Charles E. Miller

The lure to the development of a second generation of midurethral slings lay in the small but still significant number of reported complications with the TVT procedure, in which a polypropylene mesh is placed through a vaginal-to-suprapubic route. The question loomed: Could reports of vascular injury, bowel and bladder perforations, and nerve injury with TVT be eliminated?

Dr. Emmanuel Delorme addressed the issue in 2001 by describing the first transobturator tape (TOT) procedure. In this approach, the sling is placed transperineally beneath the ischiopubic rami, rather than retropubically. It mimics the shape and function of the pubocervical fascia, forming a suburethral hammock of support.

Dr. Delorme's idea was that if we could avoid passing needles through the retropubic space and instead insert the tape through a transobturator approach, we would have little or no chance of hitting the bladder or urethra—bladder perforations have occurred in approximately 3% of TVT procedures, according to reports—and we would alleviate the risk of bowel injury. Nor would we go near the abdominal vessels. Routine cystoscopy, moreover, might be unnecessary.

Today, transobturator tape (TOT) procedures are fast proving to be a safer—and at least equally effective—alternative to the original TVT procedure described by Dr. Ulf Ulmsten in 1996.

In the first randomized, prospective trial comparing TVT and TOT in approximately 60 patients, Dr. Renaud de Tayrac demonstrated that at 1 year, similar numbers of patients were cured and significantly improved (over 90%). Patients undergoing TOT, interestingly, had significantly lower postoperative rates of retention. They also had shorter operation times. And whereas bladder perforation occurred in almost 10% of the TVT patients, that complication affected none of the TOT patients.

(The de Tayrac paper was published in 2004 in the American Journal of Obstetrics and Gynecology, but it was later retracted, unfortunately, for lack of Institutional Review Board approval.)

Although longer-term data from prospective randomized studies are still forthcoming, additional studies of increasingly larger numbers of patients are clearly demonstrating that TOT offers comparable results to retropubic slings, with the benefit of lower complication rates and shorter operating times.

Some data suggest, just as Dr. de Tayrac's work did, that TOT is also more forgiving with respect to voiding, and may be particularly preferable for patients with mixed incontinence or any symptoms of urge incontinence. It appears that TOT is less likely to impair bladder emptying, which, ironically, can be more problematic to patients than their original stress incontinence. The last thing we want to do is to alleviate the stress urinary incontinence only to induce or exacerbate any urge urinary incontinence.

There's still a place for retropubic slings, however. Small trials have also shown that patients with intrinsic sphincter deficiency (ISD) have a higher success rate with the TVT procedure than with TOT, which makes sense when we consider the configurations of the two midurethral slings: the original retropubic sling's U-shaped fit around the urethra, and the gentler hammocklike configuration of the transobturator sling. All told, TVT is significantly more effective than TOT when the urethral closure pressure while sitting with a full bladder is less than 43 cm H₂O.

For most patients other than those with ISD, though, TOT now seems to be the preferable minimally invasive treatment. In addition to being safe and effective, it is easier to learn than the original TVT approach, especially for physicians who are not yet comfortable or experienced with the retropubic space.

Work on yet another generation of midurethral slings is advancing quickly, but physicians today are utilizing two TOT techniques: In the original technique—coined the “outside-in” or “out-to-in” procedure (the technique described by Dr. Delorme)—the transobturator sling is placed inward through the obturator foramens from the labiocrural folds. The second technique—the newer version of TOT—involves placing the sling outward from the vaginal side toward labiocrural folds and, accordingly, is referred to as the “inside-out” or “in-to-out” TOT procedure.

The two techniques are quite different, and most physicians now favor one approach more than the other when they decide to perform TOT.

Peter Sand, M.D.: The Outside-In Approach to TOT

For me, the outside-in approach, which uses a transobturator-to-vagina approach to mesh placement, is a logical choice. The TOT procedure was first described this way, and I have seen no need to deviate from it. It is simpler than the inside-out approach, and I see no logic to performing it the other way.

First of all, we know we're improving outcomes with TOT in many women. In a retrospective cohort study comparing the TOT sling procedure (107 patients) with TVT (91 patients) at the Evanston Continence Center, we found that TOT resulted in significantly less postoperative retention and lower rates of de novo urge urinary incontinence.

Based on the results of 14-week postoperative urodynamic testing that was completed by about 66% of the patients, we found no significant difference in the percentage of patients cured of stress urinary incontinence (97% TVT vs. 90% TOT). And based on results of postoperative quality-of-life questionnaires, we concluded that subjective cure rates were similar between the groups (87% TVT vs. 89% TOT).

TOT did, however, offer the advantage of significantly less postoperative retention and lower rates of de novo urge urinary incontinence. Just as other data have shown, we've found that patients get back to normal voiding sooner with TOT. There was also a trend toward better resolution of urge urinary incontinence with TOT in these women with mixed incontinence symptoms.

Research suggests that we can achieve the same outcomes with either the outside-in or inside-out approach. Dr. Harry Vervest of Tilburg, the Netherlands, recently completed a randomized comparison of the outside-in and inside-out approaches in 75 women and found no significant differences in intraoperative or postoperative characteristics of the two procedures. Other studies have had similar conclusions.

Dr. Vervest looked at factors such as type of anesthesia, length of surgery, and amount of blood loss, as well as the length of catheter use and postoperative voiding parameters. He has reported that there were no complications with either method.

For me, however, the outside-in approach is a better choice. For one thing, I like to insert the needle where I have the most control. And overall, the outside-in approach is simpler than the other technique and does not result in the medial thigh pain that we hear about with the inside-out technique.

There are three different types of mesh-passer systems available. They use specially designed helical, curved, or hook needles. With each of these systems, the outside-in procedure involves three small incisions and the following essential steps:

A small vertical incision is made on the lateral edge of each labium majorum, medial to the labiocrural fold and posterior to the base of the adductor longus tendon. Once you identify the tendon, you'll find a depressed area that is the obturator foramen about an inch below the tendon. You can make a small stab wound on the medial edge of the obturator foramen bilaterally.

Another vertical incision is made on the anterior vaginal wall under the midurethra. You can dissect the vaginal epithelium from the underlying periurethral connective tissue, and then bluntly dissect under the vaginal epithelium about 2 cm bilaterally.

Then you can spread the scissors wide enough so that you can insert your index finger and point it toward one of the labiocrural incisions.

Starting with the right-side incision, you will angle your right index finger toward the incision in the labiocrural fold. The tip of the right-handed needle can then be pushed with your right thumb along the posterior surface of the ischiopubic ramus. You'll push through the obturator externus muscle, the obturator membrane, and the obturator internus muscle, feeling three separate pops before you feel the needle on your right index finger behind the endopelvic connective tissue.

Once you ensure that the needle is truly free of the overlying vaginal epithelium, you can connect the polypropylene mesh to the needle and rotate the needle back out through the obturator foramen. The same procedure can then be repeated on the other side.

To establish proper tension, I like to place a right-angle clamp between the urethra and under the mesh and open it approximately 1 cm. I also check to ensure that the weave of the mesh below the urethra looks exactly like the weave of the mesh that exits through the labial incisions without any tension.

Some physicians use spacing devices, but I like to look at the mesh visually. If the mesh underneath the urethra does not look distorted and looks similar to the mesh protruding through the skin, then I know the sling is not under tension. I'll then go ahead and trim the mesh back against the skin and use simple sutures to close the incisions on each side.

The safety of this approach is ensured by fingertip guidance of the needle through the obturator membrane and the positioning of the index finger toward the incision and the cross-arm of the needle. This way, you're essentially opposing your thumb and index finger, ensuring proper passage of the needle.

Some physicians worry about the obturator canal's being several centimeters away from the path, but I believe that any injury would more likely occur through the inside-out approach.

Cystoscopy does not need to be performed routinely as it does with TVT, but the key here is the word “routinely.” Whether or not cystoscopy is used is really dependent on the operator's judgment.

Vincent Lucente, M.D.: The Inside-Out Approach to TOT

The inside-out technique, which I use, was developed for the purpose of even further minimizing risk to the urethra and bladder and ensuring minimal dissection of the vaginal tissue.

Although Dr. Delorme's outside-in procedure was indeed a significant development for the treatment of stress urinary incontinence—and although most available studies show that the two approaches are similar in safety and efficacy—there have been several clinical reports and anatomical studies documenting that bladder and urethra injuries still occur with the technique.

This remaining potential for injury prompted Dr. Jean de Laval, of the University of Liège (Belgium), to develop an alternative TOT approach that he believed would be even safer because the TOT needle would travel out and away from the lower urinary tract.

I am convinced that his technique offers several advantages. For one thing, it essentially eliminates any risk of injury to the urethra and bladder. It also avoids potential injury to the anterior branch of the obturator artery, which runs around the outer perimeter of the obturator foramen. In the outside-in procedure, the instruments run along the edge of the foramen and can potentially disrupt that anterior branch. The hematomas that can occur—and there have been some reported—are not at all life threatening, but they can cause a protracted recovery for our patients.

I also believe that whenever we're traversing instruments through the body, we're always most accurate where we start our journey. By starting at the urethra and traveling away, I believe we're going to achieve more consistent and accurate placement of the sling at the midurethral position.

The greatest advantage to the inside-out technique, I believe, is one that has not been documented or well studied but still lingers in my mind. That is, because we need to do less periurethral dissection, we're minimizing the risk of urethral denervation.

The outside-in technique involves more periurethral dissection: One simply must dissect more tissue to assure the palpation guidance of the incoming instruments. Healing and re-enervation do occur, of course, but I believe the dissection inevitably increases the risk of sphincteric denervation, and that women may not get “back to baseline,” so to speak—that they may suffer an insult that could lead later to ISD. It is quite possible that we are denervating the urethra musculature in subtle ways that cannot be measured now but will become apparent 10–15 years later as our patients age. I would rather avoid that possibility.

The key to the inside-out technique is the use of local anesthesia. The procedure enables us to use local anesthesia, fortunately, but it must be utilized thoroughly. Local anesthetic not only must infiltrate the area under the urethra and into the vagina, but it also must infiltrate the skin, fat, and—most importantly—the muscle of the inner thighs. With proper techniques, we can markedly reduce the likelihood of postoperative thigh pain.

The device used in the procedure includes a pair of helical passers that are assembled with polyethylene tubes bound to a polypropylene tape and one winged guide. The guide ensures that the tape will be passed accurately through the obturator membrane without entering the pelvic space.

The points where the needles will exit are identified by tracing a horizontal line at the level of the urethral meatus, and a second line 2 cm above this. The exit points are on this second line, 2 cm lateral to the folds of the thigh. We will make incisions at each exit point once the helical passer hits the skin; for now, we just mark the expected exit points and infiltrate with local anesthetic.

We then make a 1-cm long midline vaginal incision, starting 1 cm proximal to the urethral meatus. We dissect using a push-spread technique, orienting our scissors on a plane slightly above the horizontal, with a 45-degree angle relative to the urethral sagittal plane, toward the upper part of the ischiopubic ramus.

The winged guide is inserted into the tract at the same angle, until it passes the inferior pubic ramus. With the winged guide in place, a helical passer is then inserted into the tract. When the device is pushed slightly, the passer will move through the obturator membrane, at which point it is no longer advanced but rather is simply rotated and swung into position, which allows it to curve around the bone and exit through the thigh.

The helical passer can then be removed with a reverse rotation of the handle, and the plastic tube and tape can be pulled completely through the skin.

We repeat the technique on the other side, of course, and then ensure that the tape lies flat under the urethra without tension. I choose to set the tape using a “cough test.” This has been shown to be superior to empiric or visual setting in a study by Dr. Miles Murphy and colleagues at the University of Louisville (Ky.).

Because the inside-out technique offers safety advantages over the outside-in technique, I believe we have an obligation to at least inform patients that the option exists, even if we're having success with the original retropubic TVT or the outside-in procedure.

We also can look forward to seeing yet another generation of synthetic midurethral slings in the coming year or so. The new sling can be placed in either a hammock or a “U” configuration with only a single incision in the anterior vaginal wall. An instrument deploys the tape by pushing it into position, rather than by pulling it into position as the TVT and obturator procedures do. There is no exit site, so even less tissue is traumatized.

We'll need to demonstrate durability and acquire more robust data, but the preliminary data look promising.

EMILY BRANNAN, ILLUSTRATION

The Transobturator Tape Procedure

In the August edition of Master Class, Dr. Mickey Karram discussed the use of tension-free vaginal tape (TVT) for the treatment of symptomatic stress urinary incontinence. Although both the success rate and subsequent patient satisfaction with TVT have proved to be excellent, the risk of bladder perforation remains a concern. Because of this risk, I have continued to perform laparoscopic retropubic urethropexy (Burch procedure) for severe stress urinary incontinence.

In this edition of Master Class, the second-generation midurethral sling—known as the transobturator tape (TOT) procedure—will be discussed. This technique, when used in patients without internal sphincter deficiency and/or low urethral opening pressures, has proved to be not only efficacious, but safe as well. In my early experience, TOT has proved to be an easy procedure to master.

The TOT procedure can be performed via two distinct approaches. I have asked Dr. Peter Sand to present the “outside-in” technique. Dr. Sand is professor of obstetrics and gynecology at Northwestern University, Chicago. He is the director of Evanston Northwestern Healthcare's division of urogynecology and reconstructive pelvic surgery, as well as the director of the fellowship program in female pelvic medicine. Dr. Sand also directs the Evanston Continence Center.

Discussing the “inside-out” approach to TOT will be Dr. Vincent Lucente. Dr. Lucente is a clinical professor of obstetrics and gynecology at Temple University in Philadelphia. He is the chief of gynecology at St. Luke's Health Network in Allentown, Pa., and the medical director of the network's continence management center. Dr. Lucente is also the chief medical officer of the Institute for Female Pelvic Medicine and Reconstructive Surgery in Allentown, as well as chief of the Section of Female Pelvic Medicine and Reconstructive Surgery at Abington (Pa.) Memorial Hospital.

The lure to the development of a second generation of midurethral slings lay in the small but still significant number of reported complications with the TVT procedure, in which a polypropylene mesh is placed through a vaginal-to-suprapubic route. The question loomed: Could reports of vascular injury, bowel and bladder perforations, and nerve injury with TVT be eliminated?

Dr. Emmanuel Delorme addressed the issue in 2001 by describing the first transobturator tape (TOT) procedure. In this approach, the sling is placed transperineally beneath the ischiopubic rami, rather than retropubically. It mimics the shape and function of the pubocervical fascia, forming a suburethral hammock of support.

Dr. Delorme's idea was that if we could avoid passing needles through the retropubic space and instead insert the tape through a transobturator approach, we would have little or no chance of hitting the bladder or urethra—bladder perforations have occurred in approximately 3% of TVT procedures, according to reports—and we would alleviate the risk of bowel injury. Nor would we go near the abdominal vessels. Routine cystoscopy, moreover, might be unnecessary.

Today, transobturator tape (TOT) procedures are fast proving to be a safer—and at least equally effective—alternative to the original TVT procedure described by Dr. Ulf Ulmsten in 1996.

In the first randomized, prospective trial comparing TVT and TOT in approximately 60 patients, Dr. Renaud de Tayrac demonstrated that at 1 year, similar numbers of patients were cured and significantly improved (over 90%). Patients undergoing TOT, interestingly, had significantly lower postoperative rates of retention. They also had shorter operation times. And whereas bladder perforation occurred in almost 10% of the TVT patients, that complication affected none of the TOT patients.

(The de Tayrac paper was published in 2004 in the American Journal of Obstetrics and Gynecology, but it was later retracted, unfortunately, for lack of Institutional Review Board approval.)

Although longer-term data from prospective randomized studies are still forthcoming, additional studies of increasingly larger numbers of patients are clearly demonstrating that TOT offers comparable results to retropubic slings, with the benefit of lower complication rates and shorter operating times.

Some data suggest, just as Dr. de Tayrac's work did, that TOT is also more forgiving with respect to voiding, and may be particularly preferable for patients with mixed incontinence or any symptoms of urge incontinence. It appears that TOT is less likely to impair bladder emptying, which, ironically, can be more problematic to patients than their original stress incontinence. The last thing we want to do is to alleviate the stress urinary incontinence only to induce or exacerbate any urge urinary incontinence.

There's still a place for retropubic slings, however. Small trials have also shown that patients with intrinsic sphincter deficiency (ISD) have a higher success rate with the TVT procedure than with TOT, which makes sense when we consider the configurations of the two midurethral slings: the original retropubic sling's U-shaped fit around the urethra, and the gentler hammocklike configuration of the transobturator sling. All told, TVT is significantly more effective than TOT when the urethral closure pressure while sitting with a full bladder is less than 43 cm H₂O.

For most patients other than those with ISD, though, TOT now seems to be the preferable minimally invasive treatment. In addition to being safe and effective, it is easier to learn than the original TVT approach, especially for physicians who are not yet comfortable or experienced with the retropubic space.

Work on yet another generation of midurethral slings is advancing quickly, but physicians today are utilizing two TOT techniques: In the original technique—coined the “outside-in” or “out-to-in” procedure (the technique described by Dr. Delorme)—the transobturator sling is placed inward through the obturator foramens from the labiocrural folds. The second technique—the newer version of TOT—involves placing the sling outward from the vaginal side toward labiocrural folds and, accordingly, is referred to as the “inside-out” or “in-to-out” TOT procedure.

The two techniques are quite different, and most physicians now favor one approach more than the other when they decide to perform TOT.

Peter Sand, M.D.: The Outside-In Approach to TOT

For me, the outside-in approach, which uses a transobturator-to-vagina approach to mesh placement, is a logical choice. The TOT procedure was first described this way, and I have seen no need to deviate from it. It is simpler than the inside-out approach, and I see no logic to performing it the other way.

First of all, we know we're improving outcomes with TOT in many women. In a retrospective cohort study comparing the TOT sling procedure (107 patients) with TVT (91 patients) at the Evanston Continence Center, we found that TOT resulted in significantly less postoperative retention and lower rates of de novo urge urinary incontinence.

Based on the results of 14-week postoperative urodynamic testing that was completed by about 66% of the patients, we found no significant difference in the percentage of patients cured of stress urinary incontinence (97% TVT vs. 90% TOT). And based on results of postoperative quality-of-life questionnaires, we concluded that subjective cure rates were similar between the groups (87% TVT vs. 89% TOT).

TOT did, however, offer the advantage of significantly less postoperative retention and lower rates of de novo urge urinary incontinence. Just as other data have shown, we've found that patients get back to normal voiding sooner with TOT. There was also a trend toward better resolution of urge urinary incontinence with TOT in these women with mixed incontinence symptoms.

Research suggests that we can achieve the same outcomes with either the outside-in or inside-out approach. Dr. Harry Vervest of Tilburg, the Netherlands, recently completed a randomized comparison of the outside-in and inside-out approaches in 75 women and found no significant differences in intraoperative or postoperative characteristics of the two procedures. Other studies have had similar conclusions.

Dr. Vervest looked at factors such as type of anesthesia, length of surgery, and amount of blood loss, as well as the length of catheter use and postoperative voiding parameters. He has reported that there were no complications with either method.

For me, however, the outside-in approach is a better choice. For one thing, I like to insert the needle where I have the most control. And overall, the outside-in approach is simpler than the other technique and does not result in the medial thigh pain that we hear about with the inside-out technique.

There are three different types of mesh-passer systems available. They use specially designed helical, curved, or hook needles. With each of these systems, the outside-in procedure involves three small incisions and the following essential steps:

A small vertical incision is made on the lateral edge of each labium majorum, medial to the labiocrural fold and posterior to the base of the adductor longus tendon. Once you identify the tendon, you'll find a depressed area that is the obturator foramen about an inch below the tendon. You can make a small stab wound on the medial edge of the obturator foramen bilaterally.

Another vertical incision is made on the anterior vaginal wall under the midurethra. You can dissect the vaginal epithelium from the underlying periurethral connective tissue, and then bluntly dissect under the vaginal epithelium about 2 cm bilaterally.

Then you can spread the scissors wide enough so that you can insert your index finger and point it toward one of the labiocrural incisions.

Starting with the right-side incision, you will angle your right index finger toward the incision in the labiocrural fold. The tip of the right-handed needle can then be pushed with your right thumb along the posterior surface of the ischiopubic ramus. You'll push through the obturator externus muscle, the obturator membrane, and the obturator internus muscle, feeling three separate pops before you feel the needle on your right index finger behind the endopelvic connective tissue.

Once you ensure that the needle is truly free of the overlying vaginal epithelium, you can connect the polypropylene mesh to the needle and rotate the needle back out through the obturator foramen. The same procedure can then be repeated on the other side.

To establish proper tension, I like to place a right-angle clamp between the urethra and under the mesh and open it approximately 1 cm. I also check to ensure that the weave of the mesh below the urethra looks exactly like the weave of the mesh that exits through the labial incisions without any tension.

Some physicians use spacing devices, but I like to look at the mesh visually. If the mesh underneath the urethra does not look distorted and looks similar to the mesh protruding through the skin, then I know the sling is not under tension. I'll then go ahead and trim the mesh back against the skin and use simple sutures to close the incisions on each side.

The safety of this approach is ensured by fingertip guidance of the needle through the obturator membrane and the positioning of the index finger toward the incision and the cross-arm of the needle. This way, you're essentially opposing your thumb and index finger, ensuring proper passage of the needle.

Some physicians worry about the obturator canal's being several centimeters away from the path, but I believe that any injury would more likely occur through the inside-out approach.

Cystoscopy does not need to be performed routinely as it does with TVT, but the key here is the word “routinely.” Whether or not cystoscopy is used is really dependent on the operator's judgment.

Vincent Lucente, M.D.: The Inside-Out Approach to TOT

The inside-out technique, which I use, was developed for the purpose of even further minimizing risk to the urethra and bladder and ensuring minimal dissection of the vaginal tissue.

Although Dr. Delorme's outside-in procedure was indeed a significant development for the treatment of stress urinary incontinence—and although most available studies show that the two approaches are similar in safety and efficacy—there have been several clinical reports and anatomical studies documenting that bladder and urethra injuries still occur with the technique.

This remaining potential for injury prompted Dr. Jean de Laval, of the University of Liège (Belgium), to develop an alternative TOT approach that he believed would be even safer because the TOT needle would travel out and away from the lower urinary tract.

I am convinced that his technique offers several advantages. For one thing, it essentially eliminates any risk of injury to the urethra and bladder. It also avoids potential injury to the anterior branch of the obturator artery, which runs around the outer perimeter of the obturator foramen. In the outside-in procedure, the instruments run along the edge of the foramen and can potentially disrupt that anterior branch. The hematomas that can occur—and there have been some reported—are not at all life threatening, but they can cause a protracted recovery for our patients.

I also believe that whenever we're traversing instruments through the body, we're always most accurate where we start our journey. By starting at the urethra and traveling away, I believe we're going to achieve more consistent and accurate placement of the sling at the midurethral position.

The greatest advantage to the inside-out technique, I believe, is one that has not been documented or well studied but still lingers in my mind. That is, because we need to do less periurethral dissection, we're minimizing the risk of urethral denervation.

The outside-in technique involves more periurethral dissection: One simply must dissect more tissue to assure the palpation guidance of the incoming instruments. Healing and re-enervation do occur, of course, but I believe the dissection inevitably increases the risk of sphincteric denervation, and that women may not get “back to baseline,” so to speak—that they may suffer an insult that could lead later to ISD. It is quite possible that we are denervating the urethra musculature in subtle ways that cannot be measured now but will become apparent 10–15 years later as our patients age. I would rather avoid that possibility.

The key to the inside-out technique is the use of local anesthesia. The procedure enables us to use local anesthesia, fortunately, but it must be utilized thoroughly. Local anesthetic not only must infiltrate the area under the urethra and into the vagina, but it also must infiltrate the skin, fat, and—most importantly—the muscle of the inner thighs. With proper techniques, we can markedly reduce the likelihood of postoperative thigh pain.

The device used in the procedure includes a pair of helical passers that are assembled with polyethylene tubes bound to a polypropylene tape and one winged guide. The guide ensures that the tape will be passed accurately through the obturator membrane without entering the pelvic space.

The points where the needles will exit are identified by tracing a horizontal line at the level of the urethral meatus, and a second line 2 cm above this. The exit points are on this second line, 2 cm lateral to the folds of the thigh. We will make incisions at each exit point once the helical passer hits the skin; for now, we just mark the expected exit points and infiltrate with local anesthetic.

We then make a 1-cm long midline vaginal incision, starting 1 cm proximal to the urethral meatus. We dissect using a push-spread technique, orienting our scissors on a plane slightly above the horizontal, with a 45-degree angle relative to the urethral sagittal plane, toward the upper part of the ischiopubic ramus.

The winged guide is inserted into the tract at the same angle, until it passes the inferior pubic ramus. With the winged guide in place, a helical passer is then inserted into the tract. When the device is pushed slightly, the passer will move through the obturator membrane, at which point it is no longer advanced but rather is simply rotated and swung into position, which allows it to curve around the bone and exit through the thigh.

The helical passer can then be removed with a reverse rotation of the handle, and the plastic tube and tape can be pulled completely through the skin.

We repeat the technique on the other side, of course, and then ensure that the tape lies flat under the urethra without tension. I choose to set the tape using a “cough test.” This has been shown to be superior to empiric or visual setting in a study by Dr. Miles Murphy and colleagues at the University of Louisville (Ky.).

Because the inside-out technique offers safety advantages over the outside-in technique, I believe we have an obligation to at least inform patients that the option exists, even if we're having success with the original retropubic TVT or the outside-in procedure.

We also can look forward to seeing yet another generation of synthetic midurethral slings in the coming year or so. The new sling can be placed in either a hammock or a “U” configuration with only a single incision in the anterior vaginal wall. An instrument deploys the tape by pushing it into position, rather than by pulling it into position as the TVT and obturator procedures do. There is no exit site, so even less tissue is traumatized.

We'll need to demonstrate durability and acquire more robust data, but the preliminary data look promising.

EMILY BRANNAN, ILLUSTRATION

The Transobturator Tape Procedure

In the August edition of Master Class, Dr. Mickey Karram discussed the use of tension-free vaginal tape (TVT) for the treatment of symptomatic stress urinary incontinence. Although both the success rate and subsequent patient satisfaction with TVT have proved to be excellent, the risk of bladder perforation remains a concern. Because of this risk, I have continued to perform laparoscopic retropubic urethropexy (Burch procedure) for severe stress urinary incontinence.

In this edition of Master Class, the second-generation midurethral sling—known as the transobturator tape (TOT) procedure—will be discussed. This technique, when used in patients without internal sphincter deficiency and/or low urethral opening pressures, has proved to be not only efficacious, but safe as well. In my early experience, TOT has proved to be an easy procedure to master.

The TOT procedure can be performed via two distinct approaches. I have asked Dr. Peter Sand to present the “outside-in” technique. Dr. Sand is professor of obstetrics and gynecology at Northwestern University, Chicago. He is the director of Evanston Northwestern Healthcare's division of urogynecology and reconstructive pelvic surgery, as well as the director of the fellowship program in female pelvic medicine. Dr. Sand also directs the Evanston Continence Center.

Discussing the “inside-out” approach to TOT will be Dr. Vincent Lucente. Dr. Lucente is a clinical professor of obstetrics and gynecology at Temple University in Philadelphia. He is the chief of gynecology at St. Luke's Health Network in Allentown, Pa., and the medical director of the network's continence management center. Dr. Lucente is also the chief medical officer of the Institute for Female Pelvic Medicine and Reconstructive Surgery in Allentown, as well as chief of the Section of Female Pelvic Medicine and Reconstructive Surgery at Abington (Pa.) Memorial Hospital.

The lure to the development of a second generation of midurethral slings lay in the small but still significant number of reported complications with the TVT procedure, in which a polypropylene mesh is placed through a vaginal-to-suprapubic route. The question loomed: Could reports of vascular injury, bowel and bladder perforations, and nerve injury with TVT be eliminated?

Dr. Emmanuel Delorme addressed the issue in 2001 by describing the first transobturator tape (TOT) procedure. In this approach, the sling is placed transperineally beneath the ischiopubic rami, rather than retropubically. It mimics the shape and function of the pubocervical fascia, forming a suburethral hammock of support.

Dr. Delorme's idea was that if we could avoid passing needles through the retropubic space and instead insert the tape through a transobturator approach, we would have little or no chance of hitting the bladder or urethra—bladder perforations have occurred in approximately 3% of TVT procedures, according to reports—and we would alleviate the risk of bowel injury. Nor would we go near the abdominal vessels. Routine cystoscopy, moreover, might be unnecessary.

Today, transobturator tape (TOT) procedures are fast proving to be a safer—and at least equally effective—alternative to the original TVT procedure described by Dr. Ulf Ulmsten in 1996.

In the first randomized, prospective trial comparing TVT and TOT in approximately 60 patients, Dr. Renaud de Tayrac demonstrated that at 1 year, similar numbers of patients were cured and significantly improved (over 90%). Patients undergoing TOT, interestingly, had significantly lower postoperative rates of retention. They also had shorter operation times. And whereas bladder perforation occurred in almost 10% of the TVT patients, that complication affected none of the TOT patients.

(The de Tayrac paper was published in 2004 in the American Journal of Obstetrics and Gynecology, but it was later retracted, unfortunately, for lack of Institutional Review Board approval.)

Although longer-term data from prospective randomized studies are still forthcoming, additional studies of increasingly larger numbers of patients are clearly demonstrating that TOT offers comparable results to retropubic slings, with the benefit of lower complication rates and shorter operating times.

Some data suggest, just as Dr. de Tayrac's work did, that TOT is also more forgiving with respect to voiding, and may be particularly preferable for patients with mixed incontinence or any symptoms of urge incontinence. It appears that TOT is less likely to impair bladder emptying, which, ironically, can be more problematic to patients than their original stress incontinence. The last thing we want to do is to alleviate the stress urinary incontinence only to induce or exacerbate any urge urinary incontinence.

There's still a place for retropubic slings, however. Small trials have also shown that patients with intrinsic sphincter deficiency (ISD) have a higher success rate with the TVT procedure than with TOT, which makes sense when we consider the configurations of the two midurethral slings: the original retropubic sling's U-shaped fit around the urethra, and the gentler hammocklike configuration of the transobturator sling. All told, TVT is significantly more effective than TOT when the urethral closure pressure while sitting with a full bladder is less than 43 cm H₂O.

For most patients other than those with ISD, though, TOT now seems to be the preferable minimally invasive treatment. In addition to being safe and effective, it is easier to learn than the original TVT approach, especially for physicians who are not yet comfortable or experienced with the retropubic space.

Work on yet another generation of midurethral slings is advancing quickly, but physicians today are utilizing two TOT techniques: In the original technique—coined the “outside-in” or “out-to-in” procedure (the technique described by Dr. Delorme)—the transobturator sling is placed inward through the obturator foramens from the labiocrural folds. The second technique—the newer version of TOT—involves placing the sling outward from the vaginal side toward labiocrural folds and, accordingly, is referred to as the “inside-out” or “in-to-out” TOT procedure.

The two techniques are quite different, and most physicians now favor one approach more than the other when they decide to perform TOT.

Peter Sand, M.D.: The Outside-In Approach to TOT

For me, the outside-in approach, which uses a transobturator-to-vagina approach to mesh placement, is a logical choice. The TOT procedure was first described this way, and I have seen no need to deviate from it. It is simpler than the inside-out approach, and I see no logic to performing it the other way.

First of all, we know we're improving outcomes with TOT in many women. In a retrospective cohort study comparing the TOT sling procedure (107 patients) with TVT (91 patients) at the Evanston Continence Center, we found that TOT resulted in significantly less postoperative retention and lower rates of de novo urge urinary incontinence.

Based on the results of 14-week postoperative urodynamic testing that was completed by about 66% of the patients, we found no significant difference in the percentage of patients cured of stress urinary incontinence (97% TVT vs. 90% TOT). And based on results of postoperative quality-of-life questionnaires, we concluded that subjective cure rates were similar between the groups (87% TVT vs. 89% TOT).

TOT did, however, offer the advantage of significantly less postoperative retention and lower rates of de novo urge urinary incontinence. Just as other data have shown, we've found that patients get back to normal voiding sooner with TOT. There was also a trend toward better resolution of urge urinary incontinence with TOT in these women with mixed incontinence symptoms.

Research suggests that we can achieve the same outcomes with either the outside-in or inside-out approach. Dr. Harry Vervest of Tilburg, the Netherlands, recently completed a randomized comparison of the outside-in and inside-out approaches in 75 women and found no significant differences in intraoperative or postoperative characteristics of the two procedures. Other studies have had similar conclusions.

Dr. Vervest looked at factors such as type of anesthesia, length of surgery, and amount of blood loss, as well as the length of catheter use and postoperative voiding parameters. He has reported that there were no complications with either method.

For me, however, the outside-in approach is a better choice. For one thing, I like to insert the needle where I have the most control. And overall, the outside-in approach is simpler than the other technique and does not result in the medial thigh pain that we hear about with the inside-out technique.

There are three different types of mesh-passer systems available. They use specially designed helical, curved, or hook needles. With each of these systems, the outside-in procedure involves three small incisions and the following essential steps:

A small vertical incision is made on the lateral edge of each labium majorum, medial to the labiocrural fold and posterior to the base of the adductor longus tendon. Once you identify the tendon, you'll find a depressed area that is the obturator foramen about an inch below the tendon. You can make a small stab wound on the medial edge of the obturator foramen bilaterally.

Another vertical incision is made on the anterior vaginal wall under the midurethra. You can dissect the vaginal epithelium from the underlying periurethral connective tissue, and then bluntly dissect under the vaginal epithelium about 2 cm bilaterally.

Then you can spread the scissors wide enough so that you can insert your index finger and point it toward one of the labiocrural incisions.

Starting with the right-side incision, you will angle your right index finger toward the incision in the labiocrural fold. The tip of the right-handed needle can then be pushed with your right thumb along the posterior surface of the ischiopubic ramus. You'll push through the obturator externus muscle, the obturator membrane, and the obturator internus muscle, feeling three separate pops before you feel the needle on your right index finger behind the endopelvic connective tissue.

Once you ensure that the needle is truly free of the overlying vaginal epithelium, you can connect the polypropylene mesh to the needle and rotate the needle back out through the obturator foramen. The same procedure can then be repeated on the other side.

To establish proper tension, I like to place a right-angle clamp between the urethra and under the mesh and open it approximately 1 cm. I also check to ensure that the weave of the mesh below the urethra looks exactly like the weave of the mesh that exits through the labial incisions without any tension.

Some physicians use spacing devices, but I like to look at the mesh visually. If the mesh underneath the urethra does not look distorted and looks similar to the mesh protruding through the skin, then I know the sling is not under tension. I'll then go ahead and trim the mesh back against the skin and use simple sutures to close the incisions on each side.

The safety of this approach is ensured by fingertip guidance of the needle through the obturator membrane and the positioning of the index finger toward the incision and the cross-arm of the needle. This way, you're essentially opposing your thumb and index finger, ensuring proper passage of the needle.

Some physicians worry about the obturator canal's being several centimeters away from the path, but I believe that any injury would more likely occur through the inside-out approach.

Cystoscopy does not need to be performed routinely as it does with TVT, but the key here is the word “routinely.” Whether or not cystoscopy is used is really dependent on the operator's judgment.

Vincent Lucente, M.D.: The Inside-Out Approach to TOT

The inside-out technique, which I use, was developed for the purpose of even further minimizing risk to the urethra and bladder and ensuring minimal dissection of the vaginal tissue.

Although Dr. Delorme's outside-in procedure was indeed a significant development for the treatment of stress urinary incontinence—and although most available studies show that the two approaches are similar in safety and efficacy—there have been several clinical reports and anatomical studies documenting that bladder and urethra injuries still occur with the technique.

This remaining potential for injury prompted Dr. Jean de Laval, of the University of Liège (Belgium), to develop an alternative TOT approach that he believed would be even safer because the TOT needle would travel out and away from the lower urinary tract.

I am convinced that his technique offers several advantages. For one thing, it essentially eliminates any risk of injury to the urethra and bladder. It also avoids potential injury to the anterior branch of the obturator artery, which runs around the outer perimeter of the obturator foramen. In the outside-in procedure, the instruments run along the edge of the foramen and can potentially disrupt that anterior branch. The hematomas that can occur—and there have been some reported—are not at all life threatening, but they can cause a protracted recovery for our patients.

I also believe that whenever we're traversing instruments through the body, we're always most accurate where we start our journey. By starting at the urethra and traveling away, I believe we're going to achieve more consistent and accurate placement of the sling at the midurethral position.

The greatest advantage to the inside-out technique, I believe, is one that has not been documented or well studied but still lingers in my mind. That is, because we need to do less periurethral dissection, we're minimizing the risk of urethral denervation.

The outside-in technique involves more periurethral dissection: One simply must dissect more tissue to assure the palpation guidance of the incoming instruments. Healing and re-enervation do occur, of course, but I believe the dissection inevitably increases the risk of sphincteric denervation, and that women may not get “back to baseline,” so to speak—that they may suffer an insult that could lead later to ISD. It is quite possible that we are denervating the urethra musculature in subtle ways that cannot be measured now but will become apparent 10–15 years later as our patients age. I would rather avoid that possibility.

The key to the inside-out technique is the use of local anesthesia. The procedure enables us to use local anesthesia, fortunately, but it must be utilized thoroughly. Local anesthetic not only must infiltrate the area under the urethra and into the vagina, but it also must infiltrate the skin, fat, and—most importantly—the muscle of the inner thighs. With proper techniques, we can markedly reduce the likelihood of postoperative thigh pain.

The device used in the procedure includes a pair of helical passers that are assembled with polyethylene tubes bound to a polypropylene tape and one winged guide. The guide ensures that the tape will be passed accurately through the obturator membrane without entering the pelvic space.

The points where the needles will exit are identified by tracing a horizontal line at the level of the urethral meatus, and a second line 2 cm above this. The exit points are on this second line, 2 cm lateral to the folds of the thigh. We will make incisions at each exit point once the helical passer hits the skin; for now, we just mark the expected exit points and infiltrate with local anesthetic.

We then make a 1-cm long midline vaginal incision, starting 1 cm proximal to the urethral meatus. We dissect using a push-spread technique, orienting our scissors on a plane slightly above the horizontal, with a 45-degree angle relative to the urethral sagittal plane, toward the upper part of the ischiopubic ramus.

The winged guide is inserted into the tract at the same angle, until it passes the inferior pubic ramus. With the winged guide in place, a helical passer is then inserted into the tract. When the device is pushed slightly, the passer will move through the obturator membrane, at which point it is no longer advanced but rather is simply rotated and swung into position, which allows it to curve around the bone and exit through the thigh.

The helical passer can then be removed with a reverse rotation of the handle, and the plastic tube and tape can be pulled completely through the skin.

We repeat the technique on the other side, of course, and then ensure that the tape lies flat under the urethra without tension. I choose to set the tape using a “cough test.” This has been shown to be superior to empiric or visual setting in a study by Dr. Miles Murphy and colleagues at the University of Louisville (Ky.).

Because the inside-out technique offers safety advantages over the outside-in technique, I believe we have an obligation to at least inform patients that the option exists, even if we're having success with the original retropubic TVT or the outside-in procedure.

We also can look forward to seeing yet another generation of synthetic midurethral slings in the coming year or so. The new sling can be placed in either a hammock or a “U” configuration with only a single incision in the anterior vaginal wall. An instrument deploys the tape by pushing it into position, rather than by pulling it into position as the TVT and obturator procedures do. There is no exit site, so even less tissue is traumatized.

We'll need to demonstrate durability and acquire more robust data, but the preliminary data look promising.

EMILY BRANNAN, ILLUSTRATION

The Transobturator Tape Procedure

In the August edition of Master Class, Dr. Mickey Karram discussed the use of tension-free vaginal tape (TVT) for the treatment of symptomatic stress urinary incontinence. Although both the success rate and subsequent patient satisfaction with TVT have proved to be excellent, the risk of bladder perforation remains a concern. Because of this risk, I have continued to perform laparoscopic retropubic urethropexy (Burch procedure) for severe stress urinary incontinence.

In this edition of Master Class, the second-generation midurethral sling—known as the transobturator tape (TOT) procedure—will be discussed. This technique, when used in patients without internal sphincter deficiency and/or low urethral opening pressures, has proved to be not only efficacious, but safe as well. In my early experience, TOT has proved to be an easy procedure to master.

The TOT procedure can be performed via two distinct approaches. I have asked Dr. Peter Sand to present the “outside-in” technique. Dr. Sand is professor of obstetrics and gynecology at Northwestern University, Chicago. He is the director of Evanston Northwestern Healthcare's division of urogynecology and reconstructive pelvic surgery, as well as the director of the fellowship program in female pelvic medicine. Dr. Sand also directs the Evanston Continence Center.

Discussing the “inside-out” approach to TOT will be Dr. Vincent Lucente. Dr. Lucente is a clinical professor of obstetrics and gynecology at Temple University in Philadelphia. He is the chief of gynecology at St. Luke's Health Network in Allentown, Pa., and the medical director of the network's continence management center. Dr. Lucente is also the chief medical officer of the Institute for Female Pelvic Medicine and Reconstructive Surgery in Allentown, as well as chief of the Section of Female Pelvic Medicine and Reconstructive Surgery at Abington (Pa.) Memorial Hospital.

Today, there are more published studies on the use of tension-free vaginal tape in the treatment of stress urinary incontinence than on any other procedure that has ever been performed for stress incontinence.

When compared with traditional suspensions and slings, TVT has been shown to be at least as—if not more—efficacious for all types of stress urinary incontinence, from incontinence due to anatomical abnormalities to incontinence resulting from intrinsic sphincter deficiency and mixed incontinence.

Added to TVT's efficacy is the fact that the TVT procedure is simpler, shorter in duration (approximately 20 minutes), and less invasive than other procedures, with extremely low complication rates when the appropriate technique is utilized and retropublic anatomy is appreciated.

