Roux-en-Y gastric bypass, adjustable gastric banding or sleeve gastrectomy for severe obesity: The By-Band-Sleeve randomised controlled trial.

BackgroundBariatric surgery can improve health outcomes but high-quality comparative evidence about different procedures is limited.ObjectiveTo compare the effectiveness and cost-effectiveness of Roux-en-Y gastric bypass (Bypass), adjustable gastric banding (Band) and sleeve gastrectomy (Sleeve) for people living with severe obesity.Design, setting and participantsMulticentre, parallel-group, randomised controlled trial conducted in 12 National Health Service hospitals. Adults with a body mass index ≥ 35 kg/m2 with comorbidity or body mass index ≥ 40 kg/m2 without comorbidity were eligible. Participants were initially randomised 1 : 1 to Bypass or Band. After 32 months of recruitment, the trial was adapted to include Sleeve, and participants were randomised to Bypass, Band or Sleeve thereafter. Participants were followed up for 3 years.InterventionsBypass, Band and Sleeve surgery.Main outcome measuresPrimary outcomes were self-reported quality of life (EQ-5D-5L utility score) and weight (at least 50% excess weight lost) at 3 years. Sleeve and Bypass were each considered superior to Band if there was non-inferior excess weight loss (< 12% difference between groups) and superior quality of life. Sleeve was considered superior to Bypass by the same criteria. Secondary outcomes included comorbidities, adverse health events, generic and disease-specific quality of life at 6, 12, 24 and 36 months post randomisation, dietary intake, binge eating behaviour and cost-effectiveness.ResultsOne thousand three hundred and fifty-one participants were randomised between December 2012 and September 2019. Five participants withdrew consent to use their data, leaving 1346 (462 Bypass, 464 Band, 420 Sleeve). The mean age was 47.3 years, 1020 (75.9%) were women and the mean weight and body mass index was 129.7 kg and 46.4 kg/m2, respectively. Overall, 1183 (87.5%) of participants underwent surgery within 3 years, with a median waiting time of 5 months (interquartile range 2.5-10.1 months). At least 50% excess weight loss at 3 years was achieved for 276/405 (68.1%) participants randomised to Bypass, 97/383 (25.3%) randomised to Band and 142/342 (41.5%) randomised to Sleeve [adjusted risk difference (Bypass-Band) + 40.7%, 98% confidence interval (+ 33.9% to + 47.5%); (Sleeve-Band) + 14.7% (+ 5.2% to + 24.2%), (Sleeve-Bypass) -26.0% (-35.8% to -16.3%)]. Mean EQ-5D scores at 3 years were 0.72 (standard deviation 0.29), 0.62 (0.33) and 0.68 (0.30) for participants randomised to Bypass, Band and Sleeve, respectively [adjusted mean difference (Bypass-Band) + 0.079 (+ 0.040 to + 0.117), (Sleeve-Band) + 0.045 (+ 0.006 to + 0.085), (Sleeve-Bypass) -0.033 (-0.072 to + 0.006)]. Secondary outcomes showed similar trends. The adverse event rate was highest in the Band group and lowest with Sleeve. Bypass was the most cost-effective procedure, with probabilities < 0.3 that Sleeve or Band was the most cost-effective.LimitationsThe study was impacted by the COVID-19 pandemic which prevented some participants having surgery and/or attending hospital for study follow-up appointments, which impacted on the completeness of data for these visits.ConclusionsBypass and Sleeve are more effective than Band. Sleeve has inferior excess weight loss and lower mean quality-of-life score than Bypass.Future workLonger-term follow-up is needed to determine the sustainability of observed effects and to examine adverse events. A comparison of optimal gastric bypass and optimal medical therapy for severe obesity is now needed to inform decision-making and health policy.Trial registrationThis trial is registered as ClinicalTrials.gov: NCT02841527, ISRCTN00786323.FundingThis award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 09/127/53) and is published in full in Health Technology Assessment; Vol. 30, No. 6. See the NIHR Funding and Awards website for further award information.