Clinical trial NCT02841527: Gastric Bypass, Gastric Band or Sleeve Gastrectomy to Treat Obesity
Official title: Gastric Bypass, Adjustable Gastric Banding or Sleeve Gastrectomy Surgery to Treat Severe and Complex Obesity: a Multi-centre Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Surgery
Quality of Life
Weight Loss
Lead sponsor: University of Bristol
Sponsor class: OTHER
Collaborators: name: University of Oxford
name: University of Birmingham
First posted: 2016-07-22
Enrollment: 1351
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: The proportion achieving loss of greater than 50% of excess weight at three years.
timeFrame: Three years
measure: Health-related Quality of Life (HRQoL)
timeFrame: Three years
Secondary outcomes:
measure: Change in BMI over time adjusted for BMI at randomisation
timeFrame: Three years
measure: Percentage weight loss at 3 years
timeFrame: Three years
measure: Waist circumference at 3 years
timeFrame: Three years
measure: Time taken from randomisation to reach first loss of at least 50% of excess BMI
timeFrame: Three years
measure: Time taken from first losing 50% excess BMI to first relapse
timeFrame: Three years
measure: Generic and symptom specific Health-related Quality of Life (HRQOL)
timeFrame: Three years
measure: Generic and symptom specific Health-related Quality of Life (HRQOL)
timeFrame: Three years
measure: Generic and symptom specific Health-related Quality of Life (HRQOL)
timeFrame: Three years
measure: Generic and symptom specific Health-related Quality of Life (HRQOL)
timeFrame: Three years
measure: Generic and symptom specific Health-related Quality of Life (HRQOL)
timeFrame: Three years
measure: Resource use to three years
timeFrame: Three years
measure: Standard healthcare blood tests
timeFrame: Three years
measure: Dietary recall
timeFrame: Three years
measure: Binge eating behaviour
timeFrame: Three years
measure: Adverse health events
timeFrame: Three years
measure: Resolution of co-morbidities
timeFrame: Three years
measure: Time to resolution of co-morbidities
timeFrame: Three years
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Heart of England NHS Foundation Trust
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth and Christchurch Hospitals
city: Bristol
country: United Kingdom
facility: North Bristol NHS Trust
city: Derby
country: United Kingdom
facility: Royal Derby Hospital
city: Leeds
country: United Kingdom
facility: St James University Hospital, Leeds
city: London
country: United Kingdom
facility: Homerton University Hospital
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
city: Portsmouth
country: United Kingdom
facility: Queen Alexandra Hospital
city: Southampton
country: United Kingdom
facility: University Hospital Southampton
city: Sunderland
country: United Kingdom
facility: Sunderland Royal Hospital
city: Taunton
country: United Kingdom
facility: Musgrove Park Hospital
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospital
Study officials:
affiliation: University of Bristol
name: Jane Blazeby, BSc,MBChB,MD
role: STUDY_DIRECTOR
References:
citation: 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. No abstract available.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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. doi: 10.1007/s11695-016-2186-0.
citation: 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.
citation: 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.
citation: 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. No abstract available.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.