Comparing two types of gastric bypass surgery for obesity treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.