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Type of headwear worn during surgery had no impact on SSI rates

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Wed, 04/03/2019 - 10:24

 

– Surgeon preference for bouffant versus skull caps does not significantly impact superficial surgical site infection rates after accounting for surgical procedure type, results from a an analysis of a previously randomized, prospective trial showed.

“We are all aware of the current battle that is taking place over operating room attire based on the differences between the AORN [Association of periOperative Nurses] recommendations and ACS guidelines,” lead study author Shanu N. Kothari, MD, FACS, said at the annual clinical congress of the American College of Surgeons.

Dr. Shanu Kothari director of minimally invasive bariatric surgery at Gundersen Health System, La Crosse, Wisc.
Dr. Shanu Kothari
“To date, no strong evidence exists that bouffant caps have lower surgical site infection risk, compared to skull caps. We had an opportunity to review previously prospectively collected data at our own institution to see what impact, if any, surgical headwear has on SSI infection risk.”

In 2016, Dr. Kothari, director of minimally invasive bariatric surgery at Gundersen Health System, La Crosse, Wisc., and his associates published results from a prospective, randomized non-inferiority trial on the impact of hair removal on surgical site infection rates (J Am Coll Surg 2016;223[5]:704-11). Patients were grouped by the attending surgeons’ preferred cap choice into either bouffant or skull cap groups. Their analysis concluded that hair left on the abdomen had no impact on surgical site infection rates. “What is unique about this study is that two independent certified research nurses independently assessed every wound in that trial,” he said.

For the current study, the researchers re-examined the data by conducting a multivariate analysis to determine the influence of surgical cap choice on SSIs. Overall, 1,543 patients were included in the trial. Attending surgeons wore bouffant caps and skull caps in 39% and 61% of cases, respectively. Bouffant caps were used in 71% of colon/intestine, 42% of hernia/other, 40% of biliary cases and only 1% of foregut cases. Overall, SSIs occurred in 8% and 5% of cases in which attending surgeons wore a bouffant and skull cap, respectively (P = .016), with 6% vs. 4% classified as superficial (P = .041), 0.8% vs. 0.2% deep (P = .120), and 1% vs. 0.9% organ space (P = .790). However, when the researchers adjusted for the type of surgery and surgical approach (laparoscopic vs. open), they observed no difference in SSI rates for skull cap, compared with bouffant cap.

“Surgeon preference should dictate the choice of headwear in the operating room,” Dr. Kothari commented. “What I would encourage is perhaps a summit between thought leaders in the ACS and the AORN, [to conduct] a true review of evidence and come up with a universal guideline. There are many other issues we need to be focusing on in surgery, and this probably doesn’t have to be one of them.”

“In general, there is a complete and utter absence of any scientific evidence whatsoever for most of the things we are told to do in terms of wearing what we do in the OR,” said invited discussant E. Patchen Dellinger, MD, FACS, FIDSA, professor of surgery at the University of Washington, Seattle. “In fact, there are prospective randomized trials showing that wearing a [face] mask does not reduce surgical site infection, although I’ve been wearing a mask in the OR for approximately 48 years.”

Dr. Kothari reported having no relevant financial disclosures.

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– Surgeon preference for bouffant versus skull caps does not significantly impact superficial surgical site infection rates after accounting for surgical procedure type, results from a an analysis of a previously randomized, prospective trial showed.

“We are all aware of the current battle that is taking place over operating room attire based on the differences between the AORN [Association of periOperative Nurses] recommendations and ACS guidelines,” lead study author Shanu N. Kothari, MD, FACS, said at the annual clinical congress of the American College of Surgeons.

Dr. Shanu Kothari director of minimally invasive bariatric surgery at Gundersen Health System, La Crosse, Wisc.
Dr. Shanu Kothari
“To date, no strong evidence exists that bouffant caps have lower surgical site infection risk, compared to skull caps. We had an opportunity to review previously prospectively collected data at our own institution to see what impact, if any, surgical headwear has on SSI infection risk.”

In 2016, Dr. Kothari, director of minimally invasive bariatric surgery at Gundersen Health System, La Crosse, Wisc., and his associates published results from a prospective, randomized non-inferiority trial on the impact of hair removal on surgical site infection rates (J Am Coll Surg 2016;223[5]:704-11). Patients were grouped by the attending surgeons’ preferred cap choice into either bouffant or skull cap groups. Their analysis concluded that hair left on the abdomen had no impact on surgical site infection rates. “What is unique about this study is that two independent certified research nurses independently assessed every wound in that trial,” he said.

For the current study, the researchers re-examined the data by conducting a multivariate analysis to determine the influence of surgical cap choice on SSIs. Overall, 1,543 patients were included in the trial. Attending surgeons wore bouffant caps and skull caps in 39% and 61% of cases, respectively. Bouffant caps were used in 71% of colon/intestine, 42% of hernia/other, 40% of biliary cases and only 1% of foregut cases. Overall, SSIs occurred in 8% and 5% of cases in which attending surgeons wore a bouffant and skull cap, respectively (P = .016), with 6% vs. 4% classified as superficial (P = .041), 0.8% vs. 0.2% deep (P = .120), and 1% vs. 0.9% organ space (P = .790). However, when the researchers adjusted for the type of surgery and surgical approach (laparoscopic vs. open), they observed no difference in SSI rates for skull cap, compared with bouffant cap.

“Surgeon preference should dictate the choice of headwear in the operating room,” Dr. Kothari commented. “What I would encourage is perhaps a summit between thought leaders in the ACS and the AORN, [to conduct] a true review of evidence and come up with a universal guideline. There are many other issues we need to be focusing on in surgery, and this probably doesn’t have to be one of them.”

“In general, there is a complete and utter absence of any scientific evidence whatsoever for most of the things we are told to do in terms of wearing what we do in the OR,” said invited discussant E. Patchen Dellinger, MD, FACS, FIDSA, professor of surgery at the University of Washington, Seattle. “In fact, there are prospective randomized trials showing that wearing a [face] mask does not reduce surgical site infection, although I’ve been wearing a mask in the OR for approximately 48 years.”

Dr. Kothari reported having no relevant financial disclosures.

 

– Surgeon preference for bouffant versus skull caps does not significantly impact superficial surgical site infection rates after accounting for surgical procedure type, results from a an analysis of a previously randomized, prospective trial showed.

“We are all aware of the current battle that is taking place over operating room attire based on the differences between the AORN [Association of periOperative Nurses] recommendations and ACS guidelines,” lead study author Shanu N. Kothari, MD, FACS, said at the annual clinical congress of the American College of Surgeons.

Dr. Shanu Kothari director of minimally invasive bariatric surgery at Gundersen Health System, La Crosse, Wisc.
Dr. Shanu Kothari
“To date, no strong evidence exists that bouffant caps have lower surgical site infection risk, compared to skull caps. We had an opportunity to review previously prospectively collected data at our own institution to see what impact, if any, surgical headwear has on SSI infection risk.”

In 2016, Dr. Kothari, director of minimally invasive bariatric surgery at Gundersen Health System, La Crosse, Wisc., and his associates published results from a prospective, randomized non-inferiority trial on the impact of hair removal on surgical site infection rates (J Am Coll Surg 2016;223[5]:704-11). Patients were grouped by the attending surgeons’ preferred cap choice into either bouffant or skull cap groups. Their analysis concluded that hair left on the abdomen had no impact on surgical site infection rates. “What is unique about this study is that two independent certified research nurses independently assessed every wound in that trial,” he said.

For the current study, the researchers re-examined the data by conducting a multivariate analysis to determine the influence of surgical cap choice on SSIs. Overall, 1,543 patients were included in the trial. Attending surgeons wore bouffant caps and skull caps in 39% and 61% of cases, respectively. Bouffant caps were used in 71% of colon/intestine, 42% of hernia/other, 40% of biliary cases and only 1% of foregut cases. Overall, SSIs occurred in 8% and 5% of cases in which attending surgeons wore a bouffant and skull cap, respectively (P = .016), with 6% vs. 4% classified as superficial (P = .041), 0.8% vs. 0.2% deep (P = .120), and 1% vs. 0.9% organ space (P = .790). However, when the researchers adjusted for the type of surgery and surgical approach (laparoscopic vs. open), they observed no difference in SSI rates for skull cap, compared with bouffant cap.

“Surgeon preference should dictate the choice of headwear in the operating room,” Dr. Kothari commented. “What I would encourage is perhaps a summit between thought leaders in the ACS and the AORN, [to conduct] a true review of evidence and come up with a universal guideline. There are many other issues we need to be focusing on in surgery, and this probably doesn’t have to be one of them.”

“In general, there is a complete and utter absence of any scientific evidence whatsoever for most of the things we are told to do in terms of wearing what we do in the OR,” said invited discussant E. Patchen Dellinger, MD, FACS, FIDSA, professor of surgery at the University of Washington, Seattle. “In fact, there are prospective randomized trials showing that wearing a [face] mask does not reduce surgical site infection, although I’ve been wearing a mask in the OR for approximately 48 years.”

Dr. Kothari reported having no relevant financial disclosures.

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Key clinical point: Surgeon preference should dictate choice of headwear in the OR.

Major finding: There was no significant difference in the rate of SSI, regardless of whether a skull cap or a bouffant cap was used during surgery.

Study details: Re-examination of a prospective, randomized non-inferiority trial of 1,543 patients, on the impact of hair removal on surgical site infection rates.

Disclosures: Dr. Kothari reporting having no relevant disclosures.

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Eliminating patient-controlled analgesia accelerates discharge after bariatric surgery

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Mon, 01/07/2019 - 13:02

 

– Hospital discharge after bariatric surgery can be significantly and meaningful accelerated by using multimodality pain control techniques that do not include patient-controlled analgesia (PCA), according to data from a two-hospital study presented at Obesity Week 2017.

“It was our impression that PCA was delaying milestones of recovery, so we prospectively evaluated this hypothesis. The result was a meaningful reduction in the length of stay without any meaningful adverse consequences,” reported Aline Van, RN, a weight loss surgery nurse navigator at Doctors Hospital, Manteca, Calif.

Aline Van,a weight loss surgery nurse navigator at Doctors Hospital, Manteca, Californ
Ted Bosworth/Frontline Medical News
Aline Van
There is some irony in these results, because “we had moved to PCA as a strategy to reduce opioid use,” explained Patrick Coates, MD, who is director of metabolic bariatric surgery at Central California Bariatric Surgery, Modesto, Calif., and a coauthor. According to Dr. Coates, who performs bariatric surgery at both of the hospitals that participated in this study, “these data demonstrate that opioids can be largely avoided during recovery without any real disadvantages.”

The study was conducted because of concern that nausea and vomiting related to PCA was a common cause of discharge delay at both Doctors Hospital in Manteca (DHM) and the affiliated Doctors Medical Center (DMC) in Modesto. Led by Maria Marple, PA-C, the two-part prospective study consisted of an initial six-month evaluation of average length of stay (LOS) and a formal evaluation of the causes of delayed discharge. In the second phase, the same analyses were performed over a six-month period when PCA was halted.

At 1.83 days in one center and 1.84 days in the other, the average LOS was nearly identical during the initial six-month baseline evaluation. In the 75 patients evaluated in this period at DHC, inadequate fluid intake due to nausea and vomiting was involved in 61.7% of the cases in which discharge was delayed. At DMC, where 46 patients were evaluated in the baseline period, 47.6% of delays were due to inadequate fluid intake attributed to nausea and vomiting. In both cases, this was the most common reason for delay.

In the study period after PCA was discontinued, inadequate fluid intake remained the major cause of delayed discharges, but there were fewer discharge delays overall due to less nausea and vomiting. The average length of stay among the 104 patients treated in the study period at DHM fell to 1.64 days, while the average LOS fell to 1.66 days in the 83 patients treated at DMC. This was largely driven by a reduction in the proportion of patients with >2 days LOS, which fell from 52% to 41% at DHC (P = .04) and from 45% to 32% at DMC (P = .008).

The surgical procedures at both centers (all performed laparoscopically) included sleeve gastrectomy, gastric bypass, and duodenal switch. Although a multimodality approach is employed for postoperative pain control at both institutions, the protocols differ modestly. At DHC, acetaminophen by mouth is the primary postoperative analgesic with hydromorphone permitted if needed. At DMC, intravenous acetaminophen is used in the first 24 hours in all patients with acetaminophen/hydrocodone offered if needed.

Since the trial was completed and results analyzed, PCA has been discontinued completely at both institutions. In follow-up to date there has been a slight additional reduction in average LOS at both institutions, reaching 1.5 days at DHC and 1.61 days at DMC.

“The four to five hour average reduction in LOS following discontinuation of PCA is significant because it frees up beds at our hospital, which is run at capacity,” Ms. Van said. “When considered cumulatively, the average reduction in LOS is very meaningful.”

Although the benefits are generally attributed to reduced nausea and vomiting, which has implications for a better patient experience, Ms. Van also believes patients are having faster cognitive and physical recovery since PCA was eliminated, producing faster time to ambulation and discharge readiness.

