YOMEGA 5-7yLong-term Efficacy and Safety Evaluation of Omega Loop Bypass vs Roux-en-Y Gastric Bypass in Bariatric Surgery
Data Collection
Body Weight+5
+ Nutrition Disorders
+ Nutritional and Metabolic Diseases
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: April 1, 2022
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.248 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 9 locations
Cabinet de chirurgie générale, digestive et de l'obésité - Hôpital Privé Drôme et Ardèche
Guilherand-Granges, FranceOpen Cabinet de chirurgie générale, digestive et de l'obésité - Hôpital Privé Drôme et Ardèche in 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