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Gastric Bypass, Gastric Band or Sleeve Gastrectomy to Treat Obesity (ByBandSleeve)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02841527
Recruitment Status : Recruiting
First Posted : July 22, 2016
Last Update Posted : August 26, 2020
Sponsor:
Collaborators:
University of Oxford
University of Birmingham
Information provided by (Responsible Party):
Jane Blazeby, University of Bristol

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.


Condition or disease Intervention/treatment Phase
Obesity Surgery Quality of Life Weight Loss Procedure: Gastric Band Procedure: Gastric Bypass Procedure: Sleeve Gastrectomy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1341 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Gastric Bypass, Adjustable Gastric Banding or Sleeve Gastrectomy Surgery to Treat Severe and Complex Obesity: a Multi-centre Randomised Controlled Trial
Actual Study Start Date : January 1, 2012
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : March 31, 2023

Arm Intervention/treatment
Active Comparator: Gastric Band
The procedure will involve an operation in which a gastric Band and port will be fitted using a laparoscopic technique.
Procedure: Gastric Band
Surgical intervention in which a band is inserted around the top of the stomach to reduce its size.

Active Comparator: Gastric Bypass
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
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.

Active Comparator: Sleeve Gastrectomy
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 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.




Primary Outcome Measures :
  1. The proportion achieving loss of greater than 50% of excess weight at three years. [ Time Frame: 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])

  2. Health-related Quality of Life (HRQoL) [ Time Frame: Three years ]
    HRQoL at three 3 years, will be assessed using the EQ-5D-5L


Secondary Outcome Measures :
  1. Change in BMI over time adjusted for BMI at randomisation [ Time Frame: Three years ]
    Change in BMI over time adjusted for BMI at randomisation

  2. Percentage weight loss at 3 years [ Time Frame: Three years ]
    Percentage weight loss at 3 years

  3. Waist circumference at 3 years [ Time Frame: Three years ]
    Waist circumference at 3 years

  4. Time taken from randomisation to reach first loss of at least 50% of excess BMI [ Time Frame: Three years ]
    Time taken from randomisation to reach first loss of at least 50% of excess BMI

  5. Time taken from first losing 50% excess BMI to first relapse [ Time Frame: 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)

  6. Generic and symptom specific Health-related Quality of Life (HRQOL) [ Time Frame: Three years ]
    Impact of Weight on Quality of Life (IWQOL-Lite)

  7. Generic and symptom specific Health-related Quality of Life (HRQOL) [ Time Frame: Three years ]
    The Gastrointestinal Quality of Life Index

  8. Generic and symptom specific Health-related Quality of Life (HRQOL) [ Time Frame: Three years ]
    Eating Habits Questionnaire

  9. Generic and symptom specific Health-related Quality of Life (HRQOL) [ Time Frame: Three years ]
    SF-12v2 Health Survey

  10. Generic and symptom specific Health-related Quality of Life (HRQOL) [ Time Frame: Three years ]
    Hospital Anxiety and Depression Scale (HADS).

  11. Resource use to three years [ Time Frame: Three years ]
    Use of health service resources over the three-year study period.

  12. Standard healthcare blood tests [ Time Frame: Three years ]
    Standard NHS nutritional blood tests will be performed at each assessment.

  13. Dietary recall [ Time Frame: Three years ]
    Measures of 24 hour recall eating using a standardised and validated interview process

  14. Binge eating behaviour [ Time Frame: Three years ]
    Binge eating behaviour using a validated questionnaire

  15. Adverse health events [ Time Frame: Three years ]
    Adverse health events including the need for re-operation and cross over between interventions

  16. Resolution of co-morbidities [ Time Frame: Three years ]
    Resolution of co-morbidities at 3 years, including sleep apnoea, non alcoholic fatty liver disease, type-2 diabetes, hypertension and hyperlipidaemia.