“There really have been no negatives,” Dr. Coates confirmed. “In our experience, eliminating PCA has been better for the patients and has important implications for costs.”

Ms. Van and Dr. Coates reported no financial relationships relevant to this topic.
 

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– Hospital discharge after bariatric surgery can be significantly and meaningful accelerated by using multimodality pain control techniques that do not include patient-controlled analgesia (PCA), according to data from a two-hospital study presented at Obesity Week 2017.

“It was our impression that PCA was delaying milestones of recovery, so we prospectively evaluated this hypothesis. The result was a meaningful reduction in the length of stay without any meaningful adverse consequences,” reported Aline Van, RN, a weight loss surgery nurse navigator at Doctors Hospital, Manteca, Calif.

Aline Van,a weight loss surgery nurse navigator at Doctors Hospital, Manteca, Californ
Ted Bosworth/Frontline Medical News
Aline Van
There is some irony in these results, because “we had moved to PCA as a strategy to reduce opioid use,” explained Patrick Coates, MD, who is director of metabolic bariatric surgery at Central California Bariatric Surgery, Modesto, Calif., and a coauthor. According to Dr. Coates, who performs bariatric surgery at both of the hospitals that participated in this study, “these data demonstrate that opioids can be largely avoided during recovery without any real disadvantages.”

The study was conducted because of concern that nausea and vomiting related to PCA was a common cause of discharge delay at both Doctors Hospital in Manteca (DHM) and the affiliated Doctors Medical Center (DMC) in Modesto. Led by Maria Marple, PA-C, the two-part prospective study consisted of an initial six-month evaluation of average length of stay (LOS) and a formal evaluation of the causes of delayed discharge. In the second phase, the same analyses were performed over a six-month period when PCA was halted.

At 1.83 days in one center and 1.84 days in the other, the average LOS was nearly identical during the initial six-month baseline evaluation. In the 75 patients evaluated in this period at DHC, inadequate fluid intake due to nausea and vomiting was involved in 61.7% of the cases in which discharge was delayed. At DMC, where 46 patients were evaluated in the baseline period, 47.6% of delays were due to inadequate fluid intake attributed to nausea and vomiting. In both cases, this was the most common reason for delay.

In the study period after PCA was discontinued, inadequate fluid intake remained the major cause of delayed discharges, but there were fewer discharge delays overall due to less nausea and vomiting. The average length of stay among the 104 patients treated in the study period at DHM fell to 1.64 days, while the average LOS fell to 1.66 days in the 83 patients treated at DMC. This was largely driven by a reduction in the proportion of patients with >2 days LOS, which fell from 52% to 41% at DHC (P = .04) and from 45% to 32% at DMC (P = .008).

The surgical procedures at both centers (all performed laparoscopically) included sleeve gastrectomy, gastric bypass, and duodenal switch. Although a multimodality approach is employed for postoperative pain control at both institutions, the protocols differ modestly. At DHC, acetaminophen by mouth is the primary postoperative analgesic with hydromorphone permitted if needed. At DMC, intravenous acetaminophen is used in the first 24 hours in all patients with acetaminophen/hydrocodone offered if needed.

Since the trial was completed and results analyzed, PCA has been discontinued completely at both institutions. In follow-up to date there has been a slight additional reduction in average LOS at both institutions, reaching 1.5 days at DHC and 1.61 days at DMC.

“The four to five hour average reduction in LOS following discontinuation of PCA is significant because it frees up beds at our hospital, which is run at capacity,” Ms. Van said. “When considered cumulatively, the average reduction in LOS is very meaningful.”

Although the benefits are generally attributed to reduced nausea and vomiting, which has implications for a better patient experience, Ms. Van also believes patients are having faster cognitive and physical recovery since PCA was eliminated, producing faster time to ambulation and discharge readiness.

“There really have been no negatives,” Dr. Coates confirmed. “In our experience, eliminating PCA has been better for the patients and has important implications for costs.”

Ms. Van and Dr. Coates reported no financial relationships relevant to this topic.
 

 

– Hospital discharge after bariatric surgery can be significantly and meaningful accelerated by using multimodality pain control techniques that do not include patient-controlled analgesia (PCA), according to data from a two-hospital study presented at Obesity Week 2017.

“It was our impression that PCA was delaying milestones of recovery, so we prospectively evaluated this hypothesis. The result was a meaningful reduction in the length of stay without any meaningful adverse consequences,” reported Aline Van, RN, a weight loss surgery nurse navigator at Doctors Hospital, Manteca, Calif.

Aline Van,a weight loss surgery nurse navigator at Doctors Hospital, Manteca, Californ
Ted Bosworth/Frontline Medical News
Aline Van
There is some irony in these results, because “we had moved to PCA as a strategy to reduce opioid use,” explained Patrick Coates, MD, who is director of metabolic bariatric surgery at Central California Bariatric Surgery, Modesto, Calif., and a coauthor. According to Dr. Coates, who performs bariatric surgery at both of the hospitals that participated in this study, “these data demonstrate that opioids can be largely avoided during recovery without any real disadvantages.”

The study was conducted because of concern that nausea and vomiting related to PCA was a common cause of discharge delay at both Doctors Hospital in Manteca (DHM) and the affiliated Doctors Medical Center (DMC) in Modesto. Led by Maria Marple, PA-C, the two-part prospective study consisted of an initial six-month evaluation of average length of stay (LOS) and a formal evaluation of the causes of delayed discharge. In the second phase, the same analyses were performed over a six-month period when PCA was halted.

At 1.83 days in one center and 1.84 days in the other, the average LOS was nearly identical during the initial six-month baseline evaluation. In the 75 patients evaluated in this period at DHC, inadequate fluid intake due to nausea and vomiting was involved in 61.7% of the cases in which discharge was delayed. At DMC, where 46 patients were evaluated in the baseline period, 47.6% of delays were due to inadequate fluid intake attributed to nausea and vomiting. In both cases, this was the most common reason for delay.

In the study period after PCA was discontinued, inadequate fluid intake remained the major cause of delayed discharges, but there were fewer discharge delays overall due to less nausea and vomiting. The average length of stay among the 104 patients treated in the study period at DHM fell to 1.64 days, while the average LOS fell to 1.66 days in the 83 patients treated at DMC. This was largely driven by a reduction in the proportion of patients with >2 days LOS, which fell from 52% to 41% at DHC (P = .04) and from 45% to 32% at DMC (P = .008).

The surgical procedures at both centers (all performed laparoscopically) included sleeve gastrectomy, gastric bypass, and duodenal switch. Although a multimodality approach is employed for postoperative pain control at both institutions, the protocols differ modestly. At DHC, acetaminophen by mouth is the primary postoperative analgesic with hydromorphone permitted if needed. At DMC, intravenous acetaminophen is used in the first 24 hours in all patients with acetaminophen/hydrocodone offered if needed.

Since the trial was completed and results analyzed, PCA has been discontinued completely at both institutions. In follow-up to date there has been a slight additional reduction in average LOS at both institutions, reaching 1.5 days at DHC and 1.61 days at DMC.

“The four to five hour average reduction in LOS following discontinuation of PCA is significant because it frees up beds at our hospital, which is run at capacity,” Ms. Van said. “When considered cumulatively, the average reduction in LOS is very meaningful.”

Although the benefits are generally attributed to reduced nausea and vomiting, which has implications for a better patient experience, Ms. Van also believes patients are having faster cognitive and physical recovery since PCA was eliminated, producing faster time to ambulation and discharge readiness.

“There really have been no negatives,” Dr. Coates confirmed. “In our experience, eliminating PCA has been better for the patients and has important implications for costs.”

Ms. Van and Dr. Coates reported no financial relationships relevant to this topic.
 

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Key clinical point: When patient-controlled analgesia (PCA) after bariatric surgery is eliminated, time to discharge is accelerated with no adverse consequences.

Major finding: The average 0.2 day (4.8 hour) reduction (P < .05) was characterized as clinically meaningful.

Data source: Prospective, non-randomized study.

Disclosures: Ms. Van and Dr. Coates reported no financial relationships relevant to this topic.

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No benefit found in pre-bariatric surgery weight loss programs

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– Many third-party payers require candidates for bariatric surgery to complete weight loss programs in order to qualify for reimbursement, but two new studies presented at Obesity Week 2017 have found no identifiable justification for the delay in treatment.

“When comparing those who did or did not participate in a weight management program, there was no significant benefit in regard to surgery complications, patient rate of followup, or percent excess weight loss at 12 months,” reported Andrew Schneider, MD, who is completing his residency in general surgery in the Greenville Health Systems, Greenville, South Carolina.

Dr. Andrew Schneider
The analysis presented by Dr. Schneider was drawn from prospectively maintained data in the Greenville Health System. From 354 patients in this pool of data, a cohort of 266 required to participate in an insurance-mandated, medically supervised weight management program were compared to a second cohort of 88 patients who were not.

No significant differences were observed in a long list of procedural and outcome variables including operating time, length of hospital stay, and excess weight loss (EWL) at 3, 6, and 12 months, according to Dr. Schneider, who emphasized that no differences even approached significance.

A second study, evaluating the effect of presurgical weight management programs from a different perspective, drew the same conclusion. In this study, the goal was to correlate the number of preoperative weight loss sessions with change in multiple outcomes including EWL, according Genna Hymowitz, PhD, a psychologist at the Stony Brook Medicine Bariatric and Metabolic Weight Loss Center, Stony Brook, New York.

No correlation was observed between number of presurgical weight management program visits and any outcome evaluated in followup out to 12 months, according to Dr. Hymowitz. There was one exception.

“The number of visits attended and weight loss 3 weeks after surgery was a negative correlation, suggesting that the number of sessions attended was associated with lower excess weight loss,” Dr. Hymowitz reported.

Insurance company requirements for presurgical weight management programs vary widely, but the American Society for Metabolic and Bariatric Surgery (ASMBS) concluded in a position statement issued in 2011 that they are unsupported by controlled evidence. According to this statement, which referenced several clinical studies, “there is no evidence of any kind that insurance mandated preoperative weight loss…has any clear impact on postoperative outcomes or weight loss.”

In the ASBMS statement, the objection is directed at specific requirements for medically supervised weight loss program. These can demand six or more months of participation before reimbursement for surgery will be granted. In the ASBMS statement, mandated treatment required by insurance companies is distinguished from Medicare policy. Medicare reimbursement requires patients to fail medical treatment prior to bariatric surgery but providers are allowed to define failure. In contrast, specified periods of medical management required by insurance companies can have the effect of delaying treatment with proven efficacy in appropriate candidates.

Asked to speculate why insurance companies mandate supervised weight loss program for bariatric surgery eligibility, Dr. Schneider suggested that it might be considered a method to evaluate patient motivation and compliance. However, he also acknowledged that the requirement is likely to provide a barrier for some individuals thereby reducing surgical costs for the third-party payers.

While there are now several studies, including those cited in the ASBMS position statement, arguing that these mandates should be eliminated, longer followup is needed, according to Maher El Chaar, MD, Co-Medical Director, Bariatric surgery, St. Luke’s University Hospital, Allentown, Pennsylvania. One of the moderators for the Obesity Week session in which the two latest studies were presented, Dr. El Chaar said that insurance company representatives with whom he has spoken insist that longer-term studies are needed.

“When I point out that there is no data supporting mandated weight management programs, they tell me that there is very little data beyond 12 months,” Dr. El Chaar explained. He suggested data beyond 12 months could be helpful in the effort to get these requirements waived.

Dr. Schneider and Dr. Hymowitz reported no relevant financial relationships.


 

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– Many third-party payers require candidates for bariatric surgery to complete weight loss programs in order to qualify for reimbursement, but two new studies presented at Obesity Week 2017 have found no identifiable justification for the delay in treatment.

“When comparing those who did or did not participate in a weight management program, there was no significant benefit in regard to surgery complications, patient rate of followup, or percent excess weight loss at 12 months,” reported Andrew Schneider, MD, who is completing his residency in general surgery in the Greenville Health Systems, Greenville, South Carolina.

Dr. Andrew Schneider
The analysis presented by Dr. Schneider was drawn from prospectively maintained data in the Greenville Health System. From 354 patients in this pool of data, a cohort of 266 required to participate in an insurance-mandated, medically supervised weight management program were compared to a second cohort of 88 patients who were not.

No significant differences were observed in a long list of procedural and outcome variables including operating time, length of hospital stay, and excess weight loss (EWL) at 3, 6, and 12 months, according to Dr. Schneider, who emphasized that no differences even approached significance.

A second study, evaluating the effect of presurgical weight management programs from a different perspective, drew the same conclusion. In this study, the goal was to correlate the number of preoperative weight loss sessions with change in multiple outcomes including EWL, according Genna Hymowitz, PhD, a psychologist at the Stony Brook Medicine Bariatric and Metabolic Weight Loss Center, Stony Brook, New York.

No correlation was observed between number of presurgical weight management program visits and any outcome evaluated in followup out to 12 months, according to Dr. Hymowitz. There was one exception.

“The number of visits attended and weight loss 3 weeks after surgery was a negative correlation, suggesting that the number of sessions attended was associated with lower excess weight loss,” Dr. Hymowitz reported.

