StomaphyX vs Sham Surgery
Original Investigation Research
Invited Commentary
Weight Recidivism After Roux-en-Y Gastric Bypass We Need Better Data Jon C. Gould, MD
The prevalence of obesity and the number of bariatric surgical procedures performed annually have increased during the past 20 years. Unfortunately, some bariatric surgical patients do not achieve meaningful weight loss or regain lost weight over time. The possibility that endoscopic therapies may lead to significant weight loss for these patients without the morbidity associated with revisional surgical procedures is Related article page 372 appealing. It is not surprising that a number of companies have brought endoscopic devices designed to address this issue to market in recent years. It is likely that weight regain after Roux-en-Y gastric bypass is related to a combination of factors, including behavioral, anatomic, physiologic, and genetic mechanisms. In fact, the exact mechanism of weight regain after Roux-en-Y gas-
tric bypass is unknown. A recent systematic review1 determined that endoluminal procedures for weight regain tend to be well tolerated with limited efficacy. An article2 jointly published by the American Society for Gastrointestinal Endoscopy and the American Society for Metabolic & Bariatric Surgery recommends that endoscopic bariatric therapies be evaluated on end points, including weight loss, safety, efficacy, and durability. I commend Dr Eid and colleagues for designing a prospective sham-controlled trial to evaluate such a device, for stopping the trial when their primary end point was not met, and for publishing a negative result.3 Endoscopic bariatric revisional procedures should be performed in wellinformed patients in the context of a registered, adequately controlled clinical trial. Only then will we be able to determine whether we are on the right track.
ARTICLE INFORMATION
REFERENCES
Author Affiliation: Department of Surgery, Medical College of Wisconsin, Milwaukee.
1. Dakin GF, Eid G, Mikami D, Pryor A, Chand B; American Society for Metabolic and Bariatric Surgery (ASMBS) Emerging Technology and Procedures Committee. Endoluminal revision of gastric bypass for weight regain: a systematic review. Surg Obes Relat Dis. 2013;9(3):335-342.
Corresponding Author: Jon C. Gould, MD, Division of General Surgery, Medical College of Wisconsin, 9200 W Wisconsin Ave, Milwaukee, WI 53226 ([email protected]). Accepted for Publication: July 26, 2013. Published Online: February 19, 2014. doi:10.1001/jamasurg.2013.4076. Conflict of Interest Disclosures: None reported.
revisional surgery to reduce regained weight in Roux-en-Y gastric bypass patients: a randomized clinical trial [published online February 19, 2014]. JAMA Surg. doi:10.1001/jamasurg.2013.4051.
2. ASGE/ASMBS Task Force on Endoscopic Bariatric Therapy. A pathway to endoscopic bariatric therapies. Surg Obes Relat Dis. 2011;7(6):672-682. 3. Eid GM, McCloskey CA, Eagleton JK, Lee LB, Courcoulas AP. StomaphyX vs a sham procedure for
jamasurgery.com
JAMA Surgery April 2014 Volume 149, Number 4
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Original Investigation Research
Invited Commentary
Weight Recidivism After Roux-en-Y Gastric Bypass We Need Better Data Jon C. Gould, MD
The prevalence of obesity and the number of bariatric surgical procedures performed annually have increased during the past 20 years. Unfortunately, some bariatric surgical patients do not achieve meaningful weight loss or regain lost weight over time. The possibility that endoscopic therapies may lead to significant weight loss for these patients without the morbidity associated with revisional surgical procedures is Related article page 372 appealing. It is not surprising that a number of companies have brought endoscopic devices designed to address this issue to market in recent years. It is likely that weight regain after Roux-en-Y gastric bypass is related to a combination of factors, including behavioral, anatomic, physiologic, and genetic mechanisms. In fact, the exact mechanism of weight regain after Roux-en-Y gas-
tric bypass is unknown. A recent systematic review1 determined that endoluminal procedures for weight regain tend to be well tolerated with limited efficacy. An article2 jointly published by the American Society for Gastrointestinal Endoscopy and the American Society for Metabolic & Bariatric Surgery recommends that endoscopic bariatric therapies be evaluated on end points, including weight loss, safety, efficacy, and durability. I commend Dr Eid and colleagues for designing a prospective sham-controlled trial to evaluate such a device, for stopping the trial when their primary end point was not met, and for publishing a negative result.3 Endoscopic bariatric revisional procedures should be performed in wellinformed patients in the context of a registered, adequately controlled clinical trial. Only then will we be able to determine whether we are on the right track.
ARTICLE INFORMATION
REFERENCES
Author Affiliation: Department of Surgery, Medical College of Wisconsin, Milwaukee.
1. Dakin GF, Eid G, Mikami D, Pryor A, Chand B; American Society for Metabolic and Bariatric Surgery (ASMBS) Emerging Technology and Procedures Committee. Endoluminal revision of gastric bypass for weight regain: a systematic review. Surg Obes Relat Dis. 2013;9(3):335-342.
Corresponding Author: Jon C. Gould, MD, Division of General Surgery, Medical College of Wisconsin, 9200 W Wisconsin Ave, Milwaukee, WI 53226 ([email protected]). Accepted for Publication: July 26, 2013. Published Online: February 19, 2014. doi:10.1001/jamasurg.2013.4076. Conflict of Interest Disclosures: None reported.
revisional surgery to reduce regained weight in Roux-en-Y gastric bypass patients: a randomized clinical trial [published online February 19, 2014]. JAMA Surg. doi:10.1001/jamasurg.2013.4051.
2. ASGE/ASMBS Task Force on Endoscopic Bariatric Therapy. A pathway to endoscopic bariatric therapies. Surg Obes Relat Dis. 2011;7(6):672-682. 3. Eid GM, McCloskey CA, Eagleton JK, Lee LB, Courcoulas AP. StomaphyX vs a sham procedure for
jamasurgery.com
JAMA Surgery April 2014 Volume 149, Number 4
Copyright 2014 American Medical Association. All rights reserved.
Downloaded From: http://archsurg.jamanetwork.com/ by a New York University User on 06/11/2015
379
