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
2015-08-31
2023-05-31
Brief Summary
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Detailed Description
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The Study design is a prospective, randomized, single center study.
Study population: patients who qualify for a RYGB are eligible to participate. The primary RYGB patients may participate if there is a BMI of 35 kg / m2 with a morbidly obesity-related comorbidity or a BMI of 40kg / m2 or higher.
Intervention: The standard RYGB with a vertical pouch over a 40 french feeding tube with a volume of 30-50 ml, is compared with a banded-RYGB (BRYGB)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard RYGB
65 patients undergo a standard Roux-en-Y gastric bypass
No interventions assigned to this group
Banded RYGB
65 patients undergo a banded RYGB (BRYGB)
BRYGB
65 patients undergo a banded RYGB
Interventions
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BRYGB
65 patients undergo a banded RYGB
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
* Any kind of genetic disorders which can be of influence on the monitoring of 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) or hepatic dysfunction (liver function twice the normal values)
* Pregnancy
* Patients with treatment-resistant reflux symptoms. Defined as reflux persistent symptoms despite the use of a minimum dose of proton-pump inhibitors
18 Years
60 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, , Netherlands
Countries
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Other Identifiers
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2015-0624
Identifier Type: -
Identifier Source: org_study_id
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