Informations générales (source: ClinicalTrials.gov)
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 (YOMEGA-2)
Interventional
N/A
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
novembre 2023
décembre 2027
29 juin 2024
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.
Performed for more than 40 years, the Roux-en-Y Gastric Bypass (RYGB) is a restrictive
and malabsorptive procedure and currently is considered as gold standard procedure for
the treatment of morbid obesity and its comorbidities. However, despite the good
effectiveness (with an average Excess Weight Loss % (EWL%) of approximatively 70% at 2
years), RYGB is technically demanding procedure with learning curve requiring more than
100 cases and an overall complication rate ranging from 10% to 20% Introduced in 2001,
one anastomosis gastric bypass (OAGB) is a modified gastric bypass that consists of a
single gastrojejunal anastomosis between a long gastric pouch and a jejunal
(biliopancreatic) omega loop. In Sept. 2019, taking into account the results from YOMEGA
trial, the French High Authority for Health (Haute Autorité de Santé (HAS)) recommended
to ban OAGB with 200 cm or longer BPL and urged to assess the efficacy and safety of OAGB
with 150 cm BPL in a randomized controlled trial. Indeed, YOMEGA-2 trial is logical
continuity of the YOMEGA trial.
The aim of this study is to assess weight loss efficiency and the nutritional safety of
the OAGB-150 in comparison to a standard (RYGB).
The hypothesis of this study is that the OAGB with a 150 cm BPL could have the same
efficacy on weight loss and nutritional complication rate in comparison to the RYGB at 2
years.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Avicenne | POGHOSYAN Tigran | 12/04/2024 09:28:07 | Contacter | ||
| AP-HP - Hôpital Bichat | POGHOSYAN Tigran | 12/04/2024 09:28:07 | Contacter | ||
| AP-HP - Hôpital Europeen Georges Pompidou | POGHOSYAN Tigran | 12/04/2024 09:28:07 | Contacter | ||
| AP-HP - Hôpital La Pitié-Salpêtrière | POGHOSYAN Tigran | 12/04/2024 09:28:07 | Contacter | ||
| AP-HP - Hôpital Louis Mourier | POGHOSYAN Tigran | 12/04/2024 09:28:07 | Contacter | ||
| HOPITAL NOVO | TRELLES | 04/07/2024 11:05:07 | Contacter | ||
Critères
Tous
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
- 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
- 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