion or one performed to control a postpartum hemorrhage. Although these two antecedent factors remain the most common causes, there has been a significant increase in the number of patients who develop endometrial scarring after gynecologic surgery, particularly following abdominal and hysteroscopic myomectomy.

Women who have had myomectomy or other types of uterine surgery make up an increasing proportion of all patients with adhesion formation and a variant of Asherman's syndrome known as endometrial sclerosis.

Endometrial sclerosis, commonly called an “unstuck Asherman's,” is an end-stage disease in which the basalis layer of the endometrium has been severely damaged or even removed. In these women, the hysterosalpingography (HSG) may demonstrate a normal cavity or one of slightly reduced size, but with little or no scarring.

This change presents new challenges because the damage that follows gynecologic surgery other than curettage is a much less curable condition.

Our Index of Suspicion

Key to our role as gynecologists is suspecting the problem. Any change in menstrual flow and pattern—from amenorrhea to any decrease in the duration or amount of bleeding—that follows any type of uterine surgery, irrespective of how minimal that surgery might have been, must prompt us to suspect that this patient may have scarring in her uterus. All patients with a history of intrauterine trauma must be considered at risk.

In addition to endometrial trauma, pregnancy (or recent pregnancy) and hypoestrogenism are important keys. The pregnant or recently pregnant uterus appears to be more vulnerable to scar formation.

Concomitantly, breast-feeding increases the risk of adhesion formation because women who breast-feed remain estrogen deficient. Estrogen has a tremendous effect in promoting the healing of the uterus and regeneration of the endometrium. Women who breast-feed don't have that stimulus.

To a lesser extent, infection also can play a role. Decades ago, infection was viewed as critical, in that it was the “infected abortion” that was thought to cause Asherman's syndrome. Today, infections are an uncommon cause of the problem. I have treated more than 1,000 patients with Asherman's, and fewer than 5 had any clinical evidence of infection around the time of their original surgery. Still, the possibility of Asherman's resulting from infections still exists.

Pelvic tuberculosis by itself, without any surgical trauma, causes scarring in the uterus. Considering the diversity of our society and the rise in antibiotic-resistant TB, we ought to keep it in mind.

It is also important to appreciate the fact that the presence of normal menstrual flow does not rule out the presence of intrauterine adhesions. Approximately three-quarters of women with Asherman's syndrome have amenorrhea or hypomenorrhea, but the remainder have menses of normal flow and duration. Other symptoms of intrauterine adhesions include infertility, recurrent miscarriage, and placenta accreta or its more severe variants.

Methods of Diagnosis

The diagnosis will most frequently be made by either HSG or a saline-infusion sonogram. However, these methods provide us with only a presumptive diagnosis. Both will demonstrate irregular, lacunalike defects spaced throughout the cavity. Access to the oviducts may or may not be blocked. A definitive diagnosis comes only with hysteroscopy.

We should individualize our diagnostic methods depending on the patient's history and symptoms and our own index of suspicion. For instance, a patient who presents with amenorrhea and monthly cramping following a D&C would benefit from a pelvic ultrasound. This study is likely to demonstrate fluid in the uterus. Her hematometra is secondary to outflow tract obstruction. There is no reason in this case to do a saline-infusion sonogram or an HSG. The next appropriate step is hysteroscopy, which will allow the diagnosis to be made with certainty so that treatment can commence.

Consider another patient with postcurettage amenorrhea. She has little or no fluid in the uterus and her endometrium is thin and/or irregular. A pregnancy test is negative and a uterine sound cannot be passed into the cavity. In this case, it is wise to proceed to hysteroscopy because it would not be possible to pass the contrast material for HSG—or the saline for a saline-infusion sonogram—beyond the site that blocked passage of the sound.

Hysteroscopy provides us with absolute proof of intrauterine adhesions. It allows us to directly inspect the uterine cavity and assess the extent, nature, and location of the adhesions. This also allows us to classify the disease, which is critical because classification enables us to make meaningful comparisons among different types of treatment regimens or adjunctive therapies. Finally, adhesiolysis under hysteroscopic guidance is more efficacious and less traumatic to the adjacent normal tissue.

 

 

Scissors vs. Heat

Since the introduction of hysteroscopy to treat intrauterine adhesions, the prognosis has gone from dismal to excellent. Hysteroscopic management not only enables us to cut all the scar tissue, but it ensures that we will not damage adjacent normal endometrium. There is no justification today for treating Asherman's syndrome by a technique other than hysteroscopy.

Although comparative studies are not available, we advocate that only scissors be used to cut adhesions, and we use them in our own practice.

