Gastric bypass, adjustable gastric banding or sleeve gastrectomy surgery to treat severe and complex obesity

Not Applicable

Completed

• Conditions: Obesity; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN00786323
• Lead Sponsor: niversity of Bristol (UK)

Brief Summary

2014 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/24393291 recruiter perspectives 2014 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/24517309 protocol 2014 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/24633209 most effective operation for adults with severe and complex obesity: 2015 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/25442513 development of a core outcome set 2015 Results article in http://www.ncbi.nlm.nih.gov/pubmed/26710760 qualitative case study results from By-Band 2016 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/27169605 NHS access to bariatric surgery 2016 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/27034443 use of adjustable gastric bands for management of severe and complex obesity: 2016 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/27755555 conveying equipoise during recruitment: 2016 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/27138600 health professionals' and patients' views of the importance of outcomes 2016 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/27898680 core outcome set 2017 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/28703939 adaptation of By-Band randomized clinical trial 2017 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/28550438 costs of bariatric surgery 2017 Results article in http://www.ncbi.nlm.nih.gov/pubmed/28703939 By-Band pilot study results and explanation of By-Band-Sleeve design 2017 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/28669987 enabling recruitment success 2017 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/29252996 EQ-5D-5L to measure health-related quality of life: 2019 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/30339938 QuinteT Recruitment Intervention 2019 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/30368646 micro-costing of procedures 2024 Other publications in https://pubmed.ncbi.nlm.nih.gov/38171620/ prevalence, and severity, of anxiety and depressive symptoms (added 08/01/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-05
• Study Completion: 2022-09-30
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1351

Inclusion Criteria

Current inclusion criteria as of 23/09/2015:
Participants may enter study if ALL of the following apply:
1. Male or female patients
2. Over 18 years of age
3. Referred for bariatric surgery according to 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

Previous inclusion criteria:
The participant may enter study if ALL of the following apply:
1. Male or female patients
2. Over 18 years of age
3. Referred for bariatric surgery according to NICE guidelines - BMI of 40kg/m2 or more, OR BMI of 35 kg/m2 to 40 kg/m2 and other co-morbidities (e.g. type 2 diabetes), that could improve with weight loss
4. Willing to receive intensive management in a specialist 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

Current exclusion criteria as of 23/09/2015:
Participants may not enter study if ANY of the following apply (assessed by patient history and clinical examination)
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

Previous exclusion criteria:
The participant may not enter study if ANY of the following apply:
1. A history of previous gastric surgery or surgery for morbid obesity
2. Large abdominal ventral hernia
3. Hiatus hernia more than 5 cm
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. Surgeon unwilling to for patient to be randomised (reason to be specified)

Study & Design

• Study Type: Interventional
• Study Design: Not specified