Status:
RECRUITING
Omega Gastric Bypass (150cm) Compared to the Roux-en-Y Gastric Bypass (YOMEGA-2 Multicentric Trial)
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Obesity
Morbid
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Obesity with its consequences such as type 2 diabetes, high blood pressure, dyslipidemia, fatty liver disease, sleep apnea and cancers, remains a major healthcare problem worldwide. Bariatric surgery,...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
368 Patients enrolled
Trial Details
Trial ID
NCT06057597
Start Date
November 13 2023
End Date
December 1 2028
Last Update
November 24 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hôpital Bichat Claude-Bernard
Paris, France