Gastric Bypass, Gastric Band or Sleeve Gastrectomy to Treat Obesity

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Obesity, Surgery, Quality of Life, Weight Loss

Intervention / Treatment
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* Procedure: Gastric Band
* Procedure: Gastric Bypass
* Procedure: Sleeve Gastrectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients Over 18 years of age 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 Has been or is willing to receive intensive management in a specialist tier 3 obesity service Fit for anaesthesia and surgery Committed to follow-up and able to complete quality of life questionnaires Able to provide written informed consent. Exclusion Criteria: Previous gastric surgery or surgery for severe and complex obesity Previous abdominal surgery or gastro-intestinal (GI) condition that precludes one or more of Band, Bypass or Sleeve Large abdominal ventral hernia Pregnancy (women who have given birth and women planning pregnancy will NOT be excluded) Crohn's disease Liver cirrhosis and portal hypertension Systemic lupus erythematosis Known silicone allergy Hiatus hernia >5cm Other clinical/psychological reason, to be specified Active participation in another interventional research study which might interfere with By-Band-Sleeve

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Gastric Band<br>The procedure will involve an operation in which a gastric Band and port will be fitted using a laparoscopic technique. | Procedure: Gastric Band<br>* Surgical intervention in which a band is inserted around the top of the stomach to reduce its size.<br>|
| Active Comparator: Gastric Bypass<br>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. | Procedure: Gastric Bypass<br>* 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.<br>|
| Active Comparator: Sleeve Gastrectomy<br>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. | Procedure: Sleeve Gastrectomy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion achieving loss of greater than 50% of excess weight at three years. | The proportion achieving loss of greater than 50% of excess weight at three years (calculated as 100×[BMI at 3 years - BMI at randomisation1] / [BMI at randomisation - 25]) | Three years | 
| Health-related Quality of Life (HRQoL) | HRQoL at three 3 years, will be assessed using the EQ-5D-5L | Three years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in BMI over time adjusted for BMI at randomisation | Change in BMI over time adjusted for BMI at randomisation | Three years | 
| Percentage weight loss at 3 years | Percentage weight loss at 3 years | Three years | 
| Waist circumference at 3 years | Waist circumference at 3 years | Three years | 
| Time taken from randomisation to reach first loss of at least 50% of excess BMI | Time taken from randomisation to reach first loss of at least 50% of excess BMI | Three years | 
| Time taken from first losing 50% excess BMI to first relapse | Time taken from first losing 50% excess BMI to first relapse (defined as weight re-gain such that the target of at least 50% of excess weight loss is no longer met) | Three years | 
| Generic and symptom specific Health-related Quality of Life (HRQOL) | Impact of Weight on Quality of Life (IWQOL-Lite) | Three years | 
| Generic and symptom specific Health-related Quality of Life (HRQOL) | The Gastrointestinal Quality of Life Index | Three years | 
| Generic and symptom specific Health-related Quality of Life (HRQOL) | Eating Habits Questionnaire | Three years | 
| Generic and symptom specific Health-related Quality of Life (HRQOL) | SF-12v2 Health Survey | Three years | 
| Generic and symptom specific Health-related Quality of Life (HRQOL) | Hospital Anxiety and Depression Scale (HADS). | Three years | 
| Resource use to three years | Use of health service resources over the three-year study period. | Three years | 
| Standard healthcare blood tests | Standard NHS nutritional blood tests will be performed at each assessment. | Three years | 
| Dietary recall | Measures of 24 hour recall eating using a standardised and validated interview process | Three years | 
| Binge eating behaviour | Binge eating behaviour using a validated questionnaire | Three years | 
| Adverse health events | Adverse health events including the need for re-operation and cross over between interventions | Three years | 
| Resolution of co-morbidities | Resolution of co-morbidities at 3 years, including sleep apnoea, non alcoholic fatty liver disease, type-2 diabetes, hypertension and hyperlipidaemia. | Three years | 
| Time to resolution of co-morbidities | Time to resolution of sleep apnoea, type-2 diabetes, hypertension and hyperlipidaemia | Three years |