  17. Time to resolution of co-morbidities [ Time Frame: Three years ]
    Time to resolution of sleep apnoea, type-2 diabetes, hypertension and hyperlipidaemia



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02841527


Contacts
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Contact: Jane Blazeby, BSc,MBChB,MD +44(0)1173424007 J.M.Blazeby@bristol.ac.uk
Contact: Graziella Mazza, BSc,PhD +44(0)1173423398 G.Mazza@bristol.ac.uk

Locations
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United Kingdom
Heart of England NHS Foundation Trust Recruiting
Birmingham, United Kingdom
Contact: Rishi Singhal       rishi.singhal@heartofengland.nhs.uk   
Contact: Sally Abbott    +44(0)1214242074    sally.abbott@heartofengland.nhs.uk   
Royal Bournemouth and Christchurch Hospitals Recruiting
Bournemouth, United Kingdom
Contact: Nick Davies       nick.davies@rbch.nhs.uk   
Contact: Sarah Matthias    +44(0)1202704319    sarah.matthias@rbch.nhs.uk   
North Bristol NHS Trust Recruiting
Bristol, United Kingdom
Contact: James Hopkins    0117 4147390    James.Hopkins@nbt.nhs.uk   
Royal Derby Hospital Recruiting
Derby, United Kingdom
Contact: Paul Leeder       paul.leeder@nhs.net   
Contact: Alison Fletcher    +44(0)1332 788664    alison.fletcher4@nhs.net   
St James University Hospital, Leeds Recruiting
Leeds, United Kingdom
Contact: Jeremy Hayden       jeremy.hayden@nhs.net   
Contact: Catherine Moriarty    +44(0)1132064672    catherine.moriarty@nhs.net   
Homerton University Hospital Recruiting
London, United Kingdom
Contact: Sanjay Agrawal       sanjay.agrawal@homerton.nhs.uk   
Contact: Rosemary Mullet    +44 7818440663    rosemary.mullet@nhs.net   
Imperial College Healthcare NHS Trust Recruiting
London, United Kingdom
Contact: Ahmed R Ahmed       ahmed.ahmed@imperial.nhs.uk   
Contact: Jasmine Jose    +44(0)2033122493    jasmine.jose@imperial.nhs.uk   
Queen Alexandra Hospital Recruiting
Portsmouth, United Kingdom
Contact: Nicholas Carter       nicholas.carter@porthosp.nhs.uk   
Contact: Maria Moon    +44(0)2392286000 ext 6885    maria.moon@porthosp.nhs.uk   
University Hospital Southampton Recruiting
Southampton, United Kingdom
Contact: James Byrne    +44(0)2380777222 ext 5339    james.byrne@uhs.nhs.uk   
Contact: Amy Long    +44(0)2380777222 ext 5339    Amy.Long@uhs.nhs.uk   
Sunderland Royal Hospital Recruiting
Sunderland, United Kingdom
Contact: Neil Jennings       n.jennings@doctors.org.uk   
Musgrove Park Hospital Recruiting
Taunton, United Kingdom
Contact: Rob Andrews       r.c.andrews@exeter.ac.uk   
Contact: Nicola Salter    +44(0)1823343514    nicola.salter@tst.nhs.uk   
Sub-Investigator: Richard Welbourn         
Royal Cornwall Hospital Recruiting
Truro, United Kingdom
Contact: Ian Finlay       ian.finlay@nhs.net   
Contact: Benita Adams    01872255125    benita.adams@nhs.net   
Sponsors and Collaborators
University of Bristol
University of Oxford
University of Birmingham
Investigators
Layout table for investigator information
Study Director: Jane Blazeby, BSc,MBChB,MD University of Bristol
  Study Documents (Full-Text)

Documents provided by Jane Blazeby, University of Bristol:
Study Protocol  [PDF] September 28, 2018

Additional Information:
Publications:

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Responsible Party: Jane Blazeby, Chief Investigator, University of Bristol
ClinicalTrials.gov Identifier: NCT02841527    
Other Study ID Numbers: ORCA39300
First Posted: July 22, 2016    Key Record Dates
Last Update Posted: August 26, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All data will be anonymised and analysed in groups. Individual patient data (IPD) will be made available to the research team following analysis.
Additional relevant MeSH terms:
Layout table for MeSH terms
Obesity
Weight Loss
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Body Weight Changes