Roux-en-Y gastric bypass, adjustable gastric banding, or sleeve gastrectomy for severe obesity: the By-Band-Sleeve multi-centre, open label, three-group randomised controlled trail

The By-Band-Sleeve Collaborative Group; Blazeby, JM; Rogers, CA; Reeves, BC; Welbourn, R; Mazza, G; Gidman, E; Kanavou, S; Edwards, D; Maishman, R; Pike, K; Wordsworth, S; Pouwels, K; Doble, B; Fermont, J; Koleva Kolarova, R; Blencowe, N; Byrne, J; Thompson, JL; Pouwels, K; Donovan, JL; Paramasivan, S; Andrews, RC; Davies, N; Hayden, J; Jennings, N; Finlay, I; Singhal, R; Carter, N; Agrawal, S; Leeder, P; Ahmed, A; Hopkins, J; Whybrow, P; Realpe Rojas, A; Wilson, C; Coulman, K; Chalmers, K; Hopkins, J; Owen Smith, A; Cousins, S; Culliford, L; Dabner, L; Brierley, R; Edmond, JR

Abstract

Background
The health risks of severe obesity can be reduced with metabolic and bariatric surgery (MBS), but it is uncertain which operation is most effective or cost-effective. We compared Roux-en-Y gastric bypass (RYGB), adjustable gastric band (AGB) and sleeve gastrectomy (SG) in patients with severe obesity.
Methods
Parallel, open randomised controlled trial in adults meeting national criteria for MBS. A 2-group trial (RYGB versus AGB) became a 3-group trial to include SG 2.6 years opening, when it was widely used. 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 ≥50% excess weight loss was non-inferior (<12% difference between groups) and quality-of-life was superior, SG and RYGB were considered more effective than AGB, and SG more effective than RYGB. Cost-effectiveness of the procedures was compared.
Results
Between January 2013 and September 2019, 1351 participants were randomised across 12 hospitals in the United Kingdom; 5 withdrew consent leaving 1346 (462 RYGB, 464 AGB, 420 mean age 47·3 years, 76% women, mean body mass index 46·4 kg/m2 35 . 1183 (88%) underwent surgery. 276/405 (68%), 97/383 (25%) and 141/342 (41%) achieved ≥50% excess weight loss in the RYGB, AGB and SG groups respectively (adjusted risk difference: RYGB –AGB, +41%, 98% confidence interval [+34%, +48%]; SG–AGB, +15% [+5%, +24%]; SG– RYGB, -26% [-36%, -16%]). Mean EQ-5D scores were 0.72, 0.62 and 0.68 for RYGB, AGB and SG respectively (adjusted mean difference: RYGB–AGB, +0.08 [+0.04, +0.12]; SG–AGB, +0.05 [+0.01, +0.09]; SG3 RYGB, -0.03 [-0.07, +0.01]). 1651 adverse events were reported following surgery (5.7/year after SG, 6.0/year after RYGB and 4.6/year after AGB). RYGB was most cost-effective.
Interpretation
RYGB and SG are more effective than AGB. SG has inferior weight loss and lower mean quality of life score compared to RYGB.
Funding
National Institute for Health and Care Research Health Technology Assessment Programme (Ref:09/127/53)

Citation

The By-Band-Sleeve Collaborative Group, Blazeby, J., Rogers, C., Reeves, B., Welbourn, R., Mazza, G., Gidman, E., Kanavou, S., Edwards, D., Maishman, R., Pike, K., Wordsworth, S., Pouwels, K., Doble, B., Fermont, J., Koleva Kolarova, R., Blencowe, N., Byrne, J., Thompson, J., Pouwels, K., …Edmond, J. (online). Roux-en-Y gastric bypass, adjustable gastric banding, or sleeve gastrectomy for severe obesity: the By-Band-Sleeve multi-centre, open label, three-group randomised controlled trail. Lancet Diabetes and Endocrinology, https://doi.org/10.1016/S2213-8587%2825%2900025-7

• Journal Article Type: Article
• Acceptance Date: Jan 24, 2025
• Online Publication Date: Mar 31, 2025
• Deposit Date: Feb 17, 2025
• Publicly Available Date: Apr 3, 2025
• Journal: The Lancet Diabetes & Endocrinology
• Print ISSN: 2213-8587
• Publisher: Elsevier
• Peer Reviewed: Peer Reviewed
• DOI: https://doi.org/10.1016/S2213-8587%2825%2900025-7
• Public URL: https://hull-repository.worktribe.com/output/5041587