The Sleeve Bypass Trial: a multicentre randomized controlled trial comparing the long term outcome of laparoscopic sleeve gastrectomy and gastric bypass for morbid obesity in terms of excess BMI loss percentage and quality of life

BMC Obesity
L Ulas BiterGuido H H Mannaerts

Abstract

Obesity is an increasing disease worldwide. Bariatric surgery is the only effective therapy to induce sufficient long-term weight loss for morbidly obese patients. Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) is the gold standard surgical technique. Laparoscopic Sleeve Gastrectomy (LSG) is a new promising bariatric procedure which has the advantage of maintaining an intact gastrointestinal tract. The aim of this study is to evaluate the efficiency of both techniques. Our hypothesis is that LSG has a similar percentage excess BMI loss (%EBMIL) after 5 years compared to LRYGB. The Sleeve Bypass Trial is a randomized multicentre clinical trial: patients eligible for bariatric surgery are randomized to either LSG or LRYGB. Patients with a body mass index (BMI) ≥ 40 kg/m(2) or BMI 35 kg/m(2) with obesity related comorbidity (T2 DM, sleep apnoea, hypertension) are eligible for randomization. At randomization patients are stratified for centre, sex, T2 DM and BMI ≥ 50 kg/m(2). A total number of 620 patients will be enrolled and equally (1:1) randomized to both treatment arms. Only surgeons experienced in both operation techniques will participate in the Sleeve Bypass trial. The primary endpoint is the 5-year weight loss (%EBMIL) of L...Continue Reading

Associated Clinical Trials

Oct 27, 2016·Sonja Chiappetta, MD

References

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Citations

May 3, 2016·Emergency Medicine Clinics of North America·Kyle D LewisSamuel D Luber
Jul 12, 2016·Surgery for Obesity and Related Diseases : Official Journal of the American Society for Bariatric Surgery·Matthew J Martin, Philippe Topart
Oct 21, 2016·Obesity Surgery·Gian Franco AdamiRenzo Cordera
Oct 27, 2017·Health and Quality of Life Outcomes·Erika Paniago GuedesMaria Lucia Fleiuss Farias
Sep 14, 2019·BMJ Open·Tone Nygaard FløloJohn Roger Andersen
Aug 15, 2020·Annals of the New York Academy of Sciences·Geraldine J OoiMatthew Read
Jun 4, 2020·Obesity Facts·Rosa Marti-FernandezJoaquin Ortega-Serrano

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Methods Mentioned

BETA
gastric bypass

Software Mentioned

CONSORT

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