Extended Pouch Roux-en-Y Gastric Bypass Study

Rijnstate Hospital

Status: Completed

Conditions: Morbid Obesity

Treatments: Procedure: Standard RYGB; Procedure: Extended Pouch RYGB

Study type: Interventional

Funder types: Other

Identifiers

NCT02218957

ExtPouch

Details and patient eligibility

About

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.

Enrollment: 130 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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130 participants in 2 patient groups

Standard RYGB

Active Comparator group

Description:

Standard RYGB

Treatment:

Procedure: Standard RYGB

Extended Pouch RYGB

Experimental group

Description:

Restrictive/extended pouch RYGB

Treatment:

Procedure: Extended Pouch RYGB