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
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The purpose of this study is to assess the safety and efficiency of OAGB compared to RYGB
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Netherlands
Flevoziekenhuis
RECRUITING
Almere Stad
OLVG
NOT_YET_RECRUITING
Amsterdam
Contact Information
Primary
Stef JM Smeets, MD PhD
ssmeets@flevoziekenhuis.nl
0031368688888
Backup
Floris Bruinsma, Student
fbruinsma@flevoziekenhuis.nl
0031368688888
Time Frame
Start Date: 2021-12-13
Estimated Completion Date: 2029-11-01
Participants
Target number of participants: 298
Treatments
Active_comparator: OAGB
149 patients receiving one anastomosis gastric bypass (OAGB) with a Biliopancreatic-limb of 150cm
Active_comparator: RYGB
149 patients receiving Roux-en-Y gastric bypass (RYGB) with a Biliopancreatic-limb of 150cm
Authors
Related Therapeutic Areas
Sponsors
Leads: Flevoziekenhuis