AzTrials
AzTrials

ObesityByBandSleeveNCT02841527

Gastric Bypass, Gastric Band or Sleeve Gastrectomy to Treat Obesity

A study testing Gastric Band, Gastric Bypass and Sleeve Gastrectomy in people with Obesity and Surgery, run by University of Bristol at 12 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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'). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity, Surgery, Quality of Life
What is being tested?
Gastric Band, Gastric Bypass and Sleeve Gastrectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,351 participants
Where
12 sitesUnited Kingdom
Study dates
1 Jan 2012to 31 Mar 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female patients
  • Over 18 years of age
  • 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
  • Has been or is willing to receive intensive management in a specialist tier 3 obesity service
  • Fit for anaesthesia and surgery
  • Committed to follow-up and able to complete quality of life questionnaires
  • Able to provide written informed consent.

Who cannot join

  • Previous gastric surgery or surgery for severe and complex obesity
  • Previous abdominal surgery or gastro-intestinal (GI) condition that precludes one or more of Band, Bypass or Sleeve
  • Large abdominal ventral hernia
  • Pregnancy (women who have given birth and women planning pregnancy will NOT be excluded)
  • Crohn's disease
  • Liver cirrhosis and portal hypertension
Show all 11Show fewer
  • Systemic lupus erythematosis
  • Known silicone allergy
  • Hiatus hernia >5cm
  • Other clinical/psychological reason, to be specified
  • Active participation in another interventional research study which might interfere with By-Band-Sleeve

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

United Kingdom12 sites

  • Heart of England NHS Foundation Trust

    Birmingham

  • Royal Bournemouth and Christchurch Hospitals

    Bournemouth

  • North Bristol NHS Trust

    Bristol

  • Royal Derby Hospital

    Derby

  • St James University Hospital, Leeds

    Leeds

  • Homerton University Hospital

    London

  • Imperial College Healthcare NHS Trust

    London

  • Queen Alexandra Hospital

    Portsmouth

  • University Hospital Southampton

    Southampton

  • Sunderland Royal Hospital

    Sunderland

  • Musgrove Park Hospital

    Taunton

  • Royal Cornwall Hospital

    Truro

Other trials in United Kingdom

About this study

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

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.

Read the 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.

Being tested
Gastric Band, Gastric Bypass, Sleeve Gastrectomy
Medical subject headings
Obesity, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gastric BandProcedure or surgery

    Surgical intervention in which a band is inserted around the top of the stomach to reduce its size.

  • Gastric BypassProcedure or surgery

    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 GastrectomyProcedure or surgery

    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.

Study groups in NCT02841527
Study groupRoleWhat they receive
Gastric BandActive comparatorThe procedure will involve an operation in which a gastric Band and port will be fitted using a laparoscopic technique.
Receives: Procedure: Gastric Band
Gastric BypassActive comparatorThe 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.
Receives: Procedure: Gastric Bypass
Sleeve GastrectomyActive comparatorThe 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.
Receives: Procedure: Sleeve Gastrectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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])

    Measured: Three years

  2. Health-related Quality of Life (HRQoL)

    HRQoL at three 3 years, will be assessed using the EQ-5D-5L

    Measured: Three years

Secondary outcomes (17)

  1. Change in BMI over time adjusted for BMI at randomisation

    Change in BMI over time adjusted for BMI at randomisation

    Measured: Three years

  2. Percentage weight loss at 3 years

    Percentage weight loss at 3 years

    Measured: Three years

  3. Waist circumference at 3 years

    Waist circumference at 3 years

    Measured: Three years

  4. 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

    Measured: Three years

  5. 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)

    Measured: Three years

  6. Generic and symptom specific Health-related Quality of Life (HRQOL)

    Impact of Weight on Quality of Life (IWQOL-Lite)

    Measured: Three years

  7. Generic and symptom specific Health-related Quality of Life (HRQOL)

    The Gastrointestinal Quality of Life Index

    Measured: Three years

  8. Generic and symptom specific Health-related Quality of Life (HRQOL)

    Eating Habits Questionnaire

    Measured: Three years

  9. Generic and symptom specific Health-related Quality of Life (HRQOL)

    SF-12v2 Health Survey

    Measured: Three years

  10. Generic and symptom specific Health-related Quality of Life (HRQOL)

    Hospital Anxiety and Depression Scale (HADS).

    Measured: Three years

  11. Resource use to three years

    Use of health service resources over the three-year study period.

    Measured: Three years

  12. Standard healthcare blood tests

    Standard NHS nutritional blood tests will be performed at each assessment.

    Measured: Three years

  13. Dietary recall

    Measures of 24 hour recall eating using a standardised and validated interview process

    Measured: Three years

  14. Binge eating behaviour

    Binge eating behaviour using a validated questionnaire

    Measured: Three years

  15. Adverse health events

    Adverse health events including the need for re-operation and cross over between interventions

    Measured: Three years

  16. 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.

    Measured: Three years

  17. Time to resolution of co-morbidities

    Time to resolution of sleep apnoea, type-2 diabetes, hypertension and hyperlipidaemia

    Measured: Three years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2016 (estimated)
  2. Study start1 Jan 2012
  3. Primary completion30 Sep 2022
  4. Study completion31 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,351 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02841527
Sponsor's protocol ID
ORCA39300
Acronym
ByBandSleeve
Status last verified
May 2023
First submitted
8 Apr 2016
Last updated
12 May 2023
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No: All data will be anonymised and analysed in groups. Individual patient data (IPD) will be made available to the research team following analysis.

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. No abstract available.

    PubMed 24633209

  • 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.

    PubMed 24393291

  • 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.

    PubMed 24517309

  • 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.

    PubMed 25442513

  • 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.

    PubMed 27898680

  • 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.

    PubMed 27138600

  • 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.

    PubMed 27034443

  • 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.

    PubMed 27755555

  • 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.

    PubMed 27169605

  • 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.

    PubMed 28550438

  • 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.

    PubMed 29252996

  • 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.

    PubMed 28669987

  • 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.

    PubMed 28703939

  • 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.

    PubMed 30368646

  • 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.

    PubMed 30339938

Questions about this trial

What is this clinical trial studying?

A study testing Gastric Band, Gastric Bypass and Sleeve Gastrectomy in people with Obesity and Surgery, run by University of Bristol at 12 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The proportion achieving loss of greater than 50% of excess weight at three years. (time frame: Three years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02841527, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in