UK Clinical Research Network : Portfolio Database User Guide  
Welcome to the UK Clinical Research Network Study Portfolio : NIHR (England)  

NB: The information displayed below does not replace the protocol. The latest protocol version should always be consulted before making clinical decisions.

Gastric Bypass, adjustable gastric Banding or Sleeve gastrectomy surgery to treat severe and complex obesity: a multi-centre randomised controlled trial

Surgery (co-adopted by MetabolicEndocrine)
Portfolio Eligibility
Automatically eligible
ISRCTN 00786323
MREC N° 11/SW/0248
UKCRN ID 11911
Research Summary
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 three most commonly performed operations are laparoscopic adjustable gastric banding (’Band surgery’), laparoscopic gastric bypass (’Bypass’) and Sleeve gastrectomy ('Sleeve'). All three operations 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-Sleeve) is a randomised trial of 1341 patients in 12 hospitals to compare the effectiveness, cost effectiveness and acceptability of Band, Bypass and Sleeve surgery. The process of randomisation will mean that participants have an equal chance of having one of the three procedures, so a fair comparison between them can be made. The first phase (in two hospitals) tested the feasibility of recruitment and optimise information for patients to maximise trial recruitment. It established a core set of clinical outcomes to use to evaluate the surgery for severe and complex obesity. The second stage (in 12 hospitals) will recruit the full sample and follow-up all participants for at least three years. We 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. We will also examine patients’ detailed experiences during follow-up, nutritional outcomes, short and long term surgical complications and NHS value for money.
Study Type Interventional
Design Type Not specified, Treatment
Disease(s) Metabolic & Endocrine (not diabetes)
All Surgery
Phase III
Current Status Open
Closure Date 6/30/2018
Global Sample Size 1341
Global Recruitment to Date
Geographical Scope UK Multi-Centre
Lead Country England
Open to new sites Yes, within lead country only
Health care professionals can obtain a copy of the protocol by clicking here
Main Inclusion Criteria
1. Male or female patients 2. Over 18 years of age 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 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.
Main 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
Chief Investigator(s)
Prof Jane Blazeby
Further details, please contact
Prof Jane Blazeby

University of Bristol
Academic Unit of Primary Health Care, School of Social and Community Medicine
Canynge Hall
39 Whatley Road

Tel: 0117 9287332
Dr Graziella Mazza

University of Bristol
Clinical Trials and Evaluation Unit
Bristol Royal Infirmary Level 7
Upper Maudlin Street

Tel: 0117 3423398
Fax: 0117 3423288
Dr Chris Rogers

University of Bristol
Bristol Heart Institute,
Level 7, BRI

Bristol Royal Infirmary
Marlborough Street

Tel: 0117 342 2507
Funder(s) NIHR Health Technology Assessment
Sponsor(s) University of Bristol
If you experience problems using the application, please click here.