NCT04812132Recruiting
RCT Comparing OAGB and Long Limb Roux Gastric Bypass
A Multicentre Randomized Controlled Trial Comparing Outcome of Laparoscopic One-anastomosis Gastric Bypass and Laparoscopic Long Biliopancreatic Limb Roux Gastric Bypass for Treatment of Morbid Obesity.
Source: ClinicalTrials.gov · Last updated 23 Mar 2021 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 500 (estimated)
- First submitted
- 27 Feb 2021
- Start date
- 1 Jan 2021
- Primary completion date
- 31 Dec 2031
- Lead sponsor
- Tartu University Hospital
- Diseases
- Obesity
- NCT number
- NCT04812132
What you commit to
- Study type: Interventional
- Planned participants: 500
- From 1 Jan 2021 to the primary completion date, 31 Dec 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- abundant adhesions discovered during the surgery
- prior bariatric surgery
Other illness
- active upper gastrointestinal ulcer disease
- active symptomatic reflux disease
- active psychiatric disease (eg psychosis)
Age
- age under 18 years or over 60 years
Who the study is looking for
- BMI over 35 and obesity related disease
- BMI over 40
- age between 18-60 years
- agrees to participate in the study
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tartu University Hospital Coordinator of this site? Confirm its status | Tartu | Estonia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.