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Omega Gastric Bypass (150cm) Compared to the Roux-en-Y Gastric Bypass (YOMEGA-2 Multicentric Trial)

RecruitingNAAges 18 Years - 65 YearsAllAssistance Publique - Hôpitaux de Paris
NCT06057597 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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, combined with nutritional education and close monitoring, has been shown to be the most effective treatment for patients with morbid obesity resulting in significant and lasting weight loss and improvements in co-morbidities . With nearly 50000 procedures per year France ranks third in the world in terms of care for patients suffering from morbid (BMI ≥ 40 kg/m²) and severe (BMI 35-40 kg/m²) obesity. In parallel with the significant increase in the number of patients operated on for obesity in the world, over the past two decades, significant development has been observed in the field of bariatric surgery with a decrease or even disappearance of some procedures and the appearance of others

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📋 Eligibility rules (as published)
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
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What it tests

  • Laparoscopic OAGB
  • Laparoscopic RYGB
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Where

1 site
Hôpital Bichat Claude-Bernard
Paris, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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