Status:
RECRUITING
Comparing 150cm OAGB With 150cm Biliopancreatic Limb RYGB. A Non-inferiority Trial
Lead Sponsor:
Flevoziekenhuis
Conditions:
Bariatric Surgery Candidate
Obesity
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The purpose of this study is to assess the safety and efficiency of OAGB compared to RYGB
Detailed Description
Rationale: to compare two different types of gastric bypass operations on surgical outcome. Objective: to compare two established procedures in order to find the optimal procedure in terms of weight ...
Eligibility Criteria
Inclusion
- 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
- Presence of H. Pylori, resistant to eradication therapy
- chronic diarrhoea
- history of previous bariatric or extensive abdominal surgery
Key Trial Info
Start Date :
December 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2029
Estimated Enrollment :
298 Patients enrolled
Trial Details
Trial ID
NCT04852198
Start Date
December 13 2021
End Date
November 1 2029
Last Update
April 23 2024
Active Locations (2)
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1
Flevoziekenhuis
Almere Stad, Netherlands, 1315RA
2
OLVG
Amsterdam, Netherlands, 1061AE