Southampton researchers are set to take part in the BY-BAND study, a landmark project to assess which surgery is best – the gastric band or the gastric bypass?
Researchers from the University of Southampton and University Hospital Southampton NHS Foundation Trust will form one of two centres responsible for working out the best ways to involve patients, surgeons, and other health professionals in a short preliminary phase before including more centres across the country.
James Byrne, Consultant Surgeon, at Southampton General Hospital who is also an honorary lecturer at the University of Southampton, says: “Obesity is a serious health issue, one that is set to rise in the future. BYBAND is an important and prestigious trial that will help to determine optimum care for patients having this surgery in the UK. During the initial phase there will be a lot of work and research effort focussed on enhancing recruitment, which is likely to be the most challenging element in a study of this nature.”
Paul Roderick, Professor in Public Health at the University of Southampton, adds, “Obesity is one of the major public health threats of our time, obesity surgery has an important role to play in treating patients with severe obesity but we need better evidence on which surgical option is best for both the patient and the NHS, this study aims to investigate this important question.”
The study will compare weight changes of patients following both types of surgery over three years and test specifically whether better overall quality of life is achieved with bypass surgery.
The research team plan to study over 700 obese 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 making decisions about their treatment. 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.
The study will be led and co-ordinated from the Clinical Trials and Evaluation Unit at the University of Bristol and funded by the National Institute for Health Research Health Technology Assessment (NIHR HTA) programme. It 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.
Professor Jane Blazeby, Consultant Upper GI Surgeon at the University of Bristol, who is leading the study, adds: “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.”