Extended Pouch Roux-en-Y Gastric Bypass Study

Not Applicable

Completed

• Conditions: Morbid Obesity
• Interventions: Procedure: Standard RYGB; Procedure: Extended Pouch RYGB

• Registration Number: NCT02218957
• Lead Sponsor: Rijnstate Hospital

Brief Summary

Morbid obesity is an increasing medical problem in the western countries. It's related to comorbidities as diabetes mellitus, hypertension, OSAS, arthrosis and hypercholesterolemia. The Roux-en-Y Gastric Bypass (RYGB) is an effective surgical therapy for morbidly obese patients. A part of these patients will have disappointing results, and have weight regain on the long term. Some studies show more weight reduction by increasing the biliopancreatic limb in patients with morbid obesity.

The objective of this study is to investigate the effect of a restrictive/extended pouch on weight reduction in morbidly obese patients undergoing RYGB-surgery. We hypothesize that the restrictive/extended pouch results in more weight reduction.

The study design is a prospective, randomized control trial. The patients will be randomized in 2 groups: a standard RYGB (normal pouch) and restrictive/extended pouch RYGB.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-08-13
• Study First Submitted QC: 2014-08-14
• Study First Posted: 2014-08-18
• Primary Completion: 2015-07
• Study Completion: 2018-07
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-17
• Last Update Posted: 2024-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

Patient eligible for bariatric surgery according Fried guidelines

Primary Gastric bypass

• BMI 35 - 40 with a comorbidity
• or BMI > 40

Exclusion Criteria

• Exclusion criteria for bariatric surgery (Fried Guidelines)
• Patients with language problems that interveins to follow medical advises
• Genetic diseases that intervens to follow medical advises
• Chronic bowel diseases
• Nephrologic (MDRD <30) of liver diseases (AST/ALT more than twice the norm)
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard RYGB	Standard RYGB	Standard RYGB
Extended Pouch RYGB	Extended Pouch RYGB	Restrictive/extended pouch RYGB

Primary Outcome Measures

Name	Time	Method
Weight reduction	2 years	Excess weight loss (%EWL)

Secondary Outcome Measures

Name	Time	Method
Change in comorbidities	2 years	Preoperatively the number of patients with comorbidities will be calculated. At two year follow-up this will be calculated again. Patients will be divided in groups: 1. comorbidity resolved; 2. comorbidity improved; 3. comorbidity unchanged; 4. comorbidity worsened; This will be done for diabetes mellitus, hypertension, dislipidemia and OSAS.

Trial Locations

Locations (1)

Rijnstate Hospital; 🇳🇱 Arnhem, Gelderland, Netherlands