NCT04812132 RCT Comparing OAGB and Long Limb Roux Gastric Bypass
| NCT ID | NCT04812132 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tartu University Hospital |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2021-01-01 |
| Primary Completion | 2031-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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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 500 participants in total. It began in 2021-01-01 with a primary completion date of 2031-12-31.
⚠ 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
A prospective multicenter randomized controlled trial to compare the outcomes of one-anastomosis gastric bypass to long biliary limb Roux gastric bypass. We plan to enroll up to 500 patients from three different clinics in Estonia. Outcomes are excess weight loss %, impact on type 2 diabetes, hypertension, hyperlipidemia and obstructive sleep apnea. Other outcomes are nutritional deficiencies, occurrence of reflux disease and impact on quality of life. There are planned outpatient visits 1, 5 and 10 years after the surgery to measure the impacts. There are a lot of studies comparing OAGB to standard Roux gastric bypass but non comparing it to long biliary limb gastric bypass.
Eligibility Criteria
Inclusion Criteria: * BMI over 35 and obesity related disease * BMI over 40 * age between 18-60 years * agrees to participate in the study Exclusion Criteria: * age under 18 years or over 60 years * abundant adhesions discovered during the surgery * active upper gastrointestinal ulcer disease * prior bariatric surgery * active symptomatic reflux disease * active psychiatric disease (eg psychosis)
Frequently Asked Questions
Who can join the NCT04812132 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04812132 currently recruiting?
Yes, NCT04812132 is actively recruiting participants. Visit ClinicalTrials.gov or contact Tartu University Hospital to inquire about joining.
Where is the NCT04812132 trial being conducted?
This trial is being conducted at Tartu, Estonia.
Who is sponsoring the NCT04812132 clinical trial?
NCT04812132 is sponsored by Tartu University Hospital. The trial plans to enroll 500 participants.
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