Extended Pouch Roux-en-Y Gastric Bypass Study

• Register: ClinicalTrials.gov
• Last refreshed on: 13 June 2016
• Main ID: NCT02218957
• Date of registration: 13/08/2014
• Prospective Registration: No
• Primary sponsor: Rijnstate Hospital
• Public title: Extended Pouch Roux-en-Y Gastric Bypass Study
• Scientific title: Restrictive Extended Pouch in Roux-en-Y Gastric Bypass: a Prospective Randomized Control Trial
• Date of first enrolment: August 2014
• Target sample size: 130
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02218957
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Netherlands

Contacts

• Name: Jens Homan, MD
• Affiliation: Rijnstate Hospital Arnhem

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Morbid Obesity

Intervention(s)

Procedure: Extended Pouch RYGB

Procedure: Standard RYGB

Primary Outcome(s)

Weight reduction [Time Frame: 2 years]

Secondary Outcome(s)

Change in comorbidities [Time Frame: 2 years]

Secondary ID(s)

ExtPouch

Source(s) of Monetary Support

Please refer to primary and secondary sponsors