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Randomized Controlled Trial
. 2025 May;13(5):410-426.
doi: 10.1016/S2213-8587(25)00025-7. Epub 2025 Mar 31.

Roux-en-Y gastric bypass, adjustable gastric banding, or sleeve gastrectomy for severe obesity (By-Band-Sleeve): a multicentre, open label, three-group, randomised controlled trial

By-Band-Sleeve Collaborative Group
Collaborators
Free article
Randomized Controlled Trial

Roux-en-Y gastric bypass, adjustable gastric banding, or sleeve gastrectomy for severe obesity (By-Band-Sleeve): a multicentre, open label, three-group, randomised controlled trial

By-Band-Sleeve Collaborative Group. Lancet Diabetes Endocrinol. 2025 May.
Free article

Abstract

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/m2) were included in this report. Of 1346 participants, 462 (34%) were in the Roux-en-Y gastric bypass group, 464 (34%) in the adjustable gastric banding group, and 420 (31%) in the sleeve gastrectomy group. 1183 (88%) participants underwent surgery. 276 (68%) of 405 participants in the Roux-en-Y gastric bypass group, 97 (25%) of 383 participants in the adjustable gastric banding group and 141 (41%) of 342 participants in the sleeve gastrectomy group achieved at least 50% excess weight loss (adjusted risk difference: Roux-en-Y gastric bypass vs adjustable gastric banding 41% [98% CI 34 to 48]; sleeve gastrectomy vs adjustable gastric banding 15% [5 to 24]; sleeve gastrectomy vs Roux-en-Y gastric bypass, -26% [-36 to -16%]). Mean EQ-5D scores were 0·72 for Roux-en-Y gastric bypass, 0·62 for adjustable gastric banding, and 0·68 for sleeve gastrectomy (adjusted mean difference: Roux-en-Y gastric bypass vs adjustable gastric banding 0·08 [0·04 to 0·12], sleeve gastrectomy vs adjustable gastric banding 0·05 [0·01 to 0·09], and sleeve gastrectomy vs Roux-en-Y gastric bypass -0·03 [-0·07 to 0·01]). 1651 adverse events were reported following surgery (5·7 per year after sleeve gastrectomy, 6·0 per year after Roux-en-Y gastric bypass, and 4·6 per year after adjustable gastric banding). There were 11 deaths from randomisation to 3 years: one attributable to surgery (in the adjustable gastric bypass group, during the surgical admission) and ten not attributable to surgery (four each in the Roux-en-Y gastric bypass and adjustable gastric banding groups and two in the sleeve gastrectomy group). Roux-en-Y gastric bypass was most cost-effective.

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.

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Conflict of interest statement

Declarations of interest JMB reports membership of the National Institute of Health and Care Research (NIHR) HTA Obesity Themed Call Board 2010, the HTA Surgery Themed Call Board 2012–13, the NIHR CTU Standing Advisory Committee 2012–20, the HTA Clinical Evaluation and Trials Committee 2009–13 and the NIHR Senior Investigator Panel (2021 to present), funding from the MRC Network of Hubs for Trials Methodology Research ConDuCT and ConDuCT II and NIHR Bristol Biomedical Research Centre. She also reports research grants from the NIHR (reference NIHR205174, NIHR152268, NIHR151274, NIHR127393, and NIHR130547) and Bristol and Weston Hospitals Charity and NIHR Research Capability Fund in the last 3 years. CAR reports membership of a Clinical Trials Unit funded by the NIHR (until 30 Sept 2023), membership of the NIHR Health Technology Assessment Funding Committee Policy Group (November 2016–November 2, 2021) and the Health Technology Assessment Commissioning Committee (August 2016–November 2021), and funding from the British Heart Foundation (until 2016). JLD reports membership of the NIHR HTA Commissioning Board (2006–12), NIHR Rapid Trials and Add-on Studies Board 2012, NIHR Senior Investigator panel (2009–2012), NIHR Health Services and Delivery Research Board, Deputy Chair (2010–11). BCR reports funding from the NIHR for expenses associated with his membership of the Health Technology Assessment Commissioning Board (January 2012–March 31, 2016), the Health Technology Assessment Efficient Study Designs Board (October–December, 2014), the Health Technology Assessment Interventional Procedures Committee B Methods Group and Systematic Reviews Programme Advisory Group (Systematic Reviews NIHR Cochrane Incentive Awards and Systematic Review Advisory Group). SW reports funding from the grant paid to her employer to cover her role in the trial, and panel membership of the US National Academies Genomics and Precision Medicine Round Table. JLT reports funding from the grant paid to her employer to cover her role in the trial and consultancy fees from University of Bristol, Bristol, UK (July 2022–June 2023). JMB, CAR, BCR, EAG, SP, and KBP report funding from the grant paid to their employer to cover their role in the trial. LC reports funding from the NIHR grant paid to her employer and membership of a Clinical Trials Unit funded by NIHR (until Sept 30, 2023). KBP reports funding paid to his employer from the Wellcome Trust (222051/Z/20/Z and to be assigned), Ineos Oxford Institute for AMR Research, Coalition for Epidemic Preparedness and Innovations, UK Health Security Agency, NIHR, Medical Research Foundation, Waltham Foundation, EU-H2020 IMI-2, and EU-H2020 in the last 3 years; and membership of the UK Advisory Committee on Antimicrobial Prescribing, Resistance, and Healthcare Associated Infections. RCA reports research funding from NovoNordisk Healthcare Organisation in the last 3 years, honoraria from NovoNordisk, AstraZeneca, and Eli Lilly for education talks on diet and exercise to health care professionals, and chairmanship of Diabetes UK Clinical Study Group 3: prevention, targets, and therapies for type 2 diabetes (until May 2021). RW reports payment for his role on the Advisory Board, College of Contemporary Health, London, UK. AA reports research funding from the NIHR (reference 17/11/49) during course of the study and honoraria from Medtronic for a lecture or presentation. PCL reports receipt of funding for expenses associated with attendance at trial-related investigator meetings and Directorship of Education, Association of Laparoscopic Surgeons of Great Britain and Ireland, and Honorary Secretary of the Grey Turner Surgical Society. JPB reports funding from the grant paid to his employer to cover his role in the trial and receipt of funding for expenses associated with attendance at trial-related meetings. He also reports grant funding from Oxford Medical Products in the last 3 years, membership of the Data Monitoring and Safety committee for the NIHR-funded EMBIO study, British Obesity and metabolic Surgery Society President (2023–25), Secretary (2021–23), Treasurer (2017–21), Obesity Empowerment Network Trustee, and treasurer (2019-present), and shares in Join Embla UK. SA reports Royalty for being Editor of the book Obesity, Bariatric and Metabolic Surgery—A Practical Guide from the sales and electronic downloads every year since its publication by Springer (August, 2015), Royalty for being Editor of 2nd edition of the book Obesity, Bariatric and Metabolic Surgery—A Practical Guide by Springer (2023), honoraria for invited for lectures or presentations at national and international meetings, and Directorship of Bariatric and Metabolic Surgery UK. JH reports honoraria for speaking at meetings and expert panel review into Meshes in hernia surgery from BD Bard and shares in Dr J C Hopkins. JMF reports being an employee of, and an equity holder in, Novartis Pharma. All other authors report no competing interests.

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