This trial is active, not recruiting.

Condition morbid obesity
Treatments extended pouch rygb, standard rygb
Sponsor Rijnstate Hospital
Start date August 2014
End date October 2017
Trial size 130 participants
Trial identifier NCT02218957, ExtPouch


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
(Active Comparator)
Standard RYGB
standard rygb
Restrictive/extended pouch RYGB
extended pouch rygb

Primary Outcomes

Weight reduction
time frame: 2 years

Secondary Outcomes

Change in comorbidities
time frame: 2 years
Change in comorbidities
time frame: 2 years

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title Restrictive Extended Pouch in Roux-en-Y Gastric Bypass: a Prospective Randomized Control Trial
Principal investigator Jens Homan, MD
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Rijnstate Hospital.