Insurance company requirements for presurgical weight management programs vary widely, but the American Society for Metabolic and Bariatric Surgery (ASMBS) concluded in a position statement issued in 2011 that they are unsupported by controlled evidence. According to this statement, which referenced several clinical studies, “there is no evidence of any kind that insurance mandated preoperative weight loss…has any clear impact on postoperative outcomes or weight loss.”

In the ASBMS statement, the objection is directed at specific requirements for medically supervised weight loss program. These can demand six or more months of participation before reimbursement for surgery will be granted. In the ASBMS statement, mandated treatment required by insurance companies is distinguished from Medicare policy. Medicare reimbursement requires patients to fail medical treatment prior to bariatric surgery but providers are allowed to define failure. In contrast, specified periods of medical management required by insurance companies can have the effect of delaying treatment with proven efficacy in appropriate candidates.

Asked to speculate why insurance companies mandate supervised weight loss program for bariatric surgery eligibility, Dr. Schneider suggested that it might be considered a method to evaluate patient motivation and compliance. However, he also acknowledged that the requirement is likely to provide a barrier for some individuals thereby reducing surgical costs for the third-party payers.

While there are now several studies, including those cited in the ASBMS position statement, arguing that these mandates should be eliminated, longer followup is needed, according to Maher El Chaar, MD, Co-Medical Director, Bariatric surgery, St. Luke’s University Hospital, Allentown, Pennsylvania. One of the moderators for the Obesity Week session in which the two latest studies were presented, Dr. El Chaar said that insurance company representatives with whom he has spoken insist that longer-term studies are needed.

“When I point out that there is no data supporting mandated weight management programs, they tell me that there is very little data beyond 12 months,” Dr. El Chaar explained. He suggested data beyond 12 months could be helpful in the effort to get these requirements waived.

Dr. Schneider and Dr. Hymowitz reported no relevant financial relationships.


 

 

– Many third-party payers require candidates for bariatric surgery to complete weight loss programs in order to qualify for reimbursement, but two new studies presented at Obesity Week 2017 have found no identifiable justification for the delay in treatment.

“When comparing those who did or did not participate in a weight management program, there was no significant benefit in regard to surgery complications, patient rate of followup, or percent excess weight loss at 12 months,” reported Andrew Schneider, MD, who is completing his residency in general surgery in the Greenville Health Systems, Greenville, South Carolina.

Dr. Andrew Schneider
The analysis presented by Dr. Schneider was drawn from prospectively maintained data in the Greenville Health System. From 354 patients in this pool of data, a cohort of 266 required to participate in an insurance-mandated, medically supervised weight management program were compared to a second cohort of 88 patients who were not.

No significant differences were observed in a long list of procedural and outcome variables including operating time, length of hospital stay, and excess weight loss (EWL) at 3, 6, and 12 months, according to Dr. Schneider, who emphasized that no differences even approached significance.

A second study, evaluating the effect of presurgical weight management programs from a different perspective, drew the same conclusion. In this study, the goal was to correlate the number of preoperative weight loss sessions with change in multiple outcomes including EWL, according Genna Hymowitz, PhD, a psychologist at the Stony Brook Medicine Bariatric and Metabolic Weight Loss Center, Stony Brook, New York.

No correlation was observed between number of presurgical weight management program visits and any outcome evaluated in followup out to 12 months, according to Dr. Hymowitz. There was one exception.

“The number of visits attended and weight loss 3 weeks after surgery was a negative correlation, suggesting that the number of sessions attended was associated with lower excess weight loss,” Dr. Hymowitz reported.

Insurance company requirements for presurgical weight management programs vary widely, but the American Society for Metabolic and Bariatric Surgery (ASMBS) concluded in a position statement issued in 2011 that they are unsupported by controlled evidence. According to this statement, which referenced several clinical studies, “there is no evidence of any kind that insurance mandated preoperative weight loss…has any clear impact on postoperative outcomes or weight loss.”

In the ASBMS statement, the objection is directed at specific requirements for medically supervised weight loss program. These can demand six or more months of participation before reimbursement for surgery will be granted. In the ASBMS statement, mandated treatment required by insurance companies is distinguished from Medicare policy. Medicare reimbursement requires patients to fail medical treatment prior to bariatric surgery but providers are allowed to define failure. In contrast, specified periods of medical management required by insurance companies can have the effect of delaying treatment with proven efficacy in appropriate candidates.

Asked to speculate why insurance companies mandate supervised weight loss program for bariatric surgery eligibility, Dr. Schneider suggested that it might be considered a method to evaluate patient motivation and compliance. However, he also acknowledged that the requirement is likely to provide a barrier for some individuals thereby reducing surgical costs for the third-party payers.

While there are now several studies, including those cited in the ASBMS position statement, arguing that these mandates should be eliminated, longer followup is needed, according to Maher El Chaar, MD, Co-Medical Director, Bariatric surgery, St. Luke’s University Hospital, Allentown, Pennsylvania. One of the moderators for the Obesity Week session in which the two latest studies were presented, Dr. El Chaar said that insurance company representatives with whom he has spoken insist that longer-term studies are needed.

“When I point out that there is no data supporting mandated weight management programs, they tell me that there is very little data beyond 12 months,” Dr. El Chaar explained. He suggested data beyond 12 months could be helpful in the effort to get these requirements waived.

Dr. Schneider and Dr. Hymowitz reported no relevant financial relationships.


 

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Key clinical point: Two studies concluded mandated weight loss programs prior to bariatric surgery offer no clinical value.

Major finding: When compared for weight loss at 3, 6, or 12 months after surgery, there was no difference in weight change for participants versus non-participants.

Data source: Retrospective and prospective analyses.

Disclosures: Dr. Schneider and Dr. Hymowitz reported no relevant financial relationships.

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Seven years after bariatric surgery, more than 40% still off insulin

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– Forty-four percent of insulin-dependent patients with type 2 diabetes mellitus (DM2) were at their glycemic target without insulin a median of seven years after surgery. The data from the largest study to evaluate long-term outcomes in this population were presented at Obesity Week 2017.

“These data confirm that the impressive metabolic effects of bariatric surgery in patients with type 2 diabetes are sustained beyond five years,” reported Ali Aminian, MD, a surgeon who specializes in bariatric procedures at the Cleveland Clinic, Cleveland, Ohio. He said that long-term efficacy has not been well characterized previously.

Dr. Ali Aminian
Bariatric surgery patients treated at the Cleveland Clinic were included in this analysis if they had DM2, were taking insulin at the time of their procedure, and had been followed for at least five years. The median follow-up was 7 years with a range out to 12 years. Of the 252 patients included, 194 underwent roux-en-y gastric bypass (RYGB) and 58 underwent sleeve gastrectomy.

Reaching the glycemic target, defined as less than 7% HbA1c, without insulin was only one of the primary endpoints. The other was diabetes remission, which was defined as HbA1c less than 6.5%, fasting blood glucose less than 126 mg/dL, and being off all diabetes medications. This was observed in 15% of the patients after a median of 7 years followup.

Contrasting short-term results, defined as outcomes one to two years after bariatric surgery with the long-term followup, Dr. Aminian was able to show that declines were relatively modest over time. For example, 51% were at the glycemic target off insulin at the short-term mark, which translates into an absolute decline of only 7% relative to the 44% observed at the long-term followup assessment.

Similarly, 70% had achieved the American Diabetes Association (ADA) goal of less than 7% within the first two years of surgery, while 59% remained at this goal at the most recent followup. The proportion taking insulin at the short-term mark was 36% rising only to 40% long-term.

When data were stratified by procedure, results favored RYGB over sleeve gastrectomy. For example, 47% of the RYGB patients versus 33% of the sleeve gastrectomy patients were able to reach the ADA goal without insulin at the end of the study. The proportions in diabetes remission were 17% and 10%, respectively. RYGB was also associated with greater improvement in BMI (median -12 vs. - 8 kg/m2) and reduced late weight gain (median 20% vs. 31%).

However, Dr. Aminian, who did not provide statistical calculations for these differences, cautioned that higher risk patients might have been preferentially selected for sleeve gastrectomy. He noted that difference in median HbA1c levels was significantly lower in the RYGB group two years after surgery (P less than .001) but the numerical advantage had lost significance at the last followup (P = .32).

In an evaluation of predictors for glycemic control, a shorter duration of diabetes (less than 10 years) and good glycemic control prior to surgery were both predictors of achieving the primary outcomes on the basis of a multivariate analysis, according to Dr. Aminian. Younger age was a marginal predictor, but Dr. Aminian said that neither type of procedure nor presurgical BMI predicted outcomes from the multivariate analysis.

Relative to baseline, there were significant improvements in median LDL (P = .001). In addition, HDL, triglyceride levels, systolic, and diastolic blood pressure measurements were all significantly improved, both short-term and long-term after bariatric surgery (all P values less than .001), according to Dr. Aminian. When expressed as ADA goals, 82% of participants had blood pressure less than 140/90 mm Hg 7 years after surgery relative to 44% at baseline (P less than .001). The proportion with LDL less 100 mg/dL approached, but did not reach clinical significance (61% vs. 70%; P=0.06).

“When you consider all three parameters [ADA targets for glycemic control, blood pressure control, and lipid control], only 3% of patients met all three targets at baseline but 32% [P< less than .001] were at these targets at long-term followup,” Dr. Aminian reported.

Dr. Aminian reported having no relevant financial relationships.

As the invited discussant on these data, Raul Rosenthal, MD, Director, Bariatric and Metabolic Institute, Cleveland Clinic Florida, Weston, Florida, reiterated that time with diabetes prior to bariatric surgery may be an important predictor of postsurgical control of metabolic parameters.

“I published a paper about 10 years ago on outcomes in patients with diabetes, and in our experience 5 years was the limit. If you have a history of 5 years or less with diabetes, the chance of going into remission were 80%, and if it was more than 5 years, the likelihood dropped dramatically,” Dr. Rosenthal noted. He indicated duration of diabetes deserves further evaluation for its potential relevance to the optimal timing of bariatric surgery.
 

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– Forty-four percent of insulin-dependent patients with type 2 diabetes mellitus (DM2) were at their glycemic target without insulin a median of seven years after surgery. The data from the largest study to evaluate long-term outcomes in this population were presented at Obesity Week 2017.

“These data confirm that the impressive metabolic effects of bariatric surgery in patients with type 2 diabetes are sustained beyond five years,” reported Ali Aminian, MD, a surgeon who specializes in bariatric procedures at the Cleveland Clinic, Cleveland, Ohio. He said that long-term efficacy has not been well characterized previously.

Dr. Ali Aminian
Bariatric surgery patients treated at the Cleveland Clinic were included in this analysis if they had DM2, were taking insulin at the time of their procedure, and had been followed for at least five years. The median follow-up was 7 years with a range out to 12 years. Of the 252 patients included, 194 underwent roux-en-y gastric bypass (RYGB) and 58 underwent sleeve gastrectomy.

Reaching the glycemic target, defined as less than 7% HbA1c, without insulin was only one of the primary endpoints. The other was diabetes remission, which was defined as HbA1c less than 6.5%, fasting blood glucose less than 126 mg/dL, and being off all diabetes medications. This was observed in 15% of the patients after a median of 7 years followup.

Contrasting short-term results, defined as outcomes one to two years after bariatric surgery with the long-term followup, Dr. Aminian was able to show that declines were relatively modest over time. For example, 51% were at the glycemic target off insulin at the short-term mark, which translates into an absolute decline of only 7% relative to the 44% observed at the long-term followup assessment.

Similarly, 70% had achieved the American Diabetes Association (ADA) goal of less than 7% within the first two years of surgery, while 59% remained at this goal at the most recent followup. The proportion taking insulin at the short-term mark was 36% rising only to 40% long-term.

When data were stratified by procedure, results favored RYGB over sleeve gastrectomy. For example, 47% of the RYGB patients versus 33% of the sleeve gastrectomy patients were able to reach the ADA goal without insulin at the end of the study. The proportions in diabetes remission were 17% and 10%, respectively. RYGB was also associated with greater improvement in BMI (median -12 vs. - 8 kg/m2) and reduced late weight gain (median 20% vs. 31%).

However, Dr. Aminian, who did not provide statistical calculations for these differences, cautioned that higher risk patients might have been preferentially selected for sleeve gastrectomy. He noted that difference in median HbA1c levels was significantly lower in the RYGB group two years after surgery (P less than .001) but the numerical advantage had lost significance at the last followup (P = .32).

In an evaluation of predictors for glycemic control, a shorter duration of diabetes (less than 10 years) and good glycemic control prior to surgery were both predictors of achieving the primary outcomes on the basis of a multivariate analysis, according to Dr. Aminian. Younger age was a marginal predictor, but Dr. Aminian said that neither type of procedure nor presurgical BMI predicted outcomes from the multivariate analysis.

