BACKGROUND: The health risks of severe obesity can be reduced with metabolic and bariatric surgery, but it is uncertain which operation is most effective or cost-effective. We aimed to compare Roux-en-Y gastric bypass, adjustable gastric banding, and sleeve gastrectomy in patients with severe obesity. METHODS: By-Band-Sleeve is a pragmatic, multi-centre, open-label, randomised controlled trial conducted in 12 hospitals in the UK. Eligible participants were adults (aged ≥18 years) meeting national criteria for metabolic and bariatric surgery. Initially, a 2-group trial (Roux-en-Y gastric bypass versus adjustable gastric banding) became a 3-group trial to include sleeve gastrectomy at 2·6 years from study opening, when it became widely used in the UK. Co-primary endpoints were weight (proportion achieving ≥50% excess weight loss) and quality-of-life (EQ-5D utility score) at 3 years. If the proportion achieving at least 50% excess weight loss was non-inferior (<
12% difference between groups) and quality-of-life was superior, sleeve gastrectomy and Roux-en-Y gastric bypass were considered more effective than adjustable gastric banding, and sleeve gastrectomy more effective than Roux-en-Y gastric bypass. Cost-effectiveness of the procedures was compared. This trial is registered with ClinicalTrials.gov, NCT02841527, and ISRCTN, 00786323. RESULTS: Between Jan 16, 2013, and Sept 27, 2019, 1351 participants were randomly assigned
five withdrew consent and 1346 (mean age 47·3 [SD 10·6] years, 1020 [76%] women, 324 (24%) men, and two with missing data, mean weight of 129·7 kg [23·6] and mean BMI of 46·4 [6·9] kg/m INTERPRETATION: Roux-en-Y gastric bypass and sleeve gastrectomy are more effective than adjustable gastric banding. Sleeve gastrectomy has inferior weight loss and lower mean quality of life score compared with Roux-en-Y gastric bypass. Based on this evidence, it is recommended that patients electing to have metabolic and bariatric surgery are advised to have Roux-en-Y gastric bypass. Where contraindicated or unfeasible, sleeve gastrectomy should be offered. This evidence does not support adjustable gastric band as standard treatment for severe obesity. FUNDING: National Institute for Health and Care Research Health Technology Assessment Programme.