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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,351
Surgical intervention in which a band is inserted around the top of the stomach to reduce its size.
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.
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.
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
...and 2 more locations
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×\[BMI at 3 years - BMI at randomisation1\] / \[BMI at randomisation - 25\])
Time frame: Three years
Health-related Quality of Life (HRQoL)
HRQoL at three 3 years, will be assessed using the EQ-5D-5L
Time frame: Three years
Change in BMI over time adjusted for BMI at randomisation
Change in BMI over time adjusted for BMI at randomisation
Time frame: Three years
Percentage weight loss at 3 years
Percentage weight loss at 3 years
Time frame: Three years
Waist circumference at 3 years
Waist circumference at 3 years
Time frame: 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
Time frame: 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)
Time frame: Three years
Generic and symptom specific Health-related Quality of Life (HRQOL)
Impact of Weight on Quality of Life (IWQOL-Lite)
Time frame: Three years
Generic and symptom specific Health-related Quality of Life (HRQOL)
The Gastrointestinal Quality of Life Index
Time frame: Three years
Generic and symptom specific Health-related Quality of Life (HRQOL)
Eating Habits Questionnaire
Time frame: Three years
Generic and symptom specific Health-related Quality of Life (HRQOL)
SF-12v2 Health Survey
Time frame: Three years
Generic and symptom specific Health-related Quality of Life (HRQOL)
Hospital Anxiety and Depression Scale (HADS).
Time frame: Three years
Resource use to three years
Use of health service resources over the three-year study period.
Time frame: Three years
Standard healthcare blood tests
Standard NHS nutritional blood tests will be performed at each assessment.
Time frame: Three years
Dietary recall
Measures of 24 hour recall eating using a standardised and validated interview process
Time frame: Three years
Binge eating behaviour
Binge eating behaviour using a validated questionnaire
Time frame: Three years
Adverse health events
Adverse health events including the need for re-operation and cross over between interventions
Time frame: 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.
Time frame: Three years
Time to resolution of co-morbidities
Time to resolution of sleep apnoea, type-2 diabetes, hypertension and hyperlipidaemia
Time frame: Three years
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