Relative to baseline, there were significant improvements in median LDL (P = .001). In addition, HDL, triglyceride levels, systolic, and diastolic blood pressure measurements were all significantly improved, both short-term and long-term after bariatric surgery (all P values less than .001), according to Dr. Aminian. When expressed as ADA goals, 82% of participants had blood pressure less than 140/90 mm Hg 7 years after surgery relative to 44% at baseline (P less than .001). The proportion with LDL less 100 mg/dL approached, but did not reach clinical significance (61% vs. 70%; P=0.06).

“When you consider all three parameters [ADA targets for glycemic control, blood pressure control, and lipid control], only 3% of patients met all three targets at baseline but 32% [P< less than .001] were at these targets at long-term followup,” Dr. Aminian reported.

Dr. Aminian reported having no relevant financial relationships.

As the invited discussant on these data, Raul Rosenthal, MD, Director, Bariatric and Metabolic Institute, Cleveland Clinic Florida, Weston, Florida, reiterated that time with diabetes prior to bariatric surgery may be an important predictor of postsurgical control of metabolic parameters.

“I published a paper about 10 years ago on outcomes in patients with diabetes, and in our experience 5 years was the limit. If you have a history of 5 years or less with diabetes, the chance of going into remission were 80%, and if it was more than 5 years, the likelihood dropped dramatically,” Dr. Rosenthal noted. He indicated duration of diabetes deserves further evaluation for its potential relevance to the optimal timing of bariatric surgery.
 

 

– Forty-four percent of insulin-dependent patients with type 2 diabetes mellitus (DM2) were at their glycemic target without insulin a median of seven years after surgery. The data from the largest study to evaluate long-term outcomes in this population were presented at Obesity Week 2017.

“These data confirm that the impressive metabolic effects of bariatric surgery in patients with type 2 diabetes are sustained beyond five years,” reported Ali Aminian, MD, a surgeon who specializes in bariatric procedures at the Cleveland Clinic, Cleveland, Ohio. He said that long-term efficacy has not been well characterized previously.

Dr. Ali Aminian
Bariatric surgery patients treated at the Cleveland Clinic were included in this analysis if they had DM2, were taking insulin at the time of their procedure, and had been followed for at least five years. The median follow-up was 7 years with a range out to 12 years. Of the 252 patients included, 194 underwent roux-en-y gastric bypass (RYGB) and 58 underwent sleeve gastrectomy.

Reaching the glycemic target, defined as less than 7% HbA1c, without insulin was only one of the primary endpoints. The other was diabetes remission, which was defined as HbA1c less than 6.5%, fasting blood glucose less than 126 mg/dL, and being off all diabetes medications. This was observed in 15% of the patients after a median of 7 years followup.

Contrasting short-term results, defined as outcomes one to two years after bariatric surgery with the long-term followup, Dr. Aminian was able to show that declines were relatively modest over time. For example, 51% were at the glycemic target off insulin at the short-term mark, which translates into an absolute decline of only 7% relative to the 44% observed at the long-term followup assessment.

Similarly, 70% had achieved the American Diabetes Association (ADA) goal of less than 7% within the first two years of surgery, while 59% remained at this goal at the most recent followup. The proportion taking insulin at the short-term mark was 36% rising only to 40% long-term.

When data were stratified by procedure, results favored RYGB over sleeve gastrectomy. For example, 47% of the RYGB patients versus 33% of the sleeve gastrectomy patients were able to reach the ADA goal without insulin at the end of the study. The proportions in diabetes remission were 17% and 10%, respectively. RYGB was also associated with greater improvement in BMI (median -12 vs. - 8 kg/m2) and reduced late weight gain (median 20% vs. 31%).

However, Dr. Aminian, who did not provide statistical calculations for these differences, cautioned that higher risk patients might have been preferentially selected for sleeve gastrectomy. He noted that difference in median HbA1c levels was significantly lower in the RYGB group two years after surgery (P less than .001) but the numerical advantage had lost significance at the last followup (P = .32).

In an evaluation of predictors for glycemic control, a shorter duration of diabetes (less than 10 years) and good glycemic control prior to surgery were both predictors of achieving the primary outcomes on the basis of a multivariate analysis, according to Dr. Aminian. Younger age was a marginal predictor, but Dr. Aminian said that neither type of procedure nor presurgical BMI predicted outcomes from the multivariate analysis.

Relative to baseline, there were significant improvements in median LDL (P = .001). In addition, HDL, triglyceride levels, systolic, and diastolic blood pressure measurements were all significantly improved, both short-term and long-term after bariatric surgery (all P values less than .001), according to Dr. Aminian. When expressed as ADA goals, 82% of participants had blood pressure less than 140/90 mm Hg 7 years after surgery relative to 44% at baseline (P less than .001). The proportion with LDL less 100 mg/dL approached, but did not reach clinical significance (61% vs. 70%; P=0.06).

“When you consider all three parameters [ADA targets for glycemic control, blood pressure control, and lipid control], only 3% of patients met all three targets at baseline but 32% [P< less than .001] were at these targets at long-term followup,” Dr. Aminian reported.

Dr. Aminian reported having no relevant financial relationships.

As the invited discussant on these data, Raul Rosenthal, MD, Director, Bariatric and Metabolic Institute, Cleveland Clinic Florida, Weston, Florida, reiterated that time with diabetes prior to bariatric surgery may be an important predictor of postsurgical control of metabolic parameters.

“I published a paper about 10 years ago on outcomes in patients with diabetes, and in our experience 5 years was the limit. If you have a history of 5 years or less with diabetes, the chance of going into remission were 80%, and if it was more than 5 years, the likelihood dropped dramatically,” Dr. Rosenthal noted. He indicated duration of diabetes deserves further evaluation for its potential relevance to the optimal timing of bariatric surgery.
 

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Key clinical point: In the largest study to follow insulin-dependent patients after bariatric surgery, substantial benefits persist after median 7 years of followup.

Major finding: Among 252 insulin-dependent patients followed for a minimum of 5 years, 44% remain off insulin and 15% are off all anti-diabetic medications.

Data source: Retrospective single-center analysis.

Disclosures: Dr. Aminian reported having no relevant financial relationships.

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Weight recidivism after bariatric surgery: What constitutes failure?

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– A standard definition of bariatric surgery failure based on weight regain is needed to assess long-term outcomes in place of the seemingly arbitrary thresholds now in use, according to discussion generated by long-term outcome studies presented at Obesity Week 2017.

Dr. Michael C. Morrell a bariatric surgeon at the Gundersen Medical Foundation, Encinitas, Calif.
Ted Bosworth/Frontline Medical News
Dr. Michael C. Morrell
In one of two studies evaluating weight recidivism in long-term follow-up after bariatric surgery, failure rates at 10 years ranged from 25% to more than 70% according to the definition used, reported to Michael C. Morell, MD, a bariatric surgeon at the Gundersen Medical Foundation, Encinitas, CA.

In another study, presented by Colin Martyn, MD, a general surgery resident at Texas Tech University Health Sciences Center, El Paso, the bariatric surgery failure rate at 11 years was characterized as an “alarming” 33.9%. In this study, bariatric surgery was considered a failure if the patient did not maintain excess weight loss (EWL) of 50% or greater.

The problem with this definition, like many others, is that “it fails to recognize that there could be significant health benefits and improvements in quality of life with less weight loss,” according to Philip Schauer, MD, director of the Cleveland Clinic Bariatric and Metabolic Institute. As the invited discussant for the data presented by Dr. Martyn, Dr. Schauer acknowledged that 50% EWL has been used by others as the dividing line between success and failure, but he called it “obsolete.”

This definition was one of several applied to weight recidivism in the study presented by Dr. Morell. Others included weight regain of more than 25% EWL over the postoperative nadir, an increase in body mass index to more than 35 kg/m2 after achieving a lower BMI, and a postsurgical BMI increase of more than 5 mg/m2. Not surprisingly, weight recidivism “varied widely with regard to the definitions used,” Dr. Morell reported.

Dr. Morell’s study involved evaluation of 1,766 patients with at least 1 year of follow-up after bariatric procedure. Most (1,490 patients) underwent laparoscopic Roux-en-y gastric bypass. After 2 years of follow-up, 93% achieved at least the 50% EWL threshold of treatment success, but Dr. Morell reported that the proportion above this or any threshold progressively diminished over time. For a definition of treatment success, Dr. Morell favors maintenance of at least 20% total weight loss as a threshold of long-term clinical success, a threshold met by 75% of patients at 5 years, in his analysis.

Dr. Colin Martyn, a general surgery resident at Texas Tech University Health Sciences Center, El Paso
Ted Bosworth/Frontline Medical News
Dr. Colin Martyn
In the meta-analysis presented by Dr. Martyn, nine published studies with at least 7 years of follow-up were included. These involved a cumulative 345 patients followed for at least 7 years with diminishing numbers followed up to 11 years. Using the at least 50% EWL as the definition of treatment success, the overall failure rate was 27.8% at 7 years but climbed to 33.9% at 11 years.

As has been shown in these studies and reported previously, the regaining of weight over time after bariatric surgery is common and progressive, but both studies ignited controversy about what measure is meaningful for declaring that bariatric surgery has failed over the long term. None of the current thresholds for failure are based on evidence that clinical benefit has been lost. Rather, it appears that these are simply accepted conventions.

“It bothers me to hear the word failure in these presentations, because I think the paradigm is changing from success and failure to that of treating chronic disease,” said Stacy Brethauer, MD, a staff surgeon in the Cleveland Clinic Digestive Disease Institute. Dr. Brethauer, the moderator of the session at Obesity Week where both long-term follow-up papers were presented, agreed that the at least 50% EWL benchmark is “flawed.” He suggested that more clinically meaningful methods of evaluating long-term outcome are needed for both clinical and research purposes.

The discussant of Dr. Morell’s paper, Samer G. Mattar, MD, a bariatric surgeon at the Swedish Medical Center, Seattle, also called for metrics based on clinical benefit rather than on weight alone.

“I would caution against this overall emphasis that we seem to place on weight gain and weight loss as a benchmark and predominant objective for what we do,” he said. “Our nonsurgeon colleagues have repeatedly demonstrated clinical benefits from total body weight loss of 10% or even 5%. So let’s not beat up ourselves over trying to maintain a greater than 50% EWL in all our patients.”

 

 

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– A standard definition of bariatric surgery failure based on weight regain is needed to assess long-term outcomes in place of the seemingly arbitrary thresholds now in use, according to discussion generated by long-term outcome studies presented at Obesity Week 2017.

Dr. Michael C. Morrell a bariatric surgeon at the Gundersen Medical Foundation, Encinitas, Calif.
Ted Bosworth/Frontline Medical News
Dr. Michael C. Morrell
In one of two studies evaluating weight recidivism in long-term follow-up after bariatric surgery, failure rates at 10 years ranged from 25% to more than 70% according to the definition used, reported to Michael C. Morell, MD, a bariatric surgeon at the Gundersen Medical Foundation, Encinitas, CA.

In another study, presented by Colin Martyn, MD, a general surgery resident at Texas Tech University Health Sciences Center, El Paso, the bariatric surgery failure rate at 11 years was characterized as an “alarming” 33.9%. In this study, bariatric surgery was considered a failure if the patient did not maintain excess weight loss (EWL) of 50% or greater.

The problem with this definition, like many others, is that “it fails to recognize that there could be significant health benefits and improvements in quality of life with less weight loss,” according to Philip Schauer, MD, director of the Cleveland Clinic Bariatric and Metabolic Institute. As the invited discussant for the data presented by Dr. Martyn, Dr. Schauer acknowledged that 50% EWL has been used by others as the dividing line between success and failure, but he called it “obsolete.”

This definition was one of several applied to weight recidivism in the study presented by Dr. Morell. Others included weight regain of more than 25% EWL over the postoperative nadir, an increase in body mass index to more than 35 kg/m2 after achieving a lower BMI, and a postsurgical BMI increase of more than 5 mg/m2. Not surprisingly, weight recidivism “varied widely with regard to the definitions used,” Dr. Morell reported.

Dr. Morell’s study involved evaluation of 1,766 patients with at least 1 year of follow-up after bariatric procedure. Most (1,490 patients) underwent laparoscopic Roux-en-y gastric bypass. After 2 years of follow-up, 93% achieved at least the 50% EWL threshold of treatment success, but Dr. Morell reported that the proportion above this or any threshold progressively diminished over time. For a definition of treatment success, Dr. Morell favors maintenance of at least 20% total weight loss as a threshold of long-term clinical success, a threshold met by 75% of patients at 5 years, in his analysis.

Dr. Colin Martyn, a general surgery resident at Texas Tech University Health Sciences Center, El Paso
Ted Bosworth/Frontline Medical News
Dr. Colin Martyn
In the meta-analysis presented by Dr. Martyn, nine published studies with at least 7 years of follow-up were included. These involved a cumulative 345 patients followed for at least 7 years with diminishing numbers followed up to 11 years. Using the at least 50% EWL as the definition of treatment success, the overall failure rate was 27.8% at 7 years but climbed to 33.9% at 11 years.

As has been shown in these studies and reported previously, the regaining of weight over time after bariatric surgery is common and progressive, but both studies ignited controversy about what measure is meaningful for declaring that bariatric surgery has failed over the long term. None of the current thresholds for failure are based on evidence that clinical benefit has been lost. Rather, it appears that these are simply accepted conventions.

