Title: 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)
Funder: Department of Health and Social Care

Abstract: 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.

Lay abstract: The By-Band-sleeve study aims to find out the best type of operation to treat obesity. There are three main types of operation that are currently used in hospitals across the UK: gastric Band, gastric Bypass and Sleeve gastrectomy. This study aims to compare these three types of operation to see which one is best. Obese adults who are referred for obesity surgery under current government guidelines can participate in the study. One third of patients who take part will be treated with gastric Band surgery, one third with gastric Bypass surgery and the other third with Sleeve gastrectomy. These operations are currently in use and are not new or experimental. The type of operation will be decided randomly. Participants will also be asked to complete a series of questionnaires about their quality of life, and some participants will be invited to be interviewed about their experiences of treatment decisions. Researchers will also ask participants to provide two blood samples in addition to the samples they would give as part of their normal care, for future research into obesity. Patients will be followed up for three years after their operation. Two centres (Taunton and Southampton) took part in the trial in phase 1 and twelve centres are taking part in phase 2. The study is coordinated from the Clinical Trials and Evaluation Unit at the University of Bristol. The study opened to recruitment in November 2012 and will run for approximately ten years, until the last recruited patient is followed-up. The trial will be recruiting patients for five and half years. The main contact for the trial will be the Clinical Trials and Evaluation Unit at the University of Bristol.

Research activity codes: 6.4 SURGERY
Health categories: CANCER AND NEOPLASMS;CARDIOVASCULAR;METABOLIC AND ENDOCRINE;ORAL AND GASTROINTESTINAL;STROKE