Extending and Banding the Roux-en-Y Gastric Bypass
UPGRADE
1 other identifier
interventional
375
1 country
3
Brief Summary
The Roux-en-Y gastric bypass (RYGB) has proven to be an effective treatment for morbid obesity by reducing weight and comorbidities. Extending the pouch may improve weightloss without the increase of complications. Some patients regain weight after initially good weightloss. Placing a minimizer around the pouch may prevent weight regain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2021
Longer than P75 for not_applicable
3 active sites
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
March 1, 2021
CompletedFirst Submitted
Initial submission to the registry
May 25, 2021
CompletedFirst Posted
Study publicly available on registry
May 3, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2028
ExpectedJune 21, 2024
June 1, 2024
2.3 years
May 25, 2021
June 19, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage Total Body Weight Loss (%TBWL)
((preoperative weight - current weight) / (preoperative weight)) x 100%. Weight loss measured in kilograms
3 years
Secondary Outcomes (6)
Percentage Excess Weight Loss (%EWL)
3 years
BODY-Q: Quality of life after bariatric surgery
3 years
BAROS: Quality of life after bariatric surgery
3 years
SF-36: Quality of life after bariatric surgery
3 years
Gastroesophageal reflux disease
3 years
- +1 more secondary outcomes
Study Arms (3)
Standard RYGB
ACTIVE COMPARATOR127 patients undergo a standard Roux-en-Y gastric bypass
Extended Pouch RYGB
EXPERIMENTAL127 patients undergo a Roux-en-Y gastric bypass with an extended pouch.
Banded Extended RYGB
EXPERIMENTAL127 patients undergo a Roux-en-Y gastric bypass with a minimizer around the extended pouch.
Interventions
Roux-en-Y gastric bypass with an extended pouch
Roux-en-Y gastric bypass with a banded extended pouch
Eligibility Criteria
You may qualify if:
- All patients who are eligible for a primary RYGB
You may not qualify if:
- Bariatric surgery in medical history
- Patients with a language barrier which may affect the compliance with 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)
- Hepatic dysfunction (liver function twice the normal values)
- Pregnancy during follow-up
- Patients with treatment-resistant reflux symptoms.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Rijnstate Hospital
Arnhem, Gelderland, 6815AD, Netherlands
St. Antonius Ziekenhuis
Nieuwegein, Utrecht, 3435CM, Netherlands
NOK West
The Hague, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 25, 2021
First Posted
May 3, 2022
Study Start
March 1, 2021
Primary Completion
June 1, 2023
Study Completion (Estimated)
March 1, 2028
Last Updated
June 21, 2024
Record last verified: 2024-06