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Gastric Bypass, Adjustable Gastric Banding or Sleeve Gastrectomy Surgery to Treat Severe and Complex Obesity: a Multi-centre Randomised Controlled Trial
Obesity is an increasing health problem in the United Kingdom (UK) and is predicted to worsen. In the UK and worldwide the three most commonly performed operations are laparoscopic adjustable gastric banding ('BAND surgery'), laparoscopic gastric bypass ('BYPASS') and laparoscopic sleeve gastrectomy ('SLEEVE'). All lead to weight loss, but they are associated with different problems. This study (BYBANDSLEEVE) is a randomised trial with a target recruitment of 1341 patients in twelve hospitals and its aim is to compare the effectiveness, cost effectiveness and acceptability of BAND, BYPASS and SLEEVE surgery.
Obesity is an increasing health problem in the UK and one which is predicted to worsen. It is associated with many health problems that can shorten a person's life span and impair quality of life. Current national guidelines recommend that surgery is considered for the very overweight (morbidly obese) 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 surgery'), laparoscopic gastric bypass ('BYPASS') and laparoscopic sleeve gastrectomy ('SLEEVE'). All 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 (BYBANDSLEEVE) is a randomised trial with a recruitment target of 1341 patients in twelve hospitals and its aim is to compare the effectiveness, cost effectiveness and acceptability of BAND, BYPASS and SLEEVE surgery. The process of randomisation will mean that participants have a chance of receiving one of the three procedures, so a fair comparison between them can be made. The first phase (in two hospitals) will test the feasibility of recruitment and optimise information for patients to maximise trial recruitment. It will establish a core set of clinical outcomes to use to evaluate the surgery for morbid obesity. The second stage (in 12 hospitals) will recruit the full sample and follow up all participants for at least three years. The investigators 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. The investigators will also examine patients' detailed experiences during follow up, nutritional outcomes, short and long term surgical complications and National Health Service (NHS) value for money.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Heart of England NHS Foundation Trust
Birmingham, United Kingdom
Royal Bournemouth and Christchurch Hospitals
Bournemouth, United Kingdom
North Bristol NHS Trust
Bristol, United Kingdom
Royal Derby Hospital
Derby, United Kingdom
St James University Hospital, Leeds
Leeds, United Kingdom
Homerton University Hospital
London, United Kingdom
Imperial College Healthcare NHS Trust
London, United Kingdom
Queen Alexandra Hospital
Portsmouth, United Kingdom
University Hospital Southampton
Southampton, United Kingdom
Sunderland Royal Hospital
Sunderland, United Kingdom
Start Date
January 1, 2012
Primary Completion Date
September 30, 2022
Completion Date
March 31, 2023
Last Updated
May 12, 2023
1,351
ACTUAL participants
Gastric Band
PROCEDURE
Gastric Bypass
PROCEDURE
Sleeve Gastrectomy
PROCEDURE
Lead Sponsor
University of Bristol
Collaborators
NCT01143454
NCT07472881
Data Source & Attribution
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