NCT04852198 Comparing 150cm OAGB With 150cm Biliopancreatic Limb RYGB. A Non-inferiority Trial
| NCT ID | NCT04852198 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Flevoziekenhuis |
| Condition | Bariatric Surgery Candidate |
| Study Type | INTERVENTIONAL |
| Enrollment | 298 participants |
| Start Date | 2021-12-13 |
| Primary Completion | 2027-06-13 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 298 participants in total. It began in 2021-12-13 with a primary completion date of 2027-06-13.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to assess the safety and efficiency of OAGB compared to RYGB
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * Presence of H. Pylori, resistant to eradication therapy * chronic diarrhoea * history of previous bariatric or extensive abdominal surgery
Contact & Investigator
Stef JM Smeets, MD PhD
PRINCIPAL INVESTIGATOR
Flevoziekenhuis
Frequently Asked Questions
Who can join the NCT04852198 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Bariatric Surgery Candidate. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04852198 currently recruiting?
Yes, NCT04852198 is actively recruiting participants. Contact the research team at ssmeets@flevoziekenhuis.nl for enrollment information.
Where is the NCT04852198 trial being conducted?
This trial is being conducted at Almere Stad, Netherlands, Amsterdam, Netherlands.
Who is sponsoring the NCT04852198 clinical trial?
NCT04852198 is sponsored by Flevoziekenhuis. The principal investigator is Stef JM Smeets, MD PhD at Flevoziekenhuis. The trial plans to enroll 298 participants.