Clearly, the TVT procedure is a good treatment of choice.

TVT's Origins

The TVT procedure, which was the first use of the synthetic midurethral sling, was first done in this country in 1998.

The history of TVT is interesting because the procedure went against everything we always thought we understood about surgery for SUI: mainly, that the mechanism for continence was at the proximal urethra and bladder neck, and that surgeries for incontinence needed to either elevate or support this area. TVT, on the other hand, uses a midurethral placement. It provides a backboard under a portion of the urethra that has very little mobility.

In addition to processing this major change in thinking, many of us also thought at the time that synthetic materials should be avoided for sling procedures, and few of us could easily grasp the notion of placing a sling without fixing it to anything.

The TVT procedure was first described by Dr. Ulf Ulmsten in 1996. In the mid-1980s, he and his fellow, Dr. Peter Petros, set out to identify and describe a new minimally invasive outpatient procedure for stress incontinence.

They described a series of small studies, exploring what they called the “integral theory,” in which they looked at different slings or meshes placed at different anatomical sites underneath the urethra.

In the end, they determined that a certain type of polypropylene mesh, placed through a vaginal-to-suprapubic route using specially designed, long stainless steel needles that can be passed under local anesthesia, was the best approach.

According to Dr. Ulmsten's theory, the procedure works by reinforcing the pubourethral ligaments and levator ani muscles, as well as increasing the support of the vaginal hammock.

The Entry of Transobturator Slings

The TVT procedure required blind passage of needles through the retropubic space, a process that potentially brings the needle into close proximity with vascular structures as well as bowel and the bladder.

And indeed, there were rare reports of very serious complications related to vascular and bowel injuries.

These complications led a Frenchman, Dr. Emmanuel Delorme, to describe the first transobturator tape (TOT) procedure. The theory behind this technique, which represented a second generation of midurethral slings, was that it avoided the retropubic space and thus avoided these potential vascular, bowel, and bladder injuries.

The procedure became quite popular, and techniques to place the transobturator sling from the vaginal side or from the inner thigh were described. Experience with these modifications has grown over the last few years.

Complication rates with TOT have been low, but some complications, particularly those related to the inner thigh, have been described.

The next generation of synthetic midurethral slings, which will be available in the next year, will be even less invasive than TOT, as the sling will not have an exit site.

To date, we lack data from any long-term, randomized comparison of the two procedures, and we should not draw any conclusions until we have such long-term data. I believe we need to see a minimum follow-up of 2 years.

The data should accumulate quickly, however. In fact, a prospective, randomized comparison of TVT versus TOT has just been completed, so data should be forthcoming.

Regarding TVT specifically, we have long-term data (up to 7 years) showing that TVT maintains its high cure rate of greater than 80%.

I sometimes use TOT in my practice; at this time, it seems especially reasonable in patients at high risk for pelvic adhesions and in patients who have milder degrees of incontinence or SUI that is felt to be occult.

Performing TVT

The TVT procedure begins with the administration of a hemostatic agent and an anesthetic. (We prefer lidocaine with epinephrine.) The anterior vaginal wall is injected at the level of the distal- to midurethra.

It is important to appreciate that this portion of the anterior vaginal wall is fused to the posterior urethra. No clear plane of dissection exists between these two structures.

The tips of the scissors are then used to create two tunnels to the level of the interior pubic ramus. The bladder is emptied and, using a catheter guide, the urethra is deflected in the direction opposite to the direction in which the needle is going to be passed.

The TVT needle is then directed toward the ipsilateral shoulder, and the tip of the needle is used to penetrate the urogenital diaphragm. No more than 0.5–0.75 inch of the needle should be passed in a lateral direction.

Once the urogenital diaphragm has been penetrated, the handle of the needle is dropped, and the tip of the needle is moved in a medial and superior direction. Be certain that the needle tip maintains contact with the back of the pubic bone. This is a very important landmark, and using it will help avoid migration of the needle into dangerous areas.

The next resistance that you will feel at the tip of the needle is the undersurface of the rectus muscle.

The needle is then used to penetrate the anterior abdominal fascia, and the tip comes up through the previously created stab wound. Cystoscopy is performed with the needle in place.

It is very important to overdistend the bladder and make sure that every millimeter of the bladder wall is visualized. Subtle penetrations can be easily missed if the bladder is not overdistended. Once it can be determined for certain that the needle has not penetrated the bladder, the needle is passed and the same procedure is repeated on the opposite side.

With the plastic sheath in place, you can achieve tensioning of the sling either through a cough stress test or suprapubic pressure. Some clinicians—believing that it's unnecessary to perform any sort of stress test—prefer just to place the sling loosely below the urethra, and that's fine.

If at all possible, I like to recreate SUI with suprapubic pressure or a cough, but at times this is not possible. With experience, you'll realize that the sling is placed very loosely most of the time. My end point in the majority of cases is being able to easily pass a right-angled clamp between the sling and the posterior urethra.

Preventing Complications

The most common complication of the TVT procedure is inadvertent penetration of the bladder. However, as long as this is diagnosed and the needle is withdrawn, the bladder emptied, and the needle repassed safely, penetration will rarely, if ever, cause any significant sequelae. In my opinion, these patients really do not even require any prolonged drainage, assuming that the penetration site is in a high, nondependent portion of the bladder.

Vascular injuries occur when the tip of the needle migrates away from the back of the pubic bone. Most commonly, this occurs when the needle is continued in a lateral direction and comes in close proximity with the obturator neurovascular bundle. If the needle is continued in a lateral direction, it may come in close proximity to the external iliac artery and vein.

Regarding bowel injuries, I strongly believe that this procedure should be avoided in patients who are at high risk for significant pelvic adhesions. This category includes patients who have had a ruptured appendix with peritonitis, patients who have had severe endometriosis and are known to have significant pelvic adhesions, and any patient you feel might be at high risk for having bowel adhered very low in the pelvis.

And again, we must not underestimate the importance of maintaining the contact of the needle on the back of the pubic bone. It is attention to specific anatomical landmarks such as this that make the operation both safe and successful.

A small percentage (less than 1%) of patients will have erosion of the tape. This outcome can be easily managed by either excising the eroded part of the tape or re-covering it with healthier tissue.

Rates of partial or complete retention postoperatively—a problem after any operation for SUI—have been very low and can be managed by either stretching or cutting the tape.

MICKEY M. KARRAM M.D.

Emily Brannan, Illustration

Vascular injuries may occur when the needle is continued in a lateral direction and comes in close proximity to the obturator neurovascular bundle. Courtesy Dr. Mickey M. Karram

Stress Urinary Incontinence

Until recently, gynecologists and urologists approached stress urinary incontinence differently. Gynecologists were champions of retropubic colpopexy procedures, while urologists performed sling procedures. Through Dr. Ulf Ulmsten's landmark work on stress urinary incontinence, culminating in the use of tension-free vaginal tape (TVT) in 1996, gynecologists and urologists throughout the world came to agree on a common procedure.

Whereas laparoscopic retropubic colpopexy was the minimally invasive surgical procedure of choice in the late 1990s, the use of TVT has quickly become the preferred minimally invasive technique in the treatment of stress urinary incontinence. The rapid acceptance of the use of tension-free vaginal tape is quite understandable. Few techniques in gynecologic surgery have been as well studied.

Rapidly accumulating data indicate that the long-term results are at least as good as the standard, retropubic colpopexy. In a large, multicenter, prospective, randomized trial for stress urinary incontinence (Am. J. Obstet. Gynecol. 2004;190:324–31), the cure rates at 2 years for TVT and colposuspension were essentially the same (81% vs. 80%).

For this edition of the Master Class, I am proud to have Dr. Mickey M. Karram discussing TVT in the treatment of stress urinary incontinence. As one of the true thought leaders in urogynecology, Dr. Karram helped introduce the use of TVT in the United States.

Dr. Karram is the director of urogynecology and reconstructive pelvic surgery and the director and founder of the fellowship training program in female pelvic medicine and reconstructive surgery in the department of obstetrics and gynecology at Good Samaritan Hospital in Cincinnati. He is also affiliated with the department of obstetrics and gynecology at the University of Cincinnati and is editor-in-chief of the International Urogynecology Journal and Pelvic Floor Dysfunction.

Dr. Karram has authored over 90 peer-reviewed publications and 33 book chapters, and has edited five books. I am truly honored to have Dr. Karram introduce the important topic of synthetic midurethral slings for stress incontinence.

Today, there are more published studies on the use of tension-free vaginal tape in the treatment of stress urinary incontinence than on any other procedure that has ever been performed for stress incontinence.

When compared with traditional suspensions and slings, TVT has been shown to be at least as—if not more—efficacious for all types of stress urinary incontinence, from incontinence due to anatomical abnormalities to incontinence resulting from intrinsic sphincter deficiency and mixed incontinence.

Added to TVT's efficacy is the fact that the TVT procedure is simpler, shorter in duration (approximately 20 minutes), and less invasive than other procedures, with extremely low complication rates when the appropriate technique is utilized and retropublic anatomy is appreciated.

Clearly, the TVT procedure is a good treatment of choice.

TVT's Origins

The TVT procedure, which was the first use of the synthetic midurethral sling, was first done in this country in 1998.

The history of TVT is interesting because the procedure went against everything we always thought we understood about surgery for SUI: mainly, that the mechanism for continence was at the proximal urethra and bladder neck, and that surgeries for incontinence needed to either elevate or support this area. TVT, on the other hand, uses a midurethral placement. It provides a backboard under a portion of the urethra that has very little mobility.

In addition to processing this major change in thinking, many of us also thought at the time that synthetic materials should be avoided for sling procedures, and few of us could easily grasp the notion of placing a sling without fixing it to anything.

The TVT procedure was first described by Dr. Ulf Ulmsten in 1996. In the mid-1980s, he and his fellow, Dr. Peter Petros, set out to identify and describe a new minimally invasive outpatient procedure for stress incontinence.

They described a series of small studies, exploring what they called the “integral theory,” in which they looked at different slings or meshes placed at different anatomical sites underneath the urethra.

In the end, they determined that a certain type of polypropylene mesh, placed through a vaginal-to-suprapubic route using specially designed, long stainless steel needles that can be passed under local anesthesia, was the best approach.

According to Dr. Ulmsten's theory, the procedure works by reinforcing the pubourethral ligaments and levator ani muscles, as well as increasing the support of the vaginal hammock.

The Entry of Transobturator Slings

The TVT procedure required blind passage of needles through the retropubic space, a process that potentially brings the needle into close proximity with vascular structures as well as bowel and the bladder.

And indeed, there were rare reports of very serious complications related to vascular and bowel injuries.

These complications led a Frenchman, Dr. Emmanuel Delorme, to describe the first transobturator tape (TOT) procedure. The theory behind this technique, which represented a second generation of midurethral slings, was that it avoided the retropubic space and thus avoided these potential vascular, bowel, and bladder injuries.

The procedure became quite popular, and techniques to place the transobturator sling from the vaginal side or from the inner thigh were described. Experience with these modifications has grown over the last few years.

Complication rates with TOT have been low, but some complications, particularly those related to the inner thigh, have been described.

The next generation of synthetic midurethral slings, which will be available in the next year, will be even less invasive than TOT, as the sling will not have an exit site.

To date, we lack data from any long-term, randomized comparison of the two procedures, and we should not draw any conclusions until we have such long-term data. I believe we need to see a minimum follow-up of 2 years.

The data should accumulate quickly, however. In fact, a prospective, randomized comparison of TVT versus TOT has just been completed, so data should be forthcoming.

Regarding TVT specifically, we have long-term data (up to 7 years) showing that TVT maintains its high cure rate of greater than 80%.

I sometimes use TOT in my practice; at this time, it seems especially reasonable in patients at high risk for pelvic adhesions and in patients who have milder degrees of incontinence or SUI that is felt to be occult.

Performing TVT

The TVT procedure begins with the administration of a hemostatic agent and an anesthetic. (We prefer lidocaine with epinephrine.) The anterior vaginal wall is injected at the level of the distal- to midurethra.

It is important to appreciate that this portion of the anterior vaginal wall is fused to the posterior urethra. No clear plane of dissection exists between these two structures.

The tips of the scissors are then used to create two tunnels to the level of the interior pubic ramus. The bladder is emptied and, using a catheter guide, the urethra is deflected in the direction opposite to the direction in which the needle is going to be passed.

The TVT needle is then directed toward the ipsilateral shoulder, and the tip of the needle is used to penetrate the urogenital diaphragm. No more than 0.5–0.75 inch of the needle should be passed in a lateral direction.

Once the urogenital diaphragm has been penetrated, the handle of the needle is dropped, and the tip of the needle is moved in a medial and superior direction. Be certain that the needle tip maintains contact with the back of the pubic bone. This is a very important landmark, and using it will help avoid migration of the needle into dangerous areas.

The next resistance that you will feel at the tip of the needle is the undersurface of the rectus muscle.

The needle is then used to penetrate the anterior abdominal fascia, and the tip comes up through the previously created stab wound. Cystoscopy is performed with the needle in place.

It is very important to overdistend the bladder and make sure that every millimeter of the bladder wall is visualized. Subtle penetrations can be easily missed if the bladder is not overdistended. Once it can be determined for certain that the needle has not penetrated the bladder, the needle is passed and the same procedure is repeated on the opposite side.

With the plastic sheath in place, you can achieve tensioning of the sling either through a cough stress test or suprapubic pressure. Some clinicians—believing that it's unnecessary to perform any sort of stress test—prefer just to place the sling loosely below the urethra, and that's fine.

If at all possible, I like to recreate SUI with suprapubic pressure or a cough, but at times this is not possible. With experience, you'll realize that the sling is placed very loosely most of the time. My end point in the majority of cases is being able to easily pass a right-angled clamp between the sling and the posterior urethra.

Preventing Complications

The most common complication of the TVT procedure is inadvertent penetration of the bladder. However, as long as this is diagnosed and the needle is withdrawn, the bladder emptied, and the needle repassed safely, penetration will rarely, if ever, cause any significant sequelae. In my opinion, these patients really do not even require any prolonged drainage, assuming that the penetration site is in a high, nondependent portion of the bladder.

Vascular injuries occur when the tip of the needle migrates away from the back of the pubic bone. Most commonly, this occurs when the needle is continued in a lateral direction and comes in close proximity with the obturator neurovascular bundle. If the needle is continued in a lateral direction, it may come in close proximity to the external iliac artery and vein.

Regarding bowel injuries, I strongly believe that this procedure should be avoided in patients who are at high risk for significant pelvic adhesions. This category includes patients who have had a ruptured appendix with peritonitis, patients who have had severe endometriosis and are known to have significant pelvic adhesions, and any patient you feel might be at high risk for having bowel adhered very low in the pelvis.

And again, we must not underestimate the importance of maintaining the contact of the needle on the back of the pubic bone. It is attention to specific anatomical landmarks such as this that make the operation both safe and successful.

A small percentage (less than 1%) of patients will have erosion of the tape. This outcome can be easily managed by either excising the eroded part of the tape or re-covering it with healthier tissue.

Rates of partial or complete retention postoperatively—a problem after any operation for SUI—have been very low and can be managed by either stretching or cutting the tape.

MICKEY M. KARRAM M.D.

Emily Brannan, Illustration

Vascular injuries may occur when the needle is continued in a lateral direction and comes in close proximity to the obturator neurovascular bundle. Courtesy Dr. Mickey M. Karram

Stress Urinary Incontinence

Until recently, gynecologists and urologists approached stress urinary incontinence differently. Gynecologists were champions of retropubic colpopexy procedures, while urologists performed sling procedures. Through Dr. Ulf Ulmsten's landmark work on stress urinary incontinence, culminating in the use of tension-free vaginal tape (TVT) in 1996, gynecologists and urologists throughout the world came to agree on a common procedure.

Whereas laparoscopic retropubic colpopexy was the minimally invasive surgical procedure of choice in the late 1990s, the use of TVT has quickly become the preferred minimally invasive technique in the treatment of stress urinary incontinence. The rapid acceptance of the use of tension-free vaginal tape is quite understandable. Few techniques in gynecologic surgery have been as well studied.

Rapidly accumulating data indicate that the long-term results are at least as good as the standard, retropubic colpopexy. In a large, multicenter, prospective, randomized trial for stress urinary incontinence (Am. J. Obstet. Gynecol. 2004;190:324–31), the cure rates at 2 years for TVT and colposuspension were essentially the same (81% vs. 80%).

For this edition of the Master Class, I am proud to have Dr. Mickey M. Karram discussing TVT in the treatment of stress urinary incontinence. As one of the true thought leaders in urogynecology, Dr. Karram helped introduce the use of TVT in the United States.

Dr. Karram is the director of urogynecology and reconstructive pelvic surgery and the director and founder of the fellowship training program in female pelvic medicine and reconstructive surgery in the department of obstetrics and gynecology at Good Samaritan Hospital in Cincinnati. He is also affiliated with the department of obstetrics and gynecology at the University of Cincinnati and is editor-in-chief of the International Urogynecology Journal and Pelvic Floor Dysfunction.

Dr. Karram has authored over 90 peer-reviewed publications and 33 book chapters, and has edited five books. I am truly honored to have Dr. Karram introduce the important topic of synthetic midurethral slings for stress incontinence.

Today, there are more published studies on the use of tension-free vaginal tape in the treatment of stress urinary incontinence than on any other procedure that has ever been performed for stress incontinence.

When compared with traditional suspensions and slings, TVT has been shown to be at least as—if not more—efficacious for all types of stress urinary incontinence, from incontinence due to anatomical abnormalities to incontinence resulting from intrinsic sphincter deficiency and mixed incontinence.

Added to TVT's efficacy is the fact that the TVT procedure is simpler, shorter in duration (approximately 20 minutes), and less invasive than other procedures, with extremely low complication rates when the appropriate technique is utilized and retropublic anatomy is appreciated.

Clearly, the TVT procedure is a good treatment of choice.

TVT's Origins

The TVT procedure, which was the first use of the synthetic midurethral sling, was first done in this country in 1998.

The history of TVT is interesting because the procedure went against everything we always thought we understood about surgery for SUI: mainly, that the mechanism for continence was at the proximal urethra and bladder neck, and that surgeries for incontinence needed to either elevate or support this area. TVT, on the other hand, uses a midurethral placement. It provides a backboard under a portion of the urethra that has very little mobility.

In addition to processing this major change in thinking, many of us also thought at the time that synthetic materials should be avoided for sling procedures, and few of us could easily grasp the notion of placing a sling without fixing it to anything.

The TVT procedure was first described by Dr. Ulf Ulmsten in 1996. In the mid-1980s, he and his fellow, Dr. Peter Petros, set out to identify and describe a new minimally invasive outpatient procedure for stress incontinence.

They described a series of small studies, exploring what they called the “integral theory,” in which they looked at different slings or meshes placed at different anatomical sites underneath the urethra.

In the end, they determined that a certain type of polypropylene mesh, placed through a vaginal-to-suprapubic route using specially designed, long stainless steel needles that can be passed under local anesthesia, was the best approach.

According to Dr. Ulmsten's theory, the procedure works by reinforcing the pubourethral ligaments and levator ani muscles, as well as increasing the support of the vaginal hammock.

The Entry of Transobturator Slings

The TVT procedure required blind passage of needles through the retropubic space, a process that potentially brings the needle into close proximity with vascular structures as well as bowel and the bladder.

And indeed, there were rare reports of very serious complications related to vascular and bowel injuries.

These complications led a Frenchman, Dr. Emmanuel Delorme, to describe the first transobturator tape (TOT) procedure. The theory behind this technique, which represented a second generation of midurethral slings, was that it avoided the retropubic space and thus avoided these potential vascular, bowel, and bladder injuries.

The procedure became quite popular, and techniques to place the transobturator sling from the vaginal side or from the inner thigh were described. Experience with these modifications has grown over the last few years.

Complication rates with TOT have been low, but some complications, particularly those related to the inner thigh, have been described.

The next generation of synthetic midurethral slings, which will be available in the next year, will be even less invasive than TOT, as the sling will not have an exit site.

To date, we lack data from any long-term, randomized comparison of the two procedures, and we should not draw any conclusions until we have such long-term data. I believe we need to see a minimum follow-up of 2 years.

The data should accumulate quickly, however. In fact, a prospective, randomized comparison of TVT versus TOT has just been completed, so data should be forthcoming.

Regarding TVT specifically, we have long-term data (up to 7 years) showing that TVT maintains its high cure rate of greater than 80%.

I sometimes use TOT in my practice; at this time, it seems especially reasonable in patients at high risk for pelvic adhesions and in patients who have milder degrees of incontinence or SUI that is felt to be occult.

Performing TVT

The TVT procedure begins with the administration of a hemostatic agent and an anesthetic. (We prefer lidocaine with epinephrine.) The anterior vaginal wall is injected at the level of the distal- to midurethra.

It is important to appreciate that this portion of the anterior vaginal wall is fused to the posterior urethra. No clear plane of dissection exists between these two structures.

The tips of the scissors are then used to create two tunnels to the level of the interior pubic ramus. The bladder is emptied and, using a catheter guide, the urethra is deflected in the direction opposite to the direction in which the needle is going to be passed.

The TVT needle is then directed toward the ipsilateral shoulder, and the tip of the needle is used to penetrate the urogenital diaphragm. No more than 0.5–0.75 inch of the needle should be passed in a lateral direction.

Once the urogenital diaphragm has been penetrated, the handle of the needle is dropped, and the tip of the needle is moved in a medial and superior direction. Be certain that the needle tip maintains contact with the back of the pubic bone. This is a very important landmark, and using it will help avoid migration of the needle into dangerous areas.

The next resistance that you will feel at the tip of the needle is the undersurface of the rectus muscle.

The needle is then used to penetrate the anterior abdominal fascia, and the tip comes up through the previously created stab wound. Cystoscopy is performed with the needle in place.

It is very important to overdistend the bladder and make sure that every millimeter of the bladder wall is visualized. Subtle penetrations can be easily missed if the bladder is not overdistended. Once it can be determined for certain that the needle has not penetrated the bladder, the needle is passed and the same procedure is repeated on the opposite side.

With the plastic sheath in place, you can achieve tensioning of the sling either through a cough stress test or suprapubic pressure. Some clinicians—believing that it's unnecessary to perform any sort of stress test—prefer just to place the sling loosely below the urethra, and that's fine.

If at all possible, I like to recreate SUI with suprapubic pressure or a cough, but at times this is not possible. With experience, you'll realize that the sling is placed very loosely most of the time. My end point in the majority of cases is being able to easily pass a right-angled clamp between the sling and the posterior urethra.

Preventing Complications

The most common complication of the TVT procedure is inadvertent penetration of the bladder. However, as long as this is diagnosed and the needle is withdrawn, the bladder emptied, and the needle repassed safely, penetration will rarely, if ever, cause any significant sequelae. In my opinion, these patients really do not even require any prolonged drainage, assuming that the penetration site is in a high, nondependent portion of the bladder.

Vascular injuries occur when the tip of the needle migrates away from the back of the pubic bone. Most commonly, this occurs when the needle is continued in a lateral direction and comes in close proximity with the obturator neurovascular bundle. If the needle is continued in a lateral direction, it may come in close proximity to the external iliac artery and vein.

Regarding bowel injuries, I strongly believe that this procedure should be avoided in patients who are at high risk for significant pelvic adhesions. This category includes patients who have had a ruptured appendix with peritonitis, patients who have had severe endometriosis and are known to have significant pelvic adhesions, and any patient you feel might be at high risk for having bowel adhered very low in the pelvis.

And again, we must not underestimate the importance of maintaining the contact of the needle on the back of the pubic bone. It is attention to specific anatomical landmarks such as this that make the operation both safe and successful.

A small percentage (less than 1%) of patients will have erosion of the tape. This outcome can be easily managed by either excising the eroded part of the tape or re-covering it with healthier tissue.

Rates of partial or complete retention postoperatively—a problem after any operation for SUI—have been very low and can be managed by either stretching or cutting the tape.

MICKEY M. KARRAM M.D.

Emily Brannan, Illustration

Vascular injuries may occur when the needle is continued in a lateral direction and comes in close proximity to the obturator neurovascular bundle. Courtesy Dr. Mickey M. Karram

Stress Urinary Incontinence

Until recently, gynecologists and urologists approached stress urinary incontinence differently. Gynecologists were champions of retropubic colpopexy procedures, while urologists performed sling procedures. Through Dr. Ulf Ulmsten's landmark work on stress urinary incontinence, culminating in the use of tension-free vaginal tape (TVT) in 1996, gynecologists and urologists throughout the world came to agree on a common procedure.

Whereas laparoscopic retropubic colpopexy was the minimally invasive surgical procedure of choice in the late 1990s, the use of TVT has quickly become the preferred minimally invasive technique in the treatment of stress urinary incontinence. The rapid acceptance of the use of tension-free vaginal tape is quite understandable. Few techniques in gynecologic surgery have been as well studied.

Rapidly accumulating data indicate that the long-term results are at least as good as the standard, retropubic colpopexy. In a large, multicenter, prospective, randomized trial for stress urinary incontinence (Am. J. Obstet. Gynecol. 2004;190:324–31), the cure rates at 2 years for TVT and colposuspension were essentially the same (81% vs. 80%).

For this edition of the Master Class, I am proud to have Dr. Mickey M. Karram discussing TVT in the treatment of stress urinary incontinence. As one of the true thought leaders in urogynecology, Dr. Karram helped introduce the use of TVT in the United States.

Dr. Karram is the director of urogynecology and reconstructive pelvic surgery and the director and founder of the fellowship training program in female pelvic medicine and reconstructive surgery in the department of obstetrics and gynecology at Good Samaritan Hospital in Cincinnati. He is also affiliated with the department of obstetrics and gynecology at the University of Cincinnati and is editor-in-chief of the International Urogynecology Journal and Pelvic Floor Dysfunction.

Dr. Karram has authored over 90 peer-reviewed publications and 33 book chapters, and has edited five books. I am truly honored to have Dr. Karram introduce the important topic of synthetic midurethral slings for stress incontinence.

The concept of using grafts or mesh for rectocele repair—as well as for other hernias of pelvic organ support—makes sense. Their use can restore correct anatomical support by recreating and/or augmenting the fascial layer, enabling us to provide additional stability to traditional repairs of the posterior vaginal wall that too often may incorporate weak tissue.

Our general surgery colleagues have reduced their failure rate for hernia treatment by almost 50% by augmenting their procedures with mesh or grafts.

It was reported almost a decade ago that women have an 11% risk of needing surgery for prolapse or urinary incontinence by age 80 years—and that at least one-third will need a second surgery. Over the last 5 years, new surgical procedures for incontinence have raised our incontinence success rates to nearly 90%. Our success rate for prolapse using traditional techniques, meanwhile, remains in the 50%–70% range.

We're looking for a better mousetrap, and mesh or graft augmentation is likely to be it. Certainly, it is worth considering.

The Shortcomings of Our Traditions

Our underlying concepts of prolapse have changed. We used to think of prolapse strictly as the result of weakness in the vaginal wall and subsequent stretching. Our traditional repair technique was, simply put, to tighten the weakened tissue and narrow the vaginal wall.

The next stage in our thinking was that we were actually dealing with hernias—that is, with discrete breaks (site-specific defects) in the tissue. Our practice then progressed to opening up the vaginal mucosa, finding the defect, and closing it. This was the origin of the anterior paravaginal repair for cystocele and the posterior site-specific repair for rectocele.

There are pros and cons to both traditional ways of thinking. For instance, finding the defect and closing it are theoretically fine, but our assumption here is that the intact tissue is strong. That's not always the case. Sometimes it's hard to find the defect. And sometimes we may even create it.

Often when we're looking for better tissue to use for a central repair, we gravitate toward more lateral tissue and end up bringing too much tissue to the midline, causing dyspareunia. Or we move up in our search for tissue—that is, into the enterocele tissue—and we do our best with tissue that often is of poor quality. This may well result in a recurrence, which we often attribute to “poor protoplasm” or failure of the patient to adhere to our postoperative instructions.

And in either case, with traditional plication techniques or traditional site-specific techniques, we usually are not altering the patient's underlying risk factors for prolapse or for recurrence after surgery. Constipation; obesity; nerve or muscle damage; and occupational risk factors, such as heavy lifting are among the many remaining factors that, without strong tissue and stability, can put our repair in jeopardy.

Our most recent evolution in thinking, therefore, has been to look at our general surgeon colleagues' use of mesh and grafts to more successfully treat hernias, and to think that maybe we can do the same thing.

Choosing Donor or Synthetic Grafts

The use of grafts or mesh alleviates many of the challenges we have faced with our traditional techniques. One real benefit, for instance, is that we can extend mesh up into the enterocele and create strong tissue in a place where we previously would have worked with weak peritoneum.

A variety of graft and mesh products is available to the clinician. (See box.) The question of which materials are better is still much debated among physicians, however. The advantage of donor grafts, of course, is that they are biologic, which should significantly alleviate or even eliminate problems of erosion and rejection. The downside is that the materials are expensive and can contract over time. We also do not yet fully understand the in vivo response to these grafts. In some cases, the body may chew up the graft; in other cases, the graft may be encapsulated through an inflammatory reaction.

The advantage of synthetic meshes is that they are readily available, have more consistent material strength, and are permanent. There also is a great variety of materials to choose from—something that we should certainly view as a benefit and take advantage of. Synthetic meshes come in different weaves, with various degrees of pliability, strength, softness, and thickness. Such variables are important to consider, because the mesh we use in the vagina must be both strong enough to maintain the integrity of our repairs and flexible enough to accommodate sexual function.

The downside of synthetic meshes relates to its permanence. The mesh will be with our patient for the rest of her life, during which time rejection, infection, and especially erosion can occur. Whereas dyspareunia and failure are the major complications of traditional repairs, erosion—or exposure, as it is more frequently called today—is the primary complication associated with the use of mesh.

Our Judgment Call

At this time, we do not have enough data on rectocele repair with grafts or mesh to either uniformly recommend or uniformly reject this new type of repair. We need more evidence-based information to document its long-term efficacy.

However, these augmented procedures are now established in many settings—with observed short-term success—and I believe they should be considered for our more challenging cases.

The key to doing good rectocele repair, I believe, is first being able to identify the anatomy, and second, being able to make the clinical judgment about when and when not to use a mesh or graft. In my practice, for instance, we generally use mesh in patients with recurrences, in patients with very advanced prolapse and poor-quality tissue, and in women with a high risk for recurrence, such as those with chronic constipation, obesity, or jobs that require heavy lifting.

With mesh augmentation, we've taken our success rate to 85%–90% for all vaginal wall repairs, and to 90% for rectocele repair. The erosion rate for rectocele repair probably is about 10%. Most erosions can be managed conservatively, and few require reoperation if identified early. The dyspareunia rate is harder to get a handle on and is something we are still evaluating.

Newer Techniques, Getting Started

Some experienced physicians are now using new needle-guided mesh techniques. These procedures are quick, and some physicians value the fact that the materials come in convenient kits.

In these new techniques, needles are inserted through the transobturator approach and brought out near the ischial spine. The needles are then attached to the arms of the mesh, and the mesh is pulled through. The main disadvantage to this technique lies in the blind passage of needles through fairly long distances and critical areas where the potential for complications could include rectal injury, nerve injury, and bleeding. Another disadvantage is that the kits are relatively expensive.

I would rather attach mesh to a suture that I can see, although—in the right hands—needle-guided mesh techniques are probably safe and may result in better mesh application. Certainly you would want substantive experience and a sound knowledge of pelvic anatomy before proceeding.

Needle-guided techniques aside, the skills needed for mesh and graft augmentation of rectocele repair are logical extensions of the ob.gyn's current skill set. It is helpful, though, to revisit the anatomy in a cadaver lab, to talk with physicians who have had experience with grafts and mesh, and even to arrange preceptorships or visit the operating room to see the techniques performed. Then, as with many surgical procedures, success will depend on your skill, comfort level, and clinical judgment.

ELSEVIER GLOBAL MEDICAL NEWS

Mesh or graft placement for rectocele/enterocele repair is shown. Courtesy Dr. Neeraj Kohli/Dr. John R. Miklos

Rectocele Repair Evolves

Unfortunately, as an avid endoscopic surgeon and infertility specialist, I must admit that the most exciting arena in gynecologic surgery at present belongs to the urogynecologist. Until now, there has been little innovation within the subspecialty, even though it was well known that long-term results were compromised by weakened tissue and external factors. However, on the heels of our increased knowledge of the anatomy of the pelvic floor and the pathophysiology of incontinence and prolapse, techniques are being introduced that attempt to increase efficiency and thus decrease recurrence and the necessity of a second surgery.

I have asked Dr. Neeraj Kohli, chief of the urogynecology division at Brigham and Women's Hospital, Boston, to discuss the nuances of the use of mesh or grafts to augment rectocele repairs. A urogynecologist in the department of obstetrics, gynecology, and reproductive biology at Harvard Medical School. Dr. Kohli will make the case for the use of mesh or grafts in selected patients who in the past would have been treated via site-specific defect repair. I am certain that you will find Dr. Kohli's Master Class in gynecologic surgery to be both intriguing and thought provoking.

Tips for Success

The use of mesh or grafts is not without risk, and part of our technique and surgical process should involve a thorough effort to minimize risk. Here are some tips for avoiding complications:

▸ Cut the mesh or graft to an appropriate size and do not lay it in too tightly. Remember that mesh and grafts can contract. Adjust the material loosely and remember that its role is to prevent descent of the prolapse, not to elevate or support the tissue. A little movement of the mesh is preferred and will minimize the risk of erosion and dyspareunia.

▸ Make sure the mesh or graft lies flat, and always consider apical support. Folds in the mesh will increase the risk of erosion. The risk of complications will also increase if too few or too many sutures are used to secure the mesh. The Capio ligature device (Boston Scientific Corp.) is a good tool for placing apical sutures without extensive dissection, but it is just one of a variety of tools you can use.

▸ Ensure good hemostasis. I recommend packing the vagina for 24 hours after a mesh procedure to reduce the risk of hematoma and subsequent abscess or erosion, as well as to help the vaginal epithelium bond to the underlying mesh. We use a standardized vaginal packing with estrogen cream.

▸ Use adequate estrogenation. Both pre- and postoperative vaginal estrogen is recommended. We usually begin vaginal estrogen cream at the 2-week postoperative visit and continue it for at least 3 months.

When you start your dissection, keep it thick. The strength of the repair is dependent on the mesh, not on the patient's own tissue, so it is better to keep a thicker vaginal skin. As a result, you will reduce the risk of erosion.

The concept of using grafts or mesh for rectocele repair—as well as for other hernias of pelvic organ support—makes sense. Their use can restore correct anatomical support by recreating and/or augmenting the fascial layer, enabling us to provide additional stability to traditional repairs of the posterior vaginal wall that too often may incorporate weak tissue.

Our general surgery colleagues have reduced their failure rate for hernia treatment by almost 50% by augmenting their procedures with mesh or grafts.

It was reported almost a decade ago that women have an 11% risk of needing surgery for prolapse or urinary incontinence by age 80 years—and that at least one-third will need a second surgery. Over the last 5 years, new surgical procedures for incontinence have raised our incontinence success rates to nearly 90%. Our success rate for prolapse using traditional techniques, meanwhile, remains in the 50%–70% range.

We're looking for a better mousetrap, and mesh or graft augmentation is likely to be it. Certainly, it is worth considering.

The Shortcomings of Our Traditions

Our underlying concepts of prolapse have changed. We used to think of prolapse strictly as the result of weakness in the vaginal wall and subsequent stretching. Our traditional repair technique was, simply put, to tighten the weakened tissue and narrow the vaginal wall.

The next stage in our thinking was that we were actually dealing with hernias—that is, with discrete breaks (site-specific defects) in the tissue. Our practice then progressed to opening up the vaginal mucosa, finding the defect, and closing it. This was the origin of the anterior paravaginal repair for cystocele and the posterior site-specific repair for rectocele.

There are pros and cons to both traditional ways of thinking. For instance, finding the defect and closing it are theoretically fine, but our assumption here is that the intact tissue is strong. That's not always the case. Sometimes it's hard to find the defect. And sometimes we may even create it.

Often when we're looking for better tissue to use for a central repair, we gravitate toward more lateral tissue and end up bringing too much tissue to the midline, causing dyspareunia. Or we move up in our search for tissue—that is, into the enterocele tissue—and we do our best with tissue that often is of poor quality. This may well result in a recurrence, which we often attribute to “poor protoplasm” or failure of the patient to adhere to our postoperative instructions.

And in either case, with traditional plication techniques or traditional site-specific techniques, we usually are not altering the patient's underlying risk factors for prolapse or for recurrence after surgery. Constipation; obesity; nerve or muscle damage; and occupational risk factors, such as heavy lifting are among the many remaining factors that, without strong tissue and stability, can put our repair in jeopardy.

Our most recent evolution in thinking, therefore, has been to look at our general surgeon colleagues' use of mesh and grafts to more successfully treat hernias, and to think that maybe we can do the same thing.

Choosing Donor or Synthetic Grafts

The use of grafts or mesh alleviates many of the challenges we have faced with our traditional techniques. One real benefit, for instance, is that we can extend mesh up into the enterocele and create strong tissue in a place where we previously would have worked with weak peritoneum.

A variety of graft and mesh products is available to the clinician. (See box.) The question of which materials are better is still much debated among physicians, however. The advantage of donor grafts, of course, is that they are biologic, which should significantly alleviate or even eliminate problems of erosion and rejection. The downside is that the materials are expensive and can contract over time. We also do not yet fully understand the in vivo response to these grafts. In some cases, the body may chew up the graft; in other cases, the graft may be encapsulated through an inflammatory reaction.

The advantage of synthetic meshes is that they are readily available, have more consistent material strength, and are permanent. There also is a great variety of materials to choose from—something that we should certainly view as a benefit and take advantage of. Synthetic meshes come in different weaves, with various degrees of pliability, strength, softness, and thickness. Such variables are important to consider, because the mesh we use in the vagina must be both strong enough to maintain the integrity of our repairs and flexible enough to accommodate sexual function.

The downside of synthetic meshes relates to its permanence. The mesh will be with our patient for the rest of her life, during which time rejection, infection, and especially erosion can occur. Whereas dyspareunia and failure are the major complications of traditional repairs, erosion—or exposure, as it is more frequently called today—is the primary complication associated with the use of mesh.

Our Judgment Call

At this time, we do not have enough data on rectocele repair with grafts or mesh to either uniformly recommend or uniformly reject this new type of repair. We need more evidence-based information to document its long-term efficacy.

However, these augmented procedures are now established in many settings—with observed short-term success—and I believe they should be considered for our more challenging cases.

The key to doing good rectocele repair, I believe, is first being able to identify the anatomy, and second, being able to make the clinical judgment about when and when not to use a mesh or graft. In my practice, for instance, we generally use mesh in patients with recurrences, in patients with very advanced prolapse and poor-quality tissue, and in women with a high risk for recurrence, such as those with chronic constipation, obesity, or jobs that require heavy lifting.

With mesh augmentation, we've taken our success rate to 85%–90% for all vaginal wall repairs, and to 90% for rectocele repair. The erosion rate for rectocele repair probably is about 10%. Most erosions can be managed conservatively, and few require reoperation if identified early. The dyspareunia rate is harder to get a handle on and is something we are still evaluating.

Newer Techniques, Getting Started

Some experienced physicians are now using new needle-guided mesh techniques. These procedures are quick, and some physicians value the fact that the materials come in convenient kits.

In these new techniques, needles are inserted through the transobturator approach and brought out near the ischial spine. The needles are then attached to the arms of the mesh, and the mesh is pulled through. The main disadvantage to this technique lies in the blind passage of needles through fairly long distances and critical areas where the potential for complications could include rectal injury, nerve injury, and bleeding. Another disadvantage is that the kits are relatively expensive.

I would rather attach mesh to a suture that I can see, although—in the right hands—needle-guided mesh techniques are probably safe and may result in better mesh application. Certainly you would want substantive experience and a sound knowledge of pelvic anatomy before proceeding.

Needle-guided techniques aside, the skills needed for mesh and graft augmentation of rectocele repair are logical extensions of the ob.gyn's current skill set. It is helpful, though, to revisit the anatomy in a cadaver lab, to talk with physicians who have had experience with grafts and mesh, and even to arrange preceptorships or visit the operating room to see the techniques performed. Then, as with many surgical procedures, success will depend on your skill, comfort level, and clinical judgment.

ELSEVIER GLOBAL MEDICAL NEWS

Mesh or graft placement for rectocele/enterocele repair is shown. Courtesy Dr. Neeraj Kohli/Dr. John R. Miklos

Rectocele Repair Evolves

Unfortunately, as an avid endoscopic surgeon and infertility specialist, I must admit that the most exciting arena in gynecologic surgery at present belongs to the urogynecologist. Until now, there has been little innovation within the subspecialty, even though it was well known that long-term results were compromised by weakened tissue and external factors. However, on the heels of our increased knowledge of the anatomy of the pelvic floor and the pathophysiology of incontinence and prolapse, techniques are being introduced that attempt to increase efficiency and thus decrease recurrence and the necessity of a second surgery.

I have asked Dr. Neeraj Kohli, chief of the urogynecology division at Brigham and Women's Hospital, Boston, to discuss the nuances of the use of mesh or grafts to augment rectocele repairs. A urogynecologist in the department of obstetrics, gynecology, and reproductive biology at Harvard Medical School. Dr. Kohli will make the case for the use of mesh or grafts in selected patients who in the past would have been treated via site-specific defect repair. I am certain that you will find Dr. Kohli's Master Class in gynecologic surgery to be both intriguing and thought provoking.

Tips for Success

The use of mesh or grafts is not without risk, and part of our technique and surgical process should involve a thorough effort to minimize risk. Here are some tips for avoiding complications:

▸ Cut the mesh or graft to an appropriate size and do not lay it in too tightly. Remember that mesh and grafts can contract. Adjust the material loosely and remember that its role is to prevent descent of the prolapse, not to elevate or support the tissue. A little movement of the mesh is preferred and will minimize the risk of erosion and dyspareunia.

