ByBandSleeve: Gastric Bypass, Gastric Band or Sleeve Gastrectomy to Treat Obesity
Study Details
Study Description
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 |
|---|---|---|
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N/A |
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.
Study Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- The proportion achieving loss of greater than 50% of excess weight at three years. [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])
- Health-related Quality of Life (HRQoL) [Three years]
HRQoL at three 3 years, will be assessed using the EQ-5D-5L
Secondary Outcome Measures
- Change in BMI over time adjusted for BMI at randomisation [Three years]
Change in BMI over time adjusted for BMI at randomisation
- Percentage weight loss at 3 years [Three years]
Percentage weight loss at 3 years
- Waist circumference at 3 years [Three years]
Waist circumference at 3 years
- Time taken from randomisation to reach first loss of at least 50% of excess BMI [Three years]
Time taken from randomisation to reach first loss of at least 50% of excess BMI
- Time taken from first losing 50% excess BMI to first relapse [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)
- Generic and symptom specific Health-related Quality of Life (HRQOL) [Three years]
Impact of Weight on Quality of Life (IWQOL-Lite)
- Generic and symptom specific Health-related Quality of Life (HRQOL) [Three years]
The Gastrointestinal Quality of Life Index
- Generic and symptom specific Health-related Quality of Life (HRQOL) [Three years]
Eating Habits Questionnaire
- Generic and symptom specific Health-related Quality of Life (HRQOL) [Three years]
SF-12v2 Health Survey
- Generic and symptom specific Health-related Quality of Life (HRQOL) [Three years]
Hospital Anxiety and Depression Scale (HADS).
- Resource use to three years [Three years]
Use of health service resources over the three-year study period.
- Standard healthcare blood tests [Three years]
Standard NHS nutritional blood tests will be performed at each assessment.
- Dietary recall [Three years]
Measures of 24 hour recall eating using a standardised and validated interview process
- Binge eating behaviour [Three years]
Binge eating behaviour using a validated questionnaire
- Adverse health events [Three years]
Adverse health events including the need for re-operation and cross over between interventions
- Resolution of co-morbidities [Three years]
Resolution of co-morbidities at 3 years, including sleep apnoea, non alcoholic fatty liver disease, type-2 diabetes, hypertension and hyperlipidaemia.
- Time to resolution of co-morbidities [Three years]
Time to resolution of sleep apnoea, type-2 diabetes, hypertension and hyperlipidaemia
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female patients
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Over 18 years of age
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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
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Has been or is willing to receive intensive management in a specialist tier 3 obesity service
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Fit for anaesthesia and surgery
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Committed to follow-up and able to complete quality of life questionnaires
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Able to provide written informed consent.
Exclusion Criteria:
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Previous gastric surgery or surgery for severe and complex obesity
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Previous abdominal surgery or gastro-intestinal (GI) condition that precludes one or more of Band, Bypass or Sleeve
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Large abdominal ventral hernia
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Pregnancy (women who have given birth and women planning pregnancy will NOT be excluded)
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Crohn's disease
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Liver cirrhosis and portal hypertension
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Systemic lupus erythematosis
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Known silicone allergy
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Hiatus hernia >5cm
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Other clinical/psychological reason, to be specified
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Active participation in another interventional research study which might interfere with By-Band-Sleeve
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Heart of England NHS Foundation Trust | Birmingham | United Kingdom | ||
| 2 | Royal Bournemouth and Christchurch Hospitals | Bournemouth | United Kingdom | ||
| 3 | North Bristol NHS Trust | Bristol | United Kingdom | ||
| 4 | Royal Derby Hospital | Derby | United Kingdom | ||
| 5 | St James University Hospital, Leeds | Leeds | United Kingdom | ||
| 6 | Homerton University Hospital | London | United Kingdom | ||
| 7 | Imperial College Healthcare NHS Trust | London | United Kingdom | ||
| 8 | Queen Alexandra Hospital | Portsmouth | United Kingdom | ||
| 9 | University Hospital Southampton | Southampton | United Kingdom | ||
| 10 | Sunderland Royal Hospital | Sunderland | United Kingdom | ||
| 11 | Musgrove Park Hospital | Taunton | United Kingdom | ||
| 12 | Royal Cornwall Hospital | Truro | United Kingdom |
Sponsors and Collaborators
- University of Bristol
- University of Oxford
- University of Birmingham
Investigators
- Study Director: Jane Blazeby, BSc,MBChB,MD, University of Bristol
Study Documents (Full-Text)
More Information
Additional Information:
Publications
- Blazeby JM, Byrne J, Welbourn R. What is the most effective operation for adults with severe and complex obesity? BMJ. 2014 Mar 14;348:g1763. doi: 10.1136/bmj.g1763.
- Coulman KD, Hopkins J, Brookes ST, Chalmers K, Main B, Owen-Smith A, Andrews RC, Byrne J, Donovan JL, Mazza G, Reeves BC, Rogers CA, Thompson JL, Welbourn R, Wordsworth S, Blazeby JM; BARIACT working group. A Core Outcome Set for the Benefits and Adverse Events of Bariatric and Metabolic Surgery: The BARIACT Project. PLoS Med. 2016 Nov 29;13(11):e1002187. doi: 10.1371/journal.pmed.1002187. eCollection 2016 Nov.
- Coulman KD, Howes N, Hopkins J, Whale K, Chalmers K, Brookes S, Nicholson A, Savovic J, Ferguson Y, Owen-Smith A, Blazeby J; By-Band-Sleeve Trial Management Group, Blazeby J, Welbourn R, Byrne J, Donovan J, Reeves BC, Wordsworth S, Andrews R, Thompson JL, Mazza G, Rogers CA. A Comparison of Health Professionals' and Patients' Views of the Importance of Outcomes of Bariatric Surgery. Obes Surg. 2016 Nov;26(11):2738-2746.
