Roux-en-Y gastric bypass, gastric banding, or sleeve gastrectomy for severe obesity: Baseline data from the By-Band-Sleeve randomized controlled trial.

OBJECTIVE: This paper reports the study design, participant characteristics, and recruitment results of By-Band-Sleeve, which investigated the clinical and cost-effectiveness of gastric bypass, gastric banding, and sleeve gastrectomy in adults with severe obesity in the UK. METHODS: A pragmatic open adaptive noninferiority trial with 3-year follow-up was conducted. Participants were randomly assigned to bypass or band initially and to sleeve after the adaptation. Co-primary end points are weight loss and health-related quality of life assessed using the EQ-5D utility index. RESULTS: Between December 2012 and August 2015, the study recruited into two groups and, after the adaptation, into three groups until September 2019. The study screened 6960 patients; 4732 (68%) were eligible and 1351 (29%) were randomized; 5 subsequently withdrew consent to use data, leaving 462, 464, and 420 assigned to bypass, band, and sleeve, respectively. Baseline data showed high levels of obesity (mean BMI = 46.4 kg/m2; SD: 6.9) and comorbidities (e.g., 31% diabetes), low scores for health-related quality of life, and high levels of anxiety and depression (e.g., 25% abnormal scores). Nutritional parameters were poor, and the average equivalized household income was low (£16,667). CONCLUSIONS: By-Band-Sleeve fully recruited. Participant characteristics are consistent with contemporary patients having bariatric surgery, and therefore the results will be generalizable.