“It bothers me to hear the word failure in these presentations, because I think the paradigm is changing from success and failure to that of treating chronic disease,” said Stacy Brethauer, MD, a staff surgeon in the Cleveland Clinic Digestive Disease Institute. Dr. Brethauer, the moderator of the session at Obesity Week where both long-term follow-up papers were presented, agreed that the at least 50% EWL benchmark is “flawed.” He suggested that more clinically meaningful methods of evaluating long-term outcome are needed for both clinical and research purposes.

The discussant of Dr. Morell’s paper, Samer G. Mattar, MD, a bariatric surgeon at the Swedish Medical Center, Seattle, also called for metrics based on clinical benefit rather than on weight alone.

“I would caution against this overall emphasis that we seem to place on weight gain and weight loss as a benchmark and predominant objective for what we do,” he said. “Our nonsurgeon colleagues have repeatedly demonstrated clinical benefits from total body weight loss of 10% or even 5%. So let’s not beat up ourselves over trying to maintain a greater than 50% EWL in all our patients.”

 

 

 

– A standard definition of bariatric surgery failure based on weight regain is needed to assess long-term outcomes in place of the seemingly arbitrary thresholds now in use, according to discussion generated by long-term outcome studies presented at Obesity Week 2017.

Dr. Michael C. Morrell a bariatric surgeon at the Gundersen Medical Foundation, Encinitas, Calif.
Ted Bosworth/Frontline Medical News
Dr. Michael C. Morrell
In one of two studies evaluating weight recidivism in long-term follow-up after bariatric surgery, failure rates at 10 years ranged from 25% to more than 70% according to the definition used, reported to Michael C. Morell, MD, a bariatric surgeon at the Gundersen Medical Foundation, Encinitas, CA.

In another study, presented by Colin Martyn, MD, a general surgery resident at Texas Tech University Health Sciences Center, El Paso, the bariatric surgery failure rate at 11 years was characterized as an “alarming” 33.9%. In this study, bariatric surgery was considered a failure if the patient did not maintain excess weight loss (EWL) of 50% or greater.

The problem with this definition, like many others, is that “it fails to recognize that there could be significant health benefits and improvements in quality of life with less weight loss,” according to Philip Schauer, MD, director of the Cleveland Clinic Bariatric and Metabolic Institute. As the invited discussant for the data presented by Dr. Martyn, Dr. Schauer acknowledged that 50% EWL has been used by others as the dividing line between success and failure, but he called it “obsolete.”

This definition was one of several applied to weight recidivism in the study presented by Dr. Morell. Others included weight regain of more than 25% EWL over the postoperative nadir, an increase in body mass index to more than 35 kg/m2 after achieving a lower BMI, and a postsurgical BMI increase of more than 5 mg/m2. Not surprisingly, weight recidivism “varied widely with regard to the definitions used,” Dr. Morell reported.

Dr. Morell’s study involved evaluation of 1,766 patients with at least 1 year of follow-up after bariatric procedure. Most (1,490 patients) underwent laparoscopic Roux-en-y gastric bypass. After 2 years of follow-up, 93% achieved at least the 50% EWL threshold of treatment success, but Dr. Morell reported that the proportion above this or any threshold progressively diminished over time. For a definition of treatment success, Dr. Morell favors maintenance of at least 20% total weight loss as a threshold of long-term clinical success, a threshold met by 75% of patients at 5 years, in his analysis.

Dr. Colin Martyn, a general surgery resident at Texas Tech University Health Sciences Center, El Paso
Ted Bosworth/Frontline Medical News
Dr. Colin Martyn
In the meta-analysis presented by Dr. Martyn, nine published studies with at least 7 years of follow-up were included. These involved a cumulative 345 patients followed for at least 7 years with diminishing numbers followed up to 11 years. Using the at least 50% EWL as the definition of treatment success, the overall failure rate was 27.8% at 7 years but climbed to 33.9% at 11 years.

As has been shown in these studies and reported previously, the regaining of weight over time after bariatric surgery is common and progressive, but both studies ignited controversy about what measure is meaningful for declaring that bariatric surgery has failed over the long term. None of the current thresholds for failure are based on evidence that clinical benefit has been lost. Rather, it appears that these are simply accepted conventions.

“It bothers me to hear the word failure in these presentations, because I think the paradigm is changing from success and failure to that of treating chronic disease,” said Stacy Brethauer, MD, a staff surgeon in the Cleveland Clinic Digestive Disease Institute. Dr. Brethauer, the moderator of the session at Obesity Week where both long-term follow-up papers were presented, agreed that the at least 50% EWL benchmark is “flawed.” He suggested that more clinically meaningful methods of evaluating long-term outcome are needed for both clinical and research purposes.

The discussant of Dr. Morell’s paper, Samer G. Mattar, MD, a bariatric surgeon at the Swedish Medical Center, Seattle, also called for metrics based on clinical benefit rather than on weight alone.

“I would caution against this overall emphasis that we seem to place on weight gain and weight loss as a benchmark and predominant objective for what we do,” he said. “Our nonsurgeon colleagues have repeatedly demonstrated clinical benefits from total body weight loss of 10% or even 5%. So let’s not beat up ourselves over trying to maintain a greater than 50% EWL in all our patients.”

 

 

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Key clinical point: Many patients regain weight after bariatric surgery, but experts argue over the definition of long-term treatment failure, for which there is no standard.

Major finding: After 5 or more years of follow-up, failure rates range from 25% to 70% depending on definition of unacceptable weight regain.

Data source: A retrospective review.

Disclosures: Dr. Morell and Dr. Martyn reported no financial relationships relevant to this topic.

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DiaRem score predicts remission of type 2 diabetes after sleeve gastrectomy

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– The DiaRem score was effective in predicting remission of type 2 diabetes following laparoscopic sleeve gastrectomy, results from a single-center study showed.

Developed by clinicians at Geisinger Clinic, the DiaRem is a simple score that helps predict remission of type 2 diabetes in severely obese subjects with metabolic syndrome who undergo Roux-en-Y gastric bypass surgery (Lancet Diabetes Endocrinol 2014;2[1]:38-45). The DiaRem score spans from 0 to 22 and is divided into five groups corresponding to five probability ranges for type 2 diabetes remission: 0-2 (88%-99%), 3-7 (64%-88%), 8-12 (23%-49%), 13-17 (11%-33%), 18-22 (2%-16%). In an effort to assess the feasibility of using the DiaRem score to predict remission of type 2 diabetes after laparoscopic sleeve gastrectomy, Raul J. Rosenthal, MD, FACS, and his associates conducted a 4-year retrospective review of 162 patients at the Cleveland Clinic Florida, Weston. “This is the first report that uses the DiaRem score for similar subjects that underwent sleeve gastrectomy instead,” Dr. Rosenthal said in an interview in advance of the annual clinical congress of the American College of Surgeons.

Dr. Raul J. Rosenthal, Cleveland Clinic Florida, Weston
Dr. Raul J. Rosenthal


The mean age of the 162 patients was 55 years, 61% were women, 74% were non-Hispanic, their mean body mass index was 43.2 kg/m2, 33% had a preoperative hemoglobin A1c level between 7% and 8.9%, and 22% had an HbA1c of 9%. All had a minimum follow-up of 1 year after their laparoscopic sleeve gastrectomy and 67% had follow-up of 3 years or more, said Dr. Rosenthal, professor and chairman of the department of general surgery at Cleveland Clinic Florida.

Based on results of the DiaRem scores, 58% of patients achieved complete remission of type 2 diabetes, 6% achieved partial remission, and 36% had no remission. Specifically, 96% had DiaRem scores between 0 and 2; 92% had scores between 3 and 7; 50% had scores between 8 and 12, 20% had scores between 13 and 17, and 24% had scores between 18 and 22. “We were pleased to find out that 58% of patients that underwent sleeve gastrectomy achieved complete remission of type 2 diabetes mellitus,” said Dr. Rosenthal, who also directs the clinic’s bariatric and metabolic institute. “This compares favorably to previous reports in which patients achieved 33% of complete remission after gastric bypass.” The researchers also found that 84% of patients achieved remission in 12 months and the rest in 3 years. They observed medication reduction in 93% of the patients.

“Sleeve gastrectomy is a valid bariatric-metabolic procedure in patients with type 2 diabetes,” Dr. Rosenthal concluded. “The main limitation of this study is that is it a retrospective one, and we do not have a control group of patients that underwent gastric bypass or medical treatment to compare.”

The findings were presented at the meeting by Emanuele Lo Menzo, MD. Dr. Rosenthal disclosed that he is a consultant for Medtronic. Dr. Lo Menzo reported having no financial disclosures.

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– The DiaRem score was effective in predicting remission of type 2 diabetes following laparoscopic sleeve gastrectomy, results from a single-center study showed.

Developed by clinicians at Geisinger Clinic, the DiaRem is a simple score that helps predict remission of type 2 diabetes in severely obese subjects with metabolic syndrome who undergo Roux-en-Y gastric bypass surgery (Lancet Diabetes Endocrinol 2014;2[1]:38-45). The DiaRem score spans from 0 to 22 and is divided into five groups corresponding to five probability ranges for type 2 diabetes remission: 0-2 (88%-99%), 3-7 (64%-88%), 8-12 (23%-49%), 13-17 (11%-33%), 18-22 (2%-16%). In an effort to assess the feasibility of using the DiaRem score to predict remission of type 2 diabetes after laparoscopic sleeve gastrectomy, Raul J. Rosenthal, MD, FACS, and his associates conducted a 4-year retrospective review of 162 patients at the Cleveland Clinic Florida, Weston. “This is the first report that uses the DiaRem score for similar subjects that underwent sleeve gastrectomy instead,” Dr. Rosenthal said in an interview in advance of the annual clinical congress of the American College of Surgeons.

Dr. Raul J. Rosenthal, Cleveland Clinic Florida, Weston
Dr. Raul J. Rosenthal


The mean age of the 162 patients was 55 years, 61% were women, 74% were non-Hispanic, their mean body mass index was 43.2 kg/m2, 33% had a preoperative hemoglobin A1c level between 7% and 8.9%, and 22% had an HbA1c of 9%. All had a minimum follow-up of 1 year after their laparoscopic sleeve gastrectomy and 67% had follow-up of 3 years or more, said Dr. Rosenthal, professor and chairman of the department of general surgery at Cleveland Clinic Florida.

Based on results of the DiaRem scores, 58% of patients achieved complete remission of type 2 diabetes, 6% achieved partial remission, and 36% had no remission. Specifically, 96% had DiaRem scores between 0 and 2; 92% had scores between 3 and 7; 50% had scores between 8 and 12, 20% had scores between 13 and 17, and 24% had scores between 18 and 22. “We were pleased to find out that 58% of patients that underwent sleeve gastrectomy achieved complete remission of type 2 diabetes mellitus,” said Dr. Rosenthal, who also directs the clinic’s bariatric and metabolic institute. “This compares favorably to previous reports in which patients achieved 33% of complete remission after gastric bypass.” The researchers also found that 84% of patients achieved remission in 12 months and the rest in 3 years. They observed medication reduction in 93% of the patients.

“Sleeve gastrectomy is a valid bariatric-metabolic procedure in patients with type 2 diabetes,” Dr. Rosenthal concluded. “The main limitation of this study is that is it a retrospective one, and we do not have a control group of patients that underwent gastric bypass or medical treatment to compare.”

The findings were presented at the meeting by Emanuele Lo Menzo, MD. Dr. Rosenthal disclosed that he is a consultant for Medtronic. Dr. Lo Menzo reported having no financial disclosures.

 

– The DiaRem score was effective in predicting remission of type 2 diabetes following laparoscopic sleeve gastrectomy, results from a single-center study showed.

Developed by clinicians at Geisinger Clinic, the DiaRem is a simple score that helps predict remission of type 2 diabetes in severely obese subjects with metabolic syndrome who undergo Roux-en-Y gastric bypass surgery (Lancet Diabetes Endocrinol 2014;2[1]:38-45). The DiaRem score spans from 0 to 22 and is divided into five groups corresponding to five probability ranges for type 2 diabetes remission: 0-2 (88%-99%), 3-7 (64%-88%), 8-12 (23%-49%), 13-17 (11%-33%), 18-22 (2%-16%). In an effort to assess the feasibility of using the DiaRem score to predict remission of type 2 diabetes after laparoscopic sleeve gastrectomy, Raul J. Rosenthal, MD, FACS, and his associates conducted a 4-year retrospective review of 162 patients at the Cleveland Clinic Florida, Weston. “This is the first report that uses the DiaRem score for similar subjects that underwent sleeve gastrectomy instead,” Dr. Rosenthal said in an interview in advance of the annual clinical congress of the American College of Surgeons.

