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NB: The information displayed below does not replace the protocol. The latest protocol version should always be consulted before making clinical decisions.
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BY-BAND
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Gastric BYpass or adjustable gastric BANDing surgery to treat morbid obesity: a multi-centre randomised controlled trial - The BY-BAND Trial
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Topic
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Generic Relevance & Cross Cutting Themes
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Portfolio Eligibility
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Automatically eligible
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ISRCTN
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00786323
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EudraCT
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MREC N°
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11/SW/0248
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UKCRN ID
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11911
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WHO ID
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Research Summary
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Obesity is an increasing health problem in the UK and 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 two most commonly performed operations are laparoscopic adjustable gastric banding (’BAND surgery’) and laparoscopic gastric bypass (’BYPASS’). Both 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 (BY-BAND) is a randomised trial of 724 patients in eight hospitals to compare the effectiveness, cost effectiveness and acceptability of BAND and BYPASS surgery. The process of randomisation will mean that participants have an equal chance of having either procedure, 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 8 hospitals) will recruit the full sample and follow-up all participants for at least three years. We will compare the effects of BAND and BYPASS surgery three years after randomisation on weight loss, a wide range of symptoms and aspects of quality of life. We will also examine patients’ detailed experiences during follow-up, nutritional outcomes, short and long term surgical complications and NHS value for money.
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Study Type
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Interventional
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Design Type
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Not specified, Treatment
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Disease(s)
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Surgery
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Phase
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III
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Current Status
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Open
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Closure Date
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5/31/2016
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Global Sample Size
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724
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Global Recruitment to Date
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 10% |
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Geographical Scope
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UK Multi-Centre
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Lead Country
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England
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Open to new sites
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Yes, within lead country only
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Main Inclusion Criteria
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1. Male or female patients
2. 18 years of age or over
3. Referred for bariatric surgery according to NICE guidelines BMI
of 40kg/m2 or more, OR BMI of 35 kg/m2 to 40 kg/m2 and other co-morbidities (e.g. type 2 diabetes), that could improve with weight loss
4. Willing to receive intensive management in a specialist 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.
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Main Exclusion Criteria
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1. A history of previous gastric surgery or surgery for morbid obesity
2. Large abdominal ventral hernia
3. Hiatus hernia more than 5cm
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. Surgeon unwilling for patient to be randomised (reason to be specified)
10. Active participation in another interventional research study.
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Chief Investigator(s)
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| Prof Jane Blazeby |
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Further details, please contact
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Prof Jane Blazeby
University of Bristol
Academic Unit of Primary Health Care, School of Social and Community Medicine
Canynge Hall
39 Whatley Road
Bristol
Somerset
BS8 2PS
UNITED KINGDOM
Tel: 0117 9287332
J.M.Blazeby@bristol.ac.uk
| Dr Graziella Mazza
University of Bristol
Clinical Trials and Evaluation Unit
Bristol Royal Infirmary Level 7
Upper Maudlin Street
Bristol
England
BS2 8HW
UNITED KINGDOM
Tel: 0117 3423398
Fax: 0117 3423288
g.mazza@bristol.ac.uk
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Dr Chris Rogers
University of Bristol
Bristol Heart Institute,
Level 7, BRI
Bristol Royal Infirmary
Marlborough Street
Bristol
Somerset
BS2 8HW
UNITED KINGDOM
Tel: 0117 342 2507
chris.rogers@bristol.ac.uk
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| Funder(s) |
NIHR Health Technology Assessment
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| Sponsor(s) |
University of Bristol
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