Adhesiolysis methods that use a resectoscope, an Nd:YAG laser, or a monopolar or bipolar electrode have their proponents. However, all of these modalities deliver energy to the endometrial surface and can cause further damage to the endometrium. Remember that these same instruments are used to cause endometrial ablation.

Years ago, it was demonstrated that—in contrast to what occurs after a scalpel has been used to make an incision—tissue damage is observed far from the operative site when electrodes or an Nd:YAG laser is used for the same purpose. These energy sources offer no advantage—neither speed nor improved hemostasis (intrauterine scars do not bleed, but myometrium does)—over scissor dissection. In a patient with a damaged endometrium, it is prudent to limit the risk of further injury.

Although I have performed surgery that was not successful, it was not because of the inability of the flexible or semirigid scissors to cut through dense scars.

For women with extensive scarring, we should use simultaneous laparoscopy to reduce the risk of uterine perforation. This group of patients is increasing in relative frequency. The main antecedent factors for severe disease are the postpartum curettage performed 2–4 weeks after delivery, and scarring after myomectomy or metroplasty.

After the cutting of all adhesions under direct vision using hysteroscopy, I advise the placement of a splint into the uterus to help reduce adhesion reformation, and the prescription of 1–2 months of high-dose estrogen treatment to promote healing of the tissue and overgrowth of the endometrium.

We use the Cook balloon uterine stent, which has a triangular shape and therefore conforms to the shape of the normal uterus. (See photo, page 36.) This configuration allows it to reduce the risk of reformation of adhesions that had been along the margins of the cavity.

If the adhesions are limited to the endocervical canal and lower uterine segment, a Foley catheter is used as a stent instead of the Cook device because the former has a much wider diameter.

If a Foley catheter is used, the portion distal to the balloon is removed prior to insertion. After insertion of the Foley and inflation of its balloon, ligatures of No. 1 silk are placed around the catheter close to the cervix. This step keeps the balloon inflated and allows the trailing edge to be removed, thereby reducing patient discomfort.

The stent remains in place for 5 days to 3 weeks, depending on the type of stent used and the location and density of the adhesions. During the time that the stent is in situ, a broad-spectrum antibiotic is prescribed.

Following surgery, high-dose estrogen therapy (usually 3–4 mg of micronized oral estradiol) is prescribed for 30–60 days in order to maximally stimulate the endometrium, especially those areas under and adjacent to the adhesions. On the last 5 days of estrogen treatment, 10 mg of medroxyprogesterone acetate is added.

After the menstrual period that follows cessation of the estrogen-progestin treatment, we must perform HSG, hysteroscopy, or a saline-infusion sonogram to assess thoroughly the structure and configuration of the uterus. The last step in postoperative surveillance is a midcycle ultrasound to check endometrial growth and development.

The importance of verifying the normalcy of the uterine cavity and the complete resolution of adhesions before permitting conception cannot be overemphasized. The prognosis for the patient whose problem has been only partially solved is not good.

Variable Success, Mitigating Risks

The rates of cure of Asherman's syndrome vary dramatically according to the antecedent factors involved. In women with Asherman's syndrome that occurs after a D&C for a first-trimester abortion, whether spontaneous or induced, we can achieve a 98% structural success rate (normal follow-up HSG and ultrasound). This rate drops to 50% for Asherman's that occurs after a D&C for postpartum hemorrhage that is performed 2–4 weeks after delivery. The success rate drops further—to 20%—for treatment of scarring that follows myomectomy.

The low success rate of treatment for Asherman's after myomectomy is especially disconcerting because these cases make up an increasing proportion of all those with intrauterine adhesions that we see today. As women delay childbearing, there are more who will develop myomas prior to seeking their first pregnancy at an age older than 35 years.

 

 

If one or more myomas were removed because of symptoms, or to improve the likelihood of a successful pregnancy, then attempts to achieve a successful implantation may be stymied by the resultant scarring.

The key to increasing the cure rates for postmyomectomy Asherman's syndrome—and to reducing the incidence and severity of postmyomectomy scarring—could lie in the approach to fibroid removal.

The best approach for a woman who may want to become pregnant in the future, and who has a myoma that occupies a fair amount of the endometrial surface, may be to extract it abdominally. This approach provides a better chance of sparing the endometrium because the fibroid can often be “peeled” away from the endometrial surface, thereby maintaining the basalis layer within the outer layer of the myoma's capsule.

If the hysteroscopic approach is used, all of the endometrium over the surface of the myoma will be removed in order to extract the tumor.

The European Society of Hysteroscopy's classification of myomas is a helpful guide to plan the ideal route of surgery based on the extent of the intracavitary component. I have found this system—coupled with the size and location of the tumor (or tumors) and the patient's desire for future fertility—to be very useful in planning the ideal surgical approach.

