Comparing two types of gastric bypass for obesity treatment
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.
This study is testing which type of gastric bypass surgery, one-anastomosis or long biliary limb Roux, works better for people with obesity to help them lose weight and improve their health over time.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Tartu University Hospital Academic / other |
| Locations | 1 site (Tartu) |
| Trial ID | NCT04812132 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a prospective multicenter randomized controlled trial designed to compare the outcomes of one-anastomosis gastric bypass (OAGB) with long biliary limb Roux gastric bypass in patients suffering from obesity. The study aims to enroll up to 500 patients across three clinics in Estonia and will evaluate various outcomes including excess weight loss percentage, effects on type 2 diabetes, hypertension, hyperlipidemia, and obstructive sleep apnea. Additionally, it will assess nutritional deficiencies, reflux disease occurrence, and quality of life impacts over a follow-up period of 1, 5, and 10 years post-surgery.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-60 with a BMI over 35 and obesity-related diseases or a BMI over 40.
Not a fit: Patients under 18 or over 60 years old, those with prior bariatric surgery, or those with active gastrointestinal or psychiatric conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into which surgical approach offers better outcomes for patients with obesity and related health conditions.
How similar studies have performed: While many studies have compared OAGB to standard Roux gastric bypass, this study is novel as it specifically compares OAGB to long biliary limb gastric bypass.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Tartu
- Tartu University Hospital — Tartu, Estonia (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.