Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
130 participants
INTERVENTIONAL
2014-07-31
2018-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Standard RYGB
Standard RYGB
Standard RYGB
Extended Pouch RYGB
Restrictive/extended pouch RYGB
Extended Pouch RYGB
Interventions
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Extended Pouch RYGB
Standard RYGB
Eligibility Criteria
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Inclusion Criteria
Primary Gastric bypass
* BMI 35 - 40 with a comorbidity
* or BMI \> 40
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Rijnstate Hospital
OTHER
Responsible Party
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Principal Investigators
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Jens Homan, MD
Role: PRINCIPAL_INVESTIGATOR
Rijnstate Hospital Arnhem
Locations
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Rijnstate Hospital
Arnhem, Gelderland, Netherlands
Countries
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Other Identifiers
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ExtPouch
Identifier Type: -
Identifier Source: org_study_id
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