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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ACTIVE_NOT_RECRUITING
NA
375 participants
INTERVENTIONAL
2021-03-01
2028-03-01
Brief Summary
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Detailed Description
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A prospective randomize controlled trial.
Study population: alle patients undergoing RYGB are eligible for the study. inclusion criteria are BMI 35-40 kg/m2 with one or more obesity related comorbidities, or BMI \> 40 kg/m2 without any comorbidities.
Intervention: Standard RYGB versus an extended pouch RYGB vs a banded-extended RYGB.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Standard RYGB
127 patients undergo a standard Roux-en-Y gastric bypass
Standard RYGB
Roux-en-Y Gastric bypass
Extended Pouch RYGB
127 patients undergo a Roux-en-Y gastric bypass with an extended pouch.
Extended Pouch RYGB
Roux-en-Y gastric bypass with an extended pouch
Banded Extended RYGB
127 patients undergo a Roux-en-Y gastric bypass with a minimizer around the extended pouch.
Banded extended pouch RYGB
Roux-en-Y gastric bypass with a banded extended pouch
Interventions
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Standard RYGB
Roux-en-Y Gastric bypass
Extended Pouch RYGB
Roux-en-Y gastric bypass with an extended pouch
Banded extended pouch RYGB
Roux-en-Y gastric bypass with a banded extended pouch
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients with a language barrier which may affect the compliance with medical advice
* Patients with a disease not related to morbid obesity, such as Cushing or drug related.
* Chronic bowel disease for example Crohn's disease or colitis Colitis.
* Renal impairment (MDRD \<30)
* Hepatic dysfunction (liver function twice the normal values)
* Pregnancy during follow-up
* Patients with treatment-resistant reflux symptoms.
18 Years
65 Years
ALL
No
Sponsors
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Rijnstate Hospital
OTHER
Responsible Party
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Locations
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Rijnstate Hospital
Arnhem, Gelderland, Netherlands
St. Antonius Ziekenhuis
Nieuwegein, Utrecht, Netherlands
NOK West
The Hague, , Netherlands
Countries
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Other Identifiers
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NL62168.091.17
Identifier Type: -
Identifier Source: org_study_id
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