Gastric Bypass Gastric Band or Sleeve Gastrectomy to Treat Obesity

  • STATUS
    Recruiting
  • End date
    Mar 31, 2023
  • participants needed
    1341
  • sponsor
    University of Bristol
Updated on 21 October 2021
diabetes
anesthesia
gastrectomy
hypertension
type 2 diabetes mellitus
bariatric surgery
gastric bypass
gastric banding
sleeve gastrectomy

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.

Details
Condition Obesity, Weight Loss, surgeries, surgical procedure, Surgical aspects, surgical procedures, Surgery, adiposity, surgical treatment, quality-of-life, Quality of life
Treatment Gastric bypass, sleeve gastrectomy, Gastric Band
Clinical Study IdentifierNCT02841527
SponsorUniversity of Bristol
Last Modified on21 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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
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