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BEST: Bypass equipoise sleeve trial; rationale and design of a randomized, registry-based, multicenter trial comparing Roux-en-Y gastric bypass with sleeve gastrectomy

Journal article
Authors Suzanne Hedberg
T. Olbers
M. Peltonen
J. Österberg
M. Wirén
J. Ottosson
A. Thorell
Published in Contemporary Clinical Trials
Volume 84
ISSN 1551-7144
Publication year 2019
Published at Institute of Clinical Sciences, Department of Gastrosurgical Research and Education
Language en
Links dx.doi.org/10.1016/j.cct.2019.07.00...
Keywords Laparoscopic gastric bypass, Laparoscopic sleeve gastrectomy, Randomized clinical trial, Registry study, alcohol, adult, alcohol abuse, Article, body weight loss, controlled study, diabetes mellitus, female, follow up, gastric bypass surgery, hospitalization, human, intermethod comparison, laparoscopic surgery, major clinical study, male, multicenter study, non-inferiority trial, obese patient, obesity, outpatient care, quality of life, randomized controlled trial, study design
Subject categories Surgery, Gastroenterology and Hepatology

Abstract

Background: Laparoscopic gastric bypass (LGBP) is a well-documented surgical intervention for severe obesity. Recently, laparoscopic sleeve gastrectomy (LSG) has gained increased popularity. Short-term follow-up in limited-sized randomized trials comparing LGBP and LSG show no major differences in weight-loss, adverse events, or effect on comorbidities; however, there is a lack of sufficiently powered, pragmatic, randomized controlled trials comparing the mid- and long-term results of the two methods. Method: BEST is a randomized, registry-based, multicenter trial comparing LGBP and LSG. The trial has two primary outcomes; rates of substantial complications (SC) and total body weight loss. We hypothesize that patients treated with LSG will experience 35% fewer substantial complications during the 5-year follow-up compared to patients treated with LGBP, and that the efficacy of LSG will remain within a non-inferiority margin of 5% in terms of weight loss. Our sample size calculation, using data from the Scandinavian Obesity Surgery Registry (SOReg), shows a power of 80% for SC and > 95% for weight loss at p < .025 with a total of 2100 included patients. The design of the trial will also enable comparisons within several relevant patient subgroups. Conclusions: As a large-sized, pragmatic, randomized trial, BEST will provide robust data comparing LGBP with LSG by generating long-term results on weight loss and SC's, as well as secondary outcomes and comparisons within patient subgroups. The use of a well-established registry for registration of all data facilitates a large multicenter trial, and combines the strengths of registry studies with those of a randomized trial. Clinical Trials registry: NCT 02767505. © 2019 Elsevier Inc.

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