▸ Make sure the mesh or graft lies flat, and always consider apical support. Folds in the mesh will increase the risk of erosion. The risk of complications will also increase if too few or too many sutures are used to secure the mesh. The Capio ligature device (Boston Scientific Corp.) is a good tool for placing apical sutures without extensive dissection, but it is just one of a variety of tools you can use.

▸ Ensure good hemostasis. I recommend packing the vagina for 24 hours after a mesh procedure to reduce the risk of hematoma and subsequent abscess or erosion, as well as to help the vaginal epithelium bond to the underlying mesh. We use a standardized vaginal packing with estrogen cream.

▸ Use adequate estrogenation. Both pre- and postoperative vaginal estrogen is recommended. We usually begin vaginal estrogen cream at the 2-week postoperative visit and continue it for at least 3 months.

When you start your dissection, keep it thick. The strength of the repair is dependent on the mesh, not on the patient's own tissue, so it is better to keep a thicker vaginal skin. As a result, you will reduce the risk of erosion.

The concept of using grafts or mesh for rectocele repair—as well as for other hernias of pelvic organ support—makes sense. Their use can restore correct anatomical support by recreating and/or augmenting the fascial layer, enabling us to provide additional stability to traditional repairs of the posterior vaginal wall that too often may incorporate weak tissue.

Our general surgery colleagues have reduced their failure rate for hernia treatment by almost 50% by augmenting their procedures with mesh or grafts.

It was reported almost a decade ago that women have an 11% risk of needing surgery for prolapse or urinary incontinence by age 80 years—and that at least one-third will need a second surgery. Over the last 5 years, new surgical procedures for incontinence have raised our incontinence success rates to nearly 90%. Our success rate for prolapse using traditional techniques, meanwhile, remains in the 50%–70% range.

We're looking for a better mousetrap, and mesh or graft augmentation is likely to be it. Certainly, it is worth considering.

The Shortcomings of Our Traditions

Our underlying concepts of prolapse have changed. We used to think of prolapse strictly as the result of weakness in the vaginal wall and subsequent stretching. Our traditional repair technique was, simply put, to tighten the weakened tissue and narrow the vaginal wall.

The next stage in our thinking was that we were actually dealing with hernias—that is, with discrete breaks (site-specific defects) in the tissue. Our practice then progressed to opening up the vaginal mucosa, finding the defect, and closing it. This was the origin of the anterior paravaginal repair for cystocele and the posterior site-specific repair for rectocele.

There are pros and cons to both traditional ways of thinking. For instance, finding the defect and closing it are theoretically fine, but our assumption here is that the intact tissue is strong. That's not always the case. Sometimes it's hard to find the defect. And sometimes we may even create it.

Often when we're looking for better tissue to use for a central repair, we gravitate toward more lateral tissue and end up bringing too much tissue to the midline, causing dyspareunia. Or we move up in our search for tissue—that is, into the enterocele tissue—and we do our best with tissue that often is of poor quality. This may well result in a recurrence, which we often attribute to “poor protoplasm” or failure of the patient to adhere to our postoperative instructions.

And in either case, with traditional plication techniques or traditional site-specific techniques, we usually are not altering the patient's underlying risk factors for prolapse or for recurrence after surgery. Constipation; obesity; nerve or muscle damage; and occupational risk factors, such as heavy lifting are among the many remaining factors that, without strong tissue and stability, can put our repair in jeopardy.

Our most recent evolution in thinking, therefore, has been to look at our general surgeon colleagues' use of mesh and grafts to more successfully treat hernias, and to think that maybe we can do the same thing.

Choosing Donor or Synthetic Grafts

The use of grafts or mesh alleviates many of the challenges we have faced with our traditional techniques. One real benefit, for instance, is that we can extend mesh up into the enterocele and create strong tissue in a place where we previously would have worked with weak peritoneum.

A variety of graft and mesh products is available to the clinician. (See box.) The question of which materials are better is still much debated among physicians, however. The advantage of donor grafts, of course, is that they are biologic, which should significantly alleviate or even eliminate problems of erosion and rejection. The downside is that the materials are expensive and can contract over time. We also do not yet fully understand the in vivo response to these grafts. In some cases, the body may chew up the graft; in other cases, the graft may be encapsulated through an inflammatory reaction.

The advantage of synthetic meshes is that they are readily available, have more consistent material strength, and are permanent. There also is a great variety of materials to choose from—something that we should certainly view as a benefit and take advantage of. Synthetic meshes come in different weaves, with various degrees of pliability, strength, softness, and thickness. Such variables are important to consider, because the mesh we use in the vagina must be both strong enough to maintain the integrity of our repairs and flexible enough to accommodate sexual function.

The downside of synthetic meshes relates to its permanence. The mesh will be with our patient for the rest of her life, during which time rejection, infection, and especially erosion can occur. Whereas dyspareunia and failure are the major complications of traditional repairs, erosion—or exposure, as it is more frequently called today—is the primary complication associated with the use of mesh.

Our Judgment Call

At this time, we do not have enough data on rectocele repair with grafts or mesh to either uniformly recommend or uniformly reject this new type of repair. We need more evidence-based information to document its long-term efficacy.

However, these augmented procedures are now established in many settings—with observed short-term success—and I believe they should be considered for our more challenging cases.

The key to doing good rectocele repair, I believe, is first being able to identify the anatomy, and second, being able to make the clinical judgment about when and when not to use a mesh or graft. In my practice, for instance, we generally use mesh in patients with recurrences, in patients with very advanced prolapse and poor-quality tissue, and in women with a high risk for recurrence, such as those with chronic constipation, obesity, or jobs that require heavy lifting.

With mesh augmentation, we've taken our success rate to 85%–90% for all vaginal wall repairs, and to 90% for rectocele repair. The erosion rate for rectocele repair probably is about 10%. Most erosions can be managed conservatively, and few require reoperation if identified early. The dyspareunia rate is harder to get a handle on and is something we are still evaluating.

Newer Techniques, Getting Started

Some experienced physicians are now using new needle-guided mesh techniques. These procedures are quick, and some physicians value the fact that the materials come in convenient kits.

In these new techniques, needles are inserted through the transobturator approach and brought out near the ischial spine. The needles are then attached to the arms of the mesh, and the mesh is pulled through. The main disadvantage to this technique lies in the blind passage of needles through fairly long distances and critical areas where the potential for complications could include rectal injury, nerve injury, and bleeding. Another disadvantage is that the kits are relatively expensive.

I would rather attach mesh to a suture that I can see, although—in the right hands—needle-guided mesh techniques are probably safe and may result in better mesh application. Certainly you would want substantive experience and a sound knowledge of pelvic anatomy before proceeding.

Needle-guided techniques aside, the skills needed for mesh and graft augmentation of rectocele repair are logical extensions of the ob.gyn's current skill set. It is helpful, though, to revisit the anatomy in a cadaver lab, to talk with physicians who have had experience with grafts and mesh, and even to arrange preceptorships or visit the operating room to see the techniques performed. Then, as with many surgical procedures, success will depend on your skill, comfort level, and clinical judgment.

ELSEVIER GLOBAL MEDICAL NEWS

Mesh or graft placement for rectocele/enterocele repair is shown. Courtesy Dr. Neeraj Kohli/Dr. John R. Miklos

Rectocele Repair Evolves

Unfortunately, as an avid endoscopic surgeon and infertility specialist, I must admit that the most exciting arena in gynecologic surgery at present belongs to the urogynecologist. Until now, there has been little innovation within the subspecialty, even though it was well known that long-term results were compromised by weakened tissue and external factors. However, on the heels of our increased knowledge of the anatomy of the pelvic floor and the pathophysiology of incontinence and prolapse, techniques are being introduced that attempt to increase efficiency and thus decrease recurrence and the necessity of a second surgery.

I have asked Dr. Neeraj Kohli, chief of the urogynecology division at Brigham and Women's Hospital, Boston, to discuss the nuances of the use of mesh or grafts to augment rectocele repairs. A urogynecologist in the department of obstetrics, gynecology, and reproductive biology at Harvard Medical School. Dr. Kohli will make the case for the use of mesh or grafts in selected patients who in the past would have been treated via site-specific defect repair. I am certain that you will find Dr. Kohli's Master Class in gynecologic surgery to be both intriguing and thought provoking.

Tips for Success

The use of mesh or grafts is not without risk, and part of our technique and surgical process should involve a thorough effort to minimize risk. Here are some tips for avoiding complications:

▸ Cut the mesh or graft to an appropriate size and do not lay it in too tightly. Remember that mesh and grafts can contract. Adjust the material loosely and remember that its role is to prevent descent of the prolapse, not to elevate or support the tissue. A little movement of the mesh is preferred and will minimize the risk of erosion and dyspareunia.

▸ Make sure the mesh or graft lies flat, and always consider apical support. Folds in the mesh will increase the risk of erosion. The risk of complications will also increase if too few or too many sutures are used to secure the mesh. The Capio ligature device (Boston Scientific Corp.) is a good tool for placing apical sutures without extensive dissection, but it is just one of a variety of tools you can use.

▸ Ensure good hemostasis. I recommend packing the vagina for 24 hours after a mesh procedure to reduce the risk of hematoma and subsequent abscess or erosion, as well as to help the vaginal epithelium bond to the underlying mesh. We use a standardized vaginal packing with estrogen cream.

▸ Use adequate estrogenation. Both pre- and postoperative vaginal estrogen is recommended. We usually begin vaginal estrogen cream at the 2-week postoperative visit and continue it for at least 3 months.

When you start your dissection, keep it thick. The strength of the repair is dependent on the mesh, not on the patient's own tissue, so it is better to keep a thicker vaginal skin. As a result, you will reduce the risk of erosion.

Contrary to what many still believe, hysteroscopic myomectomy can be one of the safest, mostly easily learned surgical procedures in gynecology. It is certainly underutilized and continues to be offered and performed by relatively few gynecologists.

With proper training and attention to the preoperative evaluation, surgical technique, and strict fluid management, we can offer patients a treatment for submucous fibroids that is superior in most cases both to other surgical options—such as hysterectomy, open myomectomy, and uterine artery embolization—and to nonsurgical treatments.

The resection of submucosal myomas transcervically is a less invasive approach than are other surgical procedures. We can achieve excellent outcomes in terms of both fertility and the resolution of abnormal uterine bleeding and other symptoms. And we can do so with rates of complications, recurrence, and repeat resection that are much lower than commonly expected.

The Preoperative Evaluation

A comprehensive preoperative evaluation is critical. We want the best possible assessment of the size and location of the fibroid or fibroids, as well as the depth and even the vascularity of each fibroid.

We want to know how deeply each fibroid penetrates into the myometrium and whether it is resectable with the hysteroscope. With such an assessment, we can make a sound decision about whether the fibroid can be treated hysteroscopically and whether we, individually, have the expertise to do it. In general, the risk of fluid absorption, bleeding, and uterine perforation increases as the percentage of fibroid extending into the myometrium increases.

Diagnostic hysteroscopy, sonohysterography, transvaginal ultrasonography, and—in some cases—MRI may be used for this evaluation.

Just Before Surgery

The creation of false passages at the time of cervical dilation, cervical tears, and uterine perforation all are common to hysteroscopy performed with a stenotic, or unripe, cervix. It is therefore important that we consider administering a cervical-ripening agent as a prelude to surgery.

Some institutions and physicians will administer a cervical-ripening agent to women deemed to be at high risk of having cervical stenosis, such as patients who are nulliparous or who have had a cone biopsy. In other institutions, every patient undergoes a preoperative cervical-softening procedure.

One protocol worth serious consideration is the routine oral administration of 200 mcg of misoprostol (Cytotec) 8–12 hours before surgery for all patients, with high-risk patients receiving an additional dose 2 days before surgery. The protocol will result in a cervix that is softer, significantly less likely to tear, and certainly more easily dilated. This can be achieved with few and infrequent side effects, sometimes including some cramping, fever, or vaginal bleeding. Some, but not all, pharmacies will dispense the drug in single or double tablets; it is worth knowing where to refer patients.

Hysteroscopes and Fluid Management

Gynecologic surgeons today have a choice of three different types of instruments for resecting myomas hysteroscopically, and their relative popularity probably varies by region. The longest-standing option is a monopolar hysteroscope, which uses monopolar radiofrequency current in a wire loop. The bipolar scope, which employs bipolar energy in a wire loop, was introduced about 10 years ago.

The Smith & Nephew rotating resectoscope is the newest addition, having been available for almost a year. It differs from classic resectoscopes in two ways: The system converts electrical energy into mechanical energy to remove the fibroid, and it immediately evacuates the fibroid segments.

The uterine-distention medium used will vary by modality. Operative hysteroscopy that is performed in a monopolar environment, for instance, requires a hypotonic electrolyte-free solution, such as 1.5% glycine, 3% sorbitol, and 5% mannitol. Bipolar operative hysteroscopy can be performed using an isotonic, electrolyte-containing solution like saline or Ringer's lactate solution. The rotating resectoscope requires normal saline.

In any case, regardless of the chosen modality, fluid management is critical for intraoperative safety. It demands meticulous attention and vigilance. The exact inflow and outflow of any fluid must be monitored to prevent the complications that can result from excess fluid absorption and subsequent hyponatremia (with an electrolyte-free solution) or fluid overload.

A good fluid management system, which is essential to all operative hysteroscopy, will rapidly and continuously measure fluid input and output, and will provide a real-time assessment of the fluid deficit. Each hospital should have a protocol for fluid management that specifies, among other things, a fluid deficit at which surgery using each modality should be stopped.

We should be operating, in other words, with a set maximum allowable limit of fluid absorption. If we discontinue surgery when the fluid volume reaches this predetermined level, we can avoid major fluid-related complications.

As a general rule of thumb, monopolar systems using nonelectrolyte solutions must be stopped earlier to avoid hyponatremia.

There are variations in practice, particularly among gynecologists with significant hysteroscopy experience, but experts typically recommend a threshold of no more than 1,000 cc for monopolar systems, and a threshold of no more than 2,000 cc when electrolyte solutions are used with a bipolar system.

Particularly with larger fibroids, which require more time and more fluid, consider injecting dilute vasopressin into the cervical stroma at the start of the surgery. Several studies have shown that vasopressin reduces intravasation of the fluid, makes the cervix easier to dilate, and decreases intraoperative bleeding.

Surgical Technique

Some surgeons prefer to insert the hysteroscope into the cervix blindly, whereas many prefer to advance it under direct visualization. Some prefer mono- or bipolar scopes with a 12-degree angle, whereas others like to work with 25- or 30-degree hysteroscopes. The Smith & Nephew system uses a 0-degree scope.

There are, however, some givens. With any system, a fibroid should never be removed at its base because a free-floating fibroid is difficult to retrieve. Each fibroid should be shaved down in strips, the number of which depends largely on the size of the loop (if the monopolar or bipolar hysteroscope is being used) and the percentage of fibroid that is in the cavity.

When using the monopolar and bipolar hysteroscopes, place the loop in contact with the fibroid and then apply a minimal amount of tension going back toward the cervix before activating the electrode. Do not activate the electrode until you have the loop coming back toward the cervix.

This process must be deliberate and precise, because once the loop is activated, there is little tactile sensation. Then shave the fibroid down in strips until the myometrium is reached. With the morcellator, the rotary blade must run in contact with the fibroid.

At that point, intentionally let the endocavity deflate and the myometrium decompress. Quite often, you will find that the intramural portion of the fibroid now protrudes into the cavity, having been pushed outward as a result of the myometrial decompression and the decrease in endocavity pressure. It can then be shaved down more.

If you can see the pseudocapsule between the muscle and fibroid, you can also then use your wire loop to “massage out” any remaining portion of the fibroid. Often, if the maximum fluid absorption has not been reached, you will be able to massage it out, shave it down, massage it out more, and so forth, to the extent that you can actually resect the deep intramural portion of the myoma. If you cannot see the pseudocapsule, it is time to stop the surgery.

Some surgeons may opt at this point to proceed laparoscopically to retrieve the remaining intramural portion of the fibroid, particularly if they estimate that more than 10%–15% of the fibroid remains, and if they are operating on patients with infertility concerns or patients who are planning to undergo in-vitro fertilization. Or they may chose to come back later for a repeat procedure.

Other surgeons prefer a less aggressive approach—in which the patient's symptoms are monitored, and she returns to the office in 2–3 weeks for a flexible diagnostic hysteroscopy—particularly when dealing with patients whose symptoms do not include infertility. More often than not, any remaining portion of the fibroid will appear white and avascular and will not cause any further trouble for the patient.

The bottom line, regardless, is that hysteroscopic surgery is successful if the presenting problem is safely eradicated. Your level of aggressiveness will be determined largely by your patient's symptoms and individual situation. With a careful preoperative evaluation of the fibroids and the use of sound judgment early on about the appropriateness of the procedure and your own skills, repeat procedures will and should be unusual.

The Nuances of Intrauterine Pressure

Remember that as uterine distention pressure rises higher than the mean arterial or venous pressure, fluid absorption also rises. There is an advantage, therefore, to maintaining the lowest intrauterine pressure possible; also, more of the fibroid will protrude into the cavity. On the other hand, the greater visibility gained with greater distention makes it advantageous to work under higher pressures.

Some surgeons work at 100 mm of pressure consistently and believe they can work quickly because they can see well; others start surgery at 50–60 mm of pressure and gradually increase the pressure to achieve greater distention and visibility as needed.

Each surgeon develops his or her own technique, with the underlying goal being to maintain a balance between a pressure that gives adequate flow, distention, and visualization, and a pressure that minimizes fluid absorption. With an understanding of the underlying principles and the importance of fluid management, you will find an approach that keeps you from getting frustrated and leads to good outcomes.

Use of the Morcellation System

The new fibroid morcellation system offers some advantages—particularly when the surgeon is new to hysteroscopic procedures—because it continuously suctions away fibroid strips and eliminates the need to remove debris and redistend the cavity.

Its disadvantage, however, is that it does not allow the same breadth of surgery as can be performed with a wire loop. Generally, the new system is to be used to resect fibroids that are completely or mainly in the uterine cavity. Type II myomas, as well as large fibroids, are very difficult to deal with using this technique.

Starting Out

With any of the available devices and systems, hysteroscopic myomectomy is not nearly as technically challenging as other procedures gynecologists do. In our experience, it is not difficult to teach residents. To start, beginners should work with other physicians and remove smaller fibroids until they gain confidence. They could even start with polyps, which are easier to remove.

Those new to this procedure will soon appreciate the fact that the fears of complications are unfounded. The overall complication rate is less than 3%–-no higher, and probably lower, than the rate for other procedures like endometrial ablation—and rates of infections, hematomas, and other injuries are significantly lower than those for other procedures.

Uterine artery embolization has been gaining popularity for treatment of symptomatic uterine fibroids, and it is a procedure that patients will probably want to discuss. In many institutions, however, the procedure is not even an option for submucous fibroids, because the fibroids can separate, subsequently blocking the cervix, going through necrosis, and eventually causing sepsis and other complications. In fact, at least two deaths have been reported.

In general, patients' symptoms tend to continue after uterine artery embolization, and patients often ultimately require hysteroscopic resection.

Hysteroscopy, on the other hand, has it all for most patients: low invasiveness, high efficacy, extremely low recurrence, and excellent patient safety.

A 2-cm intracavitary fibroid is shown before surgery.

Versapoint 4-mm wire loop approaches the fibroid.

The 4-mm wire loop is placed behind the fibroid.

The postoperative resection bed is shown here. Photos courtesy Dr. Linda Bradley

Submucous Uterine Fibroids

Uterine fibroids are the most common benign tumor of the female genital tract. Almost 40% of the 600,000 hysterectomies performed each year in the United States are performed for symptomatic fibroids. Given the fact that many fibroids occur in women who want to maintain fertility, have serious health concerns, or desire the most minimally invasive option, hysterectomy often cannot be considered. When the fibroid is submucous in location, a hysteroscopic approach to myomectomy is the procedure of choice. Despite this, few gynecologists maintain this technique in their surgical armamentarium.

It is my desire that this article will spur many readers to safely proceed with hysteroscopic myomectomy. In order to accomplish this, I have asked Dr. Linda Bradley, director of hysteroscopic services at the Cleveland Clinic, and Dr. Keith Isaacson, medical director of the center for minimally invasive gynecologic surgery at Newton-Wellesley Hospital in Newton, Mass., to join me in a discussion on the advantages of the hysteroscopic approach to myomectomy.

Both Dr. Bradley and Dr. Isaacson are noted internationally for their expertise in hysteroscopic surgery. Not only are they gifted hysteroscopic surgeons, but they have written, lectured, and been principal researchers in this area as well.

On that note, let us proceed.

Contrary to what many still believe, hysteroscopic myomectomy can be one of the safest, mostly easily learned surgical procedures in gynecology. It is certainly underutilized and continues to be offered and performed by relatively few gynecologists.

With proper training and attention to the preoperative evaluation, surgical technique, and strict fluid management, we can offer patients a treatment for submucous fibroids that is superior in most cases both to other surgical options—such as hysterectomy, open myomectomy, and uterine artery embolization—and to nonsurgical treatments.

The resection of submucosal myomas transcervically is a less invasive approach than are other surgical procedures. We can achieve excellent outcomes in terms of both fertility and the resolution of abnormal uterine bleeding and other symptoms. And we can do so with rates of complications, recurrence, and repeat resection that are much lower than commonly expected.

The Preoperative Evaluation

A comprehensive preoperative evaluation is critical. We want the best possible assessment of the size and location of the fibroid or fibroids, as well as the depth and even the vascularity of each fibroid.

We want to know how deeply each fibroid penetrates into the myometrium and whether it is resectable with the hysteroscope. With such an assessment, we can make a sound decision about whether the fibroid can be treated hysteroscopically and whether we, individually, have the expertise to do it. In general, the risk of fluid absorption, bleeding, and uterine perforation increases as the percentage of fibroid extending into the myometrium increases.

Diagnostic hysteroscopy, sonohysterography, transvaginal ultrasonography, and—in some cases—MRI may be used for this evaluation.

Just Before Surgery

The creation of false passages at the time of cervical dilation, cervical tears, and uterine perforation all are common to hysteroscopy performed with a stenotic, or unripe, cervix. It is therefore important that we consider administering a cervical-ripening agent as a prelude to surgery.

Some institutions and physicians will administer a cervical-ripening agent to women deemed to be at high risk of having cervical stenosis, such as patients who are nulliparous or who have had a cone biopsy. In other institutions, every patient undergoes a preoperative cervical-softening procedure.

One protocol worth serious consideration is the routine oral administration of 200 mcg of misoprostol (Cytotec) 8–12 hours before surgery for all patients, with high-risk patients receiving an additional dose 2 days before surgery. The protocol will result in a cervix that is softer, significantly less likely to tear, and certainly more easily dilated. This can be achieved with few and infrequent side effects, sometimes including some cramping, fever, or vaginal bleeding. Some, but not all, pharmacies will dispense the drug in single or double tablets; it is worth knowing where to refer patients.

Hysteroscopes and Fluid Management

Gynecologic surgeons today have a choice of three different types of instruments for resecting myomas hysteroscopically, and their relative popularity probably varies by region. The longest-standing option is a monopolar hysteroscope, which uses monopolar radiofrequency current in a wire loop. The bipolar scope, which employs bipolar energy in a wire loop, was introduced about 10 years ago.

The Smith & Nephew rotating resectoscope is the newest addition, having been available for almost a year. It differs from classic resectoscopes in two ways: The system converts electrical energy into mechanical energy to remove the fibroid, and it immediately evacuates the fibroid segments.

The uterine-distention medium used will vary by modality. Operative hysteroscopy that is performed in a monopolar environment, for instance, requires a hypotonic electrolyte-free solution, such as 1.5% glycine, 3% sorbitol, and 5% mannitol. Bipolar operative hysteroscopy can be performed using an isotonic, electrolyte-containing solution like saline or Ringer's lactate solution. The rotating resectoscope requires normal saline.

In any case, regardless of the chosen modality, fluid management is critical for intraoperative safety. It demands meticulous attention and vigilance. The exact inflow and outflow of any fluid must be monitored to prevent the complications that can result from excess fluid absorption and subsequent hyponatremia (with an electrolyte-free solution) or fluid overload.

A good fluid management system, which is essential to all operative hysteroscopy, will rapidly and continuously measure fluid input and output, and will provide a real-time assessment of the fluid deficit. Each hospital should have a protocol for fluid management that specifies, among other things, a fluid deficit at which surgery using each modality should be stopped.

We should be operating, in other words, with a set maximum allowable limit of fluid absorption. If we discontinue surgery when the fluid volume reaches this predetermined level, we can avoid major fluid-related complications.

As a general rule of thumb, monopolar systems using nonelectrolyte solutions must be stopped earlier to avoid hyponatremia.

There are variations in practice, particularly among gynecologists with significant hysteroscopy experience, but experts typically recommend a threshold of no more than 1,000 cc for monopolar systems, and a threshold of no more than 2,000 cc when electrolyte solutions are used with a bipolar system.

Particularly with larger fibroids, which require more time and more fluid, consider injecting dilute vasopressin into the cervical stroma at the start of the surgery. Several studies have shown that vasopressin reduces intravasation of the fluid, makes the cervix easier to dilate, and decreases intraoperative bleeding.

Surgical Technique

Some surgeons prefer to insert the hysteroscope into the cervix blindly, whereas many prefer to advance it under direct visualization. Some prefer mono- or bipolar scopes with a 12-degree angle, whereas others like to work with 25- or 30-degree hysteroscopes. The Smith & Nephew system uses a 0-degree scope.

There are, however, some givens. With any system, a fibroid should never be removed at its base because a free-floating fibroid is difficult to retrieve. Each fibroid should be shaved down in strips, the number of which depends largely on the size of the loop (if the monopolar or bipolar hysteroscope is being used) and the percentage of fibroid that is in the cavity.

When using the monopolar and bipolar hysteroscopes, place the loop in contact with the fibroid and then apply a minimal amount of tension going back toward the cervix before activating the electrode. Do not activate the electrode until you have the loop coming back toward the cervix.

This process must be deliberate and precise, because once the loop is activated, there is little tactile sensation. Then shave the fibroid down in strips until the myometrium is reached. With the morcellator, the rotary blade must run in contact with the fibroid.

At that point, intentionally let the endocavity deflate and the myometrium decompress. Quite often, you will find that the intramural portion of the fibroid now protrudes into the cavity, having been pushed outward as a result of the myometrial decompression and the decrease in endocavity pressure. It can then be shaved down more.

If you can see the pseudocapsule between the muscle and fibroid, you can also then use your wire loop to “massage out” any remaining portion of the fibroid. Often, if the maximum fluid absorption has not been reached, you will be able to massage it out, shave it down, massage it out more, and so forth, to the extent that you can actually resect the deep intramural portion of the myoma. If you cannot see the pseudocapsule, it is time to stop the surgery.

Some surgeons may opt at this point to proceed laparoscopically to retrieve the remaining intramural portion of the fibroid, particularly if they estimate that more than 10%–15% of the fibroid remains, and if they are operating on patients with infertility concerns or patients who are planning to undergo in-vitro fertilization. Or they may chose to come back later for a repeat procedure.

Other surgeons prefer a less aggressive approach—in which the patient's symptoms are monitored, and she returns to the office in 2–3 weeks for a flexible diagnostic hysteroscopy—particularly when dealing with patients whose symptoms do not include infertility. More often than not, any remaining portion of the fibroid will appear white and avascular and will not cause any further trouble for the patient.

The bottom line, regardless, is that hysteroscopic surgery is successful if the presenting problem is safely eradicated. Your level of aggressiveness will be determined largely by your patient's symptoms and individual situation. With a careful preoperative evaluation of the fibroids and the use of sound judgment early on about the appropriateness of the procedure and your own skills, repeat procedures will and should be unusual.

The Nuances of Intrauterine Pressure

Remember that as uterine distention pressure rises higher than the mean arterial or venous pressure, fluid absorption also rises. There is an advantage, therefore, to maintaining the lowest intrauterine pressure possible; also, more of the fibroid will protrude into the cavity. On the other hand, the greater visibility gained with greater distention makes it advantageous to work under higher pressures.

Some surgeons work at 100 mm of pressure consistently and believe they can work quickly because they can see well; others start surgery at 50–60 mm of pressure and gradually increase the pressure to achieve greater distention and visibility as needed.

Each surgeon develops his or her own technique, with the underlying goal being to maintain a balance between a pressure that gives adequate flow, distention, and visualization, and a pressure that minimizes fluid absorption. With an understanding of the underlying principles and the importance of fluid management, you will find an approach that keeps you from getting frustrated and leads to good outcomes.

Use of the Morcellation System

The new fibroid morcellation system offers some advantages—particularly when the surgeon is new to hysteroscopic procedures—because it continuously suctions away fibroid strips and eliminates the need to remove debris and redistend the cavity.

Its disadvantage, however, is that it does not allow the same breadth of surgery as can be performed with a wire loop. Generally, the new system is to be used to resect fibroids that are completely or mainly in the uterine cavity. Type II myomas, as well as large fibroids, are very difficult to deal with using this technique.

Starting Out

With any of the available devices and systems, hysteroscopic myomectomy is not nearly as technically challenging as other procedures gynecologists do. In our experience, it is not difficult to teach residents. To start, beginners should work with other physicians and remove smaller fibroids until they gain confidence. They could even start with polyps, which are easier to remove.

Those new to this procedure will soon appreciate the fact that the fears of complications are unfounded. The overall complication rate is less than 3%–-no higher, and probably lower, than the rate for other procedures like endometrial ablation—and rates of infections, hematomas, and other injuries are significantly lower than those for other procedures.

Uterine artery embolization has been gaining popularity for treatment of symptomatic uterine fibroids, and it is a procedure that patients will probably want to discuss. In many institutions, however, the procedure is not even an option for submucous fibroids, because the fibroids can separate, subsequently blocking the cervix, going through necrosis, and eventually causing sepsis and other complications. In fact, at least two deaths have been reported.

In general, patients' symptoms tend to continue after uterine artery embolization, and patients often ultimately require hysteroscopic resection.

Hysteroscopy, on the other hand, has it all for most patients: low invasiveness, high efficacy, extremely low recurrence, and excellent patient safety.

A 2-cm intracavitary fibroid is shown before surgery.

Versapoint 4-mm wire loop approaches the fibroid.

The 4-mm wire loop is placed behind the fibroid.

The postoperative resection bed is shown here. Photos courtesy Dr. Linda Bradley

Submucous Uterine Fibroids

Uterine fibroids are the most common benign tumor of the female genital tract. Almost 40% of the 600,000 hysterectomies performed each year in the United States are performed for symptomatic fibroids. Given the fact that many fibroids occur in women who want to maintain fertility, have serious health concerns, or desire the most minimally invasive option, hysterectomy often cannot be considered. When the fibroid is submucous in location, a hysteroscopic approach to myomectomy is the procedure of choice. Despite this, few gynecologists maintain this technique in their surgical armamentarium.

It is my desire that this article will spur many readers to safely proceed with hysteroscopic myomectomy. In order to accomplish this, I have asked Dr. Linda Bradley, director of hysteroscopic services at the Cleveland Clinic, and Dr. Keith Isaacson, medical director of the center for minimally invasive gynecologic surgery at Newton-Wellesley Hospital in Newton, Mass., to join me in a discussion on the advantages of the hysteroscopic approach to myomectomy.

Both Dr. Bradley and Dr. Isaacson are noted internationally for their expertise in hysteroscopic surgery. Not only are they gifted hysteroscopic surgeons, but they have written, lectured, and been principal researchers in this area as well.

On that note, let us proceed.

Contrary to what many still believe, hysteroscopic myomectomy can be one of the safest, mostly easily learned surgical procedures in gynecology. It is certainly underutilized and continues to be offered and performed by relatively few gynecologists.

With proper training and attention to the preoperative evaluation, surgical technique, and strict fluid management, we can offer patients a treatment for submucous fibroids that is superior in most cases both to other surgical options—such as hysterectomy, open myomectomy, and uterine artery embolization—and to nonsurgical treatments.

The resection of submucosal myomas transcervically is a less invasive approach than are other surgical procedures. We can achieve excellent outcomes in terms of both fertility and the resolution of abnormal uterine bleeding and other symptoms. And we can do so with rates of complications, recurrence, and repeat resection that are much lower than commonly expected.

The Preoperative Evaluation

A comprehensive preoperative evaluation is critical. We want the best possible assessment of the size and location of the fibroid or fibroids, as well as the depth and even the vascularity of each fibroid.

We want to know how deeply each fibroid penetrates into the myometrium and whether it is resectable with the hysteroscope. With such an assessment, we can make a sound decision about whether the fibroid can be treated hysteroscopically and whether we, individually, have the expertise to do it. In general, the risk of fluid absorption, bleeding, and uterine perforation increases as the percentage of fibroid extending into the myometrium increases.

Diagnostic hysteroscopy, sonohysterography, transvaginal ultrasonography, and—in some cases—MRI may be used for this evaluation.

Just Before Surgery

The creation of false passages at the time of cervical dilation, cervical tears, and uterine perforation all are common to hysteroscopy performed with a stenotic, or unripe, cervix. It is therefore important that we consider administering a cervical-ripening agent as a prelude to surgery.

Some institutions and physicians will administer a cervical-ripening agent to women deemed to be at high risk of having cervical stenosis, such as patients who are nulliparous or who have had a cone biopsy. In other institutions, every patient undergoes a preoperative cervical-softening procedure.

One protocol worth serious consideration is the routine oral administration of 200 mcg of misoprostol (Cytotec) 8–12 hours before surgery for all patients, with high-risk patients receiving an additional dose 2 days before surgery. The protocol will result in a cervix that is softer, significantly less likely to tear, and certainly more easily dilated. This can be achieved with few and infrequent side effects, sometimes including some cramping, fever, or vaginal bleeding. Some, but not all, pharmacies will dispense the drug in single or double tablets; it is worth knowing where to refer patients.

Hysteroscopes and Fluid Management

Gynecologic surgeons today have a choice of three different types of instruments for resecting myomas hysteroscopically, and their relative popularity probably varies by region. The longest-standing option is a monopolar hysteroscope, which uses monopolar radiofrequency current in a wire loop. The bipolar scope, which employs bipolar energy in a wire loop, was introduced about 10 years ago.

The Smith & Nephew rotating resectoscope is the newest addition, having been available for almost a year. It differs from classic resectoscopes in two ways: The system converts electrical energy into mechanical energy to remove the fibroid, and it immediately evacuates the fibroid segments.

The uterine-distention medium used will vary by modality. Operative hysteroscopy that is performed in a monopolar environment, for instance, requires a hypotonic electrolyte-free solution, such as 1.5% glycine, 3% sorbitol, and 5% mannitol. Bipolar operative hysteroscopy can be performed using an isotonic, electrolyte-containing solution like saline or Ringer's lactate solution. The rotating resectoscope requires normal saline.

In any case, regardless of the chosen modality, fluid management is critical for intraoperative safety. It demands meticulous attention and vigilance. The exact inflow and outflow of any fluid must be monitored to prevent the complications that can result from excess fluid absorption and subsequent hyponatremia (with an electrolyte-free solution) or fluid overload.

A good fluid management system, which is essential to all operative hysteroscopy, will rapidly and continuously measure fluid input and output, and will provide a real-time assessment of the fluid deficit. Each hospital should have a protocol for fluid management that specifies, among other things, a fluid deficit at which surgery using each modality should be stopped.

We should be operating, in other words, with a set maximum allowable limit of fluid absorption. If we discontinue surgery when the fluid volume reaches this predetermined level, we can avoid major fluid-related complications.

As a general rule of thumb, monopolar systems using nonelectrolyte solutions must be stopped earlier to avoid hyponatremia.

There are variations in practice, particularly among gynecologists with significant hysteroscopy experience, but experts typically recommend a threshold of no more than 1,000 cc for monopolar systems, and a threshold of no more than 2,000 cc when electrolyte solutions are used with a bipolar system.

Particularly with larger fibroids, which require more time and more fluid, consider injecting dilute vasopressin into the cervical stroma at the start of the surgery. Several studies have shown that vasopressin reduces intravasation of the fluid, makes the cervix easier to dilate, and decreases intraoperative bleeding.

Surgical Technique

Some surgeons prefer to insert the hysteroscope into the cervix blindly, whereas many prefer to advance it under direct visualization. Some prefer mono- or bipolar scopes with a 12-degree angle, whereas others like to work with 25- or 30-degree hysteroscopes. The Smith & Nephew system uses a 0-degree scope.

There are, however, some givens. With any system, a fibroid should never be removed at its base because a free-floating fibroid is difficult to retrieve. Each fibroid should be shaved down in strips, the number of which depends largely on the size of the loop (if the monopolar or bipolar hysteroscope is being used) and the percentage of fibroid that is in the cavity.

When using the monopolar and bipolar hysteroscopes, place the loop in contact with the fibroid and then apply a minimal amount of tension going back toward the cervix before activating the electrode. Do not activate the electrode until you have the loop coming back toward the cervix.

This process must be deliberate and precise, because once the loop is activated, there is little tactile sensation. Then shave the fibroid down in strips until the myometrium is reached. With the morcellator, the rotary blade must run in contact with the fibroid.

At that point, intentionally let the endocavity deflate and the myometrium decompress. Quite often, you will find that the intramural portion of the fibroid now protrudes into the cavity, having been pushed outward as a result of the myometrial decompression and the decrease in endocavity pressure. It can then be shaved down more.

If you can see the pseudocapsule between the muscle and fibroid, you can also then use your wire loop to “massage out” any remaining portion of the fibroid. Often, if the maximum fluid absorption has not been reached, you will be able to massage it out, shave it down, massage it out more, and so forth, to the extent that you can actually resect the deep intramural portion of the myoma. If you cannot see the pseudocapsule, it is time to stop the surgery.

Some surgeons may opt at this point to proceed laparoscopically to retrieve the remaining intramural portion of the fibroid, particularly if they estimate that more than 10%–15% of the fibroid remains, and if they are operating on patients with infertility concerns or patients who are planning to undergo in-vitro fertilization. Or they may chose to come back later for a repeat procedure.

Other surgeons prefer a less aggressive approach—in which the patient's symptoms are monitored, and she returns to the office in 2–3 weeks for a flexible diagnostic hysteroscopy—particularly when dealing with patients whose symptoms do not include infertility. More often than not, any remaining portion of the fibroid will appear white and avascular and will not cause any further trouble for the patient.

The bottom line, regardless, is that hysteroscopic surgery is successful if the presenting problem is safely eradicated. Your level of aggressiveness will be determined largely by your patient's symptoms and individual situation. With a careful preoperative evaluation of the fibroids and the use of sound judgment early on about the appropriateness of the procedure and your own skills, repeat procedures will and should be unusual.

The Nuances of Intrauterine Pressure

Remember that as uterine distention pressure rises higher than the mean arterial or venous pressure, fluid absorption also rises. There is an advantage, therefore, to maintaining the lowest intrauterine pressure possible; also, more of the fibroid will protrude into the cavity. On the other hand, the greater visibility gained with greater distention makes it advantageous to work under higher pressures.

Some surgeons work at 100 mm of pressure consistently and believe they can work quickly because they can see well; others start surgery at 50–60 mm of pressure and gradually increase the pressure to achieve greater distention and visibility as needed.

Each surgeon develops his or her own technique, with the underlying goal being to maintain a balance between a pressure that gives adequate flow, distention, and visualization, and a pressure that minimizes fluid absorption. With an understanding of the underlying principles and the importance of fluid management, you will find an approach that keeps you from getting frustrated and leads to good outcomes.

Use of the Morcellation System

The new fibroid morcellation system offers some advantages—particularly when the surgeon is new to hysteroscopic procedures—because it continuously suctions away fibroid strips and eliminates the need to remove debris and redistend the cavity.

Its disadvantage, however, is that it does not allow the same breadth of surgery as can be performed with a wire loop. Generally, the new system is to be used to resect fibroids that are completely or mainly in the uterine cavity. Type II myomas, as well as large fibroids, are very difficult to deal with using this technique.

Starting Out

With any of the available devices and systems, hysteroscopic myomectomy is not nearly as technically challenging as other procedures gynecologists do. In our experience, it is not difficult to teach residents. To start, beginners should work with other physicians and remove smaller fibroids until they gain confidence. They could even start with polyps, which are easier to remove.

Those new to this procedure will soon appreciate the fact that the fears of complications are unfounded. The overall complication rate is less than 3%–-no higher, and probably lower, than the rate for other procedures like endometrial ablation—and rates of infections, hematomas, and other injuries are significantly lower than those for other procedures.

Uterine artery embolization has been gaining popularity for treatment of symptomatic uterine fibroids, and it is a procedure that patients will probably want to discuss. In many institutions, however, the procedure is not even an option for submucous fibroids, because the fibroids can separate, subsequently blocking the cervix, going through necrosis, and eventually causing sepsis and other complications. In fact, at least two deaths have been reported.

In general, patients' symptoms tend to continue after uterine artery embolization, and patients often ultimately require hysteroscopic resection.

Hysteroscopy, on the other hand, has it all for most patients: low invasiveness, high efficacy, extremely low recurrence, and excellent patient safety.

A 2-cm intracavitary fibroid is shown before surgery.

Versapoint 4-mm wire loop approaches the fibroid.

The 4-mm wire loop is placed behind the fibroid.

The postoperative resection bed is shown here. Photos courtesy Dr. Linda Bradley

Submucous Uterine Fibroids

Uterine fibroids are the most common benign tumor of the female genital tract. Almost 40% of the 600,000 hysterectomies performed each year in the United States are performed for symptomatic fibroids. Given the fact that many fibroids occur in women who want to maintain fertility, have serious health concerns, or desire the most minimally invasive option, hysterectomy often cannot be considered. When the fibroid is submucous in location, a hysteroscopic approach to myomectomy is the procedure of choice. Despite this, few gynecologists maintain this technique in their surgical armamentarium.