We also should be extremely selective in our use of GnRH agonists. These agents allow anemia to be reversed, cause endometrial atrophy, and can make myomectomy easier to perform. However, the atrophic, estrogen-depleted endometrium may be more prone to adhesion formation.

To prevent intrauterine scarring following a D&C performed for postpartum hemorrhage 2–4 weeks after delivery, when the uterus is most vulnerable to scarring, I would propose to the patient that she not breast-feed, that a splint be placed in her uterus, and that she receive estrogen therapy. Although there are no studies on the efficacy of this prophylactic approach, these measures may help prevent the development of intrauterine adhesions, which are quite difficult to cure.

Administering prophylactic antibiotics at the time of D&C is a common practice and may help prevent subclinical infection. For the pregnancy loss that occurs very early in gestation, medical rather than surgical termination may be considered as a method of reducing the risk of scar formation. If curettage is necessary, it is advisable to perform surgery shortly after the fetal demise has been diagnosed. Curettage performed long after fetal demise is associated with a higher risk of scar formation, probably because some degree of fibrosis has begun.

Subsequent Pregnancy

The overall pregnancy rate after successful treatment for intrauterine adhesions is approximately 75%. (Other causes of infertility prevent us from reaching 100%.) In patients who conceive, approximately 85% of the pregnancies are successful. During pregnancy, there are several potential complications that must be anticipated in patients who have been treated for Asherman's syndrome. One is an incompetent cervix. These patients often have had many cervical dilatations because of curettages and hysteroscopies before becoming pregnant. An ultrasound can be used to assess the shortening of the cervix and any funneling of the membranes.

We must also consider the possibility of placenta accreta, which can be easily diagnosed with either high-resolution ultrasound or MRI in late pregnancy.

The advantages of suspecting the problem are several. For example, a patient can bank her own blood because placenta accreta can be associated with significant blood loss at delivery, and she can plan the timing and/or site of her delivery to optimize hospital resources and ensure access to a large amount of blood products and consultants from various specialties.

Even if the placenta appears to have been delivered complete and intact, uterine exploration is advised to verify that there are no retained fragments. Placenta accreta occurs significantly more often in patients who become pregnant with only partially treated Asherman's syndrome than in patients whose uterine cavity is normal. The successful-pregnancy rate in patients with incompletely resolved intrauterine adhesions is only 20%, and 18%–28% of these patients will have placental complications.

This means that once a diagnosis of intrauterine adhesions has been made, the patient should be offered therapy if she wishes to conceive. The recommendation to “try to conceive and see how it works” is a recipe for a bad outcome.

About 20% of my patients have needed more than one procedure in order to restore the cavity to normalcy. The second—or, rarely, even a fifth—procedure may be considered extreme if the postoperative HSG and ultrasound that followed a prior hysteroscopic adhesiolysis were “pretty normal.” However, the poor outcome in those with partially treated disease speaks volumes, especially in women who are older and are less fertile than in the past.

 

 

An important resource for patients with this condition is Asherman's Syndrome International, which is accessible at

http://groups.yahoo.com/group/Ashermans

Intrauterine Adhesions

Intrauterine adhesions continue to plague gynecologists and reproductive endocrinologists. Approximately 70 years ago, Asherman and Toaff came out with their landmark paper on patients who present with intrauterine synechiae and amenorrhea: Asherman's syndrome. The scarring can affect not only menstrual flow, but implantation as well, even in the environment of apparently normal menstruation.

When these adhesions are removed, proper care must be taken to minimize damage to the normal intrauterine cavity. Moreover, strategies must be considered to reduce subsequent postoperative adhesions. This is especially problematic because the intrauterine cavity is a pseudospace. The removal of intrauterine synechiae places traumatized tissue against traumatized tissue. This situation would appear to enable subsequent postoperative adhesion formation.

For this Master Class in gynecologic surgery, I have elicited the help of Dr. Charles March. Dr. March spent 30 years in the department of obstetrics and gynecology at the University of Southern California, Los Angeles, where he became professor in 1987. During his tenure there, Dr. March was a prolific writer, especially in the area of operative hysteroscopy, and was the recipient of numerous awards including many resident-teaching awards. In 2000, Dr. March was given a Pioneer in Hysteroscopy award from the American Association of Gynecologic Laparoscopists.

Since 2003, Dr. March has been in private practice, where he specializes in infertility treatment and sees patients from across the country for operative hysteroscopy secondary to intrauterine synechiae. Even so, Dr. March continues to win teaching awards, now as a voluntary faculty member.

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