An interventional study of Gastric Band and Gastric Bypass in Obesity, Surgery and Quality of Life, sponsored by University of Bristol. Completed at 12 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-12.
Sponsored by University of Bristol · Not applicable, Interventional, and Treatment
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's enrollment of 1,351 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →University of Bristol is the lead sponsor of 22 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The procedure will involve an operation in which a gastric Band and port will be fitted using a laparoscopic technique.
Procedure: Gastric Band
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
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
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.
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
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — All data will be anonymised and analysed in groups. Individual patient data (IPD) will be made available to the research team following analysis.
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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University of Bristol