It is my desire that this article will spur many readers to safely proceed with hysteroscopic myomectomy. In order to accomplish this, I have asked Dr. Linda Bradley, director of hysteroscopic services at the Cleveland Clinic, and Dr. Keith Isaacson, medical director of the center for minimally invasive gynecologic surgery at Newton-Wellesley Hospital in Newton, Mass., to join me in a discussion on the advantages of the hysteroscopic approach to myomectomy.

Both Dr. Bradley and Dr. Isaacson are noted internationally for their expertise in hysteroscopic surgery. Not only are they gifted hysteroscopic surgeons, but they have written, lectured, and been principal researchers in this area as well.

On that note, let us proceed.

Prior to the introduction of laparoscopic assistance, vaginal hysterectomy (VH) was the only minimally invasive option for removing the uterus, and for decades studies have shown that vaginal hysterectomy results in significantly less morbidity than does abdominal hysterectomy. Most recently, investigators who reviewed randomized, controlled trials of hysterectomy for the international Cochrane Collaboration concluded that traditional vaginal hysterectomies should be performed “whenever technically feasible”—even in a world of increasingly popular laparoscopic approaches.

In recent years, technologic advances have resulted in innovative approaches for hysterectomy, including laparoscopically assisted vaginal hysterectomy (LAVH), laparoscopic supracervical hysterectomy (LSH), and total laparoscopic hysterectomy. Despite multiple options for minimally invasive hysterectomy and the evidence suggesting that vaginal hysterectomy should be performed whenever feasible, the majority of hysterectomies in the United States are performed abdominally, and the overall rate of vaginal hysterectomy has held steady.

Comfort level is a major determinant of the type of hysterectomy performed. Many surgeons have not performed sufficient laparoscopic surgeries during residency and do not have the opportunity to receive the appropriate additional training needed to perform laparoscopic techniques requiring advanced skills. Moreover, gynecologic surgeons who have been trained in residency to perform basic vaginal hysterectomy too often dismiss this option because of uterine enlargement or other factors, such as nulliparity, endometriosis, or prior pelvic surgery. In the end, too many patients are denied an attempt at a minimally invasive approach and undergo abdominal hysterectomy.

In many of these cases, a traditional, minimally invasive vaginal approach is achievable. By thoroughly evaluating uterine mobility—ideally, in the operating room—and by more frequently using the relatively simple technique of morcellation to remove the large uterus (which is common among patients needing hysterectomies), we can markedly reduce the rate of abdominal hysterectomy and its ensuing morbidities.

Because it is a relatively straightforward, natural extension of a core procedure for many gynecologists, morcellation can be more quickly and universally applied in practice than are the advanced laparoscopic techniques that many of us strive to learn.

Assessing Uterine Mobility

For successful vaginal hysterectomy with morcellation, the lower uterine segment must be mobile enough to allow control of the uterine arteries and entry into the anterior and posterior cul-de-sacs. These are the essential prerequisites for morcellation; once the cul-de-sacs are entered and the uterine vessels are controlled, we will be able to complete the majority of cases regardless of uterine size.

We should assess uterine mobility in every patient, regardless of the presence or absence of presumptive risk factors such as nulliparity, endometriosis, or pelvic adhesions. In general, mobility is sufficient if we are able to pull the cervix down to the lower third of the vagina.

We can assess the patient's uterine mobility during the office visit to have some assurance of the likelihood of being able to perform vaginal hysterectomy. In general, however, mobility will be notably greater once the patient is under anesthesia, and we really should assess it in the operating room in any case. In a broader sense, performing an examination under anesthesia of uterine mobility, vaginal anatomy, and support to the cervix affords us the opportunity to individualize the hysterectomy and determine the best approach for the patient, rather than pigeonhole the patient into any one particular procedure.

In the patient with uterine enlargement, we should aim to be prepared to perform vaginal hysterectomy with morcellation whenever feasible. If uterine support is normal and vaginal hysterectomy is not technically feasible, laparoscopic assistance should be considered. Although there are no studies directly comparing vaginal hysterectomy and LSH, these two procedures may be the best options for the patient with uterine enlargement. The determining factor between these two approaches should be the presence or absence of uterine mobility, and this should be assessed intraoperatively.

This valuable course of intraoperative decision making begins, of course, with a discussion with the patient about the various options, about the goal of performing an appropriate procedure with the least morbidity, and about her preferences on whether her cervix should stay in or not. In essence, we want to be able to involve the patient beforehand and then tell her that “no matter what, when you're in the recovery room, we will have completed the hysterectomy that is best for you.” Often, we will find that vaginal hysterectomy with morcellation is a viable option when we evaluate the patient under anesthesia.

Performing Morcellation

There are two basic types of morcellation: the wedge technique, and the intramyometrial-coring (also known as the Lash) technique.

In the wedge technique, the cervix is bivalved in the anteroposterior plane to the level of the lower uterine segment. Occasionally, this step alone will result in sufficient mobility to allow delivery of the uterine fundus. Once the cervix is bisected, use a clamp—I prefer a Lahey goiter clamp—to grasp the anterior or posterior uterine wall from endometrium to serosa, and excise a wedge-shaped portion of the uterine wall.

Continue this process until the uterine fundus can be delivered and the remaining pedicles clamped and cut to allow removal of the uterus. Typically, you will encounter individual myomas and can remove these separately.

The Lash technique—or intramyometrial coring—involves a circular incision in the myometrium at the level of the upper cervix. Make successive circumferential incisions, and you will essentially core out the myometrium while the integrity of the endometrial cavity is maintained.

Because the coring technique allows the removal of an intact endometrium, it may be an advantage if you are concerned about unexpected endometrial pathology. With office biopsies and modern imaging techniques, the chance of an unexpected finding of significant pathology should be minimal. Overall, I believe, the wedge technique is technically easier.

In either case, morcellation follows entry into both the anterior and posterior cul-de-sacs and control of the uterine vessels. Generally, I attempt anterior entry first, which allows me to palpate the ureters prior to clamping and cutting the pedicles. Other surgeons advocate entering the posterior cul-de-sac first, because the inability to enter posteriorly is generally considered an indication to abandon the vaginal approach. Regardless of order, both cul-de-sacs must be entered and the uterine vasculare pedicles controlled before proceeding with morcellation.

While at the Mayo Clinic a decade ago, my colleagues and I reviewed the hysterectomies performed over a 2-year period in patients with a uterine weight of 200–600 g. Patients with adnexal masses and malignancy were excluded.

Of 298 patients who were evaluated in the operating room, nearly half (48%) of those with a uterine weight of 200–400 g were deemed to be candidates for vaginal hysterectomy, based on the presence of sufficient uterine mobility. Even in the group with uterine weights of 400–600 g, 11% of patients had sufficient mobility to allow a vaginal approach. This included nulliparous patients and those with previous pelvic surgery and endometriosis.

Vaginal hysterectomy was successful in 97% of these patients, and its complication rate was significantly lower than that of abdominal hysterectomy, regardless of uterine weight. Morcellation, we found, was required in approximately 70%.

The study showed that although uterine size limits its use, the most important factor in deciding to perform vaginal hysterectomy was the presence of uterine mobility and accessibility. It also showed that because some patients with nulliparity, previous pelvic surgery, and endometriosis will still have sufficient mobility, these factors should not be considered as contraindications to the vaginal approach.

Incorporating Laparoscopy

Over the past decade, rates of LAVH have risen significantly, while the overall rate of vaginal hysterectomy has remained stable. This is concerning because, undoubtedly, many of these patients are candidates for traditional vaginal hysterectomy. Numerous studies, including the recent Cochrane Collaboration review, have shown that LAVH does not improve morbidity over traditional vaginal hysterectomy, and is more time consuming and costly.

Ideally, the use of the laparoscope should allow abdominal hysterectomy to be converted to a minimally invasive procedure. As I see it, the laparoscope can be used to address situations that result in uterine immobility, such as nulliparity, adhesions, and endometriosis, thus allowing conversion of these cases to LAVH.

Additionally, we can use laparoscopy to ensure ovarian removal at the time of vaginal hysterectomy, although some would suggest proceeding with traditional vaginal hysterectomy first and only employing laparoscopy if you're having technical difficulty removing the ovaries vaginally. Multiple studies report more than 90% success in removing ovaries at the time of vaginal hysterectomy, suggesting that laparoscopic assistance for ovarian removal should be required in less than 10% of cases.

My own experience with ovarian removal is similar to these studies, so I prefer to attempt vaginal removal first and reserve the use of the laparoscope for the few patients in whom I find it necessary.

Total vs. Supracervical Hysterectomy

The recent introduction of the laparoscopic morcellator allows removal of an enlarged uterus with a laparoscopic approach and has resulted in an increased use of LSH for patients with uterine enlargement.

Although some surgeons counsel patients that keeping their cervix will result in improved pelvic support and sexual function, studies comparing total hysterectomy with supracervical hysterectomy have shown no difference in bladder function and sexual function and support the premise that it's the anatomy of the vagina, and not the presence of the cervix, that is important. (We still need well-designed randomized, controlled trials that compare the morbidities and outcomes of LSH with LAVH and vaginal hysterectomy.)

In patients who already have normal pelvic support, LSH utilizing the laparoscopic morcellator may offer the best option for removal of the enlarged uterus, whereas those patients with uterine mobility are best treated by vaginal hysterectomy with traditional morcellation.

Ideally, we should be in a position to offer both approaches to the patient and should decide which to use based on examination under anesthesia in the operating room. If neither can be achieved, the patient may require abdominal hysterectomy, but at least we will have made an appropriate attempt at a less invasive procedure.

Until we have data pointing us elsewhere, we should embrace the minimally invasive gold standard of vaginal hysterectomy, employing morcellation for the larger uterus more often and turning to laparoscopy when necessary. Hysterectomies are most commonly done in reproductive-age women with fibroids or bleeding, a significant number of whom have enlarged uteri, so our ability to reduce the rate of abdominal hysterectomy—and increase the rate of the less morbid vaginal approach—is significant.

On the left, a wedge is excised from the posterior uterus. On the right, individual myomas are removed as they are encountered during morcellation. Photos courtesy Dr. Michael Moen

Size Doesn't Have to Count

Despite a trend toward minimally invasive gynecologic surgery, nearly 75% of hysterectomies in the United States are still performed via open laparotomy. The most common reason an open approach is selected by the gynecologic surgeon is concern about uterine size.

As editor of the Master Class columns on gynecologic surgery, I have enlisted Dr. Michael Moen to discuss the technique enabling removal of the larger uterus via a vaginal route.

Dr. Moen directs the division of urogynecology at Advocate Lutheran General Hospital in Park Ridge, Ill. He is also affiliated with the department of ob.gyn. at the University of Illinois at Chicago, and is a cofounder of Illinois Urogynecology Ltd. Dr. Moen is a fellow of both the American College of Obstetricians and Gynecologists and the American College of Surgeons, and is a member of the American Urogynecologic Society, the International Urogynecological Association, the Society of Gynecologic Surgeons, and the American Association of Gynecologic Laparoscopists.

While at the Mayo Clinic in Rochester, Minn., Dr. Moen was the lead author of an article on vaginal hysterectomy in patients with benign uterine enlargement for the Journal of Pelvic Surgery, along with his mentor, Dr. Raymond Lee.

Key Points: Vaginal Morcellation

▸ Ensure uterine mobility.

▸ Control uterine vessels.

▸ Proceed with morcellation of uterus.

Option 1: Wedge Technique

Divide cervix in anteroposterior plane to lower uterine segment.

Excise wedge-shaped portions of uterus.

Option 2: Lash Technique (Intramyometrial Coring)

Make successive circular incisions in myometrium to core it out.

Source: Dr. Miller

Prior to the introduction of laparoscopic assistance, vaginal hysterectomy (VH) was the only minimally invasive option for removing the uterus, and for decades studies have shown that vaginal hysterectomy results in significantly less morbidity than does abdominal hysterectomy. Most recently, investigators who reviewed randomized, controlled trials of hysterectomy for the international Cochrane Collaboration concluded that traditional vaginal hysterectomies should be performed “whenever technically feasible”—even in a world of increasingly popular laparoscopic approaches.

In recent years, technologic advances have resulted in innovative approaches for hysterectomy, including laparoscopically assisted vaginal hysterectomy (LAVH), laparoscopic supracervical hysterectomy (LSH), and total laparoscopic hysterectomy. Despite multiple options for minimally invasive hysterectomy and the evidence suggesting that vaginal hysterectomy should be performed whenever feasible, the majority of hysterectomies in the United States are performed abdominally, and the overall rate of vaginal hysterectomy has held steady.

Comfort level is a major determinant of the type of hysterectomy performed. Many surgeons have not performed sufficient laparoscopic surgeries during residency and do not have the opportunity to receive the appropriate additional training needed to perform laparoscopic techniques requiring advanced skills. Moreover, gynecologic surgeons who have been trained in residency to perform basic vaginal hysterectomy too often dismiss this option because of uterine enlargement or other factors, such as nulliparity, endometriosis, or prior pelvic surgery. In the end, too many patients are denied an attempt at a minimally invasive approach and undergo abdominal hysterectomy.

In many of these cases, a traditional, minimally invasive vaginal approach is achievable. By thoroughly evaluating uterine mobility—ideally, in the operating room—and by more frequently using the relatively simple technique of morcellation to remove the large uterus (which is common among patients needing hysterectomies), we can markedly reduce the rate of abdominal hysterectomy and its ensuing morbidities.

Because it is a relatively straightforward, natural extension of a core procedure for many gynecologists, morcellation can be more quickly and universally applied in practice than are the advanced laparoscopic techniques that many of us strive to learn.

Assessing Uterine Mobility

For successful vaginal hysterectomy with morcellation, the lower uterine segment must be mobile enough to allow control of the uterine arteries and entry into the anterior and posterior cul-de-sacs. These are the essential prerequisites for morcellation; once the cul-de-sacs are entered and the uterine vessels are controlled, we will be able to complete the majority of cases regardless of uterine size.

We should assess uterine mobility in every patient, regardless of the presence or absence of presumptive risk factors such as nulliparity, endometriosis, or pelvic adhesions. In general, mobility is sufficient if we are able to pull the cervix down to the lower third of the vagina.

We can assess the patient's uterine mobility during the office visit to have some assurance of the likelihood of being able to perform vaginal hysterectomy. In general, however, mobility will be notably greater once the patient is under anesthesia, and we really should assess it in the operating room in any case. In a broader sense, performing an examination under anesthesia of uterine mobility, vaginal anatomy, and support to the cervix affords us the opportunity to individualize the hysterectomy and determine the best approach for the patient, rather than pigeonhole the patient into any one particular procedure.

In the patient with uterine enlargement, we should aim to be prepared to perform vaginal hysterectomy with morcellation whenever feasible. If uterine support is normal and vaginal hysterectomy is not technically feasible, laparoscopic assistance should be considered. Although there are no studies directly comparing vaginal hysterectomy and LSH, these two procedures may be the best options for the patient with uterine enlargement. The determining factor between these two approaches should be the presence or absence of uterine mobility, and this should be assessed intraoperatively.

This valuable course of intraoperative decision making begins, of course, with a discussion with the patient about the various options, about the goal of performing an appropriate procedure with the least morbidity, and about her preferences on whether her cervix should stay in or not. In essence, we want to be able to involve the patient beforehand and then tell her that “no matter what, when you're in the recovery room, we will have completed the hysterectomy that is best for you.” Often, we will find that vaginal hysterectomy with morcellation is a viable option when we evaluate the patient under anesthesia.

Performing Morcellation

There are two basic types of morcellation: the wedge technique, and the intramyometrial-coring (also known as the Lash) technique.

In the wedge technique, the cervix is bivalved in the anteroposterior plane to the level of the lower uterine segment. Occasionally, this step alone will result in sufficient mobility to allow delivery of the uterine fundus. Once the cervix is bisected, use a clamp—I prefer a Lahey goiter clamp—to grasp the anterior or posterior uterine wall from endometrium to serosa, and excise a wedge-shaped portion of the uterine wall.

Continue this process until the uterine fundus can be delivered and the remaining pedicles clamped and cut to allow removal of the uterus. Typically, you will encounter individual myomas and can remove these separately.

The Lash technique—or intramyometrial coring—involves a circular incision in the myometrium at the level of the upper cervix. Make successive circumferential incisions, and you will essentially core out the myometrium while the integrity of the endometrial cavity is maintained.

Because the coring technique allows the removal of an intact endometrium, it may be an advantage if you are concerned about unexpected endometrial pathology. With office biopsies and modern imaging techniques, the chance of an unexpected finding of significant pathology should be minimal. Overall, I believe, the wedge technique is technically easier.

In either case, morcellation follows entry into both the anterior and posterior cul-de-sacs and control of the uterine vessels. Generally, I attempt anterior entry first, which allows me to palpate the ureters prior to clamping and cutting the pedicles. Other surgeons advocate entering the posterior cul-de-sac first, because the inability to enter posteriorly is generally considered an indication to abandon the vaginal approach. Regardless of order, both cul-de-sacs must be entered and the uterine vasculare pedicles controlled before proceeding with morcellation.

While at the Mayo Clinic a decade ago, my colleagues and I reviewed the hysterectomies performed over a 2-year period in patients with a uterine weight of 200–600 g. Patients with adnexal masses and malignancy were excluded.

Of 298 patients who were evaluated in the operating room, nearly half (48%) of those with a uterine weight of 200–400 g were deemed to be candidates for vaginal hysterectomy, based on the presence of sufficient uterine mobility. Even in the group with uterine weights of 400–600 g, 11% of patients had sufficient mobility to allow a vaginal approach. This included nulliparous patients and those with previous pelvic surgery and endometriosis.

Vaginal hysterectomy was successful in 97% of these patients, and its complication rate was significantly lower than that of abdominal hysterectomy, regardless of uterine weight. Morcellation, we found, was required in approximately 70%.

The study showed that although uterine size limits its use, the most important factor in deciding to perform vaginal hysterectomy was the presence of uterine mobility and accessibility. It also showed that because some patients with nulliparity, previous pelvic surgery, and endometriosis will still have sufficient mobility, these factors should not be considered as contraindications to the vaginal approach.

Incorporating Laparoscopy

Over the past decade, rates of LAVH have risen significantly, while the overall rate of vaginal hysterectomy has remained stable. This is concerning because, undoubtedly, many of these patients are candidates for traditional vaginal hysterectomy. Numerous studies, including the recent Cochrane Collaboration review, have shown that LAVH does not improve morbidity over traditional vaginal hysterectomy, and is more time consuming and costly.

Ideally, the use of the laparoscope should allow abdominal hysterectomy to be converted to a minimally invasive procedure. As I see it, the laparoscope can be used to address situations that result in uterine immobility, such as nulliparity, adhesions, and endometriosis, thus allowing conversion of these cases to LAVH.

Additionally, we can use laparoscopy to ensure ovarian removal at the time of vaginal hysterectomy, although some would suggest proceeding with traditional vaginal hysterectomy first and only employing laparoscopy if you're having technical difficulty removing the ovaries vaginally. Multiple studies report more than 90% success in removing ovaries at the time of vaginal hysterectomy, suggesting that laparoscopic assistance for ovarian removal should be required in less than 10% of cases.

My own experience with ovarian removal is similar to these studies, so I prefer to attempt vaginal removal first and reserve the use of the laparoscope for the few patients in whom I find it necessary.

Total vs. Supracervical Hysterectomy

The recent introduction of the laparoscopic morcellator allows removal of an enlarged uterus with a laparoscopic approach and has resulted in an increased use of LSH for patients with uterine enlargement.

Although some surgeons counsel patients that keeping their cervix will result in improved pelvic support and sexual function, studies comparing total hysterectomy with supracervical hysterectomy have shown no difference in bladder function and sexual function and support the premise that it's the anatomy of the vagina, and not the presence of the cervix, that is important. (We still need well-designed randomized, controlled trials that compare the morbidities and outcomes of LSH with LAVH and vaginal hysterectomy.)

In patients who already have normal pelvic support, LSH utilizing the laparoscopic morcellator may offer the best option for removal of the enlarged uterus, whereas those patients with uterine mobility are best treated by vaginal hysterectomy with traditional morcellation.

Ideally, we should be in a position to offer both approaches to the patient and should decide which to use based on examination under anesthesia in the operating room. If neither can be achieved, the patient may require abdominal hysterectomy, but at least we will have made an appropriate attempt at a less invasive procedure.

Until we have data pointing us elsewhere, we should embrace the minimally invasive gold standard of vaginal hysterectomy, employing morcellation for the larger uterus more often and turning to laparoscopy when necessary. Hysterectomies are most commonly done in reproductive-age women with fibroids or bleeding, a significant number of whom have enlarged uteri, so our ability to reduce the rate of abdominal hysterectomy—and increase the rate of the less morbid vaginal approach—is significant.

On the left, a wedge is excised from the posterior uterus. On the right, individual myomas are removed as they are encountered during morcellation. Photos courtesy Dr. Michael Moen

Size Doesn't Have to Count

Despite a trend toward minimally invasive gynecologic surgery, nearly 75% of hysterectomies in the United States are still performed via open laparotomy. The most common reason an open approach is selected by the gynecologic surgeon is concern about uterine size.

As editor of the Master Class columns on gynecologic surgery, I have enlisted Dr. Michael Moen to discuss the technique enabling removal of the larger uterus via a vaginal route.

Dr. Moen directs the division of urogynecology at Advocate Lutheran General Hospital in Park Ridge, Ill. He is also affiliated with the department of ob.gyn. at the University of Illinois at Chicago, and is a cofounder of Illinois Urogynecology Ltd. Dr. Moen is a fellow of both the American College of Obstetricians and Gynecologists and the American College of Surgeons, and is a member of the American Urogynecologic Society, the International Urogynecological Association, the Society of Gynecologic Surgeons, and the American Association of Gynecologic Laparoscopists.

While at the Mayo Clinic in Rochester, Minn., Dr. Moen was the lead author of an article on vaginal hysterectomy in patients with benign uterine enlargement for the Journal of Pelvic Surgery, along with his mentor, Dr. Raymond Lee.

Key Points: Vaginal Morcellation

▸ Ensure uterine mobility.

▸ Control uterine vessels.

▸ Proceed with morcellation of uterus.

Option 1: Wedge Technique

Divide cervix in anteroposterior plane to lower uterine segment.

Excise wedge-shaped portions of uterus.

Option 2: Lash Technique (Intramyometrial Coring)

Make successive circular incisions in myometrium to core it out.

Source: Dr. Miller

Prior to the introduction of laparoscopic assistance, vaginal hysterectomy (VH) was the only minimally invasive option for removing the uterus, and for decades studies have shown that vaginal hysterectomy results in significantly less morbidity than does abdominal hysterectomy. Most recently, investigators who reviewed randomized, controlled trials of hysterectomy for the international Cochrane Collaboration concluded that traditional vaginal hysterectomies should be performed “whenever technically feasible”—even in a world of increasingly popular laparoscopic approaches.

In recent years, technologic advances have resulted in innovative approaches for hysterectomy, including laparoscopically assisted vaginal hysterectomy (LAVH), laparoscopic supracervical hysterectomy (LSH), and total laparoscopic hysterectomy. Despite multiple options for minimally invasive hysterectomy and the evidence suggesting that vaginal hysterectomy should be performed whenever feasible, the majority of hysterectomies in the United States are performed abdominally, and the overall rate of vaginal hysterectomy has held steady.

Comfort level is a major determinant of the type of hysterectomy performed. Many surgeons have not performed sufficient laparoscopic surgeries during residency and do not have the opportunity to receive the appropriate additional training needed to perform laparoscopic techniques requiring advanced skills. Moreover, gynecologic surgeons who have been trained in residency to perform basic vaginal hysterectomy too often dismiss this option because of uterine enlargement or other factors, such as nulliparity, endometriosis, or prior pelvic surgery. In the end, too many patients are denied an attempt at a minimally invasive approach and undergo abdominal hysterectomy.

In many of these cases, a traditional, minimally invasive vaginal approach is achievable. By thoroughly evaluating uterine mobility—ideally, in the operating room—and by more frequently using the relatively simple technique of morcellation to remove the large uterus (which is common among patients needing hysterectomies), we can markedly reduce the rate of abdominal hysterectomy and its ensuing morbidities.

Because it is a relatively straightforward, natural extension of a core procedure for many gynecologists, morcellation can be more quickly and universally applied in practice than are the advanced laparoscopic techniques that many of us strive to learn.

Assessing Uterine Mobility

For successful vaginal hysterectomy with morcellation, the lower uterine segment must be mobile enough to allow control of the uterine arteries and entry into the anterior and posterior cul-de-sacs. These are the essential prerequisites for morcellation; once the cul-de-sacs are entered and the uterine vessels are controlled, we will be able to complete the majority of cases regardless of uterine size.

We should assess uterine mobility in every patient, regardless of the presence or absence of presumptive risk factors such as nulliparity, endometriosis, or pelvic adhesions. In general, mobility is sufficient if we are able to pull the cervix down to the lower third of the vagina.

We can assess the patient's uterine mobility during the office visit to have some assurance of the likelihood of being able to perform vaginal hysterectomy. In general, however, mobility will be notably greater once the patient is under anesthesia, and we really should assess it in the operating room in any case. In a broader sense, performing an examination under anesthesia of uterine mobility, vaginal anatomy, and support to the cervix affords us the opportunity to individualize the hysterectomy and determine the best approach for the patient, rather than pigeonhole the patient into any one particular procedure.

In the patient with uterine enlargement, we should aim to be prepared to perform vaginal hysterectomy with morcellation whenever feasible. If uterine support is normal and vaginal hysterectomy is not technically feasible, laparoscopic assistance should be considered. Although there are no studies directly comparing vaginal hysterectomy and LSH, these two procedures may be the best options for the patient with uterine enlargement. The determining factor between these two approaches should be the presence or absence of uterine mobility, and this should be assessed intraoperatively.

This valuable course of intraoperative decision making begins, of course, with a discussion with the patient about the various options, about the goal of performing an appropriate procedure with the least morbidity, and about her preferences on whether her cervix should stay in or not. In essence, we want to be able to involve the patient beforehand and then tell her that “no matter what, when you're in the recovery room, we will have completed the hysterectomy that is best for you.” Often, we will find that vaginal hysterectomy with morcellation is a viable option when we evaluate the patient under anesthesia.

Performing Morcellation

There are two basic types of morcellation: the wedge technique, and the intramyometrial-coring (also known as the Lash) technique.

In the wedge technique, the cervix is bivalved in the anteroposterior plane to the level of the lower uterine segment. Occasionally, this step alone will result in sufficient mobility to allow delivery of the uterine fundus. Once the cervix is bisected, use a clamp—I prefer a Lahey goiter clamp—to grasp the anterior or posterior uterine wall from endometrium to serosa, and excise a wedge-shaped portion of the uterine wall.

Continue this process until the uterine fundus can be delivered and the remaining pedicles clamped and cut to allow removal of the uterus. Typically, you will encounter individual myomas and can remove these separately.

The Lash technique—or intramyometrial coring—involves a circular incision in the myometrium at the level of the upper cervix. Make successive circumferential incisions, and you will essentially core out the myometrium while the integrity of the endometrial cavity is maintained.

Because the coring technique allows the removal of an intact endometrium, it may be an advantage if you are concerned about unexpected endometrial pathology. With office biopsies and modern imaging techniques, the chance of an unexpected finding of significant pathology should be minimal. Overall, I believe, the wedge technique is technically easier.

In either case, morcellation follows entry into both the anterior and posterior cul-de-sacs and control of the uterine vessels. Generally, I attempt anterior entry first, which allows me to palpate the ureters prior to clamping and cutting the pedicles. Other surgeons advocate entering the posterior cul-de-sac first, because the inability to enter posteriorly is generally considered an indication to abandon the vaginal approach. Regardless of order, both cul-de-sacs must be entered and the uterine vasculare pedicles controlled before proceeding with morcellation.

While at the Mayo Clinic a decade ago, my colleagues and I reviewed the hysterectomies performed over a 2-year period in patients with a uterine weight of 200–600 g. Patients with adnexal masses and malignancy were excluded.

Of 298 patients who were evaluated in the operating room, nearly half (48%) of those with a uterine weight of 200–400 g were deemed to be candidates for vaginal hysterectomy, based on the presence of sufficient uterine mobility. Even in the group with uterine weights of 400–600 g, 11% of patients had sufficient mobility to allow a vaginal approach. This included nulliparous patients and those with previous pelvic surgery and endometriosis.

Vaginal hysterectomy was successful in 97% of these patients, and its complication rate was significantly lower than that of abdominal hysterectomy, regardless of uterine weight. Morcellation, we found, was required in approximately 70%.

The study showed that although uterine size limits its use, the most important factor in deciding to perform vaginal hysterectomy was the presence of uterine mobility and accessibility. It also showed that because some patients with nulliparity, previous pelvic surgery, and endometriosis will still have sufficient mobility, these factors should not be considered as contraindications to the vaginal approach.

Incorporating Laparoscopy

Over the past decade, rates of LAVH have risen significantly, while the overall rate of vaginal hysterectomy has remained stable. This is concerning because, undoubtedly, many of these patients are candidates for traditional vaginal hysterectomy. Numerous studies, including the recent Cochrane Collaboration review, have shown that LAVH does not improve morbidity over traditional vaginal hysterectomy, and is more time consuming and costly.

Ideally, the use of the laparoscope should allow abdominal hysterectomy to be converted to a minimally invasive procedure. As I see it, the laparoscope can be used to address situations that result in uterine immobility, such as nulliparity, adhesions, and endometriosis, thus allowing conversion of these cases to LAVH.

Additionally, we can use laparoscopy to ensure ovarian removal at the time of vaginal hysterectomy, although some would suggest proceeding with traditional vaginal hysterectomy first and only employing laparoscopy if you're having technical difficulty removing the ovaries vaginally. Multiple studies report more than 90% success in removing ovaries at the time of vaginal hysterectomy, suggesting that laparoscopic assistance for ovarian removal should be required in less than 10% of cases.

My own experience with ovarian removal is similar to these studies, so I prefer to attempt vaginal removal first and reserve the use of the laparoscope for the few patients in whom I find it necessary.

Total vs. Supracervical Hysterectomy

The recent introduction of the laparoscopic morcellator allows removal of an enlarged uterus with a laparoscopic approach and has resulted in an increased use of LSH for patients with uterine enlargement.

Although some surgeons counsel patients that keeping their cervix will result in improved pelvic support and sexual function, studies comparing total hysterectomy with supracervical hysterectomy have shown no difference in bladder function and sexual function and support the premise that it's the anatomy of the vagina, and not the presence of the cervix, that is important. (We still need well-designed randomized, controlled trials that compare the morbidities and outcomes of LSH with LAVH and vaginal hysterectomy.)

In patients who already have normal pelvic support, LSH utilizing the laparoscopic morcellator may offer the best option for removal of the enlarged uterus, whereas those patients with uterine mobility are best treated by vaginal hysterectomy with traditional morcellation.

Ideally, we should be in a position to offer both approaches to the patient and should decide which to use based on examination under anesthesia in the operating room. If neither can be achieved, the patient may require abdominal hysterectomy, but at least we will have made an appropriate attempt at a less invasive procedure.

Until we have data pointing us elsewhere, we should embrace the minimally invasive gold standard of vaginal hysterectomy, employing morcellation for the larger uterus more often and turning to laparoscopy when necessary. Hysterectomies are most commonly done in reproductive-age women with fibroids or bleeding, a significant number of whom have enlarged uteri, so our ability to reduce the rate of abdominal hysterectomy—and increase the rate of the less morbid vaginal approach—is significant.

On the left, a wedge is excised from the posterior uterus. On the right, individual myomas are removed as they are encountered during morcellation. Photos courtesy Dr. Michael Moen

Size Doesn't Have to Count

Despite a trend toward minimally invasive gynecologic surgery, nearly 75% of hysterectomies in the United States are still performed via open laparotomy. The most common reason an open approach is selected by the gynecologic surgeon is concern about uterine size.

As editor of the Master Class columns on gynecologic surgery, I have enlisted Dr. Michael Moen to discuss the technique enabling removal of the larger uterus via a vaginal route.

Dr. Moen directs the division of urogynecology at Advocate Lutheran General Hospital in Park Ridge, Ill. He is also affiliated with the department of ob.gyn. at the University of Illinois at Chicago, and is a cofounder of Illinois Urogynecology Ltd. Dr. Moen is a fellow of both the American College of Obstetricians and Gynecologists and the American College of Surgeons, and is a member of the American Urogynecologic Society, the International Urogynecological Association, the Society of Gynecologic Surgeons, and the American Association of Gynecologic Laparoscopists.

While at the Mayo Clinic in Rochester, Minn., Dr. Moen was the lead author of an article on vaginal hysterectomy in patients with benign uterine enlargement for the Journal of Pelvic Surgery, along with his mentor, Dr. Raymond Lee.

Key Points: Vaginal Morcellation

▸ Ensure uterine mobility.

▸ Control uterine vessels.

▸ Proceed with morcellation of uterus.

Option 1: Wedge Technique

Divide cervix in anteroposterior plane to lower uterine segment.

Excise wedge-shaped portions of uterus.

Option 2: Lash Technique (Intramyometrial Coring)

Make successive circular incisions in myometrium to core it out.

Source: Dr. Miller

Surgery should be considered only in women who are hemodynamically stable and whose transvaginal ultrasound (TVUS) examination shows a tubal ectopic pregnancy or an adnexal mass suggestive of ectopic pregnancy. If TVUS does not show an abnormality, it is unlikely that an ectopic pregnancy will be visualized or palpated at surgery.

Moreover, when we need to treat surgically, we can and should use minimally invasive techniques whenever possible.

Alternatives to Surgery

Expectant management is the least desirable option because of the risk of tubal rupture. I take this approach only when I suspect ectopic pregnancy but TVUS fails to show the location of the gestational sac, and the serum levels of β-HCG are low and declining. Because of the possibility of tubal rupture, these patients must be carefully monitored until the serum β-HCG concentration falls below 15 IU/L; at this point, almost all ectopic pregnancies resolve spontaneously, without rupture.

Expectant management is never the best treatment when we have a diagnosis of ectopic pregnancy.

With an expectant management approach, we must monitor patients closely with serial β-HCG measurements every 2–3 days and also employ TVUS. The combination can provide us with information on whether we're dealing with an ectopic pregnancy or a miscarriage. A serum β-HCG concentration that is low and fails to double over 2–3 days suggests that we are dealing with either an ectopic pregnancy or failing intrauterine pregnancy.

Be aware that tubal rupture has been reported in women with low, declining, or even undetectable β-HCG levels. Rupture is mainly a result of blood distending the tube.

Some physicians will do a D&C when they're unsure about an ectopic pregnancy, but I would argue against this. First, it's surgery. Second, methotrexate (MTX) treatment has minimal side effects. Because a single intramuscular injection of methotrexate is safe, I would argue that it is the better alternative.

It can even be reasonably argued that MTX administration is a better approach to management than is expectant management. However, we have to make sure that the possibility of viable intrauterine pregnancy has been eliminated.

When MTX is administered to properly selected patients, it has a success rate up to 94%. Several randomized studies have even found that MTX treatment in selected patients with ectopic pregnancy was as effective as laparoscopic treatment.

MTX should be given to women who are hemodynamically stable and who are willing and able to comply with posttreatment monitoring; who have an initial serum β-HCG concentration lower than 5,000 IU/L; and who have no ultrasound evidence of fetal cardiac activity.

The main factor in determining who is a candidate for MTX is the level of β-HCG. A fairly recent metaanalysis of data for 1,327 women with ectopic pregnancy who were treated with MTX showed that success of the therapy was inversely associated with β-HCG levels, and that increasing levels were significantly correlated with treatment failure.

In general, if the β-HCG level is higher than 5,000 IU/L, the failure rate of therapy is significantly higher.

But other factors are important as well. Treatment failure is also associated with fetal cardiac activity. And you most certainly do not want to give MTX to a patient whom you won't see for 3 months.

Recent evidence suggests that tubal diameter or fetal size does not predict the success of medical treatment.

Laparoscopy: It's Clear

For those who do not meet the criteria for MTX administration—as well as for women who do not have timely access to a medical institution for management of tubal rupture and, of course, for women who have a ruptured ectopic pregnancy—surgery is necessary.

Three good prospective, randomized trials with a total of 231 women have compared laparotomy with laparoscopy, and have found that laparoscopic surgery is superior. Laparoscopic treatment of ectopic pregnancy resulted in less blood loss, lower analgesic requirements, shorter operative times, and briefer hospital stays. The studies also showed similar reproductive outcomes—subsequent uterine pregnancy and repeat ectopic pregnancy—after salpingostomy by either approach.

A Cochrane review published in 2000 also concluded that laparoscopic surgery is the best treatment. It reported a higher rate of persistent trophoblast with laparoscopic surgery, but concluded this was outweighed by the benefits of the more conservative laparoscopic approach. As I see it, the incidence of persistent trophoblast is related to the laparoscopic experience of the surgeon.

When a patient is unstable or in shock, I stabilize the patient first and then consult with the anesthesiologist to see if he or she is comfortable with my doing laparoscopy. In my experience, most will offer their support for a laparoscopic approach.

Most ectopic pregnancies—even interstitial pregnancy, heterotopic pregnancy, and ectopic pregnancy in the presence of hemoperitoneum—can be treated through a laparoscopic procedure. Your approach, or course, should depend upon your experience and the judgment of the anesthesiologist.

To Spare the Tube or Not

When it comes to choosing salpingostomy or salpingectomy, there are some uncertainties, and we face an absence of data from randomized studies. In some—but not all—of the nonrandomized studies that have been done, the intrauterine pregnancy rate has been higher after the tube-sparing surgery than after salpingectomy. However, the risk of recurrent ectopic pregnancy has been shown to be slightly higher after the more conservative treatment.

These differences most likely reflect tubal status and not the choice of surgical procedure. In other words, contralateral tubal abnormalities predispose patients to recurrent ectopic pregnancy regardless of the type of surgery. In one study of women who underwent laparoscopic salpingectomy, rates of intrauterine pregnancy and recurrent ectopic pregnancy were better among women who had normal contralateral tubal anatomy and no history of infertility (approximately 75% and 10%, respectively), compared with women who had abnormal tube anatomy or infertility (37% and 18%, respectively).

In the absence of data from a randomized study, though, salpingostomy should be the treatment of choice, particularly for women who want another pregnancy. I do not remove the tube in patients who wish to conceive again, provided the tube is relatively normal by gross inspection. If the patient has completed her family, I will remove the tube.

Some other ectopic pregnancies are often best treated by salpingectomy. These include cases of uncontrolled bleeding, a severely damaged tube, most cases of recurrent ectopic pregnancy within the same tube, and a tubal gestational sac larger than 3 cm in diameter. In these cases, the probability of normal tubal function in the future is low, and the likelihood of recurrent tubal problems is high.

Salpingostomy Technique

Laparoscopic salpingostomy is fairly straightforward. First, inject a dilute solution of vasopressin (0.2 IU/mL of physiologic saline) into the tubal wall at the area of maximal distention. This will minimize bleeding. Using a unipolar needle electrocautery (laser and scissors can also be used), make a 10− to 15-mm linear incision along the antimesenteric border overlying the ectopic site.

Do not use forceps and do not pull the products of conception out piece by piece, or you could cause more bleeding and mistakenly leave tissue behind. Instead, use a combination of hydrodissection with irrigating solution under high pressure and gentle blunt dissection with a suction irrigator. Remove the specimen from the abdominal cavity. A laparoscopic pouch can be useful for removing large pieces of gestational tissue.

Carefully irrigate the tube and make sure there is no bleeding. Control any bleeding points with pressure or with a light application of bipolar coagulation. If bleeding persists, ligate the vessels in the mesosalpinx with a 6–0 polyglactin suture. The suturing is technically demanding, but this is one condition in which suturing skill is extremely helpful, and all laparoscopists should acquire it.

Do not keep coagulating the inside of the tube to stop the bleeding. The thermal damage will affect the integrity of the tube, and that integrity is important for future pregnancies.

Leave the incision open to heal by secondary intention. A randomized study I led several years ago showed no difference in the rates of adhesion formation and subsequent fertility between patients who had suturing after laparotomy and those who did not. If there is no difference after laparotomy, then the outcomes associated with secondary intention and primary closure after laparoscopy will also be similar.

Some physicians have proposed giving women MTX right after surgery. Although I do not recommend administering MTX prophylactically, it might be worthwhile to administer one dose of MTX in those rare cases in which you suspect that you might have left behind some gestational tissue.

Salpingectomy Technique

There are several methods for laparoscopic salpingectomy. For one, you may ligate the part of the tube that contains the ectopic pregnancy, then resect and remove the tube.

Alternatively, use electrosurgery to coagulate the tube and mesosalpinx and then resect the specimen with scissors. The cornual portion of the tube should be desiccated close to the uterus. Elevate the tube when using the electrocautery, or you may inadvertently damage the ovarian vessels. You may perform either partial or segmental salpingectomy using a laparoscopic approach.

Regardless of the method of treatment, always check the patient's blood group. If she is Rh negative and the male partner's Rh factor is positive or unknown, the patient should be given RhoGAM.

Interstitial Pregnancy

Especially among patients who have had in vitro fertilization (IVF), you may encounter interstitial pregnancy. The conventional treatment is hysterectomy or cornual resection. But with earlier diagnosis using TVUS and β-HCG assays, it can be diagnosed early and treated medically or laparoscopically.

Start with medical treatment and resort to surgery if there is any deterioration in clinical status. There are several options for surgery, including laparoscopic cornual resection, cornuostomy, or salpingotomy. In most cases, you will want to use dilute intramyometrial vasopressin at the start of the surgery to minimize blood loss. And remember the value of suturing and the option of achieving hemostasis by ligating the ascending branches of the uterine vessels.

