YOMEGA 5-7yLong-term Efficacy and Safety Evaluation of Omega Loop Bypass vs Roux-en-Y Gastric Bypass in Bariatric Surgery
Collecte de données
Poids Corporel+5
+ Maladies nutritionnelles et métaboliques
+ Obésité
Cohorte
Suivi d'un groupe de personnes dans le temps pour mieux comprendre les causes et l'évolution d'une maladie.Résumé
Date de début de l'étude : 1 avril 2022
Date à laquelle le premier participant a commencé l'étude.The study focuses on evaluating the long-term effectiveness and safety of two surgical procedures for managing morbid obesity: the Omega Loop Bypass and the Roux-en-Y Gastric Bypass. The Roux-en-Y Gastric Bypass has been the gold standard for many years, but the Omega Loop Bypass, a simpler technique, has gained popularity. However, the Omega Loop Bypass is still controversial due to potential risks like biliary reflux and malnutrition. This study aims to provide valuable data to help determine the role of the Omega Loop Bypass in obesity management, especially considering a shorter biliopancreatic loop of 150cm, which may have lower nutritional risks and excellent weight loss results. Participants in this study are patients who have undergone either the Omega Loop Bypass or the Roux-en-Y Gastric Bypass. The primary outcome measured is weight loss, calculated using the Excess BMI Loss percentage (EBL%). This calculation involves subtracting the initial BMI from the BMI at 5 and 7 years after surgery, dividing by the difference between the initial BMI and the ideal BMI (25), and then multiplying by 100. The study also monitors the resolution of obesity-related health conditions and safety outcomes over the long term.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.248 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Cohorte
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.De 18 à 75 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Inclusion Criteria: Patients included in the YOMEGA study, randomized and operated on with the technique assigned to them (121 RYGB and 127 MGB). The main inclusion criteria for the YOMEGA study were: * Aged between 18 and 65 years old * Morbid obesity with BMI ≥ 40 kg/m2 or BMI ≥ 35 kg/m2 associated with one or more co-morbidities (type 2 diabetes, arterial hypertension, sleep apnea, dyslipidemia, arthritis) * Patient who has benefited from an upper GI endoscopy with biopsies * Patient who has benefited from a pluridisciplinary evaluation, with a favorable opinion for a gastric bypass * Patient who understands and accepts the need for a long term follow-up * Patient who agrees to be included in the study and who signs the informed consent form * Patient affiliated to a healthcare insurance plan Exclusion Criteria: Patients randomized in the YOMEGA study, not operated on with the technique assigned to them. Main non-inclusion criteria for the YOMEGA study: * History of esophagitis on upper GI endoscopy (Los Angeles classification) * Severe gastroesophageal reflux disease (GERD), resistant to medical treatment * Presence of dysplastic modifications of the gastric mucosa or a history of gastric cancer, on upper gastrointestinal endoscopy. * Presence of Helicobacter Pylori resistant to medical treatment * Presence of an unhealed gastro-duodenal ulcer or an ulcer diagnosed less than 2 months previously * History of previous bariatric surgery (gastric band, sleeve gastrectomy, vertical banded gastroplasty) * Presence of a severe and evolutive life threatening pathology, unrelated to obesity * Presence of chronic diarrhea (≥3 loose or liquid stools per day, over a period of more than 4 weeks) * Pregnancy or desire to be pregnant during the study * Binge eating disorders or other eating disorders according to DSM V criteria (Diagnostic and Statistical Manual of Mental Disorders) * Mentally unbalanced patients, under supervision or guardianship * Patient who does not understand French/is unable to give consent * Patient not affiliated to a French or European healthcare insurance * Patient who has already been included in a trial which has a conflict of interests with the present study
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Objectifs de l'étude
Objectifs principaux
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 9 sites
Cabinet de chirurgie générale, digestive et de l'obésité - Hôpital Privé Drôme et Ardèche
Guilherand-Granges, FranceOuvrir Cabinet de chirurgie générale, digestive et de l'obésité - Hôpital Privé Drôme et Ardèche dans Google MapsService de Chirurgie Générale et Endocrinienne - Hôpital Claude Huriez - CHU de Lille
Lille, FranceService de Chirurgie Digestive Hôpital Edouard Herriot
Lyon, FranceDépartement de Chirurgie Digestive et Hépatobiliaire - Hôpital Pitié Salpétrière
Paris, France