Comparing two types of gastric bypass surgery for obesity treatment
Randomized Controlled Non-inferiority Trial Evaluating the Safety and Efficacy of the Omega Gastric Bypass With 150 cm Biliopancreatic Loop Length Compared to the Roux-en-Y Gastric Bypass
This study is testing whether a new type of gastric bypass surgery works better than the traditional method for helping people with severe obesity and related health issues.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 368 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT06057597 on ClinicalTrials.gov |
What this trial studies
This clinical trial compares the effectiveness of Omega Gastric Bypass (OAGB) to the traditional Roux-en-Y Gastric Bypass (RYGB) in treating morbid obesity and its associated health conditions. The study aims to evaluate weight loss outcomes and improvements in obesity-related co-morbidities such as type 2 diabetes and high blood pressure. Participants will undergo laparoscopic surgery and receive nutritional education and monitoring post-operation. The trial is conducted in France, where bariatric surgery is a common intervention for obesity.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with morbid obesity (BMI ≥ 40 kg/m²) or severe obesity (BMI 35-40 kg/m²) with related health conditions.
Not a fit: Patients with a history of previous bariatric surgery or chronic inflammatory bowel disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide patients with a more effective surgical option for significant weight loss and improvement in obesity-related health issues.
How similar studies have performed: Other studies have shown promising results with various bariatric surgery techniques, indicating that this approach may lead to significant advancements in obesity treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient aged from 18 to 65 years old * Type III obesity (BMI ≥ 40 kg/m²), or Type II obesity BMI 35-40 kg/m2 associated with at least one co-morbidity which will be improved by surgery (high blood pressure, type 2 diabetes mellitus, obstructive sleep apnea, dyslipidemia, arthrosis) * Patient who had benefited from an Upper GI Endoscopy with biopsies to look for Helicobacter pylori within 12 months before surgery * Patient who has benefited from a multidisciplinary evaluation at least 6 months, with a favorable opinion for a gastric bypass * Patient who understood and accepted the need for a long-term follow-up * Patient who agreed to be included in the study and who signed the informed consent form * Patient affiliated to a social security scheme * For child-bearing aged women, efficient contraception Exclusion Criteria: * History of previous bariatric surgery * History of chronic inflammatory bowel disease * Presence of chronic diarrhea * Presence of a severe and evolutive life threatening pathology * Presence of dysplastic modifications of the gastric mucosa, chronic atrophic gastritis or history of gastric cancer * Presence of an unhealed gastro-duodenal ulcer * Presence of Helicobacter pylori resistant to medical treatment * Presence of esophagitis * Pregnancy or desire to be pregnant during the study * Mentally unbalanced patients, under supervision or guardianship * Patients who don't understand French and not able to give consent * Patient included and followed in another interventional trial * Unable to consent, under tutelage or curatorship, or judiciary safeguard * Presence of type 1 diabetes
Where this trial is running
Paris
- Hôpital Bichat Claude-Bernard — Paris, France (Recruiting)
Study contacts
- Principal investigator: Tigran POGHOSYAN, MD-PhD — Bichat (APHP)
- Study coordinator: Tigran POGHOSYAN, MD-PhD
- Email: tigran.poghosyan@aphp.fr
- Phone: 33 1 40 25 82 39
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.