If you perform surgery, make sure you have expertise in suturing, because you will be working in a very vascular area. Be comfortable with the procedure you are doing. I prefer laparoscopic removal of the gestation, with removal of the interstitial portion of the tube if necessary.

The risk of uterine rupture in future pregnancies after medical treatment of an interstitial pregnancy is unknown, as is the future integrity of the uterus following laparoscopic surgical treatment. We may be able to prevent future uterine rupture with proper suturing of the uterine cornu after laparoscopic treatment. Nevertheless, discuss the possibility of rupture occurring during a subsequent pregnancy with patients undergoing any treatment for interstitial pregnancy.

Likewise, monitor women with a history of interstitial pregnancy very closely. I usually recommend cesarean delivery to avoid potential uterine rupture during labor.

With any pregnancy after IVF, make sure that an ectopic pregnancy is not accompanied by pregnancy in the uterus. If you see both, you should not even consider medical therapy.

Persistent Ectopic Pregnancy

Persistent ectopic pregnancy occurs more often after salpingostomy performed with laparoscopy than after salpingostomy through laparotomy (about 8% compared with 4%). The difference used to be much greater and probably reflects the surgeon's learning curve.

Some authors have recommended weekly serum β-HCG measurements after laparoscopic salpingostomy to exclude persistent ectopic pregnancy. We perform a single serum β-HCG measurement 1 week after surgery. If the level is more than 5% of the preoperative value, we will repeat the measurement 1 week later.

If the level does not decline after the second week, we administer a single dose of MTX (50 mg/m

A large ischemic ectopic pregnancy can be painful emotionally as well as physically.

Salpingostomy has been performed and the ectopic gestation extruded outside the fallopian tube.

One suture to approximate the tubal incision has been placed, a step that requires exacting skill. Photos courtesy Dr. Togas Tulandi

Treating Ectopic Pregnancy

As editor of Master Class columns on gynecologic surgery, I am especially pleased to have Togas Tulandi, M.D., contribute this article on the current treatment of ectopic pregnancy. Dr. Tulandi is a professor of ob.gyn. and the Milton Leong Chair in Reproductive Medicine (the first Canadian chair in reproductive medicine) at McGill University in Montreal.

As a clinical researcher, Dr. Tulandi has been quite prolific. He has published more than 200 articles, 250 abstracts, 40 book chapters, and eight books. Dr. Tulandi also is the current president of the Society of Reproductive Surgeons, an affiliated society of the American Society for Reproductive Medicine.

As the readership no doubt will observe, Dr. Tulandi has a rather conservative view of treatment of ectopic pregnancy with medical therapy (methotrexate). Moreover, he provides valid reasons why laparoscopy is considered the preferred surgical treatment for ectopic pregnancy.

Although Dr. Tulandi points out that data are lacking when deciding between salpingectomy vs. salpingostomy, he does provide reasonable recommendations to assist in deciding between the two procedures.

In addition, Dr. Tulandi shares valuable insight on interstitial pregnancy as well as persistent ectopic pregnancy.

Once again, I am very proud to have Dr. Tulandi's involvement with OB.GYN. NEWS and the Master Class.

Surgery should be considered only in women who are hemodynamically stable and whose transvaginal ultrasound (TVUS) examination shows a tubal ectopic pregnancy or an adnexal mass suggestive of ectopic pregnancy. If TVUS does not show an abnormality, it is unlikely that an ectopic pregnancy will be visualized or palpated at surgery.

Moreover, when we need to treat surgically, we can and should use minimally invasive techniques whenever possible.

Alternatives to Surgery

Expectant management is the least desirable option because of the risk of tubal rupture. I take this approach only when I suspect ectopic pregnancy but TVUS fails to show the location of the gestational sac, and the serum levels of β-HCG are low and declining. Because of the possibility of tubal rupture, these patients must be carefully monitored until the serum β-HCG concentration falls below 15 IU/L; at this point, almost all ectopic pregnancies resolve spontaneously, without rupture.

Expectant management is never the best treatment when we have a diagnosis of ectopic pregnancy.

With an expectant management approach, we must monitor patients closely with serial β-HCG measurements every 2–3 days and also employ TVUS. The combination can provide us with information on whether we're dealing with an ectopic pregnancy or a miscarriage. A serum β-HCG concentration that is low and fails to double over 2–3 days suggests that we are dealing with either an ectopic pregnancy or failing intrauterine pregnancy.

Be aware that tubal rupture has been reported in women with low, declining, or even undetectable β-HCG levels. Rupture is mainly a result of blood distending the tube.

Some physicians will do a D&C when they're unsure about an ectopic pregnancy, but I would argue against this. First, it's surgery. Second, methotrexate (MTX) treatment has minimal side effects. Because a single intramuscular injection of methotrexate is safe, I would argue that it is the better alternative.

It can even be reasonably argued that MTX administration is a better approach to management than is expectant management. However, we have to make sure that the possibility of viable intrauterine pregnancy has been eliminated.

When MTX is administered to properly selected patients, it has a success rate up to 94%. Several randomized studies have even found that MTX treatment in selected patients with ectopic pregnancy was as effective as laparoscopic treatment.

MTX should be given to women who are hemodynamically stable and who are willing and able to comply with posttreatment monitoring; who have an initial serum β-HCG concentration lower than 5,000 IU/L; and who have no ultrasound evidence of fetal cardiac activity.

The main factor in determining who is a candidate for MTX is the level of β-HCG. A fairly recent metaanalysis of data for 1,327 women with ectopic pregnancy who were treated with MTX showed that success of the therapy was inversely associated with β-HCG levels, and that increasing levels were significantly correlated with treatment failure.

In general, if the β-HCG level is higher than 5,000 IU/L, the failure rate of therapy is significantly higher.

But other factors are important as well. Treatment failure is also associated with fetal cardiac activity. And you most certainly do not want to give MTX to a patient whom you won't see for 3 months.

Recent evidence suggests that tubal diameter or fetal size does not predict the success of medical treatment.

Laparoscopy: It's Clear

For those who do not meet the criteria for MTX administration—as well as for women who do not have timely access to a medical institution for management of tubal rupture and, of course, for women who have a ruptured ectopic pregnancy—surgery is necessary.

Three good prospective, randomized trials with a total of 231 women have compared laparotomy with laparoscopy, and have found that laparoscopic surgery is superior. Laparoscopic treatment of ectopic pregnancy resulted in less blood loss, lower analgesic requirements, shorter operative times, and briefer hospital stays. The studies also showed similar reproductive outcomes—subsequent uterine pregnancy and repeat ectopic pregnancy—after salpingostomy by either approach.

A Cochrane review published in 2000 also concluded that laparoscopic surgery is the best treatment. It reported a higher rate of persistent trophoblast with laparoscopic surgery, but concluded this was outweighed by the benefits of the more conservative laparoscopic approach. As I see it, the incidence of persistent trophoblast is related to the laparoscopic experience of the surgeon.

When a patient is unstable or in shock, I stabilize the patient first and then consult with the anesthesiologist to see if he or she is comfortable with my doing laparoscopy. In my experience, most will offer their support for a laparoscopic approach.

Most ectopic pregnancies—even interstitial pregnancy, heterotopic pregnancy, and ectopic pregnancy in the presence of hemoperitoneum—can be treated through a laparoscopic procedure. Your approach, or course, should depend upon your experience and the judgment of the anesthesiologist.

To Spare the Tube or Not

When it comes to choosing salpingostomy or salpingectomy, there are some uncertainties, and we face an absence of data from randomized studies. In some—but not all—of the nonrandomized studies that have been done, the intrauterine pregnancy rate has been higher after the tube-sparing surgery than after salpingectomy. However, the risk of recurrent ectopic pregnancy has been shown to be slightly higher after the more conservative treatment.

These differences most likely reflect tubal status and not the choice of surgical procedure. In other words, contralateral tubal abnormalities predispose patients to recurrent ectopic pregnancy regardless of the type of surgery. In one study of women who underwent laparoscopic salpingectomy, rates of intrauterine pregnancy and recurrent ectopic pregnancy were better among women who had normal contralateral tubal anatomy and no history of infertility (approximately 75% and 10%, respectively), compared with women who had abnormal tube anatomy or infertility (37% and 18%, respectively).

In the absence of data from a randomized study, though, salpingostomy should be the treatment of choice, particularly for women who want another pregnancy. I do not remove the tube in patients who wish to conceive again, provided the tube is relatively normal by gross inspection. If the patient has completed her family, I will remove the tube.

Some other ectopic pregnancies are often best treated by salpingectomy. These include cases of uncontrolled bleeding, a severely damaged tube, most cases of recurrent ectopic pregnancy within the same tube, and a tubal gestational sac larger than 3 cm in diameter. In these cases, the probability of normal tubal function in the future is low, and the likelihood of recurrent tubal problems is high.

Salpingostomy Technique

Laparoscopic salpingostomy is fairly straightforward. First, inject a dilute solution of vasopressin (0.2 IU/mL of physiologic saline) into the tubal wall at the area of maximal distention. This will minimize bleeding. Using a unipolar needle electrocautery (laser and scissors can also be used), make a 10− to 15-mm linear incision along the antimesenteric border overlying the ectopic site.

Do not use forceps and do not pull the products of conception out piece by piece, or you could cause more bleeding and mistakenly leave tissue behind. Instead, use a combination of hydrodissection with irrigating solution under high pressure and gentle blunt dissection with a suction irrigator. Remove the specimen from the abdominal cavity. A laparoscopic pouch can be useful for removing large pieces of gestational tissue.

Carefully irrigate the tube and make sure there is no bleeding. Control any bleeding points with pressure or with a light application of bipolar coagulation. If bleeding persists, ligate the vessels in the mesosalpinx with a 6–0 polyglactin suture. The suturing is technically demanding, but this is one condition in which suturing skill is extremely helpful, and all laparoscopists should acquire it.

Do not keep coagulating the inside of the tube to stop the bleeding. The thermal damage will affect the integrity of the tube, and that integrity is important for future pregnancies.

Leave the incision open to heal by secondary intention. A randomized study I led several years ago showed no difference in the rates of adhesion formation and subsequent fertility between patients who had suturing after laparotomy and those who did not. If there is no difference after laparotomy, then the outcomes associated with secondary intention and primary closure after laparoscopy will also be similar.

Some physicians have proposed giving women MTX right after surgery. Although I do not recommend administering MTX prophylactically, it might be worthwhile to administer one dose of MTX in those rare cases in which you suspect that you might have left behind some gestational tissue.

Salpingectomy Technique

There are several methods for laparoscopic salpingectomy. For one, you may ligate the part of the tube that contains the ectopic pregnancy, then resect and remove the tube.

Alternatively, use electrosurgery to coagulate the tube and mesosalpinx and then resect the specimen with scissors. The cornual portion of the tube should be desiccated close to the uterus. Elevate the tube when using the electrocautery, or you may inadvertently damage the ovarian vessels. You may perform either partial or segmental salpingectomy using a laparoscopic approach.

Regardless of the method of treatment, always check the patient's blood group. If she is Rh negative and the male partner's Rh factor is positive or unknown, the patient should be given RhoGAM.

Interstitial Pregnancy

Especially among patients who have had in vitro fertilization (IVF), you may encounter interstitial pregnancy. The conventional treatment is hysterectomy or cornual resection. But with earlier diagnosis using TVUS and β-HCG assays, it can be diagnosed early and treated medically or laparoscopically.

Start with medical treatment and resort to surgery if there is any deterioration in clinical status. There are several options for surgery, including laparoscopic cornual resection, cornuostomy, or salpingotomy. In most cases, you will want to use dilute intramyometrial vasopressin at the start of the surgery to minimize blood loss. And remember the value of suturing and the option of achieving hemostasis by ligating the ascending branches of the uterine vessels.

If you perform surgery, make sure you have expertise in suturing, because you will be working in a very vascular area. Be comfortable with the procedure you are doing. I prefer laparoscopic removal of the gestation, with removal of the interstitial portion of the tube if necessary.

The risk of uterine rupture in future pregnancies after medical treatment of an interstitial pregnancy is unknown, as is the future integrity of the uterus following laparoscopic surgical treatment. We may be able to prevent future uterine rupture with proper suturing of the uterine cornu after laparoscopic treatment. Nevertheless, discuss the possibility of rupture occurring during a subsequent pregnancy with patients undergoing any treatment for interstitial pregnancy.

Likewise, monitor women with a history of interstitial pregnancy very closely. I usually recommend cesarean delivery to avoid potential uterine rupture during labor.

With any pregnancy after IVF, make sure that an ectopic pregnancy is not accompanied by pregnancy in the uterus. If you see both, you should not even consider medical therapy.

Persistent Ectopic Pregnancy

Persistent ectopic pregnancy occurs more often after salpingostomy performed with laparoscopy than after salpingostomy through laparotomy (about 8% compared with 4%). The difference used to be much greater and probably reflects the surgeon's learning curve.

Some authors have recommended weekly serum β-HCG measurements after laparoscopic salpingostomy to exclude persistent ectopic pregnancy. We perform a single serum β-HCG measurement 1 week after surgery. If the level is more than 5% of the preoperative value, we will repeat the measurement 1 week later.

If the level does not decline after the second week, we administer a single dose of MTX (50 mg/m

A large ischemic ectopic pregnancy can be painful emotionally as well as physically.

Salpingostomy has been performed and the ectopic gestation extruded outside the fallopian tube.

One suture to approximate the tubal incision has been placed, a step that requires exacting skill. Photos courtesy Dr. Togas Tulandi

Treating Ectopic Pregnancy

As editor of Master Class columns on gynecologic surgery, I am especially pleased to have Togas Tulandi, M.D., contribute this article on the current treatment of ectopic pregnancy. Dr. Tulandi is a professor of ob.gyn. and the Milton Leong Chair in Reproductive Medicine (the first Canadian chair in reproductive medicine) at McGill University in Montreal.

As a clinical researcher, Dr. Tulandi has been quite prolific. He has published more than 200 articles, 250 abstracts, 40 book chapters, and eight books. Dr. Tulandi also is the current president of the Society of Reproductive Surgeons, an affiliated society of the American Society for Reproductive Medicine.

As the readership no doubt will observe, Dr. Tulandi has a rather conservative view of treatment of ectopic pregnancy with medical therapy (methotrexate). Moreover, he provides valid reasons why laparoscopy is considered the preferred surgical treatment for ectopic pregnancy.

Although Dr. Tulandi points out that data are lacking when deciding between salpingectomy vs. salpingostomy, he does provide reasonable recommendations to assist in deciding between the two procedures.

In addition, Dr. Tulandi shares valuable insight on interstitial pregnancy as well as persistent ectopic pregnancy.

Once again, I am very proud to have Dr. Tulandi's involvement with OB.GYN. NEWS and the Master Class.

Surgery should be considered only in women who are hemodynamically stable and whose transvaginal ultrasound (TVUS) examination shows a tubal ectopic pregnancy or an adnexal mass suggestive of ectopic pregnancy. If TVUS does not show an abnormality, it is unlikely that an ectopic pregnancy will be visualized or palpated at surgery.

Moreover, when we need to treat surgically, we can and should use minimally invasive techniques whenever possible.

Alternatives to Surgery

Expectant management is the least desirable option because of the risk of tubal rupture. I take this approach only when I suspect ectopic pregnancy but TVUS fails to show the location of the gestational sac, and the serum levels of β-HCG are low and declining. Because of the possibility of tubal rupture, these patients must be carefully monitored until the serum β-HCG concentration falls below 15 IU/L; at this point, almost all ectopic pregnancies resolve spontaneously, without rupture.

Expectant management is never the best treatment when we have a diagnosis of ectopic pregnancy.

With an expectant management approach, we must monitor patients closely with serial β-HCG measurements every 2–3 days and also employ TVUS. The combination can provide us with information on whether we're dealing with an ectopic pregnancy or a miscarriage. A serum β-HCG concentration that is low and fails to double over 2–3 days suggests that we are dealing with either an ectopic pregnancy or failing intrauterine pregnancy.

Be aware that tubal rupture has been reported in women with low, declining, or even undetectable β-HCG levels. Rupture is mainly a result of blood distending the tube.

Some physicians will do a D&C when they're unsure about an ectopic pregnancy, but I would argue against this. First, it's surgery. Second, methotrexate (MTX) treatment has minimal side effects. Because a single intramuscular injection of methotrexate is safe, I would argue that it is the better alternative.

It can even be reasonably argued that MTX administration is a better approach to management than is expectant management. However, we have to make sure that the possibility of viable intrauterine pregnancy has been eliminated.

When MTX is administered to properly selected patients, it has a success rate up to 94%. Several randomized studies have even found that MTX treatment in selected patients with ectopic pregnancy was as effective as laparoscopic treatment.

MTX should be given to women who are hemodynamically stable and who are willing and able to comply with posttreatment monitoring; who have an initial serum β-HCG concentration lower than 5,000 IU/L; and who have no ultrasound evidence of fetal cardiac activity.

The main factor in determining who is a candidate for MTX is the level of β-HCG. A fairly recent metaanalysis of data for 1,327 women with ectopic pregnancy who were treated with MTX showed that success of the therapy was inversely associated with β-HCG levels, and that increasing levels were significantly correlated with treatment failure.

In general, if the β-HCG level is higher than 5,000 IU/L, the failure rate of therapy is significantly higher.

But other factors are important as well. Treatment failure is also associated with fetal cardiac activity. And you most certainly do not want to give MTX to a patient whom you won't see for 3 months.

Recent evidence suggests that tubal diameter or fetal size does not predict the success of medical treatment.

Laparoscopy: It's Clear

For those who do not meet the criteria for MTX administration—as well as for women who do not have timely access to a medical institution for management of tubal rupture and, of course, for women who have a ruptured ectopic pregnancy—surgery is necessary.

Three good prospective, randomized trials with a total of 231 women have compared laparotomy with laparoscopy, and have found that laparoscopic surgery is superior. Laparoscopic treatment of ectopic pregnancy resulted in less blood loss, lower analgesic requirements, shorter operative times, and briefer hospital stays. The studies also showed similar reproductive outcomes—subsequent uterine pregnancy and repeat ectopic pregnancy—after salpingostomy by either approach.

A Cochrane review published in 2000 also concluded that laparoscopic surgery is the best treatment. It reported a higher rate of persistent trophoblast with laparoscopic surgery, but concluded this was outweighed by the benefits of the more conservative laparoscopic approach. As I see it, the incidence of persistent trophoblast is related to the laparoscopic experience of the surgeon.

When a patient is unstable or in shock, I stabilize the patient first and then consult with the anesthesiologist to see if he or she is comfortable with my doing laparoscopy. In my experience, most will offer their support for a laparoscopic approach.

Most ectopic pregnancies—even interstitial pregnancy, heterotopic pregnancy, and ectopic pregnancy in the presence of hemoperitoneum—can be treated through a laparoscopic procedure. Your approach, or course, should depend upon your experience and the judgment of the anesthesiologist.

To Spare the Tube or Not

When it comes to choosing salpingostomy or salpingectomy, there are some uncertainties, and we face an absence of data from randomized studies. In some—but not all—of the nonrandomized studies that have been done, the intrauterine pregnancy rate has been higher after the tube-sparing surgery than after salpingectomy. However, the risk of recurrent ectopic pregnancy has been shown to be slightly higher after the more conservative treatment.

These differences most likely reflect tubal status and not the choice of surgical procedure. In other words, contralateral tubal abnormalities predispose patients to recurrent ectopic pregnancy regardless of the type of surgery. In one study of women who underwent laparoscopic salpingectomy, rates of intrauterine pregnancy and recurrent ectopic pregnancy were better among women who had normal contralateral tubal anatomy and no history of infertility (approximately 75% and 10%, respectively), compared with women who had abnormal tube anatomy or infertility (37% and 18%, respectively).

In the absence of data from a randomized study, though, salpingostomy should be the treatment of choice, particularly for women who want another pregnancy. I do not remove the tube in patients who wish to conceive again, provided the tube is relatively normal by gross inspection. If the patient has completed her family, I will remove the tube.

Some other ectopic pregnancies are often best treated by salpingectomy. These include cases of uncontrolled bleeding, a severely damaged tube, most cases of recurrent ectopic pregnancy within the same tube, and a tubal gestational sac larger than 3 cm in diameter. In these cases, the probability of normal tubal function in the future is low, and the likelihood of recurrent tubal problems is high.

Salpingostomy Technique

Laparoscopic salpingostomy is fairly straightforward. First, inject a dilute solution of vasopressin (0.2 IU/mL of physiologic saline) into the tubal wall at the area of maximal distention. This will minimize bleeding. Using a unipolar needle electrocautery (laser and scissors can also be used), make a 10− to 15-mm linear incision along the antimesenteric border overlying the ectopic site.

Do not use forceps and do not pull the products of conception out piece by piece, or you could cause more bleeding and mistakenly leave tissue behind. Instead, use a combination of hydrodissection with irrigating solution under high pressure and gentle blunt dissection with a suction irrigator. Remove the specimen from the abdominal cavity. A laparoscopic pouch can be useful for removing large pieces of gestational tissue.

Carefully irrigate the tube and make sure there is no bleeding. Control any bleeding points with pressure or with a light application of bipolar coagulation. If bleeding persists, ligate the vessels in the mesosalpinx with a 6–0 polyglactin suture. The suturing is technically demanding, but this is one condition in which suturing skill is extremely helpful, and all laparoscopists should acquire it.

Do not keep coagulating the inside of the tube to stop the bleeding. The thermal damage will affect the integrity of the tube, and that integrity is important for future pregnancies.

Leave the incision open to heal by secondary intention. A randomized study I led several years ago showed no difference in the rates of adhesion formation and subsequent fertility between patients who had suturing after laparotomy and those who did not. If there is no difference after laparotomy, then the outcomes associated with secondary intention and primary closure after laparoscopy will also be similar.

Some physicians have proposed giving women MTX right after surgery. Although I do not recommend administering MTX prophylactically, it might be worthwhile to administer one dose of MTX in those rare cases in which you suspect that you might have left behind some gestational tissue.

Salpingectomy Technique

There are several methods for laparoscopic salpingectomy. For one, you may ligate the part of the tube that contains the ectopic pregnancy, then resect and remove the tube.

Alternatively, use electrosurgery to coagulate the tube and mesosalpinx and then resect the specimen with scissors. The cornual portion of the tube should be desiccated close to the uterus. Elevate the tube when using the electrocautery, or you may inadvertently damage the ovarian vessels. You may perform either partial or segmental salpingectomy using a laparoscopic approach.

Regardless of the method of treatment, always check the patient's blood group. If she is Rh negative and the male partner's Rh factor is positive or unknown, the patient should be given RhoGAM.

Interstitial Pregnancy

Especially among patients who have had in vitro fertilization (IVF), you may encounter interstitial pregnancy. The conventional treatment is hysterectomy or cornual resection. But with earlier diagnosis using TVUS and β-HCG assays, it can be diagnosed early and treated medically or laparoscopically.

Start with medical treatment and resort to surgery if there is any deterioration in clinical status. There are several options for surgery, including laparoscopic cornual resection, cornuostomy, or salpingotomy. In most cases, you will want to use dilute intramyometrial vasopressin at the start of the surgery to minimize blood loss. And remember the value of suturing and the option of achieving hemostasis by ligating the ascending branches of the uterine vessels.

If you perform surgery, make sure you have expertise in suturing, because you will be working in a very vascular area. Be comfortable with the procedure you are doing. I prefer laparoscopic removal of the gestation, with removal of the interstitial portion of the tube if necessary.

The risk of uterine rupture in future pregnancies after medical treatment of an interstitial pregnancy is unknown, as is the future integrity of the uterus following laparoscopic surgical treatment. We may be able to prevent future uterine rupture with proper suturing of the uterine cornu after laparoscopic treatment. Nevertheless, discuss the possibility of rupture occurring during a subsequent pregnancy with patients undergoing any treatment for interstitial pregnancy.

Likewise, monitor women with a history of interstitial pregnancy very closely. I usually recommend cesarean delivery to avoid potential uterine rupture during labor.

With any pregnancy after IVF, make sure that an ectopic pregnancy is not accompanied by pregnancy in the uterus. If you see both, you should not even consider medical therapy.

Persistent Ectopic Pregnancy

Persistent ectopic pregnancy occurs more often after salpingostomy performed with laparoscopy than after salpingostomy through laparotomy (about 8% compared with 4%). The difference used to be much greater and probably reflects the surgeon's learning curve.

Some authors have recommended weekly serum β-HCG measurements after laparoscopic salpingostomy to exclude persistent ectopic pregnancy. We perform a single serum β-HCG measurement 1 week after surgery. If the level is more than 5% of the preoperative value, we will repeat the measurement 1 week later.

If the level does not decline after the second week, we administer a single dose of MTX (50 mg/m

A large ischemic ectopic pregnancy can be painful emotionally as well as physically.

Salpingostomy has been performed and the ectopic gestation extruded outside the fallopian tube.

One suture to approximate the tubal incision has been placed, a step that requires exacting skill. Photos courtesy Dr. Togas Tulandi

Treating Ectopic Pregnancy

As editor of Master Class columns on gynecologic surgery, I am especially pleased to have Togas Tulandi, M.D., contribute this article on the current treatment of ectopic pregnancy. Dr. Tulandi is a professor of ob.gyn. and the Milton Leong Chair in Reproductive Medicine (the first Canadian chair in reproductive medicine) at McGill University in Montreal.

As a clinical researcher, Dr. Tulandi has been quite prolific. He has published more than 200 articles, 250 abstracts, 40 book chapters, and eight books. Dr. Tulandi also is the current president of the Society of Reproductive Surgeons, an affiliated society of the American Society for Reproductive Medicine.

As the readership no doubt will observe, Dr. Tulandi has a rather conservative view of treatment of ectopic pregnancy with medical therapy (methotrexate). Moreover, he provides valid reasons why laparoscopy is considered the preferred surgical treatment for ectopic pregnancy.

Although Dr. Tulandi points out that data are lacking when deciding between salpingectomy vs. salpingostomy, he does provide reasonable recommendations to assist in deciding between the two procedures.

In addition, Dr. Tulandi shares valuable insight on interstitial pregnancy as well as persistent ectopic pregnancy.

Once again, I am very proud to have Dr. Tulandi's involvement with OB.GYN. NEWS and the Master Class.

Despite many advances in minimally invasive tubal ligation surgery, it remains a more complicated procedure than vasectomy to achieve sterilization, the most common contraceptive option in the United States today.

The introduction of a transcervical method of sterilization through the use of the Essure procedure is changing that. We can now offer patients a quick, exceedingly safe, incisionless tubal occlusion procedure that has been found 99.8% effective at 3 years, and, in one report, 99.74% effective at 5 years of follow-up.

I am incorporating Essure into my practice, and have found it so useful that I have chosen to share it in this month's Master Class.

In general terms, Essure is a microinsert placed into the fallopian tube via a hysteroscopically guided catheter.

The microinsert consists of a flexible stainless-steel inner coil, a dynamic outer coil made of nickel titanium alloy (nitinol), and an innermost layer of polyethylene terephthalate (PET) fibers. These fibers gradually elicit a benign localized tissue ingrowth that occludes the tubal lumen.

A follow-up hysterosalpingogram (HSG) 3 months post procedure confirms proper device placement and tubal occlusion.

The concept that led to the development of Essure tubal occlusion evolved from neurosurgery, in which coils have been used to block vessels. However, specialized coils had to be designed that would expand to the diameter and length of the fallopian tube.

The tissue response that is seen following placement of the microinsert is comparable to what has long been seen with heart valves and vascular grafts. Thus, even though this precise indication is new, the technology has been around for quite some time, and has been found to be safe and effective.

When I talk with a potential candidate for Essure tubal occlusion, our discussion is much the same as it would be for tubal ligation: The patient must desire permanent, nonreversible contraception.

She must be at least 3 months post pregnancy, and must not have tubal disease or scarring inside the uterus that would preclude visualization of the tubal ostia.

The patient cannot have a severe nickel allergy, because nitinol makes up the outer coil of the microinsert. Moreover, women who have a history of a severe allergic response to iodine are poor candidates because iodine is used during the follow-up HSG.

Finally, women who are on immunosuppressive therapy may take longer than 3 months to have an occlusive response. As long as such patients understand this potential limitation, immunosuppressive therapy is not a contraindication. In fact, my first Essure patient was on immunosuppressive therapy secondary to breast cancer.

Presurgical steps can be taken to improve visualization of the ostia. I sometimes prescribe oral, transdermal, or injectable contraception for 3 months before the procedure to thin the endometrium. Visualization also is enhanced by scheduling the procedure within the first 2 weeks of a patient's menstrual cycle.

General anesthesia is not required for the procedure. I instruct patients to take an NSAID 1 hour before surgery. I perform the procedure with intravenous sedation (30 mg IV ketorolac) in an outpatient surgical suite. However, many physicians are simply using a paracervical block and performing the Essure procedure in their offices.

If visualization is inadequate because of debris, endometrial fluff, or clots, simply flush the uterus, aspirate, and gently remove the obstructive material with graspers. Confirm visibility of both ostia before placing either microinsert. Start with the tube that appears to be the most difficult.

Use 2–3 liters of warmed saline to enhance uterine dilatation and tubal cannulation; the warmth will minimize tubal spasm as well as increase patient comfort. Avoid uterine overdistention by using gravity feed rather than pump-delivered saline for input and output.

Inadequate uterine distention resulting from a patulous cervix may be overcome by gently twisting the tenaculum 45 degrees, either by using an additional tenaculum to seal the cervix, or by placing the tenaculum at the 1 o'clock and 5 o'clock positions or the 7 o'clock and 11 o'clock positions (or both).

Feed the introducer through the cervix and uterus into the fallopian tube.

To minimize “splash back” of fluid when inserting the Essure catheter into the introducer, leave the stylet within the introducer until the last minute, just before you are ready to deliver the catheter into it. When you remove the stylet, squeeze the end of the introducer and then insert the Essure catheter. Do not use the stopcock to block the fluid until the introducer is withdrawn; otherwise, the introducer might be severed while in the hysteroscope.

Depending on the size of the hysteroscope, the introducer may be a tight fit. To minimize the risk of damage to the tip of the Essure catheter, do not force the introducer when resistance is felt. In such a case, simply withdraw the introducer/stylet unit approximately 1 mm. This may mean the introducer/stylet extends more than halfway outside the sealing cap of the working channel, but this is not a problem. Just insert the catheter through the introducer as usual once the stylet is removed.

Approach the ostia as closely as possible, waiting until the ostium occupies most of the hysteroscope's screen.

The Essure catheter includes visual cues to guide you, including a flat black positioning marker.

Before you deploy the microinsert by depressing the button on the handle, check the position of the catheter by looking for the marker just outside the tubal ostia. You should also see the distal tip of the orange release catheter in the same visual field.

Reducing tubal spasm will greatly improve the ease of placement. Wait a few seconds for a spasm to pass, then approach the tube very closely and gently rotate the device inside the tube.

Once the procedure is complete, patients should remain in the office for about 45 minutes before returning home. Some can return to work and daily activities immediately; virtually all will be back to their normal routines within 24 hours.

Almost always, ibuprofen is the strongest medication required for postprocedural pain.

The procedure is exceedingly safe. There is a small risk (less than 1%) of tubal perforation at the time of the procedure; however, no interventional therapy is required.

Likewise, the risks of infection, bleeding, and uterine perforation are extremely low.

Schedule patients for a return visit in 3 months for an HSG, during which you will inspect the tubes for evidence of tissue ingrowth. In the meantime, stress the importance of using an alternative form of contraception, as sterilization cannot be guaranteed until tubal occlusion can be confirmed.

When performing the postprocedure HSG, use minimal volume and pressure. Doing so serves two purposes: avoiding unnecessary patient discomfort, and minimizing the chance of a false-positive result because of high-pressure instillation.

If you refer patients to a radiologist for HSGs, emphasize the importance of these key points. When capturing images, the clinician should ensure proper occlusion by magnifying the cornual region of each implanted tube.

With proper technique, competency in this procedure can be achieved quickly. I have found patient satisfaction to be very high.

The ease and efficacy of the procedure, lack of necessity for general anesthetic, and rapid patient recovery all combine to make Essure tubal occlusion a valuable technique for gynecologists to master.

Confirm visibility of both ostia before placing either microinsert.

The Essure microinsert is inserted into the tubal ostia at the level of the black marker.

The delivery catheter is retracted. The notch at the opening of the tubal ostia shows correct placement.

The delivery wire is retracted from the microinsert.

The microinsert is now firmly embedded in the fallopian tube. Photos courtesy Dr. Charles E. Miller

Despite many advances in minimally invasive tubal ligation surgery, it remains a more complicated procedure than vasectomy to achieve sterilization, the most common contraceptive option in the United States today.

The introduction of a transcervical method of sterilization through the use of the Essure procedure is changing that. We can now offer patients a quick, exceedingly safe, incisionless tubal occlusion procedure that has been found 99.8% effective at 3 years, and, in one report, 99.74% effective at 5 years of follow-up.

I am incorporating Essure into my practice, and have found it so useful that I have chosen to share it in this month's Master Class.

In general terms, Essure is a microinsert placed into the fallopian tube via a hysteroscopically guided catheter.

The microinsert consists of a flexible stainless-steel inner coil, a dynamic outer coil made of nickel titanium alloy (nitinol), and an innermost layer of polyethylene terephthalate (PET) fibers. These fibers gradually elicit a benign localized tissue ingrowth that occludes the tubal lumen.

A follow-up hysterosalpingogram (HSG) 3 months post procedure confirms proper device placement and tubal occlusion.

The concept that led to the development of Essure tubal occlusion evolved from neurosurgery, in which coils have been used to block vessels. However, specialized coils had to be designed that would expand to the diameter and length of the fallopian tube.

The tissue response that is seen following placement of the microinsert is comparable to what has long been seen with heart valves and vascular grafts. Thus, even though this precise indication is new, the technology has been around for quite some time, and has been found to be safe and effective.

When I talk with a potential candidate for Essure tubal occlusion, our discussion is much the same as it would be for tubal ligation: The patient must desire permanent, nonreversible contraception.

She must be at least 3 months post pregnancy, and must not have tubal disease or scarring inside the uterus that would preclude visualization of the tubal ostia.

The patient cannot have a severe nickel allergy, because nitinol makes up the outer coil of the microinsert. Moreover, women who have a history of a severe allergic response to iodine are poor candidates because iodine is used during the follow-up HSG.

Finally, women who are on immunosuppressive therapy may take longer than 3 months to have an occlusive response. As long as such patients understand this potential limitation, immunosuppressive therapy is not a contraindication. In fact, my first Essure patient was on immunosuppressive therapy secondary to breast cancer.

Presurgical steps can be taken to improve visualization of the ostia. I sometimes prescribe oral, transdermal, or injectable contraception for 3 months before the procedure to thin the endometrium. Visualization also is enhanced by scheduling the procedure within the first 2 weeks of a patient's menstrual cycle.

General anesthesia is not required for the procedure. I instruct patients to take an NSAID 1 hour before surgery. I perform the procedure with intravenous sedation (30 mg IV ketorolac) in an outpatient surgical suite. However, many physicians are simply using a paracervical block and performing the Essure procedure in their offices.

If visualization is inadequate because of debris, endometrial fluff, or clots, simply flush the uterus, aspirate, and gently remove the obstructive material with graspers. Confirm visibility of both ostia before placing either microinsert. Start with the tube that appears to be the most difficult.

Use 2–3 liters of warmed saline to enhance uterine dilatation and tubal cannulation; the warmth will minimize tubal spasm as well as increase patient comfort. Avoid uterine overdistention by using gravity feed rather than pump-delivered saline for input and output.

Inadequate uterine distention resulting from a patulous cervix may be overcome by gently twisting the tenaculum 45 degrees, either by using an additional tenaculum to seal the cervix, or by placing the tenaculum at the 1 o'clock and 5 o'clock positions or the 7 o'clock and 11 o'clock positions (or both).

Feed the introducer through the cervix and uterus into the fallopian tube.

To minimize “splash back” of fluid when inserting the Essure catheter into the introducer, leave the stylet within the introducer until the last minute, just before you are ready to deliver the catheter into it. When you remove the stylet, squeeze the end of the introducer and then insert the Essure catheter. Do not use the stopcock to block the fluid until the introducer is withdrawn; otherwise, the introducer might be severed while in the hysteroscope.

Depending on the size of the hysteroscope, the introducer may be a tight fit. To minimize the risk of damage to the tip of the Essure catheter, do not force the introducer when resistance is felt. In such a case, simply withdraw the introducer/stylet unit approximately 1 mm. This may mean the introducer/stylet extends more than halfway outside the sealing cap of the working channel, but this is not a problem. Just insert the catheter through the introducer as usual once the stylet is removed.

Approach the ostia as closely as possible, waiting until the ostium occupies most of the hysteroscope's screen.

The Essure catheter includes visual cues to guide you, including a flat black positioning marker.

Before you deploy the microinsert by depressing the button on the handle, check the position of the catheter by looking for the marker just outside the tubal ostia. You should also see the distal tip of the orange release catheter in the same visual field.

Reducing tubal spasm will greatly improve the ease of placement. Wait a few seconds for a spasm to pass, then approach the tube very closely and gently rotate the device inside the tube.

Once the procedure is complete, patients should remain in the office for about 45 minutes before returning home. Some can return to work and daily activities immediately; virtually all will be back to their normal routines within 24 hours.

Almost always, ibuprofen is the strongest medication required for postprocedural pain.

The procedure is exceedingly safe. There is a small risk (less than 1%) of tubal perforation at the time of the procedure; however, no interventional therapy is required.

Likewise, the risks of infection, bleeding, and uterine perforation are extremely low.

Schedule patients for a return visit in 3 months for an HSG, during which you will inspect the tubes for evidence of tissue ingrowth. In the meantime, stress the importance of using an alternative form of contraception, as sterilization cannot be guaranteed until tubal occlusion can be confirmed.

When performing the postprocedure HSG, use minimal volume and pressure. Doing so serves two purposes: avoiding unnecessary patient discomfort, and minimizing the chance of a false-positive result because of high-pressure instillation.

If you refer patients to a radiologist for HSGs, emphasize the importance of these key points. When capturing images, the clinician should ensure proper occlusion by magnifying the cornual region of each implanted tube.

With proper technique, competency in this procedure can be achieved quickly. I have found patient satisfaction to be very high.

The ease and efficacy of the procedure, lack of necessity for general anesthetic, and rapid patient recovery all combine to make Essure tubal occlusion a valuable technique for gynecologists to master.

Confirm visibility of both ostia before placing either microinsert.

The Essure microinsert is inserted into the tubal ostia at the level of the black marker.

The delivery catheter is retracted. The notch at the opening of the tubal ostia shows correct placement.

The delivery wire is retracted from the microinsert.

The microinsert is now firmly embedded in the fallopian tube. Photos courtesy Dr. Charles E. Miller

Despite many advances in minimally invasive tubal ligation surgery, it remains a more complicated procedure than vasectomy to achieve sterilization, the most common contraceptive option in the United States today.

The introduction of a transcervical method of sterilization through the use of the Essure procedure is changing that. We can now offer patients a quick, exceedingly safe, incisionless tubal occlusion procedure that has been found 99.8% effective at 3 years, and, in one report, 99.74% effective at 5 years of follow-up.

I am incorporating Essure into my practice, and have found it so useful that I have chosen to share it in this month's Master Class.

In general terms, Essure is a microinsert placed into the fallopian tube via a hysteroscopically guided catheter.

The microinsert consists of a flexible stainless-steel inner coil, a dynamic outer coil made of nickel titanium alloy (nitinol), and an innermost layer of polyethylene terephthalate (PET) fibers. These fibers gradually elicit a benign localized tissue ingrowth that occludes the tubal lumen.

A follow-up hysterosalpingogram (HSG) 3 months post procedure confirms proper device placement and tubal occlusion.

The concept that led to the development of Essure tubal occlusion evolved from neurosurgery, in which coils have been used to block vessels. However, specialized coils had to be designed that would expand to the diameter and length of the fallopian tube.

The tissue response that is seen following placement of the microinsert is comparable to what has long been seen with heart valves and vascular grafts. Thus, even though this precise indication is new, the technology has been around for quite some time, and has been found to be safe and effective.

When I talk with a potential candidate for Essure tubal occlusion, our discussion is much the same as it would be for tubal ligation: The patient must desire permanent, nonreversible contraception.

She must be at least 3 months post pregnancy, and must not have tubal disease or scarring inside the uterus that would preclude visualization of the tubal ostia.

The patient cannot have a severe nickel allergy, because nitinol makes up the outer coil of the microinsert. Moreover, women who have a history of a severe allergic response to iodine are poor candidates because iodine is used during the follow-up HSG.

Finally, women who are on immunosuppressive therapy may take longer than 3 months to have an occlusive response. As long as such patients understand this potential limitation, immunosuppressive therapy is not a contraindication. In fact, my first Essure patient was on immunosuppressive therapy secondary to breast cancer.

Presurgical steps can be taken to improve visualization of the ostia. I sometimes prescribe oral, transdermal, or injectable contraception for 3 months before the procedure to thin the endometrium. Visualization also is enhanced by scheduling the procedure within the first 2 weeks of a patient's menstrual cycle.

General anesthesia is not required for the procedure. I instruct patients to take an NSAID 1 hour before surgery. I perform the procedure with intravenous sedation (30 mg IV ketorolac) in an outpatient surgical suite. However, many physicians are simply using a paracervical block and performing the Essure procedure in their offices.

If visualization is inadequate because of debris, endometrial fluff, or clots, simply flush the uterus, aspirate, and gently remove the obstructive material with graspers. Confirm visibility of both ostia before placing either microinsert. Start with the tube that appears to be the most difficult.

Use 2–3 liters of warmed saline to enhance uterine dilatation and tubal cannulation; the warmth will minimize tubal spasm as well as increase patient comfort. Avoid uterine overdistention by using gravity feed rather than pump-delivered saline for input and output.

