BY-BAND study to compare two types of gastric surgery for obesity

Surgery for obesity improves lives and may save money. There are two very commonly performed operations to treat morbid obesity in the UK but it is unclear which is the most effective and provides the greatest benefit for patients and the NHS.

The BY-BAND study led by the University of Bristol and funded by the National Institute for Health Research Health Technology Assessment (NIHR HTA) programme will compare the outcomes of stomach bypass and stomach band operations.

Professor Jane Blazeby, Consultant Upper GI Surgeon in the School of Social and Community Medicine at the University of Bristol, who is leading the study, said: "Obesity is an increasing health problem in the UK, which is predicted to worsen. Current national guidelines recommend that surgery should be considered for morbidly obese people or for those remaining obese after trying other options.

"The BY-BAND study will compare two types of operation, gastric bypass and gastric banding, to find out which one has the greater benefits."

BY-BAND will compare weight changes over three years between the two types of surgery and test specifically whether better overall quality of life is achieved with bypass surgery.

Due to the way surgery is organised BY-BAND will have a short preliminary phase in two hospitals to work out the best ways to involve patients, surgeons, and other health professionals before including more centres across the country.

The research team plan to study over 700 very over weight patients in a randomised trial. BY-BAND will also document differences in surgical complications, both at the time of surgery and for up to three years, and value for money for the NHS between the operations.

Obese adults who are referred for obesity surgery under current government guidelines can participate in the study. Half of patients who take part will be treated with gastric band surgery and the other half with gastric bypass surgery. Both operations are currently in use and neither operation is new or experimental. The type of operation will be decided by randomisation.

Participants will also be asked to complete a series of questionnaires about their quality of life, and some participants will 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.

There will be two centres (Taunton and the University of Southampton) taking part in the trial in phase one and eight centres taking part in phase two. The study will be co-ordinated from the Clinical Trials and Evaluation Unit at the University of Bristol.

The study is expected to start recruitment in April 2012 and will run for approximately eight years, until the last recruited patient is followed-up. The trial will be recruiting patients until 2015 and the findings will be published in 2018.