Woman and Man
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Extract
Background and study aims Obesity is an increasing health problem in the UK and is predicted to get worse. The three recognised operations in bariatric surgery are laparoscopic adjustable gastric banding (small inner tube placed around the stomach to reduce its capacity), laparoscopic gastric bypass (operation to make the stomach smaller and the digestive system shorter) and sleeve gastrectomy (operation to make the stomach smaller). This study aims to compare these three types of operation to see which one is better. Who can participate? Obese males and females over the age of 18 years who are referred for obesity surgery (at the recruiting centres) under current government guidelines can participate in the study. Participants should have a body mass index (BMI) of 40kg/m2 or more, or a BMI of 35 kg/m2 to 40 kg/m2 with other risk factors (e.g. type 2 diabetes), that could improve with weight loss. What does the study involve? Participants are randomly allocated to be treated with either gastric band surgery, gastric bypass surgery or sleeve gastrectomy surgery. All three operations are standard treatments for severe and complex obesity. At the moment nobody knows which is best and we are doing this study to compare them. The type of operation you have will be decided randomly; you could receive any one of the three operations. The method of selecting the operation is designed to ensure that very similar patients receive each operation. This is the only way that allows us to compare the three operations fairly. Participants will also be asked to complete a series of questionnaires at regular intervals up to three years after the operation 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. What are the possible benefits and risks of participating? There is no direct benefit for people enrolling in the study, although some people find that interviews help them talk through their situation and this is comforting. There should be no additional physical risk to you because all three operations offered are standard treatments for severe and complex obesity. Where is the study run from? 1. Musgrove Park Hospital, Taunton 2. University Hospital Southampton 3. Royal Bournemouth and Christchurch Hospital 4. St James University Hospital, Leeds 5. Sunderland Royal Hospital 6. Royal Cornwall Hospital, Truro 7. Homerton University Hospital 8. Royal Derby Hospital 9. Queen Alexandra Hospital, Portsmouth 10. Heart of England NHS Foundation Trust, Birmingham When is the study starting and how long is it expected to run for? January 2012 to December 2021. Who is funding the study? The National Institute of Health Research, Health Technology Assessment Programme are funding the study. Who is the main contact? Dr Graziella Mazza [email protected]
Inclusion criteria
- obesity