Gastric Bypass, Gastric Band or Sleeve Gastrectomy to Treat Obesity (ByBandSleeve)

University of Bristol

Status: Completed

Conditions: Weight Loss; Quality of Life; Surgery; Obesity

Treatments: Procedure: Gastric Bypass; Procedure: Sleeve Gastrectomy; Procedure: Gastric Band

Study type: Interventional

Funder types: Other

Identifiers

NCT02841527

ORCA39300

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,351 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female patients
2. Over 18 years of age
3. Referred for bariatric surgery according to the National Institute for Health and Care Excellence (NICE) guidelines - BMI of 40kg/m2 or more, OR BMI of 35 kg/m2 to 40 kg/m2 and other significant disease (e.g. type 2 diabetes or high blood pressure) OR BMI of 30 kg/m2 or more and recent onset diabetes OR Asian family origin with lower BMI and recent onset diabetes, that could improve with weight loss
4. Has been or is willing to receive intensive management in a specialist tier 3 obesity service
5. Fit for anaesthesia and surgery
6. Committed to follow-up and able to complete quality of life questionnaires
7. Able to provide written informed consent.

Exclusion criteria

1. Previous gastric surgery or surgery for severe and complex obesity
2. Previous abdominal surgery or gastro-intestinal (GI) condition that precludes one or more of Band, Bypass or Sleeve
3. Large abdominal ventral hernia
4. Pregnancy (women who have given birth and women planning pregnancy will NOT be excluded)
5. Crohn's disease
6. Liver cirrhosis and portal hypertension
7. Systemic lupus erythematosis
8. Known silicone allergy
9. Hiatus hernia >5cm
10. Other clinical/psychological reason, to be specified
11. Active participation in another interventional research study which might interfere with By-Band-Sleeve

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,351 participants in 3 patient groups

Gastric Band

Active Comparator group

Description:

The procedure will involve an operation in which a gastric Band and port will be fitted using a laparoscopic technique.

Treatment:

Procedure: Gastric Band

Gastric Bypass

Active Comparator group

Description:

The procedure will involve a laparoscopic operation in which 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.

Treatment:

Procedure: Gastric Bypass

Sleeve Gastrectomy

Active Comparator group

Description:

The procedure involves an operation 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 using a laparoscopic technique.

Treatment:

Procedure: Sleeve Gastrectomy