Obesity, Quality of Life, Surgery, Weight Loss
Conditions
Brief 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.
Interventions
PROCEDUREGastric Band
Surgical intervention in which a band is inserted around the top of the stomach to reduce its size.
PROCEDUREGastric 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.
PROCEDURESleeve 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.
Sponsors
University of Oxford
University of Birmingham
University of Bristol
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion achieving loss of greater than 50% of excess weight at three years. | Three years | The proportion achieving loss of greater than 50% of excess weight at three years (calculated as 100×\[BMI at 3 years - BMI at randomisation1\] / \[BMI at randomisation - 25\]) |
| Health-related Quality of Life (HRQoL) | Three years | HRQoL at three 3 years, will be assessed using the EQ-5D-5L |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Waist circumference at 3 years | Three years | Waist circumference at 3 years |
| Time taken from randomisation to reach first loss of at least 50% of excess BMI | Three years | Time taken from randomisation to reach first loss of at least 50% of excess BMI |
| Time taken from first losing 50% excess BMI to first relapse | Three years | 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) |
| Generic and symptom specific Health-related Quality of Life (HRQOL) | Three years | Impact of Weight on Quality of Life (IWQOL-Lite) |
| Resource use to three years | Three years | Use of health service resources over the three-year study period. |
| Change in BMI over time adjusted for BMI at randomisation | Three years | Change in BMI over time adjusted for BMI at randomisation |
| Dietary recall | Three years | Measures of 24 hour recall eating using a standardised and validated interview process |
| Binge eating behaviour | Three years | Binge eating behaviour using a validated questionnaire |
| Adverse health events | Three years | Adverse health events including the need for re-operation and cross over between interventions |
| Resolution of co-morbidities | Three years | Resolution of co-morbidities at 3 years, including sleep apnoea, non alcoholic fatty liver disease, type-2 diabetes, hypertension and hyperlipidaemia. |
| Time to resolution of co-morbidities | Three years | Time to resolution of sleep apnoea, type-2 diabetes, hypertension and hyperlipidaemia |
| Standard healthcare blood tests | Three years | Standard NHS nutritional blood tests will be performed at each assessment. |
| Percentage weight loss at 3 years | Three years | Percentage weight loss at 3 years |
Countries
United Kingdom
Outcome results
None listed