Gastric Bypass, Gastric Band or Sleeve Gastrectomy to Treat Obesity

Obesity Clinical Trial

— ByBandSleeve  

Official title:

Gastric Bypass, Adjustable Gastric Banding or Sleeve Gastrectomy Surgery to Treat Severe and Complex Obesity: a Multi-centre Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02841527
• Other study ID #: ORCA39300
• Status: Completed
• Phase: N/A
• Start date: January 1, 2012
• Est. completion date: March 31, 2023

Study information

• Verified date: May 2023
• Source: University of Bristol
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1351
• Est. completion date: March 31, 2023
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Quality of Life
• Surgery
• Weight Loss

Intervention

Procedure:
• Gastric Band
Surgical intervention in which a band is inserted around the top of the stomach to reduce its size.
• 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.
• 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.

Locations

Country	Name	City	State
United Kingdom	Heart of England NHS Foundation Trust	Birmingham
United Kingdom	Royal Bournemouth and Christchurch Hospitals	Bournemouth
United Kingdom	North Bristol NHS Trust	Bristol
United Kingdom	Royal Derby Hospital	Derby
United Kingdom	St James University Hospital, Leeds	Leeds
United Kingdom	Homerton University Hospital	London
United Kingdom	Imperial College Healthcare NHS Trust	London
United Kingdom	Queen Alexandra Hospital	Portsmouth
United Kingdom	University Hospital Southampton	Southampton
United Kingdom	Sunderland Royal Hospital	Sunderland
United Kingdom	Musgrove Park Hospital	Taunton
United Kingdom	Royal Cornwall Hospital	Truro

Sponsors (3)

Lead Sponsor	Collaborator
University of Bristol	University of Birmingham, University of Oxford

Country where clinical trial is conducted

United Kingdom, 

References & Publications (15)

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. — View 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. — View 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. — View 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. — View 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. Erratum In: Obes Surg. 2017 Aug;27(8):2193. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion achieving loss of greater than 50% of excess weight at 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])	Three years
Primary	Health-related Quality of Life (HRQoL)	HRQoL at three 3 years, will be assessed using the EQ-5D-5L	Three years
Secondary	Change in BMI over time adjusted for BMI at randomisation	Change in BMI over time adjusted for BMI at randomisation	Three years
Secondary	Percentage weight loss at 3 years	Percentage weight loss at 3 years	Three years
Secondary	Waist circumference at 3 years	Waist circumference at 3 years	Three years
Secondary	Time taken from randomisation to reach first loss of at least 50% of excess BMI	Time taken from randomisation to reach first loss of at least 50% of excess BMI	Three years
Secondary	Time taken from first losing 50% excess BMI to first relapse	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)	Three years
Secondary	Generic and symptom specific Health-related Quality of Life (HRQOL)	Impact of Weight on Quality of Life (IWQOL-Lite)	Three years
Secondary	Generic and symptom specific Health-related Quality of Life (HRQOL)	The Gastrointestinal Quality of Life Index	Three years
Secondary	Generic and symptom specific Health-related Quality of Life (HRQOL)	Eating Habits Questionnaire	Three years
Secondary	Generic and symptom specific Health-related Quality of Life (HRQOL)	SF-12v2 Health Survey	Three years
Secondary	Generic and symptom specific Health-related Quality of Life (HRQOL)	Hospital Anxiety and Depression Scale (HADS).	Three years
Secondary	Resource use to three years	Use of health service resources over the three-year study period.	Three years
Secondary	Standard healthcare blood tests	Standard NHS nutritional blood tests will be performed at each assessment.	Three years
Secondary	Dietary recall	Measures of 24 hour recall eating using a standardised and validated interview process	Three years
Secondary	Binge eating behaviour	Binge eating behaviour using a validated questionnaire	Three years
Secondary	Adverse health events	Adverse health events including the need for re-operation and cross over between interventions	Three years
Secondary	Resolution of co-morbidities	Resolution of co-morbidities at 3 years, including sleep apnoea, non alcoholic fatty liver disease, type-2 diabetes, hypertension and hyperlipidaemia.	Three years
Secondary	Time to resolution of co-morbidities	Time to resolution of sleep apnoea, type-2 diabetes, hypertension and hyperlipidaemia	Three years

External Links

•   By-Band-Sleeve study website