RecruitingNot ApplicableNCT04852198
Comparing 150cm OAGB With 150cm Biliopancreatic Limb RYGB. A Non-inferiority Trial
A Study on Safety and Efficacy Comparing 150cm One Anastomosis Gastric Bypass With 150cm Biliopancreatic Limb Roux-en-Y Gastric Bypass (Roux-en-WHY?): An Open Label, Multicentre Non-inferiority Randomized Controlled Trial
Sponsor
Flevoziekenhuis
Enrollment
298 participants
Start Date
Dec 13, 2021
Study Type
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to assess the safety and efficiency of OAGB compared to RYGB
Eligibility
Min Age: 18 YearsMax Age: 65 Years
Inclusion Criteria2
- body-mass index (BMI) of 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)
- a positive evaluation by our BMDT
Exclusion Criteria3
- Presence of H. Pylori, resistant to eradication therapy
- chronic diarrhoea
- history of previous bariatric or extensive abdominal surgery
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Interventions
PROCEDUREOAGB
Simplified gastric bypass procedure
PROCEDURERYGB
Roux-en-Y gastric bypass. Standard procedure in the Netherlands
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04852198
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