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
Authors: Sally Abbott, Benita Adams, Sanjay Agrawal, Ahmed Ahmed, Hazem Al Momani, Waleed Al-Khyatt, Omer Al-Taan, Robert C Andrews, Manuela Antognozzi, Sherif Awad, Altaf Awan, Shlok Balupuri, Samir Bellani, John Bessent, Jonathan Betts, Jane M Blazeby, Natalie Blencowe, Rachel Brierley, Julia Brown, James P Byrne, Richard Byrom, Heike Cappel-Porter, Nicholas Carter, Katy Chalmers, Vasileios Charalampakis, James Clark, Michael Clarke, Caroline Clay (deceased), Joanna Coast, Paul Corrigan, Allwyn Cota, Karen Coulman, Sian Cousins, Lucy Culliford, Lucy Dabner, Sabrina Dabner, Markos Daskalakis, Nick Davies, Simon Dexter, John Dixon, Jenny L Donovan, Janet Edmond, Danielle Edwards, Rebecca Evans, Khaleelur Fareed, Jilles M Fermont, Nicholas Finer, Ian Finlay, Tracey Fong, Hassina Furreed, Eleanor A Gidman, Anna Gilbert, Jeremy Gilbert, Kirsty Gladas, Beth Greenslade, Sherif Hakky, Jeremy Hayden, Jennifer Henderson, Jodie Henman, James Hewes, Rachael Heys, Marianne Hollyman, James Hopkins, Helen Horton, Buddika Jayathilaka, Neil Jennings, Sofia Kanavou, Surinder Kaur, Jamie Kelly, Benjamin Knight, Rositsa Koleva-Kolarova, Jenny Lamb, Paul Leeder, Chiwen Lin, Amy Long, John Loy, Charlotte McCaie, Holly Mckeon, Brijesh Madhok, Kamal Mahawar, David Mahon, Rachel Maishman, Matthew Mason, Priya Mathew, Sarah Matthias, Graziella Mazza, Samir Mehta, Peter Mekhail, Alexander Mikulski, Simon Monkhouse, Maria Moon, Krishna Moorthy, Catherine Moriarty, Steve Morris, Rajwinder Nijjar, Hamish Noble, Sally Norton, Abby O'Connell, Mary O'Kane, Torsten Olbers, Alan Osborne, Stephen Palmer, Sangeetha Paramasivan, Katie Pike, Dimitri Pournaras, Koen Pouwels, Mark Priestley, Sanjay Purkayastha, Craig Ramsay, Alba X Realpe, Barnaby C Reeves, Martin Richardson, Andrew G Robertson, Paul Roderick, Chris A Rogers, Nicki Salter, Jade Salter-Hewitt, Pedro Braga Sardo, Abeezar Ismail Sarela, Rishi Singhal, Peter K Small, Neil Smith, Shaw Somers, Paul Super, Michel Suter, Muwaffaq Telfah, Janice L Thompson, Kerry Thorpe, Jill Townley, Christos Tsironis, Richard Welbourn, Paul Whybrow, John Wilding, James Williamson, Caroline Wilson, Sarah Wordsworth, Rachael Wright
Journal: The Lancet Diabetes & Endocrinology (2025)

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. 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. 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. 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. National Institute for Health and Care Research Health Technology Assessment Programme.