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

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Sep 21, 2023

Keywords

ClinConnect Summary

The YOMEGA-2 trial is studying two types of weight loss surgery: the Roux-en-Y Gastric Bypass (RYGB) and a newer method called One Anastomosis Gastric Bypass (OAGB) with a 150 cm loop. Both surgeries are designed to help people with severe obesity (a body mass index, or BMI, of 40 or higher, or 35-40 with related health issues like diabetes or high blood pressure) lose weight and improve their overall health. The goal of the trial is to see if the OAGB can provide similar weight loss results and have the same safety profile as the RYGB after two years.

To join this study, participants need to be between 18 and 65 years old, have a BMI of 35 or higher with related health issues, and agree to long-term follow-up after the surgery. They should also have undergone certain medical evaluations before being considered. Participants will receive either the OAGB or RYGB and will be monitored closely for weight loss and any nutritional issues that may arise. This trial is a great opportunity for those who want to improve their health through surgery and contribute to important research in obesity treatment.

Gender

ALL

Eligibility 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