Dr. Raul J. Rosenthal, Cleveland Clinic Florida, Weston
Dr. Raul J. Rosenthal


The mean age of the 162 patients was 55 years, 61% were women, 74% were non-Hispanic, their mean body mass index was 43.2 kg/m2, 33% had a preoperative hemoglobin A1c level between 7% and 8.9%, and 22% had an HbA1c of 9%. All had a minimum follow-up of 1 year after their laparoscopic sleeve gastrectomy and 67% had follow-up of 3 years or more, said Dr. Rosenthal, professor and chairman of the department of general surgery at Cleveland Clinic Florida.

Based on results of the DiaRem scores, 58% of patients achieved complete remission of type 2 diabetes, 6% achieved partial remission, and 36% had no remission. Specifically, 96% had DiaRem scores between 0 and 2; 92% had scores between 3 and 7; 50% had scores between 8 and 12, 20% had scores between 13 and 17, and 24% had scores between 18 and 22. “We were pleased to find out that 58% of patients that underwent sleeve gastrectomy achieved complete remission of type 2 diabetes mellitus,” said Dr. Rosenthal, who also directs the clinic’s bariatric and metabolic institute. “This compares favorably to previous reports in which patients achieved 33% of complete remission after gastric bypass.” The researchers also found that 84% of patients achieved remission in 12 months and the rest in 3 years. They observed medication reduction in 93% of the patients.

“Sleeve gastrectomy is a valid bariatric-metabolic procedure in patients with type 2 diabetes,” Dr. Rosenthal concluded. “The main limitation of this study is that is it a retrospective one, and we do not have a control group of patients that underwent gastric bypass or medical treatment to compare.”

The findings were presented at the meeting by Emanuele Lo Menzo, MD. Dr. Rosenthal disclosed that he is a consultant for Medtronic. Dr. Lo Menzo reported having no financial disclosures.

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Key clinical point: The DiaRem score is useful in predicting remission of type 2 diabetes following laparoscopic sleeve gastrectomy.

Major finding: Results of the DiaRem scores indicated that 58% of patients achieved complete remission of type 2 diabetes.

Study details: A retrospective analysis of 162 patients who underwent laparoscopic sleeve gastrectomy.

Disclosures: Dr. Rosenthal disclosed that he is a consultant for Medtronic. Dr. Lo Menzo reported having no financial disclosures.

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VIDEO: SBO in bariatric patient can mean internal herniation

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– You get a call from the emergency department at 3 a.m. A 48-year-old woman is presenting with fever, nausea, vomiting, and left upper quadrant pain. And the patient says she had a gastric bypass procedure 3 years ago.

Time to panic? Not necessarily, but things can, and occasionally do, go bad for these patients, even if they have had a long-stable bypass, Jennifer Choi, MD, FACS, said in a video interview at the annual clinical congress of the American College of Surgeons.

“We do have to remember that our bariatric surgery patients can develop all of the same kinds of problems that anyone else can,” said Dr. Choi, a general surgeon at Indiana University, Indianapolis. “Appendicitis, diverticulitis, abdominal wall hernias, and other common things do happen.”

In her book, though, a patient with a gastric bypass who presents with a combination of small-bowel obstruction and pain has an internal herniation until proven otherwise.

“The symptoms can be subtle, and they can either have been building for several weeks or have an acute onset,” Dr. Choi said. These can include nausea, dry heaves, bloating, or nonbilious vomiting. Pain is typically located in the left upper quadrant or mid-back, especially if the hernia is located at one of the two most common spots: Petersen’s defect. This is the point where the biliopancreatic loop tends to slip under the alimentary loop and become trapped. Imaging will show a typical swirling of blood vessels around the herniation, accompanied by dilated small bowel at the point of obstruction.

At the other common herniation point, the site of the jejunojejunostomy, the alimentary loop can slip under the biliopancreatic loop. On imaging, jejunum will be seen in the upper right quadrant.

Both of these can be surgical emergencies, Dr. Choi said. “This needs an operation sooner, rather than later. It needs to be reduced and repaired.”

She typically performs this laparoscopically, but said that some surgeons prefer an open approach, which is a perfectly sound option.

“The key to a successful repair is to start at the ileocecal valve, because it is consistent and fixed, and run the bowel from distal to proximal to reduce the internal hernia. Then close the defect with a permanent suture,” she said.

Chylous ascites is almost always present in these cases because the herniation traumatizes the lymphatic system, Dr. Choi added. “It doesn’t all always have to be removed at the time of surgery, but just be aware that this is definitely something we do see, almost all the time in bariatric patients with these internal hernias.”

Dr. Choi had no financial disclosures.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
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– You get a call from the emergency department at 3 a.m. A 48-year-old woman is presenting with fever, nausea, vomiting, and left upper quadrant pain. And the patient says she had a gastric bypass procedure 3 years ago.

Time to panic? Not necessarily, but things can, and occasionally do, go bad for these patients, even if they have had a long-stable bypass, Jennifer Choi, MD, FACS, said in a video interview at the annual clinical congress of the American College of Surgeons.

“We do have to remember that our bariatric surgery patients can develop all of the same kinds of problems that anyone else can,” said Dr. Choi, a general surgeon at Indiana University, Indianapolis. “Appendicitis, diverticulitis, abdominal wall hernias, and other common things do happen.”

In her book, though, a patient with a gastric bypass who presents with a combination of small-bowel obstruction and pain has an internal herniation until proven otherwise.

“The symptoms can be subtle, and they can either have been building for several weeks or have an acute onset,” Dr. Choi said. These can include nausea, dry heaves, bloating, or nonbilious vomiting. Pain is typically located in the left upper quadrant or mid-back, especially if the hernia is located at one of the two most common spots: Petersen’s defect. This is the point where the biliopancreatic loop tends to slip under the alimentary loop and become trapped. Imaging will show a typical swirling of blood vessels around the herniation, accompanied by dilated small bowel at the point of obstruction.

At the other common herniation point, the site of the jejunojejunostomy, the alimentary loop can slip under the biliopancreatic loop. On imaging, jejunum will be seen in the upper right quadrant.

Both of these can be surgical emergencies, Dr. Choi said. “This needs an operation sooner, rather than later. It needs to be reduced and repaired.”

She typically performs this laparoscopically, but said that some surgeons prefer an open approach, which is a perfectly sound option.

“The key to a successful repair is to start at the ileocecal valve, because it is consistent and fixed, and run the bowel from distal to proximal to reduce the internal hernia. Then close the defect with a permanent suture,” she said.

Chylous ascites is almost always present in these cases because the herniation traumatizes the lymphatic system, Dr. Choi added. “It doesn’t all always have to be removed at the time of surgery, but just be aware that this is definitely something we do see, almost all the time in bariatric patients with these internal hernias.”

Dr. Choi had no financial disclosures.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

 

– You get a call from the emergency department at 3 a.m. A 48-year-old woman is presenting with fever, nausea, vomiting, and left upper quadrant pain. And the patient says she had a gastric bypass procedure 3 years ago.

Time to panic? Not necessarily, but things can, and occasionally do, go bad for these patients, even if they have had a long-stable bypass, Jennifer Choi, MD, FACS, said in a video interview at the annual clinical congress of the American College of Surgeons.

“We do have to remember that our bariatric surgery patients can develop all of the same kinds of problems that anyone else can,” said Dr. Choi, a general surgeon at Indiana University, Indianapolis. “Appendicitis, diverticulitis, abdominal wall hernias, and other common things do happen.”

In her book, though, a patient with a gastric bypass who presents with a combination of small-bowel obstruction and pain has an internal herniation until proven otherwise.

“The symptoms can be subtle, and they can either have been building for several weeks or have an acute onset,” Dr. Choi said. These can include nausea, dry heaves, bloating, or nonbilious vomiting. Pain is typically located in the left upper quadrant or mid-back, especially if the hernia is located at one of the two most common spots: Petersen’s defect. This is the point where the biliopancreatic loop tends to slip under the alimentary loop and become trapped. Imaging will show a typical swirling of blood vessels around the herniation, accompanied by dilated small bowel at the point of obstruction.

At the other common herniation point, the site of the jejunojejunostomy, the alimentary loop can slip under the biliopancreatic loop. On imaging, jejunum will be seen in the upper right quadrant.

Both of these can be surgical emergencies, Dr. Choi said. “This needs an operation sooner, rather than later. It needs to be reduced and repaired.”

She typically performs this laparoscopically, but said that some surgeons prefer an open approach, which is a perfectly sound option.

“The key to a successful repair is to start at the ileocecal valve, because it is consistent and fixed, and run the bowel from distal to proximal to reduce the internal hernia. Then close the defect with a permanent suture,” she said.

Chylous ascites is almost always present in these cases because the herniation traumatizes the lymphatic system, Dr. Choi added. “It doesn’t all always have to be removed at the time of surgery, but just be aware that this is definitely something we do see, almost all the time in bariatric patients with these internal hernias.”

Dr. Choi had no financial disclosures.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
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Antibiotic exposure blunted metabolic improvement following vertical sleeve gastrectomy

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Wed, 01/02/2019 - 10:00

 

Antibiotic-associated dysbiosis diminished or eliminated the metabolic benefits of vertical sleeve gastrectomy, results from a mouse study demonstrated.

The finding raises the question of whether patients with suboptimal outcomes following vertical sleeve gastrectomy may benefit from microbial modulation.

Dr. Cyrus Jahansouz of the University of Minnesota
Dr. Cyrus Jahansouz
“More work is needed to clarify the role of the microbiome as it pertains to bariatric surgery,” lead study author Cyrus Jahansouz, MD, said in an interview in advance of the annual clinical congress of the American College of Surgeons. “However, it appears that factors that alter the gut microbial composition following surgery, such as antibiotics, can potentially lead to failure of metabolic improvement following surgery.”

According to Dr. Jahansouz of the University of Minnesota Microbiota Transplantation Program, mechanisms mediating metabolic improvement following bariatric surgery remain incompletely understood. “Outcomes are also somewhat variable: As many as 40%-75% of patients regain weight in the years following nadir of weight loss,” he said. “Human studies have shown an acute and sustained shift in the gut microbiota, and an altered bile acid profile. Bile acids increase following surgery.”

Meanwhile, mice deficient in Farnesoid X-receptor (FXR) and Takeda G protein–coupled Receptor 5 (TGR5) do not experience metabolic improvement following bariatric surgery; the composition of the microbiome can significantly impact the composition of bile acids.

“By altering the postsurgical composition of mice following bariatric surgery, we eliminate the metabolic benefits of surgery, possibly by altering bile acid profiles,” Dr. Jahansouz said.

For the trial, diet-induced obese mice were randomized to vertical sleeve gastrectomy (VSG) or sham surgery, with or without exposure to antibiotics that selectively suppress mainly gram-positive (fidaxomicin, streptomycin) or gram-negative (ceftriaxone) bacteria on postoperative days 1-4. The researchers characterized fecal microbiota before surgery and on postoperative days 7 and 28. Mice were metabolically characterized on postoperative days 30-32 and euthanized on postoperative day 35.

Mice in the VSG group experienced weight loss and shifts in the intestinal microbiota composition, compared with those in the sham surgery group.

“Antibiotic exposure resulted in sustained reductions in alpha (within sample) diversity of microbiota and shifts in its composition,” the researchers wrote in their abstract. “Different antimicrobial specificity of antibiotics led to functionally distinct physiologic effects. Specifically, fidaxomicin and streptomycin markedly altered hepatic bile acid signaling and lipid metabolism, while ceftriaxone resulted in greater reduction in the expression of key antimicrobial peptides.

“However, VSG mice exposed to antibiotics, regardless of their specificity, had significantly increased subcutaneous adiposity and impaired glucose homeostasis without changes in food intake, relative to control mice,” the investigators noted.

Dr. Jahansouz said that he was surprised by the fact that all three antibiotics tested, no matter their specificity in gut bacteria eliminated, resulted in significantly diminished weight loss and metabolic improvement following vertical sleeve gastrectomy in the mouse model. He acknowledged that translating the findings from mice to humans is a key limitation of the analysis.

“There are fundamental physiologic differences between mice and humans that need consideration in all murine models of metabolic disorders,” he said. “Therefore, it is critical that insights gained from these models are followed up in human studies.”

The study was funded by the American Diabetes Association and a Minnesota Discovery, Research and InnoVation Economy grant from the University of Minnesota. Dr. Jahansouz reported having no financial disclosures.
 

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Antibiotic-associated dysbiosis diminished or eliminated the metabolic benefits of vertical sleeve gastrectomy, results from a mouse study demonstrated.

The finding raises the question of whether patients with suboptimal outcomes following vertical sleeve gastrectomy may benefit from microbial modulation.

Dr. Cyrus Jahansouz of the University of Minnesota
Dr. Cyrus Jahansouz
“More work is needed to clarify the role of the microbiome as it pertains to bariatric surgery,” lead study author Cyrus Jahansouz, MD, said in an interview in advance of the annual clinical congress of the American College of Surgeons. “However, it appears that factors that alter the gut microbial composition following surgery, such as antibiotics, can potentially lead to failure of metabolic improvement following surgery.”

