Comparing 150cm OAGB With 150cm Biliopancreatic Limb RYGB. A Non-inferiority Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorFlevoziekenhuis
About this trial
The purpose of this study is to assess the safety and efficiency of OAGB compared to RYGB
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Presence of H. Pylori, resistant to eradication therapy
chronic diarrhoea
history of previous bariatric or extensive abdominal surgery
Trial design
Design model
Parallel
Treatments tested in this trial
OAGB
Procedure/SurgerySimplified gastric bypass procedure
RYGB
Procedure/SurgeryRoux-en-Y gastric bypass. Standard procedure in the Netherlands
Treatment groups
298 Participants
are divided into 2 treatment groupsGroup A: OAGBActive comparator 1 intervention
Group B: RYGBActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Percentage excess BMI loss at 2 years (%EBMIL)
Percentage excess BMI loss after 2 years of follow-up
Time frame
2 yearsSponsors and contacts
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Source ClinicalTrials.gov