Gastric Bypass, adjustable gastric Banding or Sleeve gastrectomy surgery to treat severe and complex obesity: a multi-centre randomised controlled trial (The By-Band-Sleeve Study)

Obesity is an increasing health problem in the UK and which is predicted to worsen. Current national guidelines recommend that surgery is considered for morbidly obese people or for those remaining obese after trying other options. In the UK and worldwide the three most commonly performed operations are laparoscopic adjustable gastric banding ('Band'), laparoscopic gastric bypass ('Bypass') and Sleeve gastrectomy ('Sleeve'). All three lead to weight loss, but they are associated with different problems. In the short term there are varying complications and inconvenience relating to the operation. In the longer term there are different outcomes relating to weight regain, symptoms and side effects of surgery. This study (By-Band-Sleeve) is a randomised trial of 1341 patients in twelve hospitals to compare the effectiveness, cost effectiveness and acceptability of Band, Bypass and Sleeve surgery. The process of randomisation will mean that participants have an chance of having any of the three procedures, so a fair comparison between them can be made. The first phase (in two hospitals) tested the feasibility of recruitment and optimise information for patients to maximise trial recruitment. The current second stage (in 12 hospitals) will recruit the full sample and follow-up all participants for at least three years. We will compare the effects of Band, Bypass and Sleeve surgery three years after randomisation on weight loss, a wide range of symptoms and aspects of quality of life. We will also examine patients’ detailed experiences during follow-up, nutritional outcomes, short and long term surgical complications and NHS value for money. Alongside the trial, we are establishing a core set of clinical outcomes to use to evaluate the surgery for complex and morbid obesity.