- Doble B, Welbourn R, Carter N, Byrne J, Rogers CA, Blazeby JM, Wordsworth S; By-Band-Sleeve Trial Management Group. Multi-Centre Micro-Costing of Roux-En-Y Gastric Bypass, Sleeve Gastrectomy and Adjustable Gastric Banding Procedures for the Treatment of Severe, Complex Obesity. Obes Surg. 2019 Feb;29(2):474-484. doi: 10.1007/s11695-018-3553-9.
- Doble B, Wordsworth S, Rogers CA, Welbourn R, Byrne J, Blazeby JM; By-Band-Sleeve Trial Management Group. What Are the Real Procedural Costs of Bariatric Surgery? A Systematic Literature Review of Published Cost Analyses. Obes Surg. 2017 Aug;27(8):2179-2192. doi: 10.1007/s11695-017-2749-8. Review. Erratum in: Obes Surg. 2017 Aug;27(8):2193.
- Donovan JL, Paramasivan S, de Salis I, Toerien M. Clear obstacles and hidden challenges: understanding recruiter perspectives in six pragmatic randomised controlled trials. Trials. 2014 Jan 6;15:5. doi: 10.1186/1745-6215-15-5.
- Fermont JM, Blazeby JM, Rogers CA, Wordsworth S; By-Band-Sleeve Study Management Group. The EQ-5D-5L is a valid approach to measure health related quality of life in patients undergoing bariatric surgery. PLoS One. 2017 Dec 18;12(12):e0189190. doi: 10.1371/journal.pone.0189190. eCollection 2017.
- Hopkins JC, Blazeby JM, Rogers CA, Welbourn R. The use of adjustable gastric bands for management of severe and complex obesity. Br Med Bull. 2016 Jun;118(1):64-72. doi: 10.1093/bmb/ldw012. Epub 2016 Mar 31. Review.
- Hopkins JC, Howes N, Chalmers K, Savovic J, Whale K, Coulman KD, Welbourn R, Whistance RN, Andrews RC, Byrne JP, Mahon D, Blazeby JM; By-Band Trial Management Group. Outcome reporting in bariatric surgery: an in-depth analysis to inform the development of a core outcome set, the BARIACT Study. Obes Rev. 2015 Jan;16(1):88-106. doi: 10.1111/obr.12240. Epub 2014 Nov 30.
- Paramasivan S, Rogers CA, Welbourn R, Byrne JP, Salter N, Mahon D, Noble H, Kelly J, Mazza G, Whybrow P, Andrews RC, Wilson C, Blazeby JM, Donovan JL. Enabling recruitment success in bariatric surgical trials: pilot phase of the By-Band-Sleeve study. Int J Obes (Lond). 2017 Nov;41(11):1654-1661. doi: 10.1038/ijo.2017.153. Epub 2017 Jul 3.
- Rogers CA, Reeves BC, Byrne J, Donovan JL, Mazza G, Paramasivan S, Andrews RC, Wordsworth S, Thompson J, Blazeby JM, Welbourn R; By-Band-Sleeve study investigators. Adaptation of the By-Band randomized clinical trial to By-Band-Sleeve to include a new intervention and maintain relevance of the study to practice. Br J Surg. 2017 Aug;104(9):1207-1214. doi: 10.1002/bjs.10562.
- Rogers CA, Welbourn R, Byrne J, Donovan JL, Reeves BC, Wordsworth S, Andrews R, Thompson JL, Roderick P, Mahon D, Noble H, Kelly J, Mazza G, Pike K, Paramasivan S, Blencowe N, Perkins M, Porter T, Blazeby JM. The By-Band study: gastric bypass or adjustable gastric band surgery to treat morbid obesity: study protocol for a multi-centre randomised controlled trial with an internal pilot phase. Trials. 2014 Feb 11;15:53. doi: 10.1186/1745-6215-15-53.
- Rooshenas L, Elliott D, Wade J, Jepson M, Paramasivan S, Strong S, Wilson C, Beard D, Blazeby JM, Birtle A, Halliday A, Rogers CA, Stein R, Donovan JL; ACST-2 study group; By-Band-Sleeve study group; Chemorad study group; CSAW study group; Optima prelim study group; POUT study group. Conveying Equipoise during Recruitment for Clinical Trials: Qualitative Synthesis of Clinicians' Practices across Six Randomised Controlled Trials. PLoS Med. 2016 Oct 18;13(10):e1002147. doi: 10.1371/journal.pmed.1002147. eCollection 2016 Oct.
- Rooshenas L, Scott LJ, Blazeby JM, Rogers CA, Tilling KM, Husbands S, Conefrey C, Mills N, Stein RC, Metcalfe C, Carr AJ, Beard DJ, Davis T, Paramasivan S, Jepson M, Avery K, Elliott D, Wilson C, Donovan JL; By-Band-Sleeve study group; CSAW study group; HAND-1 study group; Optima prelim study group; Romio feasibility study group. The QuinteT Recruitment Intervention supported five randomized trials to recruit to target: a mixed-methods evaluation. J Clin Epidemiol. 2019 Feb;106:108-120. doi: 10.1016/j.jclinepi.2018.10.004. Epub 2018 Oct 16.
- Welbourn R, le Roux CW, Owen-Smith A, Wordsworth S, Blazeby JM. Why the NHS should do more bariatric surgery; how much should we do? BMJ. 2016 May 11;353:i1472. doi: 10.1136/bmj.i1472.
- ORCA39300