Banded Versus Non-banded Roux-en-y Gastric Bypass
Bandolera
1 other identifier
interventional
130
1 country
1
Brief Summary
A Roux-en-Y Gastric Bypass (RYGB) is on the long term not always successful in every patient because weight regain can occur. An intervention to prevent weight regain in the future is to place a silicone band (non-adjustable) around the pouch of the RYGB (Banded-RYGB: BRYGB) which increases weight loss and decreases weight regain on the longer term. The question is whether primary application of a banded bypass gives a greater weight loss and / or prevent weight regain in the future versus a standard RYGB.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 3, 2015
CompletedFirst Posted
Study publicly available on registry
September 10, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2023
CompletedJune 21, 2024
June 1, 2024
3.8 years
September 3, 2015
June 18, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage total body weight loss (%TBWL)
weight loss is measured in kilogram.
3 years
Secondary Outcomes (6)
Percentage excess weight loss (%EWL)
3 years
percentage total body weight regain (%TBWR)
3 years
Decrease in type 2 diabetes mellitus
3 years
Quality of life
3 years
Decrease in dyslipidaemia
3 years
- +1 more secondary outcomes
Study Arms (2)
Standard RYGB
NO INTERVENTION65 patients undergo a standard Roux-en-Y gastric bypass
Banded RYGB
ACTIVE COMPARATOR65 patients undergo a banded RYGB (BRYGB)
Interventions
Eligibility Criteria
You may qualify if:
- all patients who are eligible for a primary RYGB
You may not qualify if:
- Bariatric surgery in history
- Patients with a language barrier which may affect the compliance with medical advice
- Any kind of genetic disorders which can be of influence on the monitoring of medical advice
- Patients with a disease not related to morbid obesity, such as Cushing or drug related.
- Chronic bowel disease for example Crohn's disease or colitis Colitis.
- Renal impairment (MDRD \<30) or hepatic dysfunction (liver function twice the normal values)
- Pregnancy
- Patients with treatment-resistant reflux symptoms. Defined as reflux persistent symptoms despite the use of a minimum dose of proton-pump inhibitors
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rijnstate Hospital
Arnhem, 6800WC, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 3, 2015
First Posted
September 10, 2015
Study Start
August 1, 2015
Primary Completion
May 1, 2019
Study Completion
May 1, 2023
Last Updated
June 21, 2024
Record last verified: 2024-06