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.

L Ulas Biter,Hans J J Zengerink,Stefanie R Van Mil,Guido H H Mannaerts,J Frans Smulders,Ralph P M Gadiot,Brechtje A Grotenhuis,Martin Dunkelgrün

doi:10.1186/s40608-015-0058-0

L Ulas Biter, Hans J J Zengerink + Show 6 more

Open Access

https://doi.org/10.1186/s40608-015-0058-0

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Journal: BMC obesity	Publication Date: Aug 26, 2015
Citations: 57	License type: cc-by

Affiliation: Sint Franciscus Gasthuis

Abstract

BackgroundObesity 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.Methods/DesignThe 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/m2 or BMI 35 kg/m2 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/m2. 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 LSG and LRYGB. Secondary endpoints are resolution of obesity related comorbidity, complications, revision bariatric surgery and quality of life (QOL) defined in various questionnaires.DiscussionLong-term %EBMIL between the two treatment strategies used to be in favour of LRYGB, but more recent results throughout the world show similar %EBMIL in both techniques. If weight loss is comparable, obesity-related comorbidity and QOL after bariatric procedures should be taken into account when deciding on which surgical technique is to be preferred for certain subgroups in the future.Trial registrationDutch Trial Register: NTR 4741.

Highlights

If weight loss is comparable, obesity-related comorbidity and quality of life (QOL) after bariatric procedures should be taken into account when deciding on which surgical technique is to be preferred for certain subgroups in the future
Laparoscopic sleeve gastrectomy (LSG) is a relative new procedure which was first described by Marceau and Hess in the 1990s as a part of the BPD duodenal switch and LSG is later popularized by Regan and Gagner as a first stage procedure prior to a duodenal switch (DS) in super obese patients to reduce treatment related mortality [32]
LSG is currently used as a single stage procedure in morbidly obese patients resulting in a percentage excess body mass index (BMI) loss (%EBMIL) ranging between 50 % and 83 % and having a favourable impact on comorbidities [18,19,20,21,22]

Summary

Introduction

Bariatric surgery is the only effective therapy to induce sufficient long-term weight loss for morbidly obese patients. It induces health risks, diminishes quality of life, psychosocial problems and increases public costs. When patients become morbidly obese, health risks increase rapidly [1]. Bariatric surgery is considered the best treatment to realize long-term sufficient weight loss in morbidly obese patients [2,3,4]. Besides weight loss, it has profound effects on obesity-related comorbidities, such as T2DM, hypertension and sleep apnoea [5, 6]

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