Inadequate uterine distention resulting from a patulous cervix may be overcome by gently twisting the tenaculum 45 degrees, either by using an additional tenaculum to seal the cervix, or by placing the tenaculum at the 1 o'clock and 5 o'clock positions or the 7 o'clock and 11 o'clock positions (or both).

Feed the introducer through the cervix and uterus into the fallopian tube.

To minimize “splash back” of fluid when inserting the Essure catheter into the introducer, leave the stylet within the introducer until the last minute, just before you are ready to deliver the catheter into it. When you remove the stylet, squeeze the end of the introducer and then insert the Essure catheter. Do not use the stopcock to block the fluid until the introducer is withdrawn; otherwise, the introducer might be severed while in the hysteroscope.

Depending on the size of the hysteroscope, the introducer may be a tight fit. To minimize the risk of damage to the tip of the Essure catheter, do not force the introducer when resistance is felt. In such a case, simply withdraw the introducer/stylet unit approximately 1 mm. This may mean the introducer/stylet extends more than halfway outside the sealing cap of the working channel, but this is not a problem. Just insert the catheter through the introducer as usual once the stylet is removed.

Approach the ostia as closely as possible, waiting until the ostium occupies most of the hysteroscope's screen.

The Essure catheter includes visual cues to guide you, including a flat black positioning marker.

Before you deploy the microinsert by depressing the button on the handle, check the position of the catheter by looking for the marker just outside the tubal ostia. You should also see the distal tip of the orange release catheter in the same visual field.

Reducing tubal spasm will greatly improve the ease of placement. Wait a few seconds for a spasm to pass, then approach the tube very closely and gently rotate the device inside the tube.

Once the procedure is complete, patients should remain in the office for about 45 minutes before returning home. Some can return to work and daily activities immediately; virtually all will be back to their normal routines within 24 hours.

Almost always, ibuprofen is the strongest medication required for postprocedural pain.

The procedure is exceedingly safe. There is a small risk (less than 1%) of tubal perforation at the time of the procedure; however, no interventional therapy is required.

Likewise, the risks of infection, bleeding, and uterine perforation are extremely low.

Schedule patients for a return visit in 3 months for an HSG, during which you will inspect the tubes for evidence of tissue ingrowth. In the meantime, stress the importance of using an alternative form of contraception, as sterilization cannot be guaranteed until tubal occlusion can be confirmed.

When performing the postprocedure HSG, use minimal volume and pressure. Doing so serves two purposes: avoiding unnecessary patient discomfort, and minimizing the chance of a false-positive result because of high-pressure instillation.

If you refer patients to a radiologist for HSGs, emphasize the importance of these key points. When capturing images, the clinician should ensure proper occlusion by magnifying the cornual region of each implanted tube.

With proper technique, competency in this procedure can be achieved quickly. I have found patient satisfaction to be very high.

The ease and efficacy of the procedure, lack of necessity for general anesthetic, and rapid patient recovery all combine to make Essure tubal occlusion a valuable technique for gynecologists to master.

Confirm visibility of both ostia before placing either microinsert.

The Essure microinsert is inserted into the tubal ostia at the level of the black marker.

The delivery catheter is retracted. The notch at the opening of the tubal ostia shows correct placement.

The delivery wire is retracted from the microinsert.

The microinsert is now firmly embedded in the fallopian tube. Photos courtesy Dr. Charles E. Miller

There was a time when almost all women with symptomatic leiomyomas were amenable to hysterectomy or myomectomy when medical therapy failed to relieve their pelvic pressure and pain, menorrhagia, and, in many cases, anemia.

Today, that has changed.

An increasing number of women don't want myomectomies or hysterectomies, regardless of whether they are performed abdominally or laparoscopically or—in the case of hysterectomies—vaginally. They go to the Internet and easily click on the names of 1,000 radiologists who promise a nonsurgical alternative that will “melt away” their fibroids.

Uterine artery embolization (UAE) involves making an incision in the groin and then threading a catheter through the femoral artery to the uterine artery to deliver thousands of polyvinyl particles into the uterus, as well as into the arteries, veins, and peripheral vessels that supply it. The intention is to cause transient uterine ischemia.

Originally used as a presurgical procedure to reduce blood loss during myomectomy or hysterectomy, UAE was also found to be effective in treating life-threatening bleeding that resulted from myomas. Success in controlling bleeding and improving symptoms led to its use as an alternative to primary surgery for leiomyomas in the late 1990s.

A recent surge in popularity was sparked by Food and Drug Administration approval of Embosphere microparticles for UAE and an aggressive marketing campaign by radiologists performing the procedure.

An Alternative to UAE

Laparoscopic uterine artery occlusion (UAO) offers a minimally invasive surgical option that also causes transient uterine ischemia and subsequent relief of leiomyoma symptoms, utilizing the same principles as UAE but permitting the gynecologic surgeon to inspect the uterine cavity, address other gynecologic issues, and rule out uterine cancer. Understanding either procedure requires a basic understanding of the principle behind bilateral UAO.

The uterine arteries provide most of the uterine blood supply. When this blood flow is blocked—either by polyvinyl microparticles, as in UAE, or by vascular clips during laparoscopic UAO—blood will then clot within the myometrium.

The myometrium becomes hypoxic and its metabolism undergoes a shift from oxidative pathways to anaerobic glycolysis.

Within hours to days, clots are lysed within the myometrium, and collateral arteries begin to reperfuse the uterus.

Myomas, in contrast, cannot lyse clotted blood and reperfuse. They eventually become infarcted and die.

In a proof-of-hypothesis study conducted by my colleagues and me several years ago, we found that the percentage and rate of decline and the return to baseline of pH (a proxy for hypoxia and lactic acidosis) after bilateral UAO were quite variable.

The myometrium has a complex, redundant blood supply that varies from patient to patient (J. Am. Assoc. Gynecol. Laparosc. 2003;10:553–66).

In the vast majority of women, these secondary, tertiary, and quaternary vascular pathways are insufficient to maintain aerobic metabolism.

In 1%–2% of women, however, one uterine artery is hypoplastic, and a large communicating artery connects the ovarian artery to the uterus. Without occlusion of this artery in these patients, the blood supply to the uterus would be maintained despite bilateral UAO.

In our study reviewing eight cases, the uterine pH change from baseline ranged from 0.4 to 1.7 units over a time period that ranged from 5 minutes to 210 minutes after bilateral UAO.

The time for pH to return to baseline ranged from 20 minutes to 660 minutes (J. Am. Assoc. Gynecol. Laparosc. 2002; 9:191–8).

Other investigators have shown via MRI that clots form more quickly in myomas (as indicated by uptake of contrast media) than in the myometrium, and myoma tissue remains unperfused at 1 year, even as myometrium demonstrates normal perfusion at 1, 2, 3, 4, and 6 months, and 1 year.

In our first study of laparoscopic UAO for symptomatic leiomyomas, we enrolled eight women whom we had counseled extensively about various alternatives, including gonadotropin-releasing hormones, hysterectomy, myomectomy, and embolization.

Operative Technique

The operative procedure is quite straightforward.

Patients are placed in dorsolithotomy position under general anesthesia. A Foley catheter is placed into the bladder. An examination is performed, followed by hysteroscopy, and—if warranted by findings—endometrial biopsies are performed. A uterine cannula is inserted for uterine manipulation.

Depending on uterine size, a 10-mm port is inserted using open technique in the umbilicus or the left upper abdominal quadrant.

For safety reasons, accessing the peritoneum above the psoas muscle prevents direct trauma to retroperitoneal vessels. Entering retroperitoneum lateral to the posterior broad ligament avoids uterine expansion.

Pneumoperitoneum is established under videolaparoscopic guidance. Two additional ports—one is a 5-mm port; the other is a 5-mm or 12-mm port—are then inserted under visualization bilaterally above the inferior epigastric vessels.

Use uterine countertraction on the ipsilateral side while identifying the round ligament. Incise the posterior broad ligament laterally next to the round ligament over the psoas muscle, using endoscopic scissors.

This will free periadnexal adhesions and release uterine lateral displacement from myomas; it also avoids injury to the femoral vessels.

Grasp the cut edges of peritoneum and pull them laterally. Dissect to below the round ligament and lateral to the uterus.

Identify the lateral umbilical ligaments—vestigial obliterated umbilical arteries that reflect from the anterior peritoneum and become retroperitoneal in this avascular area. Trace the fibrous white element cephalad.

When this ligament is pulled laterally, it is easy to visualize the origin of the uterine artery by following the fibrous, bloodless, obliterant hypogastric artery to the internal iliac artery. This artery is straight for the first 2–3 cm, where it can be seen pulsating; it then becomes tortuous and surrounded by veins as it crosses medially above the ureter. It is an extensible artery that tolerates significant maneuvers.

Apply two successive preloaded 5-mm or 10-mm vascular clips at an area that is devoid of venous plexus, further from the ureter and more lateral to the uterus than during laparoscopic hysterectomy.

We do not dissect the round ligaments, vesicouterine space, or ureters.

Blanching of the uterus can be observed once both arteries are occluded.

Manageable Complications

In our study, there were no perioperative complications, and estimated blood loss was less than 25 dL in all cases. The average operating time was 35 minutes, which we have now reduced to 20 minutes in our current experience of more than 100 cases.

Postoperative pain was managed by nonsteroidal anti-inflammatory drugs in all but one case, a patient who requested parenteral narcotic analgesia in the recovery room. In our more recent experience, the majority of patients require only ibuprofen, with an occasional use of Vicodin or Tylenol #3. The study patients were discharged after 12–20 hours, a period primarily for monitoring purposes related to the protocol; today, our patients go home the same day as their surgery.

Among eight patients in the study, seven reported complete resolution of fibroid-related pain at 3 months. One patient's pain declined from moderate to mild. These results have remained consistent in our larger series.

The five patients who previously reported menorrhagia reported eumenorrhea; no patients became amenorrheic. We have seen two patients in our larger series become menopausal, but both were older than 50 years at the time of surgery. None of the patients we have followed with FSH levels has lost ovarian function.

The average decrease in uterine volume at 3 months was 39.4%.

One of our patients has become pregnant and is currently doing well at 20 weeks' gestation.

Complications have been few. Among our original study patients, one passed round tissue vaginally 3 months postoperatively, but her white blood count was normal and she showed no signs of infection.

Simple endometrial adenomatous hyperplasia was diagnosed on the day of another patient's procedure; repeat office curettage showed benign endometrium 3 months later.

We bill for this procedure using code #37617 (ligation of major artery of the abdomen), after having obtained precertification with insurance companies. We have had no trouble being reimbursed for the procedure.

This procedure carries a very low risk of anesthesia complications, and abdominal entry injuries are possible.

Any procedure involving UAO has potential complications related to uterine ischemia.

Prolapse, vaginal expulsion of necrotic tissue, and pelvic infection are possible. Selecting patients who have adequate perfusion around myomas may decrease the risk of postocclusion infection.

Patient selection is also important with regard to myoma size. Laparoscopic visualization becomes difficult in patients beyond a 20-week gestation uterine size, and we therefore refer these patients for embolization if they will not consider myomectomy or hysterectomy.

A Comparison of the Two Procedures

As opposed to radiologic embolization, which is a blind procedure, laparoscopic UAO offers an opportunity to diagnose endometrial cancer and sarcomas via fine-needle aspiration and myometrial biopsy.

Additionally, it can be offered as a global treatment for gynecologic complaints other than leiomyomas.

The majority of patients who are candidates for these procedures also have adhesions and/or endometriosis that may be a cocontributor to their pelvic pain.

In conclusion, we have found that the risks of laparoscopic UAO are minimal, and the benefits to carefully selected patients are considerable.

By contrast, radiologic UAE is a simple procedure that has been proven efficacious for reducing symptoms. It is not, however, without risks.

Misembolization has been reported to the collateral uterine-ovarian vessel and the legs. Unintended embolization can lead to ovarian failure in 1%–4% of cases.

Pain is a considerable feature of the procedure, both from hypoxia and cramping, as the uterus attempts to expel the polyvinyl pellets. Many patients remain in the hospital for 23 hours on a morphine pump.

Up to 15% of patients experience postembolization syndrome, characterized by fever, anorexia, and nausea/vomiting.

Most importantly, radiologic UAE can be performed in patients with undiagnosed cancer that can evade diagnosis for many months.

There are several reports of embolization in a patient with undiagnosed uterine sarcoma.

Endometrial biopsy and MRI can assist in the presurgical diagnosis of sarcoma; however, the laparoscopic approach is clearly more thorough in ruling out cancer.

The only real obstacle to widespread use of laparoscopic UAO is the dearth of advanced laparoscopic surgery training among U.S. gynecologic surgeons. This is a retroperitoneal vascular procedure, requiring skillful knowledge of the vascular anatomy.

Future Vaginal Approach?

Because there appears to be a need for a gynecologic alternative to the increasingly popular radiologic UAE, I have recently been working with colleagues and a private company—Vascular Control Systems of San Juan Capistrano, Calif.—to develop a technique to temporarily occlude the uterine arteries with a Doppler-guided, uterine artery clamp using a vaginal approach.

This procedure is still experimental, and we have thus far achieved fibroid shrinkage of approximately 30%. A clinical trial is under way to advance and improve this technique.

In this view of the left retroperitoneum, two 5-mm endoscopic clips occlude the proximal portion of the left uterine artery.

This uterus is blanched as a result of hypoperfusion and ischemia after laparoscopic bilateral uterine artery occlusion. Photos courtesy Dr. Moises Lichtinger

Gynecologists Strike Back With Laparoscopic Uterine Artery Occlusion

One only needs to check the Internet to see how aggressively our colleagues in radiology are marketing uterine artery embolization/uterine fibroid embolization.

Although the radiologic approach certainly has merit, the risk of inadvertent embolization to other organs is recognized. Laparoscopic uterine artery occlusion not only removes this concern but also returns to the practicing gynecologist the treatment of leiomyomas.

Moises Lichtinger, M.D., is a well-known advocate of laparoscopic uterine artery occlusion for the symptomatic uterine fibroid. Not only has he worked to develop a safe and reproducible technique for the laparoscopic approach, but he is researching a transvaginal approach to uterine artery occlusion as well, in cooperation with Vascular Control Systems of San Juan Capistrano, Calif.

Dr. Lichtinger currently chairs the department of obstetrics and gynecology at Holy Cross Hospital in Fort Lauderdale, Fla.

He received his undergraduate and M.D. degrees in Mexico and completed his internship and residency at Jackson Memorial Hospital in Miami. He remained at Jackson Memorial to complete a gynecologic oncology fellowship as well.

There was a time when almost all women with symptomatic leiomyomas were amenable to hysterectomy or myomectomy when medical therapy failed to relieve their pelvic pressure and pain, menorrhagia, and, in many cases, anemia.

Today, that has changed.

An increasing number of women don't want myomectomies or hysterectomies, regardless of whether they are performed abdominally or laparoscopically or—in the case of hysterectomies—vaginally. They go to the Internet and easily click on the names of 1,000 radiologists who promise a nonsurgical alternative that will “melt away” their fibroids.

Uterine artery embolization (UAE) involves making an incision in the groin and then threading a catheter through the femoral artery to the uterine artery to deliver thousands of polyvinyl particles into the uterus, as well as into the arteries, veins, and peripheral vessels that supply it. The intention is to cause transient uterine ischemia.

Originally used as a presurgical procedure to reduce blood loss during myomectomy or hysterectomy, UAE was also found to be effective in treating life-threatening bleeding that resulted from myomas. Success in controlling bleeding and improving symptoms led to its use as an alternative to primary surgery for leiomyomas in the late 1990s.

A recent surge in popularity was sparked by Food and Drug Administration approval of Embosphere microparticles for UAE and an aggressive marketing campaign by radiologists performing the procedure.

An Alternative to UAE

Laparoscopic uterine artery occlusion (UAO) offers a minimally invasive surgical option that also causes transient uterine ischemia and subsequent relief of leiomyoma symptoms, utilizing the same principles as UAE but permitting the gynecologic surgeon to inspect the uterine cavity, address other gynecologic issues, and rule out uterine cancer. Understanding either procedure requires a basic understanding of the principle behind bilateral UAO.

The uterine arteries provide most of the uterine blood supply. When this blood flow is blocked—either by polyvinyl microparticles, as in UAE, or by vascular clips during laparoscopic UAO—blood will then clot within the myometrium.

The myometrium becomes hypoxic and its metabolism undergoes a shift from oxidative pathways to anaerobic glycolysis.

Within hours to days, clots are lysed within the myometrium, and collateral arteries begin to reperfuse the uterus.

Myomas, in contrast, cannot lyse clotted blood and reperfuse. They eventually become infarcted and die.

In a proof-of-hypothesis study conducted by my colleagues and me several years ago, we found that the percentage and rate of decline and the return to baseline of pH (a proxy for hypoxia and lactic acidosis) after bilateral UAO were quite variable.

The myometrium has a complex, redundant blood supply that varies from patient to patient (J. Am. Assoc. Gynecol. Laparosc. 2003;10:553–66).

In the vast majority of women, these secondary, tertiary, and quaternary vascular pathways are insufficient to maintain aerobic metabolism.

In 1%–2% of women, however, one uterine artery is hypoplastic, and a large communicating artery connects the ovarian artery to the uterus. Without occlusion of this artery in these patients, the blood supply to the uterus would be maintained despite bilateral UAO.

In our study reviewing eight cases, the uterine pH change from baseline ranged from 0.4 to 1.7 units over a time period that ranged from 5 minutes to 210 minutes after bilateral UAO.

The time for pH to return to baseline ranged from 20 minutes to 660 minutes (J. Am. Assoc. Gynecol. Laparosc. 2002; 9:191–8).

Other investigators have shown via MRI that clots form more quickly in myomas (as indicated by uptake of contrast media) than in the myometrium, and myoma tissue remains unperfused at 1 year, even as myometrium demonstrates normal perfusion at 1, 2, 3, 4, and 6 months, and 1 year.

In our first study of laparoscopic UAO for symptomatic leiomyomas, we enrolled eight women whom we had counseled extensively about various alternatives, including gonadotropin-releasing hormones, hysterectomy, myomectomy, and embolization.

Operative Technique

The operative procedure is quite straightforward.

Patients are placed in dorsolithotomy position under general anesthesia. A Foley catheter is placed into the bladder. An examination is performed, followed by hysteroscopy, and—if warranted by findings—endometrial biopsies are performed. A uterine cannula is inserted for uterine manipulation.

Depending on uterine size, a 10-mm port is inserted using open technique in the umbilicus or the left upper abdominal quadrant.

For safety reasons, accessing the peritoneum above the psoas muscle prevents direct trauma to retroperitoneal vessels. Entering retroperitoneum lateral to the posterior broad ligament avoids uterine expansion.

Pneumoperitoneum is established under videolaparoscopic guidance. Two additional ports—one is a 5-mm port; the other is a 5-mm or 12-mm port—are then inserted under visualization bilaterally above the inferior epigastric vessels.

Use uterine countertraction on the ipsilateral side while identifying the round ligament. Incise the posterior broad ligament laterally next to the round ligament over the psoas muscle, using endoscopic scissors.

This will free periadnexal adhesions and release uterine lateral displacement from myomas; it also avoids injury to the femoral vessels.

Grasp the cut edges of peritoneum and pull them laterally. Dissect to below the round ligament and lateral to the uterus.

Identify the lateral umbilical ligaments—vestigial obliterated umbilical arteries that reflect from the anterior peritoneum and become retroperitoneal in this avascular area. Trace the fibrous white element cephalad.

When this ligament is pulled laterally, it is easy to visualize the origin of the uterine artery by following the fibrous, bloodless, obliterant hypogastric artery to the internal iliac artery. This artery is straight for the first 2–3 cm, where it can be seen pulsating; it then becomes tortuous and surrounded by veins as it crosses medially above the ureter. It is an extensible artery that tolerates significant maneuvers.

Apply two successive preloaded 5-mm or 10-mm vascular clips at an area that is devoid of venous plexus, further from the ureter and more lateral to the uterus than during laparoscopic hysterectomy.

We do not dissect the round ligaments, vesicouterine space, or ureters.

Blanching of the uterus can be observed once both arteries are occluded.

Manageable Complications

In our study, there were no perioperative complications, and estimated blood loss was less than 25 dL in all cases. The average operating time was 35 minutes, which we have now reduced to 20 minutes in our current experience of more than 100 cases.

Postoperative pain was managed by nonsteroidal anti-inflammatory drugs in all but one case, a patient who requested parenteral narcotic analgesia in the recovery room. In our more recent experience, the majority of patients require only ibuprofen, with an occasional use of Vicodin or Tylenol #3. The study patients were discharged after 12–20 hours, a period primarily for monitoring purposes related to the protocol; today, our patients go home the same day as their surgery.

Among eight patients in the study, seven reported complete resolution of fibroid-related pain at 3 months. One patient's pain declined from moderate to mild. These results have remained consistent in our larger series.

The five patients who previously reported menorrhagia reported eumenorrhea; no patients became amenorrheic. We have seen two patients in our larger series become menopausal, but both were older than 50 years at the time of surgery. None of the patients we have followed with FSH levels has lost ovarian function.

The average decrease in uterine volume at 3 months was 39.4%.

One of our patients has become pregnant and is currently doing well at 20 weeks' gestation.

Complications have been few. Among our original study patients, one passed round tissue vaginally 3 months postoperatively, but her white blood count was normal and she showed no signs of infection.

Simple endometrial adenomatous hyperplasia was diagnosed on the day of another patient's procedure; repeat office curettage showed benign endometrium 3 months later.

We bill for this procedure using code #37617 (ligation of major artery of the abdomen), after having obtained precertification with insurance companies. We have had no trouble being reimbursed for the procedure.

This procedure carries a very low risk of anesthesia complications, and abdominal entry injuries are possible.

Any procedure involving UAO has potential complications related to uterine ischemia.

Prolapse, vaginal expulsion of necrotic tissue, and pelvic infection are possible. Selecting patients who have adequate perfusion around myomas may decrease the risk of postocclusion infection.

Patient selection is also important with regard to myoma size. Laparoscopic visualization becomes difficult in patients beyond a 20-week gestation uterine size, and we therefore refer these patients for embolization if they will not consider myomectomy or hysterectomy.

A Comparison of the Two Procedures

As opposed to radiologic embolization, which is a blind procedure, laparoscopic UAO offers an opportunity to diagnose endometrial cancer and sarcomas via fine-needle aspiration and myometrial biopsy.

Additionally, it can be offered as a global treatment for gynecologic complaints other than leiomyomas.

The majority of patients who are candidates for these procedures also have adhesions and/or endometriosis that may be a cocontributor to their pelvic pain.

In conclusion, we have found that the risks of laparoscopic UAO are minimal, and the benefits to carefully selected patients are considerable.

By contrast, radiologic UAE is a simple procedure that has been proven efficacious for reducing symptoms. It is not, however, without risks.

Misembolization has been reported to the collateral uterine-ovarian vessel and the legs. Unintended embolization can lead to ovarian failure in 1%–4% of cases.

Pain is a considerable feature of the procedure, both from hypoxia and cramping, as the uterus attempts to expel the polyvinyl pellets. Many patients remain in the hospital for 23 hours on a morphine pump.

Up to 15% of patients experience postembolization syndrome, characterized by fever, anorexia, and nausea/vomiting.

Most importantly, radiologic UAE can be performed in patients with undiagnosed cancer that can evade diagnosis for many months.

There are several reports of embolization in a patient with undiagnosed uterine sarcoma.

Endometrial biopsy and MRI can assist in the presurgical diagnosis of sarcoma; however, the laparoscopic approach is clearly more thorough in ruling out cancer.

The only real obstacle to widespread use of laparoscopic UAO is the dearth of advanced laparoscopic surgery training among U.S. gynecologic surgeons. This is a retroperitoneal vascular procedure, requiring skillful knowledge of the vascular anatomy.

Future Vaginal Approach?

Because there appears to be a need for a gynecologic alternative to the increasingly popular radiologic UAE, I have recently been working with colleagues and a private company—Vascular Control Systems of San Juan Capistrano, Calif.—to develop a technique to temporarily occlude the uterine arteries with a Doppler-guided, uterine artery clamp using a vaginal approach.

This procedure is still experimental, and we have thus far achieved fibroid shrinkage of approximately 30%. A clinical trial is under way to advance and improve this technique.

In this view of the left retroperitoneum, two 5-mm endoscopic clips occlude the proximal portion of the left uterine artery.

This uterus is blanched as a result of hypoperfusion and ischemia after laparoscopic bilateral uterine artery occlusion. Photos courtesy Dr. Moises Lichtinger

Gynecologists Strike Back With Laparoscopic Uterine Artery Occlusion

One only needs to check the Internet to see how aggressively our colleagues in radiology are marketing uterine artery embolization/uterine fibroid embolization.

Although the radiologic approach certainly has merit, the risk of inadvertent embolization to other organs is recognized. Laparoscopic uterine artery occlusion not only removes this concern but also returns to the practicing gynecologist the treatment of leiomyomas.

Moises Lichtinger, M.D., is a well-known advocate of laparoscopic uterine artery occlusion for the symptomatic uterine fibroid. Not only has he worked to develop a safe and reproducible technique for the laparoscopic approach, but he is researching a transvaginal approach to uterine artery occlusion as well, in cooperation with Vascular Control Systems of San Juan Capistrano, Calif.

Dr. Lichtinger currently chairs the department of obstetrics and gynecology at Holy Cross Hospital in Fort Lauderdale, Fla.

He received his undergraduate and M.D. degrees in Mexico and completed his internship and residency at Jackson Memorial Hospital in Miami. He remained at Jackson Memorial to complete a gynecologic oncology fellowship as well.

There was a time when almost all women with symptomatic leiomyomas were amenable to hysterectomy or myomectomy when medical therapy failed to relieve their pelvic pressure and pain, menorrhagia, and, in many cases, anemia.

Today, that has changed.

An increasing number of women don't want myomectomies or hysterectomies, regardless of whether they are performed abdominally or laparoscopically or—in the case of hysterectomies—vaginally. They go to the Internet and easily click on the names of 1,000 radiologists who promise a nonsurgical alternative that will “melt away” their fibroids.

Uterine artery embolization (UAE) involves making an incision in the groin and then threading a catheter through the femoral artery to the uterine artery to deliver thousands of polyvinyl particles into the uterus, as well as into the arteries, veins, and peripheral vessels that supply it. The intention is to cause transient uterine ischemia.

Originally used as a presurgical procedure to reduce blood loss during myomectomy or hysterectomy, UAE was also found to be effective in treating life-threatening bleeding that resulted from myomas. Success in controlling bleeding and improving symptoms led to its use as an alternative to primary surgery for leiomyomas in the late 1990s.

A recent surge in popularity was sparked by Food and Drug Administration approval of Embosphere microparticles for UAE and an aggressive marketing campaign by radiologists performing the procedure.

An Alternative to UAE

Laparoscopic uterine artery occlusion (UAO) offers a minimally invasive surgical option that also causes transient uterine ischemia and subsequent relief of leiomyoma symptoms, utilizing the same principles as UAE but permitting the gynecologic surgeon to inspect the uterine cavity, address other gynecologic issues, and rule out uterine cancer. Understanding either procedure requires a basic understanding of the principle behind bilateral UAO.

The uterine arteries provide most of the uterine blood supply. When this blood flow is blocked—either by polyvinyl microparticles, as in UAE, or by vascular clips during laparoscopic UAO—blood will then clot within the myometrium.

The myometrium becomes hypoxic and its metabolism undergoes a shift from oxidative pathways to anaerobic glycolysis.

Within hours to days, clots are lysed within the myometrium, and collateral arteries begin to reperfuse the uterus.

Myomas, in contrast, cannot lyse clotted blood and reperfuse. They eventually become infarcted and die.

In a proof-of-hypothesis study conducted by my colleagues and me several years ago, we found that the percentage and rate of decline and the return to baseline of pH (a proxy for hypoxia and lactic acidosis) after bilateral UAO were quite variable.

The myometrium has a complex, redundant blood supply that varies from patient to patient (J. Am. Assoc. Gynecol. Laparosc. 2003;10:553–66).

In the vast majority of women, these secondary, tertiary, and quaternary vascular pathways are insufficient to maintain aerobic metabolism.

In 1%–2% of women, however, one uterine artery is hypoplastic, and a large communicating artery connects the ovarian artery to the uterus. Without occlusion of this artery in these patients, the blood supply to the uterus would be maintained despite bilateral UAO.

In our study reviewing eight cases, the uterine pH change from baseline ranged from 0.4 to 1.7 units over a time period that ranged from 5 minutes to 210 minutes after bilateral UAO.

The time for pH to return to baseline ranged from 20 minutes to 660 minutes (J. Am. Assoc. Gynecol. Laparosc. 2002; 9:191–8).

Other investigators have shown via MRI that clots form more quickly in myomas (as indicated by uptake of contrast media) than in the myometrium, and myoma tissue remains unperfused at 1 year, even as myometrium demonstrates normal perfusion at 1, 2, 3, 4, and 6 months, and 1 year.

In our first study of laparoscopic UAO for symptomatic leiomyomas, we enrolled eight women whom we had counseled extensively about various alternatives, including gonadotropin-releasing hormones, hysterectomy, myomectomy, and embolization.

Operative Technique

The operative procedure is quite straightforward.

Patients are placed in dorsolithotomy position under general anesthesia. A Foley catheter is placed into the bladder. An examination is performed, followed by hysteroscopy, and—if warranted by findings—endometrial biopsies are performed. A uterine cannula is inserted for uterine manipulation.

Depending on uterine size, a 10-mm port is inserted using open technique in the umbilicus or the left upper abdominal quadrant.

For safety reasons, accessing the peritoneum above the psoas muscle prevents direct trauma to retroperitoneal vessels. Entering retroperitoneum lateral to the posterior broad ligament avoids uterine expansion.

Pneumoperitoneum is established under videolaparoscopic guidance. Two additional ports—one is a 5-mm port; the other is a 5-mm or 12-mm port—are then inserted under visualization bilaterally above the inferior epigastric vessels.

Use uterine countertraction on the ipsilateral side while identifying the round ligament. Incise the posterior broad ligament laterally next to the round ligament over the psoas muscle, using endoscopic scissors.

This will free periadnexal adhesions and release uterine lateral displacement from myomas; it also avoids injury to the femoral vessels.

Grasp the cut edges of peritoneum and pull them laterally. Dissect to below the round ligament and lateral to the uterus.

Identify the lateral umbilical ligaments—vestigial obliterated umbilical arteries that reflect from the anterior peritoneum and become retroperitoneal in this avascular area. Trace the fibrous white element cephalad.

When this ligament is pulled laterally, it is easy to visualize the origin of the uterine artery by following the fibrous, bloodless, obliterant hypogastric artery to the internal iliac artery. This artery is straight for the first 2–3 cm, where it can be seen pulsating; it then becomes tortuous and surrounded by veins as it crosses medially above the ureter. It is an extensible artery that tolerates significant maneuvers.

Apply two successive preloaded 5-mm or 10-mm vascular clips at an area that is devoid of venous plexus, further from the ureter and more lateral to the uterus than during laparoscopic hysterectomy.

We do not dissect the round ligaments, vesicouterine space, or ureters.

Blanching of the uterus can be observed once both arteries are occluded.

Manageable Complications

In our study, there were no perioperative complications, and estimated blood loss was less than 25 dL in all cases. The average operating time was 35 minutes, which we have now reduced to 20 minutes in our current experience of more than 100 cases.

Postoperative pain was managed by nonsteroidal anti-inflammatory drugs in all but one case, a patient who requested parenteral narcotic analgesia in the recovery room. In our more recent experience, the majority of patients require only ibuprofen, with an occasional use of Vicodin or Tylenol #3. The study patients were discharged after 12–20 hours, a period primarily for monitoring purposes related to the protocol; today, our patients go home the same day as their surgery.

Among eight patients in the study, seven reported complete resolution of fibroid-related pain at 3 months. One patient's pain declined from moderate to mild. These results have remained consistent in our larger series.

The five patients who previously reported menorrhagia reported eumenorrhea; no patients became amenorrheic. We have seen two patients in our larger series become menopausal, but both were older than 50 years at the time of surgery. None of the patients we have followed with FSH levels has lost ovarian function.

The average decrease in uterine volume at 3 months was 39.4%.

One of our patients has become pregnant and is currently doing well at 20 weeks' gestation.

Complications have been few. Among our original study patients, one passed round tissue vaginally 3 months postoperatively, but her white blood count was normal and she showed no signs of infection.

Simple endometrial adenomatous hyperplasia was diagnosed on the day of another patient's procedure; repeat office curettage showed benign endometrium 3 months later.

We bill for this procedure using code #37617 (ligation of major artery of the abdomen), after having obtained precertification with insurance companies. We have had no trouble being reimbursed for the procedure.

This procedure carries a very low risk of anesthesia complications, and abdominal entry injuries are possible.

Any procedure involving UAO has potential complications related to uterine ischemia.

Prolapse, vaginal expulsion of necrotic tissue, and pelvic infection are possible. Selecting patients who have adequate perfusion around myomas may decrease the risk of postocclusion infection.

Patient selection is also important with regard to myoma size. Laparoscopic visualization becomes difficult in patients beyond a 20-week gestation uterine size, and we therefore refer these patients for embolization if they will not consider myomectomy or hysterectomy.

A Comparison of the Two Procedures

As opposed to radiologic embolization, which is a blind procedure, laparoscopic UAO offers an opportunity to diagnose endometrial cancer and sarcomas via fine-needle aspiration and myometrial biopsy.

Additionally, it can be offered as a global treatment for gynecologic complaints other than leiomyomas.

The majority of patients who are candidates for these procedures also have adhesions and/or endometriosis that may be a cocontributor to their pelvic pain.

In conclusion, we have found that the risks of laparoscopic UAO are minimal, and the benefits to carefully selected patients are considerable.

By contrast, radiologic UAE is a simple procedure that has been proven efficacious for reducing symptoms. It is not, however, without risks.

Misembolization has been reported to the collateral uterine-ovarian vessel and the legs. Unintended embolization can lead to ovarian failure in 1%–4% of cases.

Pain is a considerable feature of the procedure, both from hypoxia and cramping, as the uterus attempts to expel the polyvinyl pellets. Many patients remain in the hospital for 23 hours on a morphine pump.

Up to 15% of patients experience postembolization syndrome, characterized by fever, anorexia, and nausea/vomiting.

Most importantly, radiologic UAE can be performed in patients with undiagnosed cancer that can evade diagnosis for many months.

There are several reports of embolization in a patient with undiagnosed uterine sarcoma.

Endometrial biopsy and MRI can assist in the presurgical diagnosis of sarcoma; however, the laparoscopic approach is clearly more thorough in ruling out cancer.

The only real obstacle to widespread use of laparoscopic UAO is the dearth of advanced laparoscopic surgery training among U.S. gynecologic surgeons. This is a retroperitoneal vascular procedure, requiring skillful knowledge of the vascular anatomy.

Future Vaginal Approach?

Because there appears to be a need for a gynecologic alternative to the increasingly popular radiologic UAE, I have recently been working with colleagues and a private company—Vascular Control Systems of San Juan Capistrano, Calif.—to develop a technique to temporarily occlude the uterine arteries with a Doppler-guided, uterine artery clamp using a vaginal approach.

This procedure is still experimental, and we have thus far achieved fibroid shrinkage of approximately 30%. A clinical trial is under way to advance and improve this technique.

In this view of the left retroperitoneum, two 5-mm endoscopic clips occlude the proximal portion of the left uterine artery.

This uterus is blanched as a result of hypoperfusion and ischemia after laparoscopic bilateral uterine artery occlusion. Photos courtesy Dr. Moises Lichtinger

Gynecologists Strike Back With Laparoscopic Uterine Artery Occlusion

One only needs to check the Internet to see how aggressively our colleagues in radiology are marketing uterine artery embolization/uterine fibroid embolization.

Although the radiologic approach certainly has merit, the risk of inadvertent embolization to other organs is recognized. Laparoscopic uterine artery occlusion not only removes this concern but also returns to the practicing gynecologist the treatment of leiomyomas.

Moises Lichtinger, M.D., is a well-known advocate of laparoscopic uterine artery occlusion for the symptomatic uterine fibroid. Not only has he worked to develop a safe and reproducible technique for the laparoscopic approach, but he is researching a transvaginal approach to uterine artery occlusion as well, in cooperation with Vascular Control Systems of San Juan Capistrano, Calif.

Dr. Lichtinger currently chairs the department of obstetrics and gynecology at Holy Cross Hospital in Fort Lauderdale, Fla.

He received his undergraduate and M.D. degrees in Mexico and completed his internship and residency at Jackson Memorial Hospital in Miami. He remained at Jackson Memorial to complete a gynecologic oncology fellowship as well.

Safe laparoscopic access begins before an incision is ever made.

It begins when you review the patient's history, which includes any pertinent previous surgeries. It extends to the examination, which should rule out pelvic or abdominal masses, hepatomegaly, or an enlarged spleen. If questions about the patient's anatomy arise, imaging may be helpful. I recently had an in vitro fertilization patient with ovarian torsion for whom ultrasound was needed to locate the limits of the ovaries, which reached the umbilicus.

During surgical preparation in the operating room, the patient's bladder should be drained with a Foley catheter to ensure that it is deflated; otherwise, it may extend into the operative field and be punctured on initial access. The anesthesiologist should drain the stomach contents with oral or nasogastric suction.

Optimal patient positioning is critical.

Keep the table at waist height. You want the movement of the trocar to be as controlled as possible, optimizing proprioception and fine muscle control of your hand so that the entry force arises from small, controlled muscle movements of the forearm, hand, and wrist—not from large, less-controlled movements from your shoulder girdle. By keeping your forearms perpendicular to the patient, the force is directed along the axis of the trocar. It is essential that you maintain control of that force upon entry, so that you neither push the trocar too far nor exert lateral force.

Ensure that the table is flat. Placing the patient into premature Trendelenburg's position will change the physical relationship of the major vessels. The patient's body should lie flat from left to right to allow better anticipation of the side wall and iliac vessels.

There are several schools of thought regarding trocar placement. I enter directly in the center of the umbilicus. Some surgeons prefer an infraumbilical approach; however, I have never seen a wound infection in the center of the umbilicus when it has been meticulously disinfected with swabs during preparation of the patient. Here in the center of the umbilicus, the abdominal wall is at its thinnest, and all layers of the abdominal wall are fused. Above or below the umbilicus, there are thicker, unfused layers of tissue that are more difficult to cut through, increasing the risk of false passage.

Before initial trocar placement, palpate the promontory of the sacrum and the bifurcation of the aorta, which may be above (in most cases), at the level of, or even below the umbilicus, and make a mental map of your entry angle.

When you prepare to enter, place the trocars perfectly centrally from right to left and perpendicular to the skin; do not angle them laterally. Maintain control over the angle as you push. Iliac vessel injuries can occur when the surgeon thinks the trocar is straight, but the angle of his or her hand shifts as more force is applied. It is difficult to push straight down with force. A right-handed surgeon will tend to angle to the left; a left-handed surgeon will tend to angle to the right. Recognize this tendency and avoid it.

Remember that the abdominal-peritoneal cavity is a potential space until you enter and air or gas is allowed to enter. During initial entry, keep the valve to the Veress or trocar open so that air can enter and allow organs to fall away from the abdominal wall. At this point, it is crucial to elevate the anterior abdominal wall as much as possible, either by hand or with towel clips. On my side of the patient, I grasp the anterior wall very firmly with my hand lateral to the umbilicus while, on the other side, my assistant elevates the wall with her hand lateral to the umbilicus. I find that this technique allows sharp retraction more effectively than grasping singly inferior to the umbilicus.

Other surgeons prefer to use two perforating towel clips on the umbilical ring. During your next case, when the laparoscope is already in, try different methods of abdominal wall elevation and see which grasping strategy lifts the abdominal wall most effectively in your hands.

Keep in mind that you may have to adjust your angle of entry depending on the patient's degree of obesity; otherwise, you may find yourself tunneling in subcutaneous fat. The more obese the patient, the more perpendicular the angle of your initial entry should be.

Although you do have to tailor your technique to the obese patient's anatomy, obesity generally is not a contraindication to laparoscopic surgery. Surgical and postsurgical risks are elevated in obese patients; however, open surgery poses significant risks to these patients as well.

With very thin patients, use less force, as the distance from the abdominal wall to retroperitoneal structures is closer, and injuries from hitting the posterior retroperitoneum are more likely.

There are various methods to ensure that the initial entry into the peritoneal cavity is correct and that no injury occurs. None of these methods is foolproof. I most often use a radially dilating trocar inserted over a Veress needle. It is inserted initially with the valve open, so that air can enter and open up the potential space. Then, I inject saline and assess whether it flows easily. Next, I aspirate, checking for blood, feces, or saline from the subcutaneous space. I add a drop of saline as I lift up on the abdominal wall to perform the hanging-drop test. None of these maneuvers has good sensitivity or specificity.

The single most useful test to confirm correct intraperitoneal placement is the observation of low entry pressure from the carbon-dioxide gas. The observation of an initially negative pressure with elevation of the abdominal wall is reassuring as well. Some surgeons prefer to increase distention pressure for subsequent trocar placement.

Another method I sometimes use involves direct entry with a microlaparoscope. Insert a Veress needle with a 2-mm or 3-mm trocar over it and directly look inside with a 2-mm or 3-mm laparoscope before insufflation. In this method, elevation of the abdominal wall by hand is crucial for visualization.

Patients with a history of surgery may have adhesions at or near the umbilicus. Although various alternative sites have been suggested, the one that provides the lowest-risk access in the majority of patients is the left upper quadrant at Palmer's point, the midclavicular line below the left lowermost inferior rib. In almost all patients, even those who've had many previous surgeries, this area will be free of adhesions.

This entry site is close to the stomach, so make sure the anesthesiologist has suctioned stomach contents before surgery. Splenomegaly could complicate entry at this site.

