Comparing 150cm OAGB With 150cm Biliopancreatic Limb RYGB. A Non-inferiority Trial
NCT ID: NCT04852198
Last Updated: 2024-04-23
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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RECRUITING
NA
298 participants
INTERVENTIONAL
2021-12-13
2029-11-01
Brief Summary
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Detailed Description
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Objective: to compare two established procedures in order to find the optimal procedure in terms of weight loss and metabolic control that is associated with the fewest side-effects and complications, and decreased invasiveness.
Study design: A multicentre, open label, non-inferiority randomized controlled trial Study population: Patients are eligible for inclusion if their body-mass index (BMI) was 40 kg/m2 or higher, or 35 kg/m2 or higher with the presence of at least one comorbidity (type 2 diabetes, high blood pressure, obstructive sleep apnoea, dyslipidaemia, osteoarthritis of the hip or knee) and a positive evaluation by our bariatric multidisciplinary team (BMDT) and are aged 18-65.
Intervention: Group 1: One Anastomosis Gastric Bypass with 150cm biliopancreatic limb. Group 2: Roux-en-Y gastric bypass with biliopancreatic limb of 150cm and 75cm alimentary limb.
Main study parameters/endpoints:
Primary endpoint:
% Excess BMI loss at two years
Secondary endpoints:
Metabolic status Nutritional status Comorbidity remission QOL Complications or serious adverse events (SAE's)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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OAGB
149 patients receiving one anastomosis gastric bypass (OAGB) with a Biliopancreatic-limb of 150cm
OAGB
Simplified gastric bypass procedure
RYGB
149 patients receiving Roux-en-Y gastric bypass (RYGB) with a Biliopancreatic-limb of 150cm
RYGB
Roux-en-Y gastric bypass. Standard procedure in the Netherlands
Interventions
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OAGB
Simplified gastric bypass procedure
RYGB
Roux-en-Y gastric bypass. Standard procedure in the Netherlands
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* a positive evaluation by our BMDT
Exclusion Criteria
* chronic diarrhoea
* history of previous bariatric or extensive abdominal surgery
18 Years
65 Years
ALL
No
Sponsors
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Flevoziekenhuis
OTHER
Responsible Party
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Principal Investigators
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Stef JM Smeets, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Flevoziekenhuis
Locations
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Flevoziekenhuis
Almere Stad, , Netherlands
OLVG
Amsterdam, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NL74137.018.20
Identifier Type: OTHER
Identifier Source: secondary_id
FZ 20/22
Identifier Type: -
Identifier Source: org_study_id
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