According to Dr. Jahansouz of the University of Minnesota Microbiota Transplantation Program, mechanisms mediating metabolic improvement following bariatric surgery remain incompletely understood. “Outcomes are also somewhat variable: As many as 40%-75% of patients regain weight in the years following nadir of weight loss,” he said. “Human studies have shown an acute and sustained shift in the gut microbiota, and an altered bile acid profile. Bile acids increase following surgery.”

Meanwhile, mice deficient in Farnesoid X-receptor (FXR) and Takeda G protein–coupled Receptor 5 (TGR5) do not experience metabolic improvement following bariatric surgery; the composition of the microbiome can significantly impact the composition of bile acids.

“By altering the postsurgical composition of mice following bariatric surgery, we eliminate the metabolic benefits of surgery, possibly by altering bile acid profiles,” Dr. Jahansouz said.

For the trial, diet-induced obese mice were randomized to vertical sleeve gastrectomy (VSG) or sham surgery, with or without exposure to antibiotics that selectively suppress mainly gram-positive (fidaxomicin, streptomycin) or gram-negative (ceftriaxone) bacteria on postoperative days 1-4. The researchers characterized fecal microbiota before surgery and on postoperative days 7 and 28. Mice were metabolically characterized on postoperative days 30-32 and euthanized on postoperative day 35.

Mice in the VSG group experienced weight loss and shifts in the intestinal microbiota composition, compared with those in the sham surgery group.

“Antibiotic exposure resulted in sustained reductions in alpha (within sample) diversity of microbiota and shifts in its composition,” the researchers wrote in their abstract. “Different antimicrobial specificity of antibiotics led to functionally distinct physiologic effects. Specifically, fidaxomicin and streptomycin markedly altered hepatic bile acid signaling and lipid metabolism, while ceftriaxone resulted in greater reduction in the expression of key antimicrobial peptides.

“However, VSG mice exposed to antibiotics, regardless of their specificity, had significantly increased subcutaneous adiposity and impaired glucose homeostasis without changes in food intake, relative to control mice,” the investigators noted.

Dr. Jahansouz said that he was surprised by the fact that all three antibiotics tested, no matter their specificity in gut bacteria eliminated, resulted in significantly diminished weight loss and metabolic improvement following vertical sleeve gastrectomy in the mouse model. He acknowledged that translating the findings from mice to humans is a key limitation of the analysis.

“There are fundamental physiologic differences between mice and humans that need consideration in all murine models of metabolic disorders,” he said. “Therefore, it is critical that insights gained from these models are followed up in human studies.”

The study was funded by the American Diabetes Association and a Minnesota Discovery, Research and InnoVation Economy grant from the University of Minnesota. Dr. Jahansouz reported having no financial disclosures.
 

 

Antibiotic-associated dysbiosis diminished or eliminated the metabolic benefits of vertical sleeve gastrectomy, results from a mouse study demonstrated.

The finding raises the question of whether patients with suboptimal outcomes following vertical sleeve gastrectomy may benefit from microbial modulation.

Dr. Cyrus Jahansouz of the University of Minnesota
Dr. Cyrus Jahansouz
“More work is needed to clarify the role of the microbiome as it pertains to bariatric surgery,” lead study author Cyrus Jahansouz, MD, said in an interview in advance of the annual clinical congress of the American College of Surgeons. “However, it appears that factors that alter the gut microbial composition following surgery, such as antibiotics, can potentially lead to failure of metabolic improvement following surgery.”

According to Dr. Jahansouz of the University of Minnesota Microbiota Transplantation Program, mechanisms mediating metabolic improvement following bariatric surgery remain incompletely understood. “Outcomes are also somewhat variable: As many as 40%-75% of patients regain weight in the years following nadir of weight loss,” he said. “Human studies have shown an acute and sustained shift in the gut microbiota, and an altered bile acid profile. Bile acids increase following surgery.”

Meanwhile, mice deficient in Farnesoid X-receptor (FXR) and Takeda G protein–coupled Receptor 5 (TGR5) do not experience metabolic improvement following bariatric surgery; the composition of the microbiome can significantly impact the composition of bile acids.

“By altering the postsurgical composition of mice following bariatric surgery, we eliminate the metabolic benefits of surgery, possibly by altering bile acid profiles,” Dr. Jahansouz said.

For the trial, diet-induced obese mice were randomized to vertical sleeve gastrectomy (VSG) or sham surgery, with or without exposure to antibiotics that selectively suppress mainly gram-positive (fidaxomicin, streptomycin) or gram-negative (ceftriaxone) bacteria on postoperative days 1-4. The researchers characterized fecal microbiota before surgery and on postoperative days 7 and 28. Mice were metabolically characterized on postoperative days 30-32 and euthanized on postoperative day 35.

Mice in the VSG group experienced weight loss and shifts in the intestinal microbiota composition, compared with those in the sham surgery group.

“Antibiotic exposure resulted in sustained reductions in alpha (within sample) diversity of microbiota and shifts in its composition,” the researchers wrote in their abstract. “Different antimicrobial specificity of antibiotics led to functionally distinct physiologic effects. Specifically, fidaxomicin and streptomycin markedly altered hepatic bile acid signaling and lipid metabolism, while ceftriaxone resulted in greater reduction in the expression of key antimicrobial peptides.

“However, VSG mice exposed to antibiotics, regardless of their specificity, had significantly increased subcutaneous adiposity and impaired glucose homeostasis without changes in food intake, relative to control mice,” the investigators noted.

Dr. Jahansouz said that he was surprised by the fact that all three antibiotics tested, no matter their specificity in gut bacteria eliminated, resulted in significantly diminished weight loss and metabolic improvement following vertical sleeve gastrectomy in the mouse model. He acknowledged that translating the findings from mice to humans is a key limitation of the analysis.

“There are fundamental physiologic differences between mice and humans that need consideration in all murine models of metabolic disorders,” he said. “Therefore, it is critical that insights gained from these models are followed up in human studies.”

The study was funded by the American Diabetes Association and a Minnesota Discovery, Research and InnoVation Economy grant from the University of Minnesota. Dr. Jahansouz reported having no financial disclosures.
 

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Key clinical point: Postsurgical disruption of intestinal microbiota composition attenuates the metabolic efficacy of vertical sleeve gastrectomy.

Major finding: VSG mice exposed to antibiotics had significantly increased subcutaneous adiposity and impaired glucose homeostasis without changes in food intake, compared with control mice.

Study details: A study of diet-induced obese mice that were randomized to VSG or sham surgery, with or without exposure to antibiotics.

Disclosures: The study was funded by the American Diabetes Association and a Minnesota Discovery, Research and InnoVation Economy grant from the University of Minnesota. Dr. Jahansouz reported having no financial disclosures.

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Low risk of bariatric surgery complications in IBD

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Bariatric surgery is safe and feasible in patients with inflammatory bowel disease (IBD), with a low risk of postoperative complications vs. controls, according to results of a recent cohort study.

Besides a significantly higher risk of perioperative small-bowel obstruction and a 1-day increase in hospital stay, outcomes were comparable between patients with IBD and controls (Obes Surg. 2017 Oct 10. doi: 10.1007/s11695-017-2955-4).

Limitations of the retrospective study, according to the authors, included a potential underestimation of short-term postoperative complications, since the data set used in the study was limited to in-hospital stays and would not include events occurring after discharge.

Nevertheless, “our data show that it is reasonable to carefully proceed with bariatric interventions in obese IBD patients, especially those who are at higher risk of cardiovascular mortality and drastic need for weight reduction, to accrue benefits of weight loss,” wrote Fateh Bazerbachi, MD, of the Mayo Clinic, Rochester, Minn. and his coauthors.

Bariatric surgery is the “most effective solution” for obesity, and “appropriate candidates should not be deprived of this important, potentially life-saving procedure, if the intervention is deemed acceptably safe,” Dr. Bazerbachi and his colleagues noted.

Their cohort study included data for 314,864 adult patients in the Nationwide Inpatient Sample who underwent bariatric surgery between 2011 and 2013. Of that group, 790 patients had underlying IBD (459 Crohn’s disease, 331 ulcerative colitis). Remaining patients made up the comparator group.

The primary outcomes evaluated in the study included risks of systemic and technical complications. Risk of perioperative small-bowel obstruction was significantly higher in the IBD group (adjusted odds ratio, 4.0; 95% confidence interval, 2.2-7.4). However, the rates of other complications were similar between the two groups, data show.

Secondary outcomes in the study included length of hospital stay and mortality. Mean length of hospital stay was 3.4 days for IBD patients, vs. 2.5 days for the comparison group (P = .01), according to the report. Mortality was 0.25% for controls, while no deaths were reported in the IBD group.

In the future, bariatric surgeons may face increasing demand to treat IBD patients, given the increasing prevalence of obesity in the IBD patient population, Dr. Bazerbachi and his colleagues said.

Some surgeons may believe that bariatric intervention is more challenging in IBD patients, in part because of the underlying inflammatory state that might interfere with healing of wounds and recovery of bowel motility, they said. Bariatric surgery, however, can reduce body mass index, which in turn might make future IBD surgeries less challenging.

Another potential advantage is reduction in cardiovascular risk, which is elevated in IBD patients both due to obesity as well as the IBD condition, they added.

“Further studies are certainly needed to examine long-term outcomes of bariatric surgery on IBD and to determine whether cardiovascular mortality is reduced from these interventions in this susceptible cohort of obese IBD patients,” Dr. Bazerbachi and his colleagues wrote.

The authors declared that they had no conflicts of interest.

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Bariatric surgery is safe and feasible in patients with inflammatory bowel disease (IBD), with a low risk of postoperative complications vs. controls, according to results of a recent cohort study.

Besides a significantly higher risk of perioperative small-bowel obstruction and a 1-day increase in hospital stay, outcomes were comparable between patients with IBD and controls (Obes Surg. 2017 Oct 10. doi: 10.1007/s11695-017-2955-4).

Limitations of the retrospective study, according to the authors, included a potential underestimation of short-term postoperative complications, since the data set used in the study was limited to in-hospital stays and would not include events occurring after discharge.

Nevertheless, “our data show that it is reasonable to carefully proceed with bariatric interventions in obese IBD patients, especially those who are at higher risk of cardiovascular mortality and drastic need for weight reduction, to accrue benefits of weight loss,” wrote Fateh Bazerbachi, MD, of the Mayo Clinic, Rochester, Minn. and his coauthors.

Bariatric surgery is the “most effective solution” for obesity, and “appropriate candidates should not be deprived of this important, potentially life-saving procedure, if the intervention is deemed acceptably safe,” Dr. Bazerbachi and his colleagues noted.

Their cohort study included data for 314,864 adult patients in the Nationwide Inpatient Sample who underwent bariatric surgery between 2011 and 2013. Of that group, 790 patients had underlying IBD (459 Crohn’s disease, 331 ulcerative colitis). Remaining patients made up the comparator group.

The primary outcomes evaluated in the study included risks of systemic and technical complications. Risk of perioperative small-bowel obstruction was significantly higher in the IBD group (adjusted odds ratio, 4.0; 95% confidence interval, 2.2-7.4). However, the rates of other complications were similar between the two groups, data show.

Secondary outcomes in the study included length of hospital stay and mortality. Mean length of hospital stay was 3.4 days for IBD patients, vs. 2.5 days for the comparison group (P = .01), according to the report. Mortality was 0.25% for controls, while no deaths were reported in the IBD group.

In the future, bariatric surgeons may face increasing demand to treat IBD patients, given the increasing prevalence of obesity in the IBD patient population, Dr. Bazerbachi and his colleagues said.

Some surgeons may believe that bariatric intervention is more challenging in IBD patients, in part because of the underlying inflammatory state that might interfere with healing of wounds and recovery of bowel motility, they said. Bariatric surgery, however, can reduce body mass index, which in turn might make future IBD surgeries less challenging.

Another potential advantage is reduction in cardiovascular risk, which is elevated in IBD patients both due to obesity as well as the IBD condition, they added.

“Further studies are certainly needed to examine long-term outcomes of bariatric surgery on IBD and to determine whether cardiovascular mortality is reduced from these interventions in this susceptible cohort of obese IBD patients,” Dr. Bazerbachi and his colleagues wrote.

The authors declared that they had no conflicts of interest.

Bariatric surgery is safe and feasible in patients with inflammatory bowel disease (IBD), with a low risk of postoperative complications vs. controls, according to results of a recent cohort study.

Besides a significantly higher risk of perioperative small-bowel obstruction and a 1-day increase in hospital stay, outcomes were comparable between patients with IBD and controls (Obes Surg. 2017 Oct 10. doi: 10.1007/s11695-017-2955-4).

Limitations of the retrospective study, according to the authors, included a potential underestimation of short-term postoperative complications, since the data set used in the study was limited to in-hospital stays and would not include events occurring after discharge.

Nevertheless, “our data show that it is reasonable to carefully proceed with bariatric interventions in obese IBD patients, especially those who are at higher risk of cardiovascular mortality and drastic need for weight reduction, to accrue benefits of weight loss,” wrote Fateh Bazerbachi, MD, of the Mayo Clinic, Rochester, Minn. and his coauthors.

