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/m 2) 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.
| Original language | English |
|---|---|
| Article number | In Press |
| Pages (from-to) | 410-426 |
| Number of pages | 17 |
| Journal | The Lancet Diabetes & Endocrinology |
| Volume | 13 |
| Issue number | 5 |
| Early online date | 31 Mar 2025 |
| DOIs | |
| Publication status | Published - May 2025 |
Funding
The study was funded by the NIHR Health Technology Assessment programme (reference number 09/127/53). The study was designed and delivered in collaboration with the Bristol Trials Centre, a UK Clinical Research Collaboration\u2013registered clinical trials unit (CTU), which received NIHR CTU support funding. Several methodological developments (eg, the QuinteT Recruitment Intervention, the core outcome set, the systematic review, and quality assurance work) were additionally supported by the MRC ConDuCT-I (G0800800) and II (MR/K025643/1) Hubs for Trials Methodology Research, the Bristol and Weston Biomedical Research Centre (NIHR203315) and an NIHR doctoral fellowship held by Natalie Blencowe. Chris A Rogers was funded by the British Heart Foundation until 2016. The views and opinions expressed are those of the authors and do not necessarily reflect those of the NIHR Health Technology Assessment programme, the NHS, or the Department of Health and Social Care. We thank all patients who participated in the trial and the families who supported them. We also acknowledge the support of the teams at the study centres.
| Funders | Funder number |
|---|---|
| National Institute for Health and Care Research | |
| British Heart Foundation | |
| Health Technology Assessment Programme | 09/127/53 |
| Health Technology Assessment Programme | |
| Medical Research Council | G0800800, MR/K025643/1 |
| NIHR Bristol Biomedical Research Centre | NIHR203315 |
