Extending and Banding the Roux-en-Y Gastric Bypass
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 375
- Locations
- 6
- Primary Endpoint
- Percentage Total Body Weight Loss (%TBWL)
Study Overview
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.
Detailed Description
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.
A prospective randomize controlled trial.
Study population: alle patients undergoing RYGB are eligible for the study. inclusion criteria are BMI 35-40 kg/m2 with one or more obesity related comorbidities, or BMI > 40 kg/m2 without any comorbidities.
Intervention: Standard RYGB versus an extended pouch RYGB vs a banded-extended RYGB.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All patients who are eligible for a primary RYGB
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Percentage Total Body Weight Loss (%TBWL)
Time Frame: 3 years
((preoperative weight - current weight) / (preoperative weight)) x 100%. Weight loss measured in kilograms
Secondary Outcomes
- 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)
- Change in comorbidities in patients pre- and postoperative(3 years)