Bariatric surgery is the “most effective solution” for obesity, and “appropriate candidates should not be deprived of this important, potentially life-saving procedure, if the intervention is deemed acceptably safe,” Dr. Bazerbachi and his colleagues noted.

Their cohort study included data for 314,864 adult patients in the Nationwide Inpatient Sample who underwent bariatric surgery between 2011 and 2013. Of that group, 790 patients had underlying IBD (459 Crohn’s disease, 331 ulcerative colitis). Remaining patients made up the comparator group.

The primary outcomes evaluated in the study included risks of systemic and technical complications. Risk of perioperative small-bowel obstruction was significantly higher in the IBD group (adjusted odds ratio, 4.0; 95% confidence interval, 2.2-7.4). However, the rates of other complications were similar between the two groups, data show.

Secondary outcomes in the study included length of hospital stay and mortality. Mean length of hospital stay was 3.4 days for IBD patients, vs. 2.5 days for the comparison group (P = .01), according to the report. Mortality was 0.25% for controls, while no deaths were reported in the IBD group.

In the future, bariatric surgeons may face increasing demand to treat IBD patients, given the increasing prevalence of obesity in the IBD patient population, Dr. Bazerbachi and his colleagues said.

Some surgeons may believe that bariatric intervention is more challenging in IBD patients, in part because of the underlying inflammatory state that might interfere with healing of wounds and recovery of bowel motility, they said. Bariatric surgery, however, can reduce body mass index, which in turn might make future IBD surgeries less challenging.

Another potential advantage is reduction in cardiovascular risk, which is elevated in IBD patients both due to obesity as well as the IBD condition, they added.

“Further studies are certainly needed to examine long-term outcomes of bariatric surgery on IBD and to determine whether cardiovascular mortality is reduced from these interventions in this susceptible cohort of obese IBD patients,” Dr. Bazerbachi and his colleagues wrote.

The authors declared that they had no conflicts of interest.

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Key clinical point: Watch for perioperative small-bowel obstruction in IBD patients undergoing bariatric surgery.

Major finding: IBD patients had a higher risk of perioperative small bowel obstruction (adjusted odds ratio, 4.0; 95% confidence interval, 2.2-7.4) and a 1-day increase in hospital stay (P = .01), compared with controls.

Data source: Retrospective cohort study of Nationwide Inpatient Sample data including 790 patients with underlying IBD.

Disclosures: The authors declared that they had no conflicts of interest.

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Many women have unprotected sex in year after bariatric surgery

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Fri, 01/18/2019 - 17:07

More than 40% of reproductive-age women reported having unprotected sex in the year after undergoing bariatric surgery, despite recommendations to avoid pregnancy for at least a year, a new study finds. Another 4% of women reported trying to conceive in the 12 months after surgery.

“We were surprised to find such a large percentage of women were not using contraception, and we were also surprised to find so many were actively trying to conceive,” the study’s lead author Marie N. Menke, MD, MPH, of the University of Pittsburgh, said in an interview. “Reproductive-age women who are considering bariatric surgery should be counseled that they should plan to use contraceptives after surgery for about 12-18 months.”

Pregnancy isn’t recommended over that period mainly because of the risks to the fetus, Dr. Menke said. “These risks are different from obesity in general. We don’t know exactly why surgery causes these risks, but ideally, patients would be weight-stable prior to conception.”

In 2013, the American Association of Clinical Endocrinologists, the Obesity Society, and the American Society for Metabolic & Bariatric Surgery provided a Grade D recommendation for a 12-18 month delay in conception (Obesity [Silver Spring] 2013;21[suppl 1]:S1-27). A recent study provided more insight into the potential risks of pregnancy soon after weight-loss procedures. It reported that, compared with those who gave birth more than 4 years later, women who gave birth within 2 years of bariatric surgery had higher risks of premature birth, admission to neonatal intensive care units, and small-for-gestational-age infants (JAMA Surg. 2017 Feb 1;152[2]:1-8).

The current prospective cohort study included women who underwent bariatric surgery for the first time during 2005-2009 at 10 U.S. hospitals. The women, all aged 18-44 years, answered questions for as long as 7 years, until January 2015 (Obstet Gynecol. 2017 Oct 6. doi: 10.1097/AOG.0000000000002323).

The analysis included 710 women who provided conception data. The median body mass index of the women was 46.3 kg/m2. Most patients underwent Roux-en-Y gastric bypass (73%), followed by laparoscopic adjustable gastric banding (23%).

Researchers found that 4.3% of the women tried to conceive in the first year after surgery (95% confidence interval, 2.4-6.3), and 13.1% did so in the second year (95% CI, 9.3-17.0; P less than .001).

During the first year after surgery, 12.7% of women had no intercourse (95% CI, 9.4-16.0), 40.5% had only protected intercourse (95% CI, 35.6-45.4), and 41.5% (95% CI, 36.4-46.6) had unprotected intercourse while not trying to conceive.

Why are the unprotected sex numbers so high? “We wonder if some women simply feel that they cannot get pregnant,” Dr. Menke said. “Our group has previously reported that 42% of women who had attempted to conceive prior to bariatric surgery had a history of infertility. Some of these women went on to deliver a live birth, but many did not.”

The study reports that 183 of the 710 women did ultimately conceive and that the number may be as high as 237 because data were missing for 54 women who may have not wanted to report a nonlive birth. Of the women who reported conceiving, 68.9% had live births, 1.1% had stillbirths, 1.1% had ectopic pregnancies, 21.9% miscarried and 7.1% had abortions.

“We’d really like this research to be a reason to consider presurgical contraceptive counseling as one of the steps prior to bariatric surgery,” Dr. Menke said. “This may include a referral by the bariatric surgeon to a physician would who provide counseling, prescribe, or both.”

The study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Menke reported having no relevant disclosures. Her coauthors reported financial relationships with pharmaceutical and medical device companies with products to treat metabolic diseases.

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More than 40% of reproductive-age women reported having unprotected sex in the year after undergoing bariatric surgery, despite recommendations to avoid pregnancy for at least a year, a new study finds. Another 4% of women reported trying to conceive in the 12 months after surgery.

“We were surprised to find such a large percentage of women were not using contraception, and we were also surprised to find so many were actively trying to conceive,” the study’s lead author Marie N. Menke, MD, MPH, of the University of Pittsburgh, said in an interview. “Reproductive-age women who are considering bariatric surgery should be counseled that they should plan to use contraceptives after surgery for about 12-18 months.”

Pregnancy isn’t recommended over that period mainly because of the risks to the fetus, Dr. Menke said. “These risks are different from obesity in general. We don’t know exactly why surgery causes these risks, but ideally, patients would be weight-stable prior to conception.”

In 2013, the American Association of Clinical Endocrinologists, the Obesity Society, and the American Society for Metabolic & Bariatric Surgery provided a Grade D recommendation for a 12-18 month delay in conception (Obesity [Silver Spring] 2013;21[suppl 1]:S1-27). A recent study provided more insight into the potential risks of pregnancy soon after weight-loss procedures. It reported that, compared with those who gave birth more than 4 years later, women who gave birth within 2 years of bariatric surgery had higher risks of premature birth, admission to neonatal intensive care units, and small-for-gestational-age infants (JAMA Surg. 2017 Feb 1;152[2]:1-8).

The current prospective cohort study included women who underwent bariatric surgery for the first time during 2005-2009 at 10 U.S. hospitals. The women, all aged 18-44 years, answered questions for as long as 7 years, until January 2015 (Obstet Gynecol. 2017 Oct 6. doi: 10.1097/AOG.0000000000002323).

The analysis included 710 women who provided conception data. The median body mass index of the women was 46.3 kg/m2. Most patients underwent Roux-en-Y gastric bypass (73%), followed by laparoscopic adjustable gastric banding (23%).

Researchers found that 4.3% of the women tried to conceive in the first year after surgery (95% confidence interval, 2.4-6.3), and 13.1% did so in the second year (95% CI, 9.3-17.0; P less than .001).

During the first year after surgery, 12.7% of women had no intercourse (95% CI, 9.4-16.0), 40.5% had only protected intercourse (95% CI, 35.6-45.4), and 41.5% (95% CI, 36.4-46.6) had unprotected intercourse while not trying to conceive.

Why are the unprotected sex numbers so high? “We wonder if some women simply feel that they cannot get pregnant,” Dr. Menke said. “Our group has previously reported that 42% of women who had attempted to conceive prior to bariatric surgery had a history of infertility. Some of these women went on to deliver a live birth, but many did not.”

The study reports that 183 of the 710 women did ultimately conceive and that the number may be as high as 237 because data were missing for 54 women who may have not wanted to report a nonlive birth. Of the women who reported conceiving, 68.9% had live births, 1.1% had stillbirths, 1.1% had ectopic pregnancies, 21.9% miscarried and 7.1% had abortions.

“We’d really like this research to be a reason to consider presurgical contraceptive counseling as one of the steps prior to bariatric surgery,” Dr. Menke said. “This may include a referral by the bariatric surgeon to a physician would who provide counseling, prescribe, or both.”

The study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Menke reported having no relevant disclosures. Her coauthors reported financial relationships with pharmaceutical and medical device companies with products to treat metabolic diseases.

More than 40% of reproductive-age women reported having unprotected sex in the year after undergoing bariatric surgery, despite recommendations to avoid pregnancy for at least a year, a new study finds. Another 4% of women reported trying to conceive in the 12 months after surgery.

“We were surprised to find such a large percentage of women were not using contraception, and we were also surprised to find so many were actively trying to conceive,” the study’s lead author Marie N. Menke, MD, MPH, of the University of Pittsburgh, said in an interview. “Reproductive-age women who are considering bariatric surgery should be counseled that they should plan to use contraceptives after surgery for about 12-18 months.”

Pregnancy isn’t recommended over that period mainly because of the risks to the fetus, Dr. Menke said. “These risks are different from obesity in general. We don’t know exactly why surgery causes these risks, but ideally, patients would be weight-stable prior to conception.”

In 2013, the American Association of Clinical Endocrinologists, the Obesity Society, and the American Society for Metabolic & Bariatric Surgery provided a Grade D recommendation for a 12-18 month delay in conception (Obesity [Silver Spring] 2013;21[suppl 1]:S1-27). A recent study provided more insight into the potential risks of pregnancy soon after weight-loss procedures. It reported that, compared with those who gave birth more than 4 years later, women who gave birth within 2 years of bariatric surgery had higher risks of premature birth, admission to neonatal intensive care units, and small-for-gestational-age infants (JAMA Surg. 2017 Feb 1;152[2]:1-8).

The current prospective cohort study included women who underwent bariatric surgery for the first time during 2005-2009 at 10 U.S. hospitals. The women, all aged 18-44 years, answered questions for as long as 7 years, until January 2015 (Obstet Gynecol. 2017 Oct 6. doi: 10.1097/AOG.0000000000002323).

The analysis included 710 women who provided conception data. The median body mass index of the women was 46.3 kg/m2. Most patients underwent Roux-en-Y gastric bypass (73%), followed by laparoscopic adjustable gastric banding (23%).

Researchers found that 4.3% of the women tried to conceive in the first year after surgery (95% confidence interval, 2.4-6.3), and 13.1% did so in the second year (95% CI, 9.3-17.0; P less than .001).

During the first year after surgery, 12.7% of women had no intercourse (95% CI, 9.4-16.0), 40.5% had only protected intercourse (95% CI, 35.6-45.4), and 41.5% (95% CI, 36.4-46.6) had unprotected intercourse while not trying to conceive.

Why are the unprotected sex numbers so high? “We wonder if some women simply feel that they cannot get pregnant,” Dr. Menke said. “Our group has previously reported that 42% of women who had attempted to conceive prior to bariatric surgery had a history of infertility. Some of these women went on to deliver a live birth, but many did not.”

The study reports that 183 of the 710 women did ultimately conceive and that the number may be as high as 237 because data were missing for 54 women who may have not wanted to report a nonlive birth. Of the women who reported conceiving, 68.9% had live births, 1.1% had stillbirths, 1.1% had ectopic pregnancies, 21.9% miscarried and 7.1% had abortions.

“We’d really like this research to be a reason to consider presurgical contraceptive counseling as one of the steps prior to bariatric surgery,” Dr. Menke said. “This may include a referral by the bariatric surgeon to a physician would who provide counseling, prescribe, or both.”

The study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Menke reported having no relevant disclosures. Her coauthors reported financial relationships with pharmaceutical and medical device companies with products to treat metabolic diseases.

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Key clinical point: Unprotected sex after bariatric surgery is common, despite recommendations against pregnancy for at least a year.

Major finding: In the first year after surgery, 4.3% of women surveyed tried to conceive (95% CI, 2.4-6.3), and another 41.5% had unprotected intercourse (95% CI, 36.4-46.6).

Data source: Prospective cohort study of 710 women, aged 18-44 years, who underwent bariatric surgery for the first time during 2005-2009 at 10 U.S. hospitals.

Disclosures: The study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Menke reported having no relevant disclosures. Her coauthors reported financial relationships with pharmaceutical and medical device companies with products to treat metabolic diseases.

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