At this site the abdominal wall is much thicker, and you will lose the typical feel of an umbilical entry. Go in carefully and in a completely controlled manner with an adjusted angle of entry. I prefer to use a microlaparoscopic entry here, although some surgeons use a Veress needle and trocar.

The open-entry technique—also called the Hasson technique—was developed in the early 1970s to mimic the steps of entry during an open surgery but with a 10-mm incision. The surgeon makes an incision in the umbilicus and dissects down layer by layer until the peritoneum is entered. The fascia is often tagged with sutures for elevation, and a blunt-tipped trocar is inserted.

The benefit of this approach is that it eliminates the step of blindly inserting something into the abdominal cavity. The drawback is that cutting and dissecting can still cause injury to underlying or adherent vital structures and may result in larger injuries in these cases.

Bowel injuries from adhesions have been reported with all known techniques.

Obviously, it would be helpful to know which technique is safest based on a well-designed, randomized, controlled trial, as most experts believe injuries from all techniques are underreported. However, significant injuries are so rare that one study reported a power analysis indicating that it would require more than 200,000 surgeries to show a 50% reduction in injuries. Most reports suggest that visceral injuries (primarily bowel injuries) occur less than 1% of the time with either an open- or closed-entry technique. A study from the Netherlands found no statistical difference between the two techniques.

Vascular injuries are even rarer than that. Advocates of open techniques suggest fewer vascular injuries occur with these techniques, but not statistically significantly so.

Recently, new trocars have been introduced that are aimed at improving safety. These devices include optical and radially dilating trocars and trocarless systems that screw or dilate their way into the abdomen. As these have come into more widespread use, injuries have been reported with them as well. It remains to be seen whether injury rates will decline significantly with other new alternatives.

Complications of laparoscopic surgery can occur when bowel or vascular injuries go unrecognized at the time of surgery. Vascular injuries can cause hemorrhage and hemodynamic instability. Retroperitoneal hematomas, in particular, can be missed unless the surgeon inspects for the presence of a large, expanding mass.

Bowel injuries may be difficult to see if the injury is small. Urinary tract injuries can also be subtle. Detection of these complications requires diligent postoperative follow-up and instructions to the patient that she should report postoperative fever, increasing pain, abdominal distention, vomiting, or heavy incisional bleeding. Be suspicious if any patient is not recovering as quickly as expected. Although most of us would recognize complications occurring within 24 hours, signs may not appear for up to a week after the procedure. Some patients with bowel perforation had no elevations in white blood count or fever at their initial postoperative checkups. The most serious complications have occurred when injuries went unrecognized.

In laparoscopic surgery, the most damage may occur during entry. Fortunately, such damage is almost totally avoidable if you use the proper techniques, a well-thought-out point of entry, and the safest equipment available.

I know laparoscopic surgeons who use a blind, primary trocar entry technique using no insufflation. They can all recount the number of cases they've done without a major adverse event; one surgeon proudly told me he “put a little nick in the common iliac artery with an accessory port” and solved the problem with rapid action and a quick stitch.

My response is that these surgeons have either been very lucky or simply haven't done enough procedures for the inevitable disasters to catch up with them. I am absolutely opposed to blindly putting large spikes into the abdomen, and I think doing so is an approach that should be condemned.

As laparoscopic surgeons, we generally operate on young, healthy patients, sometimes for elective reasons. The potential for tragedy here is great, and it makes no sense to risk lives and great bodily injury when safe and predictable alternatives are available. I conceptualize safe access by breaking it down into three precise goals:

▸ Avoiding damage to the anterior abdominal wall.

▸ Avoiding intraabdominal structures.

▸ Avoiding retroperitoneal structures. These goals are accomplished by using the most appropriate instruments available, such as a dilating trocar and adjunctive 2-mm laparoscope; choosing the optimal entry site; and properly insufflating the abdomen.

Anterior wall tissue damage can be greatly minimized by using expanding trocars that stretch the tissue rather than cut it. Many companies make disposable dilating trocars.

The reusable radially expanding system from Tyco has a sleeve that is passed into the abdominal cavity over a Veress needle; it is dilated solely with lateral pressure or force. No downward force is applied to the patient's abdomen.

When the tissue is stretched, less damage is done, less pain is caused, recovery is quicker, and the long-term risk of hernia formation is lower.

Avoiding intraabdominal structures is a matter of entry location. I agree with Dr. Palter that the thinnest tissue underlies the umbilicus, and that's where I like to place my primary port. But unfortunately, major vessels—and often adhesions—also directly underlie this spot. It's the place where laparoscopic entry is most likely to kill a patient, and I enter it only under direct visualization.

Several studies have assessed the rate of abdominal adhesions in patients who have had previous surgery. In a 1997 study, none of 45 patients had adhesions after laparoscopy, 17 of 29 had adhesions after a midvertical incision, and 11 of 39 had adhesions after a low transverse incision (J. Am. Assoc. Gynecol. Laparosc. 1997;4:353–6).

French gynecologic surgeon Alain Audebert, M.D., described adhesions in 331 patients with prior surgery. Adhesions were present in half of patients with a prior midline incision, in 21% with a lower transverse incision, and 1.8% of patients with prior laparoscopic surgery had adhesions. Even among 440 patients with no prior surgery, the rate of adhesions was 0.6%.

In a recent study of 100 of my own patients, I found adhesion formation in 16 of 36 who had midline incisions, 20 of 45 who had transverse incisions, and 7 of 19 who had other incisions.

Although it's rare, I recently operated on a patient whose only previous surgery was laparoscopic and even she had an adhesion directly under the umbilicus.

On the other hand, it is extremely rare for surgical adhesions to form over the left upper quadrant of the abdomen, because the gallbladder and appendix lie on the other side. Only trauma surgery or splenectomies are likely to result in adhesions at this anatomical location, which was first described as an entry site by Raoul Palmer, M.D., in 1972. Furthermore, although central obesity can complicate initial access at the umbilicus, the lower margin of the rib cage in the midclavicular line almost always can be palpated, providing a landmark structure for entry at this site.

It is for all these reasons that I favor a left upper quadrant entry—not just in special cases, as Dr. Palter suggested, but as a matter of routine. I have performed approximately 500 laparoscopic procedures using this approach; Dr. Audebert has performed more than 2,000.

Patients receive a nasogastric tube so that their stomachs can be emptied before the procedure to reduce the chance of this underlying organ being damaged, although a needle injury to the stomach or liver is not a major complication.

Splenomegaly is a contraindication.

I palpate the edge of the ribs at the midclavicular line at the costal margin and carefully slide a #11 blade right along the lowermost rib to create an incision only large enough to accommodate a 2-mm scope. This incision will require no stitch—just a Steri-strip—to close.

I insert a Veress needle perpendicularly, feeding it through the abdominal wall with my finger and thumb. It's a very tactile move. You should feel the clicks.

Precisely because entry at this site feels different from entry at the umbilicus, I favor doing the entry this way every time; you learn the feel of doing it right.

I then inject saline through the needle and aspirate. If solution has entered the abdominal cavity, I don't get it back. If I had entered the bowel, the return would be greenish brown or blood-tinged, and further evaluation would be required.

I then insufflate the abdomen with enough carbon dioxide to increase the intraabdominal pressure to 25 mm Hg. The volume required will vary from patient to patient. A postpartum patient may require 12 L of carbon dioxide to reach that degree of pressure; a marathon runner with a tight abdomen may get there with 4 L.

This step accomplishes the third goal: optimizing conditions to avoid retroperitoneal structures, the major vessels.

When intraabdominal pressure is at only 12 mm Hg, the abdominal wall is very close to bowel, leaving no room for error. Increased pressure leaves a bigger space between the anterior abdominal wall and the intraabdominal and retroperitoneal structures, providing a comfortable margin of safety. This is especially critical in very thin patients, whose major vessels may lie very close to the anterior abdominal wall.

Through the same small, upper-left quadrant incision, I insert a 2-mm trocar and cannula for a small laparoscope to inspect the abdomen, identify the inferior epigastric vessel, assess the location of any adhesions, and ensure that no structures have been damaged or are in the path of any intended trocar site.

For some cases, such as tubal ligation, it is possible to use this as the primary port.

More commonly, it is at this point that I determine whether I can place my primary port in the umbilicus, and I do so under direct visualization before proceeding with my surgical procedure.

It is widely believed that laparoscopic surgery injuries are underreported. Nonetheless, patterns can be determined.

A prospective, multicenter study of complications of laparoscopy conducted in the Netherlands identified 29 bowel injuries and 27 major vessel injuries in 25,764 procedures for an identical rate of 0.11%.

More importantly, with regard to entry technique, Richard Soderstrom, M.D., found in a medicolegal review that the primary port was responsible for half of all major vascular injuries during 47 endoscopic cases (J. Am. Assoc. Gynecol. Laparosc. 1997;4:395–8).

A review of malpractice cases after 296 laparoscopic cholecystectomies performed using a primary umbilical entry site found that 86% of major vascular injuries were caused by the primary port and 75% of gastrointestinal injuries were caused by a trocar (J. Gastrointest. Surg. 1997;1:138–45).

Bowel injuries can occur with any laparoscopic technique and with laparotomy as well; some studies suggest a greater risk of injury with the latter approach. Because no method has been devised to completely avoid these injuries, the key is to recognize them, either at the time of surgery, or when the patient fails to improve as expected during the postsurgical course.

We have the potential to entirely avoid major vascular injuries by use of upper left quadrant entry before placement of a central port at the umbilicus and placement of accessory trocars.

By combining appropriate entry tools, a left upper quadrant entry site, and adequate insufflation of the abdomen, risks can be reduced at every step of laparoscopic surgery.

Dr. Duncan Turner, who is performing this procedure, prefers an entry site in the left upper quadrant to avoid major structures and potential adhesions from previous surgery.

Direct visualization and adequate insufflation leave plenty of room for error when the trocar enters the intraabdominal space as shown in this image. Photos courtesy Dr. Duncan Turner

'Do No Harm'

Physician, do no harm is a credo all gynecologic surgeons must live by. Nowhere do these words ring more true than during laparoscopic surgery. With the slightest lapse in technique, the simplest of laparoscopic procedures can quickly become a nightmare both for the patient as well as the surgeon. And when is the greatest risk of injury during a laparoscopic procedure? At entry.

I have invited an expert from each coast to serve as guides to safe access into the pelvic cavity via the laparoscope. Steven F. Palter, M.D., practices reproductive medicine and gynecologic surgery at Gold Coast IVF in Syosset, N.Y.

He is an immediate past member of the board of trustees of the AAGL. Over the years, Dr. Palter has won first prize awards for presentations at three separate world congress venues: at meetings of the American Society for Reproductive Medicine, the American Urological Association, and the AAGL, where he won first prize awards twice.

Dr Palter has been a longtime advocate of safe laparoscopic access, stemming from his background in office-based laparoscopy. From 1995 to 2001, Steve served as the director of the Yale Office Laparoscopy Program.

Duncan Turner, M.D., is a current member of the board of the International Society for Gynecologic Endoscopy. He is in private practice in Santa Barbara, Calif. Duncan first lectured on avoiding trocar-related injuries in 1995 at the World Congress of Gynecologic Laparoscopy in Israel.

Since then, not only has he lectured throughout the world, but he has been involved in trocar development and evaluation as well.

Safe laparoscopic access begins before an incision is ever made.

It begins when you review the patient's history, which includes any pertinent previous surgeries. It extends to the examination, which should rule out pelvic or abdominal masses, hepatomegaly, or an enlarged spleen. If questions about the patient's anatomy arise, imaging may be helpful. I recently had an in vitro fertilization patient with ovarian torsion for whom ultrasound was needed to locate the limits of the ovaries, which reached the umbilicus.

During surgical preparation in the operating room, the patient's bladder should be drained with a Foley catheter to ensure that it is deflated; otherwise, it may extend into the operative field and be punctured on initial access. The anesthesiologist should drain the stomach contents with oral or nasogastric suction.

Optimal patient positioning is critical.

Keep the table at waist height. You want the movement of the trocar to be as controlled as possible, optimizing proprioception and fine muscle control of your hand so that the entry force arises from small, controlled muscle movements of the forearm, hand, and wrist—not from large, less-controlled movements from your shoulder girdle. By keeping your forearms perpendicular to the patient, the force is directed along the axis of the trocar. It is essential that you maintain control of that force upon entry, so that you neither push the trocar too far nor exert lateral force.

Ensure that the table is flat. Placing the patient into premature Trendelenburg's position will change the physical relationship of the major vessels. The patient's body should lie flat from left to right to allow better anticipation of the side wall and iliac vessels.

There are several schools of thought regarding trocar placement. I enter directly in the center of the umbilicus. Some surgeons prefer an infraumbilical approach; however, I have never seen a wound infection in the center of the umbilicus when it has been meticulously disinfected with swabs during preparation of the patient. Here in the center of the umbilicus, the abdominal wall is at its thinnest, and all layers of the abdominal wall are fused. Above or below the umbilicus, there are thicker, unfused layers of tissue that are more difficult to cut through, increasing the risk of false passage.

Before initial trocar placement, palpate the promontory of the sacrum and the bifurcation of the aorta, which may be above (in most cases), at the level of, or even below the umbilicus, and make a mental map of your entry angle.

When you prepare to enter, place the trocars perfectly centrally from right to left and perpendicular to the skin; do not angle them laterally. Maintain control over the angle as you push. Iliac vessel injuries can occur when the surgeon thinks the trocar is straight, but the angle of his or her hand shifts as more force is applied. It is difficult to push straight down with force. A right-handed surgeon will tend to angle to the left; a left-handed surgeon will tend to angle to the right. Recognize this tendency and avoid it.

Remember that the abdominal-peritoneal cavity is a potential space until you enter and air or gas is allowed to enter. During initial entry, keep the valve to the Veress or trocar open so that air can enter and allow organs to fall away from the abdominal wall. At this point, it is crucial to elevate the anterior abdominal wall as much as possible, either by hand or with towel clips. On my side of the patient, I grasp the anterior wall very firmly with my hand lateral to the umbilicus while, on the other side, my assistant elevates the wall with her hand lateral to the umbilicus. I find that this technique allows sharp retraction more effectively than grasping singly inferior to the umbilicus.

Other surgeons prefer to use two perforating towel clips on the umbilical ring. During your next case, when the laparoscope is already in, try different methods of abdominal wall elevation and see which grasping strategy lifts the abdominal wall most effectively in your hands.

Keep in mind that you may have to adjust your angle of entry depending on the patient's degree of obesity; otherwise, you may find yourself tunneling in subcutaneous fat. The more obese the patient, the more perpendicular the angle of your initial entry should be.

Although you do have to tailor your technique to the obese patient's anatomy, obesity generally is not a contraindication to laparoscopic surgery. Surgical and postsurgical risks are elevated in obese patients; however, open surgery poses significant risks to these patients as well.

With very thin patients, use less force, as the distance from the abdominal wall to retroperitoneal structures is closer, and injuries from hitting the posterior retroperitoneum are more likely.

There are various methods to ensure that the initial entry into the peritoneal cavity is correct and that no injury occurs. None of these methods is foolproof. I most often use a radially dilating trocar inserted over a Veress needle. It is inserted initially with the valve open, so that air can enter and open up the potential space. Then, I inject saline and assess whether it flows easily. Next, I aspirate, checking for blood, feces, or saline from the subcutaneous space. I add a drop of saline as I lift up on the abdominal wall to perform the hanging-drop test. None of these maneuvers has good sensitivity or specificity.

The single most useful test to confirm correct intraperitoneal placement is the observation of low entry pressure from the carbon-dioxide gas. The observation of an initially negative pressure with elevation of the abdominal wall is reassuring as well. Some surgeons prefer to increase distention pressure for subsequent trocar placement.

Another method I sometimes use involves direct entry with a microlaparoscope. Insert a Veress needle with a 2-mm or 3-mm trocar over it and directly look inside with a 2-mm or 3-mm laparoscope before insufflation. In this method, elevation of the abdominal wall by hand is crucial for visualization.

Patients with a history of surgery may have adhesions at or near the umbilicus. Although various alternative sites have been suggested, the one that provides the lowest-risk access in the majority of patients is the left upper quadrant at Palmer's point, the midclavicular line below the left lowermost inferior rib. In almost all patients, even those who've had many previous surgeries, this area will be free of adhesions.

This entry site is close to the stomach, so make sure the anesthesiologist has suctioned stomach contents before surgery. Splenomegaly could complicate entry at this site.

At this site the abdominal wall is much thicker, and you will lose the typical feel of an umbilical entry. Go in carefully and in a completely controlled manner with an adjusted angle of entry. I prefer to use a microlaparoscopic entry here, although some surgeons use a Veress needle and trocar.

The open-entry technique—also called the Hasson technique—was developed in the early 1970s to mimic the steps of entry during an open surgery but with a 10-mm incision. The surgeon makes an incision in the umbilicus and dissects down layer by layer until the peritoneum is entered. The fascia is often tagged with sutures for elevation, and a blunt-tipped trocar is inserted.

The benefit of this approach is that it eliminates the step of blindly inserting something into the abdominal cavity. The drawback is that cutting and dissecting can still cause injury to underlying or adherent vital structures and may result in larger injuries in these cases.

Bowel injuries from adhesions have been reported with all known techniques.

Obviously, it would be helpful to know which technique is safest based on a well-designed, randomized, controlled trial, as most experts believe injuries from all techniques are underreported. However, significant injuries are so rare that one study reported a power analysis indicating that it would require more than 200,000 surgeries to show a 50% reduction in injuries. Most reports suggest that visceral injuries (primarily bowel injuries) occur less than 1% of the time with either an open- or closed-entry technique. A study from the Netherlands found no statistical difference between the two techniques.

Vascular injuries are even rarer than that. Advocates of open techniques suggest fewer vascular injuries occur with these techniques, but not statistically significantly so.

Recently, new trocars have been introduced that are aimed at improving safety. These devices include optical and radially dilating trocars and trocarless systems that screw or dilate their way into the abdomen. As these have come into more widespread use, injuries have been reported with them as well. It remains to be seen whether injury rates will decline significantly with other new alternatives.

Complications of laparoscopic surgery can occur when bowel or vascular injuries go unrecognized at the time of surgery. Vascular injuries can cause hemorrhage and hemodynamic instability. Retroperitoneal hematomas, in particular, can be missed unless the surgeon inspects for the presence of a large, expanding mass.

Bowel injuries may be difficult to see if the injury is small. Urinary tract injuries can also be subtle. Detection of these complications requires diligent postoperative follow-up and instructions to the patient that she should report postoperative fever, increasing pain, abdominal distention, vomiting, or heavy incisional bleeding. Be suspicious if any patient is not recovering as quickly as expected. Although most of us would recognize complications occurring within 24 hours, signs may not appear for up to a week after the procedure. Some patients with bowel perforation had no elevations in white blood count or fever at their initial postoperative checkups. The most serious complications have occurred when injuries went unrecognized.

In laparoscopic surgery, the most damage may occur during entry. Fortunately, such damage is almost totally avoidable if you use the proper techniques, a well-thought-out point of entry, and the safest equipment available.

I know laparoscopic surgeons who use a blind, primary trocar entry technique using no insufflation. They can all recount the number of cases they've done without a major adverse event; one surgeon proudly told me he “put a little nick in the common iliac artery with an accessory port” and solved the problem with rapid action and a quick stitch.

My response is that these surgeons have either been very lucky or simply haven't done enough procedures for the inevitable disasters to catch up with them. I am absolutely opposed to blindly putting large spikes into the abdomen, and I think doing so is an approach that should be condemned.

As laparoscopic surgeons, we generally operate on young, healthy patients, sometimes for elective reasons. The potential for tragedy here is great, and it makes no sense to risk lives and great bodily injury when safe and predictable alternatives are available. I conceptualize safe access by breaking it down into three precise goals:

▸ Avoiding damage to the anterior abdominal wall.

▸ Avoiding intraabdominal structures.

▸ Avoiding retroperitoneal structures. These goals are accomplished by using the most appropriate instruments available, such as a dilating trocar and adjunctive 2-mm laparoscope; choosing the optimal entry site; and properly insufflating the abdomen.

Anterior wall tissue damage can be greatly minimized by using expanding trocars that stretch the tissue rather than cut it. Many companies make disposable dilating trocars.

The reusable radially expanding system from Tyco has a sleeve that is passed into the abdominal cavity over a Veress needle; it is dilated solely with lateral pressure or force. No downward force is applied to the patient's abdomen.

When the tissue is stretched, less damage is done, less pain is caused, recovery is quicker, and the long-term risk of hernia formation is lower.

Avoiding intraabdominal structures is a matter of entry location. I agree with Dr. Palter that the thinnest tissue underlies the umbilicus, and that's where I like to place my primary port. But unfortunately, major vessels—and often adhesions—also directly underlie this spot. It's the place where laparoscopic entry is most likely to kill a patient, and I enter it only under direct visualization.

Several studies have assessed the rate of abdominal adhesions in patients who have had previous surgery. In a 1997 study, none of 45 patients had adhesions after laparoscopy, 17 of 29 had adhesions after a midvertical incision, and 11 of 39 had adhesions after a low transverse incision (J. Am. Assoc. Gynecol. Laparosc. 1997;4:353–6).

French gynecologic surgeon Alain Audebert, M.D., described adhesions in 331 patients with prior surgery. Adhesions were present in half of patients with a prior midline incision, in 21% with a lower transverse incision, and 1.8% of patients with prior laparoscopic surgery had adhesions. Even among 440 patients with no prior surgery, the rate of adhesions was 0.6%.

In a recent study of 100 of my own patients, I found adhesion formation in 16 of 36 who had midline incisions, 20 of 45 who had transverse incisions, and 7 of 19 who had other incisions.

Although it's rare, I recently operated on a patient whose only previous surgery was laparoscopic and even she had an adhesion directly under the umbilicus.

On the other hand, it is extremely rare for surgical adhesions to form over the left upper quadrant of the abdomen, because the gallbladder and appendix lie on the other side. Only trauma surgery or splenectomies are likely to result in adhesions at this anatomical location, which was first described as an entry site by Raoul Palmer, M.D., in 1972. Furthermore, although central obesity can complicate initial access at the umbilicus, the lower margin of the rib cage in the midclavicular line almost always can be palpated, providing a landmark structure for entry at this site.

It is for all these reasons that I favor a left upper quadrant entry—not just in special cases, as Dr. Palter suggested, but as a matter of routine. I have performed approximately 500 laparoscopic procedures using this approach; Dr. Audebert has performed more than 2,000.

Patients receive a nasogastric tube so that their stomachs can be emptied before the procedure to reduce the chance of this underlying organ being damaged, although a needle injury to the stomach or liver is not a major complication.

Splenomegaly is a contraindication.

I palpate the edge of the ribs at the midclavicular line at the costal margin and carefully slide a #11 blade right along the lowermost rib to create an incision only large enough to accommodate a 2-mm scope. This incision will require no stitch—just a Steri-strip—to close.

I insert a Veress needle perpendicularly, feeding it through the abdominal wall with my finger and thumb. It's a very tactile move. You should feel the clicks.

Precisely because entry at this site feels different from entry at the umbilicus, I favor doing the entry this way every time; you learn the feel of doing it right.

I then inject saline through the needle and aspirate. If solution has entered the abdominal cavity, I don't get it back. If I had entered the bowel, the return would be greenish brown or blood-tinged, and further evaluation would be required.

I then insufflate the abdomen with enough carbon dioxide to increase the intraabdominal pressure to 25 mm Hg. The volume required will vary from patient to patient. A postpartum patient may require 12 L of carbon dioxide to reach that degree of pressure; a marathon runner with a tight abdomen may get there with 4 L.

This step accomplishes the third goal: optimizing conditions to avoid retroperitoneal structures, the major vessels.

When intraabdominal pressure is at only 12 mm Hg, the abdominal wall is very close to bowel, leaving no room for error. Increased pressure leaves a bigger space between the anterior abdominal wall and the intraabdominal and retroperitoneal structures, providing a comfortable margin of safety. This is especially critical in very thin patients, whose major vessels may lie very close to the anterior abdominal wall.

Through the same small, upper-left quadrant incision, I insert a 2-mm trocar and cannula for a small laparoscope to inspect the abdomen, identify the inferior epigastric vessel, assess the location of any adhesions, and ensure that no structures have been damaged or are in the path of any intended trocar site.

For some cases, such as tubal ligation, it is possible to use this as the primary port.

More commonly, it is at this point that I determine whether I can place my primary port in the umbilicus, and I do so under direct visualization before proceeding with my surgical procedure.

It is widely believed that laparoscopic surgery injuries are underreported. Nonetheless, patterns can be determined.

A prospective, multicenter study of complications of laparoscopy conducted in the Netherlands identified 29 bowel injuries and 27 major vessel injuries in 25,764 procedures for an identical rate of 0.11%.

More importantly, with regard to entry technique, Richard Soderstrom, M.D., found in a medicolegal review that the primary port was responsible for half of all major vascular injuries during 47 endoscopic cases (J. Am. Assoc. Gynecol. Laparosc. 1997;4:395–8).

A review of malpractice cases after 296 laparoscopic cholecystectomies performed using a primary umbilical entry site found that 86% of major vascular injuries were caused by the primary port and 75% of gastrointestinal injuries were caused by a trocar (J. Gastrointest. Surg. 1997;1:138–45).

Bowel injuries can occur with any laparoscopic technique and with laparotomy as well; some studies suggest a greater risk of injury with the latter approach. Because no method has been devised to completely avoid these injuries, the key is to recognize them, either at the time of surgery, or when the patient fails to improve as expected during the postsurgical course.

We have the potential to entirely avoid major vascular injuries by use of upper left quadrant entry before placement of a central port at the umbilicus and placement of accessory trocars.

By combining appropriate entry tools, a left upper quadrant entry site, and adequate insufflation of the abdomen, risks can be reduced at every step of laparoscopic surgery.

Dr. Duncan Turner, who is performing this procedure, prefers an entry site in the left upper quadrant to avoid major structures and potential adhesions from previous surgery.

Direct visualization and adequate insufflation leave plenty of room for error when the trocar enters the intraabdominal space as shown in this image. Photos courtesy Dr. Duncan Turner

'Do No Harm'

Physician, do no harm is a credo all gynecologic surgeons must live by. Nowhere do these words ring more true than during laparoscopic surgery. With the slightest lapse in technique, the simplest of laparoscopic procedures can quickly become a nightmare both for the patient as well as the surgeon. And when is the greatest risk of injury during a laparoscopic procedure? At entry.

I have invited an expert from each coast to serve as guides to safe access into the pelvic cavity via the laparoscope. Steven F. Palter, M.D., practices reproductive medicine and gynecologic surgery at Gold Coast IVF in Syosset, N.Y.

He is an immediate past member of the board of trustees of the AAGL. Over the years, Dr. Palter has won first prize awards for presentations at three separate world congress venues: at meetings of the American Society for Reproductive Medicine, the American Urological Association, and the AAGL, where he won first prize awards twice.

Dr Palter has been a longtime advocate of safe laparoscopic access, stemming from his background in office-based laparoscopy. From 1995 to 2001, Steve served as the director of the Yale Office Laparoscopy Program.

Duncan Turner, M.D., is a current member of the board of the International Society for Gynecologic Endoscopy. He is in private practice in Santa Barbara, Calif. Duncan first lectured on avoiding trocar-related injuries in 1995 at the World Congress of Gynecologic Laparoscopy in Israel.

Since then, not only has he lectured throughout the world, but he has been involved in trocar development and evaluation as well.

Safe laparoscopic access begins before an incision is ever made.

It begins when you review the patient's history, which includes any pertinent previous surgeries. It extends to the examination, which should rule out pelvic or abdominal masses, hepatomegaly, or an enlarged spleen. If questions about the patient's anatomy arise, imaging may be helpful. I recently had an in vitro fertilization patient with ovarian torsion for whom ultrasound was needed to locate the limits of the ovaries, which reached the umbilicus.

During surgical preparation in the operating room, the patient's bladder should be drained with a Foley catheter to ensure that it is deflated; otherwise, it may extend into the operative field and be punctured on initial access. The anesthesiologist should drain the stomach contents with oral or nasogastric suction.

Optimal patient positioning is critical.

Keep the table at waist height. You want the movement of the trocar to be as controlled as possible, optimizing proprioception and fine muscle control of your hand so that the entry force arises from small, controlled muscle movements of the forearm, hand, and wrist—not from large, less-controlled movements from your shoulder girdle. By keeping your forearms perpendicular to the patient, the force is directed along the axis of the trocar. It is essential that you maintain control of that force upon entry, so that you neither push the trocar too far nor exert lateral force.

Ensure that the table is flat. Placing the patient into premature Trendelenburg's position will change the physical relationship of the major vessels. The patient's body should lie flat from left to right to allow better anticipation of the side wall and iliac vessels.

There are several schools of thought regarding trocar placement. I enter directly in the center of the umbilicus. Some surgeons prefer an infraumbilical approach; however, I have never seen a wound infection in the center of the umbilicus when it has been meticulously disinfected with swabs during preparation of the patient. Here in the center of the umbilicus, the abdominal wall is at its thinnest, and all layers of the abdominal wall are fused. Above or below the umbilicus, there are thicker, unfused layers of tissue that are more difficult to cut through, increasing the risk of false passage.

Before initial trocar placement, palpate the promontory of the sacrum and the bifurcation of the aorta, which may be above (in most cases), at the level of, or even below the umbilicus, and make a mental map of your entry angle.

When you prepare to enter, place the trocars perfectly centrally from right to left and perpendicular to the skin; do not angle them laterally. Maintain control over the angle as you push. Iliac vessel injuries can occur when the surgeon thinks the trocar is straight, but the angle of his or her hand shifts as more force is applied. It is difficult to push straight down with force. A right-handed surgeon will tend to angle to the left; a left-handed surgeon will tend to angle to the right. Recognize this tendency and avoid it.

Remember that the abdominal-peritoneal cavity is a potential space until you enter and air or gas is allowed to enter. During initial entry, keep the valve to the Veress or trocar open so that air can enter and allow organs to fall away from the abdominal wall. At this point, it is crucial to elevate the anterior abdominal wall as much as possible, either by hand or with towel clips. On my side of the patient, I grasp the anterior wall very firmly with my hand lateral to the umbilicus while, on the other side, my assistant elevates the wall with her hand lateral to the umbilicus. I find that this technique allows sharp retraction more effectively than grasping singly inferior to the umbilicus.

Other surgeons prefer to use two perforating towel clips on the umbilical ring. During your next case, when the laparoscope is already in, try different methods of abdominal wall elevation and see which grasping strategy lifts the abdominal wall most effectively in your hands.

Keep in mind that you may have to adjust your angle of entry depending on the patient's degree of obesity; otherwise, you may find yourself tunneling in subcutaneous fat. The more obese the patient, the more perpendicular the angle of your initial entry should be.

Although you do have to tailor your technique to the obese patient's anatomy, obesity generally is not a contraindication to laparoscopic surgery. Surgical and postsurgical risks are elevated in obese patients; however, open surgery poses significant risks to these patients as well.

With very thin patients, use less force, as the distance from the abdominal wall to retroperitoneal structures is closer, and injuries from hitting the posterior retroperitoneum are more likely.

There are various methods to ensure that the initial entry into the peritoneal cavity is correct and that no injury occurs. None of these methods is foolproof. I most often use a radially dilating trocar inserted over a Veress needle. It is inserted initially with the valve open, so that air can enter and open up the potential space. Then, I inject saline and assess whether it flows easily. Next, I aspirate, checking for blood, feces, or saline from the subcutaneous space. I add a drop of saline as I lift up on the abdominal wall to perform the hanging-drop test. None of these maneuvers has good sensitivity or specificity.

The single most useful test to confirm correct intraperitoneal placement is the observation of low entry pressure from the carbon-dioxide gas. The observation of an initially negative pressure with elevation of the abdominal wall is reassuring as well. Some surgeons prefer to increase distention pressure for subsequent trocar placement.

Another method I sometimes use involves direct entry with a microlaparoscope. Insert a Veress needle with a 2-mm or 3-mm trocar over it and directly look inside with a 2-mm or 3-mm laparoscope before insufflation. In this method, elevation of the abdominal wall by hand is crucial for visualization.

Patients with a history of surgery may have adhesions at or near the umbilicus. Although various alternative sites have been suggested, the one that provides the lowest-risk access in the majority of patients is the left upper quadrant at Palmer's point, the midclavicular line below the left lowermost inferior rib. In almost all patients, even those who've had many previous surgeries, this area will be free of adhesions.

This entry site is close to the stomach, so make sure the anesthesiologist has suctioned stomach contents before surgery. Splenomegaly could complicate entry at this site.

At this site the abdominal wall is much thicker, and you will lose the typical feel of an umbilical entry. Go in carefully and in a completely controlled manner with an adjusted angle of entry. I prefer to use a microlaparoscopic entry here, although some surgeons use a Veress needle and trocar.

The open-entry technique—also called the Hasson technique—was developed in the early 1970s to mimic the steps of entry during an open surgery but with a 10-mm incision. The surgeon makes an incision in the umbilicus and dissects down layer by layer until the peritoneum is entered. The fascia is often tagged with sutures for elevation, and a blunt-tipped trocar is inserted.

The benefit of this approach is that it eliminates the step of blindly inserting something into the abdominal cavity. The drawback is that cutting and dissecting can still cause injury to underlying or adherent vital structures and may result in larger injuries in these cases.

Bowel injuries from adhesions have been reported with all known techniques.

Obviously, it would be helpful to know which technique is safest based on a well-designed, randomized, controlled trial, as most experts believe injuries from all techniques are underreported. However, significant injuries are so rare that one study reported a power analysis indicating that it would require more than 200,000 surgeries to show a 50% reduction in injuries. Most reports suggest that visceral injuries (primarily bowel injuries) occur less than 1% of the time with either an open- or closed-entry technique. A study from the Netherlands found no statistical difference between the two techniques.

Vascular injuries are even rarer than that. Advocates of open techniques suggest fewer vascular injuries occur with these techniques, but not statistically significantly so.

Recently, new trocars have been introduced that are aimed at improving safety. These devices include optical and radially dilating trocars and trocarless systems that screw or dilate their way into the abdomen. As these have come into more widespread use, injuries have been reported with them as well. It remains to be seen whether injury rates will decline significantly with other new alternatives.

Complications of laparoscopic surgery can occur when bowel or vascular injuries go unrecognized at the time of surgery. Vascular injuries can cause hemorrhage and hemodynamic instability. Retroperitoneal hematomas, in particular, can be missed unless the surgeon inspects for the presence of a large, expanding mass.

Bowel injuries may be difficult to see if the injury is small. Urinary tract injuries can also be subtle. Detection of these complications requires diligent postoperative follow-up and instructions to the patient that she should report postoperative fever, increasing pain, abdominal distention, vomiting, or heavy incisional bleeding. Be suspicious if any patient is not recovering as quickly as expected. Although most of us would recognize complications occurring within 24 hours, signs may not appear for up to a week after the procedure. Some patients with bowel perforation had no elevations in white blood count or fever at their initial postoperative checkups. The most serious complications have occurred when injuries went unrecognized.

In laparoscopic surgery, the most damage may occur during entry. Fortunately, such damage is almost totally avoidable if you use the proper techniques, a well-thought-out point of entry, and the safest equipment available.

I know laparoscopic surgeons who use a blind, primary trocar entry technique using no insufflation. They can all recount the number of cases they've done without a major adverse event; one surgeon proudly told me he “put a little nick in the common iliac artery with an accessory port” and solved the problem with rapid action and a quick stitch.

My response is that these surgeons have either been very lucky or simply haven't done enough procedures for the inevitable disasters to catch up with them. I am absolutely opposed to blindly putting large spikes into the abdomen, and I think doing so is an approach that should be condemned.

As laparoscopic surgeons, we generally operate on young, healthy patients, sometimes for elective reasons. The potential for tragedy here is great, and it makes no sense to risk lives and great bodily injury when safe and predictable alternatives are available. I conceptualize safe access by breaking it down into three precise goals:

▸ Avoiding damage to the anterior abdominal wall.

▸ Avoiding intraabdominal structures.

▸ Avoiding retroperitoneal structures. These goals are accomplished by using the most appropriate instruments available, such as a dilating trocar and adjunctive 2-mm laparoscope; choosing the optimal entry site; and properly insufflating the abdomen.

Anterior wall tissue damage can be greatly minimized by using expanding trocars that stretch the tissue rather than cut it. Many companies make disposable dilating trocars.

The reusable radially expanding system from Tyco has a sleeve that is passed into the abdominal cavity over a Veress needle; it is dilated solely with lateral pressure or force. No downward force is applied to the patient's abdomen.

When the tissue is stretched, less damage is done, less pain is caused, recovery is quicker, and the long-term risk of hernia formation is lower.

Avoiding intraabdominal structures is a matter of entry location. I agree with Dr. Palter that the thinnest tissue underlies the umbilicus, and that's where I like to place my primary port. But unfortunately, major vessels—and often adhesions—also directly underlie this spot. It's the place where laparoscopic entry is most likely to kill a patient, and I enter it only under direct visualization.

Several studies have assessed the rate of abdominal adhesions in patients who have had previous surgery. In a 1997 study, none of 45 patients had adhesions after laparoscopy, 17 of 29 had adhesions after a midvertical incision, and 11 of 39 had adhesions after a low transverse incision (J. Am. Assoc. Gynecol. Laparosc. 1997;4:353–6).

French gynecologic surgeon Alain Audebert, M.D., described adhesions in 331 patients with prior surgery. Adhesions were present in half of patients with a prior midline incision, in 21% with a lower transverse incision, and 1.8% of patients with prior laparoscopic surgery had adhesions. Even among 440 patients with no prior surgery, the rate of adhesions was 0.6%.

In a recent study of 100 of my own patients, I found adhesion formation in 16 of 36 who had midline incisions, 20 of 45 who had transverse incisions, and 7 of 19 who had other incisions.

Although it's rare, I recently operated on a patient whose only previous surgery was laparoscopic and even she had an adhesion directly under the umbilicus.

On the other hand, it is extremely rare for surgical adhesions to form over the left upper quadrant of the abdomen, because the gallbladder and appendix lie on the other side. Only trauma surgery or splenectomies are likely to result in adhesions at this anatomical location, which was first described as an entry site by Raoul Palmer, M.D., in 1972. Furthermore, although central obesity can complicate initial access at the umbilicus, the lower margin of the rib cage in the midclavicular line almost always can be palpated, providing a landmark structure for entry at this site.

It is for all these reasons that I favor a left upper quadrant entry—not just in special cases, as Dr. Palter suggested, but as a matter of routine. I have performed approximately 500 laparoscopic procedures using this approach; Dr. Audebert has performed more than 2,000.

Patients receive a nasogastric tube so that their stomachs can be emptied before the procedure to reduce the chance of this underlying organ being damaged, although a needle injury to the stomach or liver is not a major complication.

Splenomegaly is a contraindication.

I palpate the edge of the ribs at the midclavicular line at the costal margin and carefully slide a #11 blade right along the lowermost rib to create an incision only large enough to accommodate a 2-mm scope. This incision will require no stitch—just a Steri-strip—to close.

I insert a Veress needle perpendicularly, feeding it through the abdominal wall with my finger and thumb. It's a very tactile move. You should feel the clicks.

Precisely because entry at this site feels different from entry at the umbilicus, I favor doing the entry this way every time; you learn the feel of doing it right.

I then inject saline through the needle and aspirate. If solution has entered the abdominal cavity, I don't get it back. If I had entered the bowel, the return would be greenish brown or blood-tinged, and further evaluation would be required.

I then insufflate the abdomen with enough carbon dioxide to increase the intraabdominal pressure to 25 mm Hg. The volume required will vary from patient to patient. A postpartum patient may require 12 L of carbon dioxide to reach that degree of pressure; a marathon runner with a tight abdomen may get there with 4 L.

This step accomplishes the third goal: optimizing conditions to avoid retroperitoneal structures, the major vessels.

When intraabdominal pressure is at only 12 mm Hg, the abdominal wall is very close to bowel, leaving no room for error. Increased pressure leaves a bigger space between the anterior abdominal wall and the intraabdominal and retroperitoneal structures, providing a comfortable margin of safety. This is especially critical in very thin patients, whose major vessels may lie very close to the anterior abdominal wall.

Through the same small, upper-left quadrant incision, I insert a 2-mm trocar and cannula for a small laparoscope to inspect the abdomen, identify the inferior epigastric vessel, assess the location of any adhesions, and ensure that no structures have been damaged or are in the path of any intended trocar site.

For some cases, such as tubal ligation, it is possible to use this as the primary port.

More commonly, it is at this point that I determine whether I can place my primary port in the umbilicus, and I do so under direct visualization before proceeding with my surgical procedure.

It is widely believed that laparoscopic surgery injuries are underreported. Nonetheless, patterns can be determined.

A prospective, multicenter study of complications of laparoscopy conducted in the Netherlands identified 29 bowel injuries and 27 major vessel injuries in 25,764 procedures for an identical rate of 0.11%.

More importantly, with regard to entry technique, Richard Soderstrom, M.D., found in a medicolegal review that the primary port was responsible for half of all major vascular injuries during 47 endoscopic cases (J. Am. Assoc. Gynecol. Laparosc. 1997;4:395–8).

A review of malpractice cases after 296 laparoscopic cholecystectomies performed using a primary umbilical entry site found that 86% of major vascular injuries were caused by the primary port and 75% of gastrointestinal injuries were caused by a trocar (J. Gastrointest. Surg. 1997;1:138–45).

Bowel injuries can occur with any laparoscopic technique and with laparotomy as well; some studies suggest a greater risk of injury with the latter approach. Because no method has been devised to completely avoid these injuries, the key is to recognize them, either at the time of surgery, or when the patient fails to improve as expected during the postsurgical course.

We have the potential to entirely avoid major vascular injuries by use of upper left quadrant entry before placement of a central port at the umbilicus and placement of accessory trocars.

