NCT02841527

Gastric Bypass, Gastric Band or Sleeve Gastrectomy to Treat Obesity

Gastric Bypass, Adjustable Gastric Banding or Sleeve Gastrectomy Surgery to Treat Severe and Complex Obesity: a Multi-centre Randomised Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,351 (actual)
• Sponsor: University of Bristol · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Obesity
• Surgery
• Quality of Life
• Weight Loss

Interventions

Type	Name	Description
PROCEDURE	Gastric Band	Surgical intervention in which a band is inserted around the top of the stomach to reduce its size.
PROCEDURE	Gastric Bypass	Surgical intervention where a small pouch is made in the top of the stomach and a loop of bowel connected to this pouch to bypass the rest of the stomach.
PROCEDURE	Sleeve Gastrectomy	Surgical intervention which reduces the size of the stomach by about 75%, creating a narrow tube. It is done by stapling down the stomach and removing the remainder of the stomach.

Timeline

• Start date: 2012-01-01
• Primary completion: 2022-09-30
• Completion: 2023-03-31
• First posted: 2016-07-22
• Last updated: 2023-05-12

Locations

12 sites across 1 country: United Kingdom