By combining appropriate entry tools, a left upper quadrant entry site, and adequate insufflation of the abdomen, risks can be reduced at every step of laparoscopic surgery.

Dr. Duncan Turner, who is performing this procedure, prefers an entry site in the left upper quadrant to avoid major structures and potential adhesions from previous surgery.

Direct visualization and adequate insufflation leave plenty of room for error when the trocar enters the intraabdominal space as shown in this image. Photos courtesy Dr. Duncan Turner

'Do No Harm'

Physician, do no harm is a credo all gynecologic surgeons must live by. Nowhere do these words ring more true than during laparoscopic surgery. With the slightest lapse in technique, the simplest of laparoscopic procedures can quickly become a nightmare both for the patient as well as the surgeon. And when is the greatest risk of injury during a laparoscopic procedure? At entry.

I have invited an expert from each coast to serve as guides to safe access into the pelvic cavity via the laparoscope. Steven F. Palter, M.D., practices reproductive medicine and gynecologic surgery at Gold Coast IVF in Syosset, N.Y.

He is an immediate past member of the board of trustees of the AAGL. Over the years, Dr. Palter has won first prize awards for presentations at three separate world congress venues: at meetings of the American Society for Reproductive Medicine, the American Urological Association, and the AAGL, where he won first prize awards twice.

Dr Palter has been a longtime advocate of safe laparoscopic access, stemming from his background in office-based laparoscopy. From 1995 to 2001, Steve served as the director of the Yale Office Laparoscopy Program.

Duncan Turner, M.D., is a current member of the board of the International Society for Gynecologic Endoscopy. He is in private practice in Santa Barbara, Calif. Duncan first lectured on avoiding trocar-related injuries in 1995 at the World Congress of Gynecologic Laparoscopy in Israel.

Since then, not only has he lectured throughout the world, but he has been involved in trocar development and evaluation as well.

As editor of the Master Class columns on gynecology, I was very proud to have C.Y. Liu, M.D., present an excellent two-part discourse on pelvic floor prolapse in the October 1, 2004, and November 1, 2004, issues of OB.GYN. NEWS.

I subsequently received a letter to the editor from Marvin H. Terry Grody, M.D. In my mind, Dr. Grody has raised compelling issues, especially in regard to the importance of the perineal body in pelvic floor prolapse. Because of this, I have asked Dr. Liu and a panel of experts to discuss Dr. Grody's concerns.

I trust you will find this discussion both interesting and informative.

Dear Editors:

In the Oct. 1, 2004, issue of Ob.Gyn. News, there appeared Part 1 of a two-part series entitled “Laparoscopic Pelvic Reconstructive Surgery.” The author, C.Y. Liu, M.D., who is a well-reputed and skilled laparoscopic surgeon, acceptably covered the issues of defects of the pelvic supportive and suspensory mechanisms and their effects on associated organs. But from the viewpoint of a vaginal and pelvic reconstructive surgeon, he embodied a major misconception in his statement, “The perineal membrane and perineal body are not very crucial for pelvic organ support.”

He is not only dead wrong, but he is giving misinformation that could be seriously destructive to surgery performed by a myriad of minimally experienced young surgeons whom experts in the field are trying tenaciously to convince otherwise.

Before I go further into this matter, I must first suppress my emotionally charged conviction (shared by many others) that the average gynecologic surgeon will not achieve anywhere near the degree of success working through a telescope that has been thrust through the abdominal wall as she or he could attain much more directly with less time and expense—and probably less risk—by using alternative approaches.

Contrary to Dr. Liu's disregard of any contributive importance of the perineal body (PB), pelvic reconstructive surgeons universally consider a disrupted PB to be a critical obstacle to the achievement of durably effective success in pelvic anatomical and functional restoration. Over a period of 4 decades starting in the 1960s, David H. Nichols, M.D.—whom most of us view as one of the most renowned vaginal surgeons—firmly and repeatedly established the mandatory requirements of restitution of the normal vaginal axis in the correction of the anatomically defective pelvic floor.

For reference, a full description of the normal vaginal axis and its vital role in good pelvic support can be found in my chapter on colpoperineorrhaphy in the ninth edition of TeLinde's Operative Gynecology (Philadelphia: Lippincott Williams & Wilkins, 2003, p. 966-85).

The PB is a key element in the structural composition of the normal vaginal axis. If significant defects in the PB are ignored and not completely repaired to natural configuration in this commonly coexistent lesion in pelvic floor anatomical failure, then no matter how wonderful the surgeon feels about his or her effort in correcting the other defects, the operation is almost certainly doomed to fail in time. Such inevitability relates to the interdependence of all the elements of the connective tissue network running through the pelvis. An ignored, significantly defective PB can become the weak link that will blow the entire chain of support.

Even if we uncover the rare gynecologic surgeon possessed of laparoscopic skill equivalent to that of Dr. Liu, if the patient does not undergo a full perineorrhaphy from the vaginal approach as the last part of the total operation, then that surgeon must be considered stupid.

Finally, I must question the wisdom of publishing this laparoscopy series that focuses on a surgical approach that will unquestionably be within the province of only a highly-specialized, well-trained, innately gifted few when other easier, safer, very effective, and far less costly and time-consuming procedures can be ably pursued by a significantly larger segment of qualified operating practitioners.

Given today's world of astounding technological feats, will such a truly perverse printed exposure stimulate adventurous young gynecologic surgeons who think they are much better than they really are into imprudent undertakings beyond their true capabilities, leading to serious injury to their patients? Goodness knows what difficulties we already find in our cluttered residency programs in getting basic maneuvers (like vaginal hysterectomy) across, let alone highly sophisticated, industry-driven, potentially dangerous operative challenges performed through a spyglass.

If there are critics abroad who think I am wrong, let them please tell me.

Rather than repudiating Dr. Grody's opinion about laparoscopic surgery, I will only respond to his point about the importance of the perineal membrane and PB to pelvic organ support.

All defects should be repaired at the time of pelvic floor reconstructive surgery. Any tear or defect in the area of the perineal membrane or PB should be repaired concurrently with pelvic floor reconstruction. This point was emphasized in the final step outlined in Part 2 of my series: “Repair the rectocele and perform perineorrhaphy vaginally if necessary.”

Based upon my understanding of the functional pelvic support anatomy as well as clinical observation, I maintain my position that “the perineal membrane and perineal body are not very crucial for pelvic organ support.”

The perineal membrane is a single layer of fibromuscular tissue that spans the anterior triangle of the pelvic outlet. Laterally, it attaches to the ischiopubic ramus; medially, it fuses with the sidewalls of the vagina and perineal body. The anterior portion of the perineal membrane is fused with the muscles of the distal urethra. Rather than forming a supportive sheet as it does in the male, the perineal membrane in the female—because of the large opening of the vagina—provides only lateral attachment for the PB and some support for the lower urethra.

The PB is an ill-defined, bordered mass of dense connective tissue lying between the vagina and anus. Fused anteriorly to the posterior vaginal wall and attached laterally to the perineal membrane and bulbocavernosus and superficial transverse perineal muscles, a significant portion of what is clinically called the perineal body is actually the muscle of the external anal sphincter. The strong upward traction of the levator ani muscles is much more important in maintaining vaginal outlet support than are the bulbocavernosus and superficial transverse perineal muscle.

Contrary to Dr. Grody's assertion that the PB makes a substantial contribution to pelvic support, in actuality the support is minimal. Rather, restoration of the PB is important for sexual function and anal/fecal continence. I have examined several patients with no PB as the result of chronic unrepaired fourth-degree obstetric lacerations, yet none of them had prolapse. Similarly, women who have had a radical resection of the anus and rectum for cancer, including the entire removal of the PB, suffered no significant prolapse.

Because considerable descent (up to 1 inch) of the PB is possible during voluntary straining, the perineal membrane and PB cannot be the main supportive layer of the genital outlet. The fact that the PB can move backward 3-4 cm toward the sacrum when a weighted speculum is placed in the posterior vagina likewise indicates that the position of the PB is determined by the levator ani muscle rather than by any inherent importance of its own.

Advances in technology afford greater magnification, visualization, and accuracy—leading to a level of surgical precision heretofore impossible with the relatively “blind” vaginal approach. We must train young surgeons for these state-of-the-art advances.

Although I have the utmost respect for both Dr. Grody and Dr. Liu and I believe that everyone is entitled to his or her own opinion, Dr Liu's article is certainly not worthy of such admonishment.

Dr. Liu not only correctly addresses normal vaginal anatomy, clinical assessment, and one surgeon's approach to the anatomical correction of symptomatic prolapse, he does so in a concise, informative manner.

Dr. Grody's belief that the perineal membrane and PB are crucial for pelvic organ support is indeed just that: his belief. Using the PubMed search term “perineal body surgery,” I found no scientific literature written in the past 40 years that supports the concept that either the perineal membrane or the PB is crucial in the support of any organs of the pelvis. I have yet to read or find an article that suggests that the cure rates of sacrospinous ligament suspension; sacral colpopexy; paravaginal repair; uterosacral ligament suspension; enterocele repair; or Burch, sling, or any other prolapse corrective surgery—including colpocleisis or Lefort procedures—are improved by repairing the PB.

Furthermore, there is no scientific literature that supports the concept that poor perineal support increases the incidence of prolapse. If this were a fact, patients with traumatic or congenital cloaca would also suffer a greater incidence of vaginal prolapse. I have not seen or read of any scientific literature or text that can directly show a cause-and-effect relationship between a damaged PB and vaginal prolapse.

Dr. Grody is a purist in his pursuit of vaginal anatomic correction, but this fine trait does not constitute scientific proof for his allegation. He has the right to theorize that the anatomical correction is essential to improve long-term cure rates of prolapse surgery. But a theory is belief unsupported by substantial fact, and will thus remain just a theory.

After reading Dr. Liu's article on laparoscopic pelvic reconstructive surgery and Dr. Grody's response, I found myself perplexed. How is it that two experienced and respected surgeons can underappreciate each other's perspective on pelvic reconstructive surgery?

For the most part, I agree with most of what each has stated but disagree on the finer points. I must confess that being predominately a laparoscopic or minimally invasive surgeon, I too did not completely comprehend the complexity and functional anatomy of the PB and membrane as an important element in pelvic floor support until more recently.

Thanks to cadaver sections and MRI studies reported by John O.L. Delancey, M.D., at the joint annual meeting of the American Urogynecologic Society and the Society of Gynecologic Surgeons in 2004, we realize that the perineal membrane is a complex 3-D structure composed of a dorsal and ventral portion rather than a trilaminar sheet as previously thought. His description of the anatomical relationship to the compressor urethra, urethra vaginal sphincter, arcus tendineus, pubic bone, and levator muscles underscores the importance of this structure in pelvic support.

We now have level 1 evidence of the laparoscope's benefit in sacral colpopexies compared with an open procedure, as well as its inferiority in treating stress urinary incontinence when comparing a laparoscopic Burch with a transvaginal tape procedure. But the laparoscope is a tool that requires proper training to master. Thanks to the pioneering efforts of Dr. Liu and Dr. Miklos, the development of training centers, and the support of organizations like the American Association of Gynecologic Laparoscopists, it is no longer the gifted few who use this valuable instrument.

The recent articles by Dr. C.Y. Liu in OB.GYN.NEWS on laparoscopic pelvic reconstructive surgery, Parts 1 and 2, are a must-read for any gynecologic surgeon performing reconstructive vaginal surgery. Although the article presents Dr. Liu's laparoscopic approach to problems of vaginal suspension and support, the anatomy presented and the surgical steps discussed are clearly applicable to the repair of any vaginal prolapse via any surgical approach, including vaginal and abdominal.

The anatomy of genital prolapse is up to date, well written, and clearly explained. Part 1 contains many pearls of insight from a master of this anatomy, and it summarizes our current concepts of vaginal suspension and support. The section on clinical assessment of prolapse is practical and very helpful.

The surgical techniques presented are anatomical and readily applicable. Dr. Liu explains how to safely dissect out and investigate the suspensory anatomy to clearly define the anatomical defects that caused the vaginal prolapse. Not only does Dr. Liu address and repair the specific breaks in the continuity of the visceral connective tissue suspensory network, but he presents an excellent dissection technique for safeguarding the ureters.

One point that should have been emphasized is the requirement for cystoscopic confirmation of bilateral ureteral functioning at the end of the case.

The article explains that one of the three supporting layers of the female pelvic organs is “the perineal membrane/external anal sphincter.” What is not said is that the anal sphincter is an important component of the posterior part of the PB.

The lower third of the vagina and the anal canal/anal sphincter are fused with the PB. The PB is shaped roughly like a pyramid, with the base between the vaginal introitus and the anal sphincter. The apex is found at the junction of the lower third and the middle third of the vagina, and at the rectoanal junction. At the apex of the perineal body, the vagina slopes to a more horizontal orientation in the standing patient, whereas the anal canal forms a right angle with the lower rectum.

Portions of the pubococcygeus and puborectalis muscles insert into the apex of the PB. The rectovaginal fascia also inserts into the apex of the PB and helps in its proper anatomical orientation. The intact PB positions itself and the anus just above the level of the ischial tuberosities. The fusion of the anus and anal canal with the PB is important for their anatomical positioning and physiologic functioning in fecal continence. The fusion of the lower third of the vagina with the PB is important for its anatomical positioning and physiologic functioning in pelvic organ support. The PB assists in closing off the genital hiatus at times of increased intrapelvic pressures, supporting the pelvic organs. Another support mechanism is the flap-valve action of the levator plate.

Many women with vaginal prolapse demonstrate abnormal descent of the perineum. Dr. Liu states, “The active support of the pelvic floor comes from the levator ani muscles (the iliococcygeus and pubococcygeus muscles). These muscles close off the pelvic floor so the pelvic organs can rest upon them without tension.” This statement is true.

Dr. Liu does not mention the important action of the levator plate or the action of the PB in this vaginal support mechanism. In fact, with a poorly supportive levator plate, as is frequently seen in vaginal prolapse patients, a well-reconstructed PB will substitute as a backstop against which the resuspended vagina can be compressed for support.

The reconstructed PB will help close off the genital hiatus at times of mechanical pelvic stress. The PB must be reconstructed in shape and bulk to support and orient the anal canal and lower third of the vagina, but also to position itself and the anal canal at or above the level of the ischial tuberosities.

As Dr. Liu implies, we cannot repair or completely rehabilitate damaged and weakened pelvic floor muscles and their innervations. We should surgically reconstruct a disrupted PB. I do feel that Dr. Liu does indeed perform perineoplasty on many of his prolapse patients. He simply emphasized the reconstruction and proper placement of the pericervical ring in his excellent article.

MARVIN H. TERRY GRODY, M.D., is a professor of obstetrics and gynecology and senior attending gynecology consultant, Robert Wood Johnson Medical School at Camden (N.J.).

C.Y. LIU, M.D., is the director of the Manhattan Women's Laser Center, New York.

JOHN R. MIKLOS, M.D., is the director of the Atlanta Center for Laparoscopic Urogynecology.

VINCENT R. LUCENTE, M.D., is chief of urogynecology at Abington (Pa.) Memorial Hospital and associate professor of ob.gyn. at Pennsylvania State Medical Center, Hershey.

ROBERT M. ROGERS JR., M.D., is an attending gynecologist at the Reading Hospital and Medical Center in West Reading, Pa.

As editor of the Master Class columns on gynecology, I was very proud to have C.Y. Liu, M.D., present an excellent two-part discourse on pelvic floor prolapse in the October 1, 2004, and November 1, 2004, issues of OB.GYN. NEWS.

I subsequently received a letter to the editor from Marvin H. Terry Grody, M.D. In my mind, Dr. Grody has raised compelling issues, especially in regard to the importance of the perineal body in pelvic floor prolapse. Because of this, I have asked Dr. Liu and a panel of experts to discuss Dr. Grody's concerns.

I trust you will find this discussion both interesting and informative.

Dear Editors:

In the Oct. 1, 2004, issue of Ob.Gyn. News, there appeared Part 1 of a two-part series entitled “Laparoscopic Pelvic Reconstructive Surgery.” The author, C.Y. Liu, M.D., who is a well-reputed and skilled laparoscopic surgeon, acceptably covered the issues of defects of the pelvic supportive and suspensory mechanisms and their effects on associated organs. But from the viewpoint of a vaginal and pelvic reconstructive surgeon, he embodied a major misconception in his statement, “The perineal membrane and perineal body are not very crucial for pelvic organ support.”

He is not only dead wrong, but he is giving misinformation that could be seriously destructive to surgery performed by a myriad of minimally experienced young surgeons whom experts in the field are trying tenaciously to convince otherwise.

Before I go further into this matter, I must first suppress my emotionally charged conviction (shared by many others) that the average gynecologic surgeon will not achieve anywhere near the degree of success working through a telescope that has been thrust through the abdominal wall as she or he could attain much more directly with less time and expense—and probably less risk—by using alternative approaches.

Contrary to Dr. Liu's disregard of any contributive importance of the perineal body (PB), pelvic reconstructive surgeons universally consider a disrupted PB to be a critical obstacle to the achievement of durably effective success in pelvic anatomical and functional restoration. Over a period of 4 decades starting in the 1960s, David H. Nichols, M.D.—whom most of us view as one of the most renowned vaginal surgeons—firmly and repeatedly established the mandatory requirements of restitution of the normal vaginal axis in the correction of the anatomically defective pelvic floor.

For reference, a full description of the normal vaginal axis and its vital role in good pelvic support can be found in my chapter on colpoperineorrhaphy in the ninth edition of TeLinde's Operative Gynecology (Philadelphia: Lippincott Williams & Wilkins, 2003, p. 966-85).

The PB is a key element in the structural composition of the normal vaginal axis. If significant defects in the PB are ignored and not completely repaired to natural configuration in this commonly coexistent lesion in pelvic floor anatomical failure, then no matter how wonderful the surgeon feels about his or her effort in correcting the other defects, the operation is almost certainly doomed to fail in time. Such inevitability relates to the interdependence of all the elements of the connective tissue network running through the pelvis. An ignored, significantly defective PB can become the weak link that will blow the entire chain of support.

Even if we uncover the rare gynecologic surgeon possessed of laparoscopic skill equivalent to that of Dr. Liu, if the patient does not undergo a full perineorrhaphy from the vaginal approach as the last part of the total operation, then that surgeon must be considered stupid.

Finally, I must question the wisdom of publishing this laparoscopy series that focuses on a surgical approach that will unquestionably be within the province of only a highly-specialized, well-trained, innately gifted few when other easier, safer, very effective, and far less costly and time-consuming procedures can be ably pursued by a significantly larger segment of qualified operating practitioners.

Given today's world of astounding technological feats, will such a truly perverse printed exposure stimulate adventurous young gynecologic surgeons who think they are much better than they really are into imprudent undertakings beyond their true capabilities, leading to serious injury to their patients? Goodness knows what difficulties we already find in our cluttered residency programs in getting basic maneuvers (like vaginal hysterectomy) across, let alone highly sophisticated, industry-driven, potentially dangerous operative challenges performed through a spyglass.

If there are critics abroad who think I am wrong, let them please tell me.

Rather than repudiating Dr. Grody's opinion about laparoscopic surgery, I will only respond to his point about the importance of the perineal membrane and PB to pelvic organ support.

All defects should be repaired at the time of pelvic floor reconstructive surgery. Any tear or defect in the area of the perineal membrane or PB should be repaired concurrently with pelvic floor reconstruction. This point was emphasized in the final step outlined in Part 2 of my series: “Repair the rectocele and perform perineorrhaphy vaginally if necessary.”

Based upon my understanding of the functional pelvic support anatomy as well as clinical observation, I maintain my position that “the perineal membrane and perineal body are not very crucial for pelvic organ support.”

The perineal membrane is a single layer of fibromuscular tissue that spans the anterior triangle of the pelvic outlet. Laterally, it attaches to the ischiopubic ramus; medially, it fuses with the sidewalls of the vagina and perineal body. The anterior portion of the perineal membrane is fused with the muscles of the distal urethra. Rather than forming a supportive sheet as it does in the male, the perineal membrane in the female—because of the large opening of the vagina—provides only lateral attachment for the PB and some support for the lower urethra.

The PB is an ill-defined, bordered mass of dense connective tissue lying between the vagina and anus. Fused anteriorly to the posterior vaginal wall and attached laterally to the perineal membrane and bulbocavernosus and superficial transverse perineal muscles, a significant portion of what is clinically called the perineal body is actually the muscle of the external anal sphincter. The strong upward traction of the levator ani muscles is much more important in maintaining vaginal outlet support than are the bulbocavernosus and superficial transverse perineal muscle.

Contrary to Dr. Grody's assertion that the PB makes a substantial contribution to pelvic support, in actuality the support is minimal. Rather, restoration of the PB is important for sexual function and anal/fecal continence. I have examined several patients with no PB as the result of chronic unrepaired fourth-degree obstetric lacerations, yet none of them had prolapse. Similarly, women who have had a radical resection of the anus and rectum for cancer, including the entire removal of the PB, suffered no significant prolapse.

Because considerable descent (up to 1 inch) of the PB is possible during voluntary straining, the perineal membrane and PB cannot be the main supportive layer of the genital outlet. The fact that the PB can move backward 3-4 cm toward the sacrum when a weighted speculum is placed in the posterior vagina likewise indicates that the position of the PB is determined by the levator ani muscle rather than by any inherent importance of its own.

Advances in technology afford greater magnification, visualization, and accuracy—leading to a level of surgical precision heretofore impossible with the relatively “blind” vaginal approach. We must train young surgeons for these state-of-the-art advances.

Although I have the utmost respect for both Dr. Grody and Dr. Liu and I believe that everyone is entitled to his or her own opinion, Dr Liu's article is certainly not worthy of such admonishment.

Dr. Liu not only correctly addresses normal vaginal anatomy, clinical assessment, and one surgeon's approach to the anatomical correction of symptomatic prolapse, he does so in a concise, informative manner.

Dr. Grody's belief that the perineal membrane and PB are crucial for pelvic organ support is indeed just that: his belief. Using the PubMed search term “perineal body surgery,” I found no scientific literature written in the past 40 years that supports the concept that either the perineal membrane or the PB is crucial in the support of any organs of the pelvis. I have yet to read or find an article that suggests that the cure rates of sacrospinous ligament suspension; sacral colpopexy; paravaginal repair; uterosacral ligament suspension; enterocele repair; or Burch, sling, or any other prolapse corrective surgery—including colpocleisis or Lefort procedures—are improved by repairing the PB.

Furthermore, there is no scientific literature that supports the concept that poor perineal support increases the incidence of prolapse. If this were a fact, patients with traumatic or congenital cloaca would also suffer a greater incidence of vaginal prolapse. I have not seen or read of any scientific literature or text that can directly show a cause-and-effect relationship between a damaged PB and vaginal prolapse.

Dr. Grody is a purist in his pursuit of vaginal anatomic correction, but this fine trait does not constitute scientific proof for his allegation. He has the right to theorize that the anatomical correction is essential to improve long-term cure rates of prolapse surgery. But a theory is belief unsupported by substantial fact, and will thus remain just a theory.

After reading Dr. Liu's article on laparoscopic pelvic reconstructive surgery and Dr. Grody's response, I found myself perplexed. How is it that two experienced and respected surgeons can underappreciate each other's perspective on pelvic reconstructive surgery?

For the most part, I agree with most of what each has stated but disagree on the finer points. I must confess that being predominately a laparoscopic or minimally invasive surgeon, I too did not completely comprehend the complexity and functional anatomy of the PB and membrane as an important element in pelvic floor support until more recently.

Thanks to cadaver sections and MRI studies reported by John O.L. Delancey, M.D., at the joint annual meeting of the American Urogynecologic Society and the Society of Gynecologic Surgeons in 2004, we realize that the perineal membrane is a complex 3-D structure composed of a dorsal and ventral portion rather than a trilaminar sheet as previously thought. His description of the anatomical relationship to the compressor urethra, urethra vaginal sphincter, arcus tendineus, pubic bone, and levator muscles underscores the importance of this structure in pelvic support.

We now have level 1 evidence of the laparoscope's benefit in sacral colpopexies compared with an open procedure, as well as its inferiority in treating stress urinary incontinence when comparing a laparoscopic Burch with a transvaginal tape procedure. But the laparoscope is a tool that requires proper training to master. Thanks to the pioneering efforts of Dr. Liu and Dr. Miklos, the development of training centers, and the support of organizations like the American Association of Gynecologic Laparoscopists, it is no longer the gifted few who use this valuable instrument.

The recent articles by Dr. C.Y. Liu in OB.GYN.NEWS on laparoscopic pelvic reconstructive surgery, Parts 1 and 2, are a must-read for any gynecologic surgeon performing reconstructive vaginal surgery. Although the article presents Dr. Liu's laparoscopic approach to problems of vaginal suspension and support, the anatomy presented and the surgical steps discussed are clearly applicable to the repair of any vaginal prolapse via any surgical approach, including vaginal and abdominal.

The anatomy of genital prolapse is up to date, well written, and clearly explained. Part 1 contains many pearls of insight from a master of this anatomy, and it summarizes our current concepts of vaginal suspension and support. The section on clinical assessment of prolapse is practical and very helpful.

The surgical techniques presented are anatomical and readily applicable. Dr. Liu explains how to safely dissect out and investigate the suspensory anatomy to clearly define the anatomical defects that caused the vaginal prolapse. Not only does Dr. Liu address and repair the specific breaks in the continuity of the visceral connective tissue suspensory network, but he presents an excellent dissection technique for safeguarding the ureters.

One point that should have been emphasized is the requirement for cystoscopic confirmation of bilateral ureteral functioning at the end of the case.

The article explains that one of the three supporting layers of the female pelvic organs is “the perineal membrane/external anal sphincter.” What is not said is that the anal sphincter is an important component of the posterior part of the PB.

The lower third of the vagina and the anal canal/anal sphincter are fused with the PB. The PB is shaped roughly like a pyramid, with the base between the vaginal introitus and the anal sphincter. The apex is found at the junction of the lower third and the middle third of the vagina, and at the rectoanal junction. At the apex of the perineal body, the vagina slopes to a more horizontal orientation in the standing patient, whereas the anal canal forms a right angle with the lower rectum.

Portions of the pubococcygeus and puborectalis muscles insert into the apex of the PB. The rectovaginal fascia also inserts into the apex of the PB and helps in its proper anatomical orientation. The intact PB positions itself and the anus just above the level of the ischial tuberosities. The fusion of the anus and anal canal with the PB is important for their anatomical positioning and physiologic functioning in fecal continence. The fusion of the lower third of the vagina with the PB is important for its anatomical positioning and physiologic functioning in pelvic organ support. The PB assists in closing off the genital hiatus at times of increased intrapelvic pressures, supporting the pelvic organs. Another support mechanism is the flap-valve action of the levator plate.

Many women with vaginal prolapse demonstrate abnormal descent of the perineum. Dr. Liu states, “The active support of the pelvic floor comes from the levator ani muscles (the iliococcygeus and pubococcygeus muscles). These muscles close off the pelvic floor so the pelvic organs can rest upon them without tension.” This statement is true.

Dr. Liu does not mention the important action of the levator plate or the action of the PB in this vaginal support mechanism. In fact, with a poorly supportive levator plate, as is frequently seen in vaginal prolapse patients, a well-reconstructed PB will substitute as a backstop against which the resuspended vagina can be compressed for support.

The reconstructed PB will help close off the genital hiatus at times of mechanical pelvic stress. The PB must be reconstructed in shape and bulk to support and orient the anal canal and lower third of the vagina, but also to position itself and the anal canal at or above the level of the ischial tuberosities.

As Dr. Liu implies, we cannot repair or completely rehabilitate damaged and weakened pelvic floor muscles and their innervations. We should surgically reconstruct a disrupted PB. I do feel that Dr. Liu does indeed perform perineoplasty on many of his prolapse patients. He simply emphasized the reconstruction and proper placement of the pericervical ring in his excellent article.

MARVIN H. TERRY GRODY, M.D., is a professor of obstetrics and gynecology and senior attending gynecology consultant, Robert Wood Johnson Medical School at Camden (N.J.).

C.Y. LIU, M.D., is the director of the Manhattan Women's Laser Center, New York.

JOHN R. MIKLOS, M.D., is the director of the Atlanta Center for Laparoscopic Urogynecology.

VINCENT R. LUCENTE, M.D., is chief of urogynecology at Abington (Pa.) Memorial Hospital and associate professor of ob.gyn. at Pennsylvania State Medical Center, Hershey.

ROBERT M. ROGERS JR., M.D., is an attending gynecologist at the Reading Hospital and Medical Center in West Reading, Pa.

As editor of the Master Class columns on gynecology, I was very proud to have C.Y. Liu, M.D., present an excellent two-part discourse on pelvic floor prolapse in the October 1, 2004, and November 1, 2004, issues of OB.GYN. NEWS.

I subsequently received a letter to the editor from Marvin H. Terry Grody, M.D. In my mind, Dr. Grody has raised compelling issues, especially in regard to the importance of the perineal body in pelvic floor prolapse. Because of this, I have asked Dr. Liu and a panel of experts to discuss Dr. Grody's concerns.

I trust you will find this discussion both interesting and informative.

Dear Editors:

In the Oct. 1, 2004, issue of Ob.Gyn. News, there appeared Part 1 of a two-part series entitled “Laparoscopic Pelvic Reconstructive Surgery.” The author, C.Y. Liu, M.D., who is a well-reputed and skilled laparoscopic surgeon, acceptably covered the issues of defects of the pelvic supportive and suspensory mechanisms and their effects on associated organs. But from the viewpoint of a vaginal and pelvic reconstructive surgeon, he embodied a major misconception in his statement, “The perineal membrane and perineal body are not very crucial for pelvic organ support.”

He is not only dead wrong, but he is giving misinformation that could be seriously destructive to surgery performed by a myriad of minimally experienced young surgeons whom experts in the field are trying tenaciously to convince otherwise.

Before I go further into this matter, I must first suppress my emotionally charged conviction (shared by many others) that the average gynecologic surgeon will not achieve anywhere near the degree of success working through a telescope that has been thrust through the abdominal wall as she or he could attain much more directly with less time and expense—and probably less risk—by using alternative approaches.

Contrary to Dr. Liu's disregard of any contributive importance of the perineal body (PB), pelvic reconstructive surgeons universally consider a disrupted PB to be a critical obstacle to the achievement of durably effective success in pelvic anatomical and functional restoration. Over a period of 4 decades starting in the 1960s, David H. Nichols, M.D.—whom most of us view as one of the most renowned vaginal surgeons—firmly and repeatedly established the mandatory requirements of restitution of the normal vaginal axis in the correction of the anatomically defective pelvic floor.

For reference, a full description of the normal vaginal axis and its vital role in good pelvic support can be found in my chapter on colpoperineorrhaphy in the ninth edition of TeLinde's Operative Gynecology (Philadelphia: Lippincott Williams & Wilkins, 2003, p. 966-85).

The PB is a key element in the structural composition of the normal vaginal axis. If significant defects in the PB are ignored and not completely repaired to natural configuration in this commonly coexistent lesion in pelvic floor anatomical failure, then no matter how wonderful the surgeon feels about his or her effort in correcting the other defects, the operation is almost certainly doomed to fail in time. Such inevitability relates to the interdependence of all the elements of the connective tissue network running through the pelvis. An ignored, significantly defective PB can become the weak link that will blow the entire chain of support.

Even if we uncover the rare gynecologic surgeon possessed of laparoscopic skill equivalent to that of Dr. Liu, if the patient does not undergo a full perineorrhaphy from the vaginal approach as the last part of the total operation, then that surgeon must be considered stupid.

Finally, I must question the wisdom of publishing this laparoscopy series that focuses on a surgical approach that will unquestionably be within the province of only a highly-specialized, well-trained, innately gifted few when other easier, safer, very effective, and far less costly and time-consuming procedures can be ably pursued by a significantly larger segment of qualified operating practitioners.

Given today's world of astounding technological feats, will such a truly perverse printed exposure stimulate adventurous young gynecologic surgeons who think they are much better than they really are into imprudent undertakings beyond their true capabilities, leading to serious injury to their patients? Goodness knows what difficulties we already find in our cluttered residency programs in getting basic maneuvers (like vaginal hysterectomy) across, let alone highly sophisticated, industry-driven, potentially dangerous operative challenges performed through a spyglass.

If there are critics abroad who think I am wrong, let them please tell me.

Rather than repudiating Dr. Grody's opinion about laparoscopic surgery, I will only respond to his point about the importance of the perineal membrane and PB to pelvic organ support.

All defects should be repaired at the time of pelvic floor reconstructive surgery. Any tear or defect in the area of the perineal membrane or PB should be repaired concurrently with pelvic floor reconstruction. This point was emphasized in the final step outlined in Part 2 of my series: “Repair the rectocele and perform perineorrhaphy vaginally if necessary.”

Based upon my understanding of the functional pelvic support anatomy as well as clinical observation, I maintain my position that “the perineal membrane and perineal body are not very crucial for pelvic organ support.”

The perineal membrane is a single layer of fibromuscular tissue that spans the anterior triangle of the pelvic outlet. Laterally, it attaches to the ischiopubic ramus; medially, it fuses with the sidewalls of the vagina and perineal body. The anterior portion of the perineal membrane is fused with the muscles of the distal urethra. Rather than forming a supportive sheet as it does in the male, the perineal membrane in the female—because of the large opening of the vagina—provides only lateral attachment for the PB and some support for the lower urethra.

The PB is an ill-defined, bordered mass of dense connective tissue lying between the vagina and anus. Fused anteriorly to the posterior vaginal wall and attached laterally to the perineal membrane and bulbocavernosus and superficial transverse perineal muscles, a significant portion of what is clinically called the perineal body is actually the muscle of the external anal sphincter. The strong upward traction of the levator ani muscles is much more important in maintaining vaginal outlet support than are the bulbocavernosus and superficial transverse perineal muscle.

Contrary to Dr. Grody's assertion that the PB makes a substantial contribution to pelvic support, in actuality the support is minimal. Rather, restoration of the PB is important for sexual function and anal/fecal continence. I have examined several patients with no PB as the result of chronic unrepaired fourth-degree obstetric lacerations, yet none of them had prolapse. Similarly, women who have had a radical resection of the anus and rectum for cancer, including the entire removal of the PB, suffered no significant prolapse.

Because considerable descent (up to 1 inch) of the PB is possible during voluntary straining, the perineal membrane and PB cannot be the main supportive layer of the genital outlet. The fact that the PB can move backward 3-4 cm toward the sacrum when a weighted speculum is placed in the posterior vagina likewise indicates that the position of the PB is determined by the levator ani muscle rather than by any inherent importance of its own.

Advances in technology afford greater magnification, visualization, and accuracy—leading to a level of surgical precision heretofore impossible with the relatively “blind” vaginal approach. We must train young surgeons for these state-of-the-art advances.

Although I have the utmost respect for both Dr. Grody and Dr. Liu and I believe that everyone is entitled to his or her own opinion, Dr Liu's article is certainly not worthy of such admonishment.

Dr. Liu not only correctly addresses normal vaginal anatomy, clinical assessment, and one surgeon's approach to the anatomical correction of symptomatic prolapse, he does so in a concise, informative manner.

Dr. Grody's belief that the perineal membrane and PB are crucial for pelvic organ support is indeed just that: his belief. Using the PubMed search term “perineal body surgery,” I found no scientific literature written in the past 40 years that supports the concept that either the perineal membrane or the PB is crucial in the support of any organs of the pelvis. I have yet to read or find an article that suggests that the cure rates of sacrospinous ligament suspension; sacral colpopexy; paravaginal repair; uterosacral ligament suspension; enterocele repair; or Burch, sling, or any other prolapse corrective surgery—including colpocleisis or Lefort procedures—are improved by repairing the PB.

Furthermore, there is no scientific literature that supports the concept that poor perineal support increases the incidence of prolapse. If this were a fact, patients with traumatic or congenital cloaca would also suffer a greater incidence of vaginal prolapse. I have not seen or read of any scientific literature or text that can directly show a cause-and-effect relationship between a damaged PB and vaginal prolapse.

Dr. Grody is a purist in his pursuit of vaginal anatomic correction, but this fine trait does not constitute scientific proof for his allegation. He has the right to theorize that the anatomical correction is essential to improve long-term cure rates of prolapse surgery. But a theory is belief unsupported by substantial fact, and will thus remain just a theory.

After reading Dr. Liu's article on laparoscopic pelvic reconstructive surgery and Dr. Grody's response, I found myself perplexed. How is it that two experienced and respected surgeons can underappreciate each other's perspective on pelvic reconstructive surgery?

For the most part, I agree with most of what each has stated but disagree on the finer points. I must confess that being predominately a laparoscopic or minimally invasive surgeon, I too did not completely comprehend the complexity and functional anatomy of the PB and membrane as an important element in pelvic floor support until more recently.

Thanks to cadaver sections and MRI studies reported by John O.L. Delancey, M.D., at the joint annual meeting of the American Urogynecologic Society and the Society of Gynecologic Surgeons in 2004, we realize that the perineal membrane is a complex 3-D structure composed of a dorsal and ventral portion rather than a trilaminar sheet as previously thought. His description of the anatomical relationship to the compressor urethra, urethra vaginal sphincter, arcus tendineus, pubic bone, and levator muscles underscores the importance of this structure in pelvic support.

We now have level 1 evidence of the laparoscope's benefit in sacral colpopexies compared with an open procedure, as well as its inferiority in treating stress urinary incontinence when comparing a laparoscopic Burch with a transvaginal tape procedure. But the laparoscope is a tool that requires proper training to master. Thanks to the pioneering efforts of Dr. Liu and Dr. Miklos, the development of training centers, and the support of organizations like the American Association of Gynecologic Laparoscopists, it is no longer the gifted few who use this valuable instrument.

The recent articles by Dr. C.Y. Liu in OB.GYN.NEWS on laparoscopic pelvic reconstructive surgery, Parts 1 and 2, are a must-read for any gynecologic surgeon performing reconstructive vaginal surgery. Although the article presents Dr. Liu's laparoscopic approach to problems of vaginal suspension and support, the anatomy presented and the surgical steps discussed are clearly applicable to the repair of any vaginal prolapse via any surgical approach, including vaginal and abdominal.

The anatomy of genital prolapse is up to date, well written, and clearly explained. Part 1 contains many pearls of insight from a master of this anatomy, and it summarizes our current concepts of vaginal suspension and support. The section on clinical assessment of prolapse is practical and very helpful.

The surgical techniques presented are anatomical and readily applicable. Dr. Liu explains how to safely dissect out and investigate the suspensory anatomy to clearly define the anatomical defects that caused the vaginal prolapse. Not only does Dr. Liu address and repair the specific breaks in the continuity of the visceral connective tissue suspensory network, but he presents an excellent dissection technique for safeguarding the ureters.

One point that should have been emphasized is the requirement for cystoscopic confirmation of bilateral ureteral functioning at the end of the case.

The article explains that one of the three supporting layers of the female pelvic organs is “the perineal membrane/external anal sphincter.” What is not said is that the anal sphincter is an important component of the posterior part of the PB.

The lower third of the vagina and the anal canal/anal sphincter are fused with the PB. The PB is shaped roughly like a pyramid, with the base between the vaginal introitus and the anal sphincter. The apex is found at the junction of the lower third and the middle third of the vagina, and at the rectoanal junction. At the apex of the perineal body, the vagina slopes to a more horizontal orientation in the standing patient, whereas the anal canal forms a right angle with the lower rectum.

Portions of the pubococcygeus and puborectalis muscles insert into the apex of the PB. The rectovaginal fascia also inserts into the apex of the PB and helps in its proper anatomical orientation. The intact PB positions itself and the anus just above the level of the ischial tuberosities. The fusion of the anus and anal canal with the PB is important for their anatomical positioning and physiologic functioning in fecal continence. The fusion of the lower third of the vagina with the PB is important for its anatomical positioning and physiologic functioning in pelvic organ support. The PB assists in closing off the genital hiatus at times of increased intrapelvic pressures, supporting the pelvic organs. Another support mechanism is the flap-valve action of the levator plate.

Many women with vaginal prolapse demonstrate abnormal descent of the perineum. Dr. Liu states, “The active support of the pelvic floor comes from the levator ani muscles (the iliococcygeus and pubococcygeus muscles). These muscles close off the pelvic floor so the pelvic organs can rest upon them without tension.” This statement is true.

Dr. Liu does not mention the important action of the levator plate or the action of the PB in this vaginal support mechanism. In fact, with a poorly supportive levator plate, as is frequently seen in vaginal prolapse patients, a well-reconstructed PB will substitute as a backstop against which the resuspended vagina can be compressed for support.

The reconstructed PB will help close off the genital hiatus at times of mechanical pelvic stress. The PB must be reconstructed in shape and bulk to support and orient the anal canal and lower third of the vagina, but also to position itself and the anal canal at or above the level of the ischial tuberosities.

As Dr. Liu implies, we cannot repair or completely rehabilitate damaged and weakened pelvic floor muscles and their innervations. We should surgically reconstruct a disrupted PB. I do feel that Dr. Liu does indeed perform perineoplasty on many of his prolapse patients. He simply emphasized the reconstruction and proper placement of the pericervical ring in his excellent article.

MARVIN H. TERRY GRODY, M.D., is a professor of obstetrics and gynecology and senior attending gynecology consultant, Robert Wood Johnson Medical School at Camden (N.J.).

C.Y. LIU, M.D., is the director of the Manhattan Women's Laser Center, New York.

JOHN R. MIKLOS, M.D., is the director of the Atlanta Center for Laparoscopic Urogynecology.

VINCENT R. LUCENTE, M.D., is chief of urogynecology at Abington (Pa.) Memorial Hospital and associate professor of ob.gyn. at Pennsylvania State Medical Center, Hershey.

ROBERT M. ROGERS JR., M.D., is an attending gynecologist at the Reading Hospital and Medical Center in West Reading, Pa.