[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100438851":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":13,"studyPopulation":13,"armGroups":22,"interventions":35,"overallOfficials":44,"centralContacts":49,"locations":56,"responsibleParty":160,"collaborators":13,"id":162,"slug":13,"hasResults":163,"nctId":164,"briefTitle":165,"officialTitle":165,"acronym":166,"eligibilityCriteria":167,"healthyVolunteers":163,"sex":168,"minAge":169,"maxAge":13,"enrollmentInfo":170,"targetDuration":13,"studyType":173,"phases":174,"briefSummary":176,"conditions":177,"keywords":179,"overallStatus":59,"whyStopped":13,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":191},{"fullName":5,"class":6},"Centre Hospitalier Departemental Vendee","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Evaluate de novo GERD of patient benefited from sleeve gastrectomy with omentopexy versus sleeve gastrectomy alone","Presence of de novo GERD defined by a clinical score of CARLSSON \\>= 4 and\u002For the use of a PPIs treatment","2 years postoperatively",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":19,"maskingDescription":13,"whoMasked":20},"SINGLE",[21],"PARTICIPANT",[23,29],{"label":24,"type":25,"description":26,"interventionNames":27},"Sleeve gastrectomy","ACTIVE_COMPARATOR","realization of a sleeve gastrectomy alone",[28],"Procedure: sleeve gastrectomy",{"label":30,"type":31,"description":32,"interventionNames":33},"sleeve gastrectomy with omentopexy","EXPERIMENTAL","realization of a sleeve gastrectomy followed by an omentopexy",[34],"Procedure: sleeve gastrectomy with omentopexy",[36,41],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":13},"PROCEDURE","sleeve gastrectomy","The sleeve gastrectomy is a surgical weight-loss procedure, about 80% of the stomach is removed",[24],{"type":37,"name":30,"description":42,"armGroupLabels":43,"otherNames":13},"After sleeve gastrectomy procedure, the omentopexy involves suturing the omentum back to the greater curvature of the stomach in several locations, depending on the length of the greater curvature",[30],[45],{"name":46,"affiliation":47,"role":48},"Emeric Abet, Dr","CHD Vendée","PRINCIPAL_INVESTIGATOR",[50],{"name":51,"role":52,"phone":53,"phoneExt":54,"email":55},"Agnès Dorion","CONTACT","251446380","+33","agnes.dorion@chd-vendee.fr",[57,72,83,95,107,116,127,139,148],{"facility":58,"status":59,"city":60,"state":13,"zip":13,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"CH de la Cote Basque","RECRUITING","Bayonne","France","FR",{"type":64,"coordinates":65},"Point",[66,67],-1.473,43.49316,{"lat":67,"lon":66},[70],{"name":71,"role":48,"phone":13,"phoneExt":13,"email":13},"Renaud GONTIER, Dr",{"facility":47,"status":59,"city":73,"state":13,"zip":74,"country":61,"countryCode":62,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"La Roche-sur-Yon","85000",{"type":64,"coordinates":76},[77,78],-1.42757,46.66974,{"lat":78,"lon":77},[81],{"name":82,"role":48,"phone":13,"phoneExt":13,"email":13},"Emeric ABET, Dr",{"facility":84,"status":59,"city":85,"state":13,"zip":86,"country":61,"countryCode":62,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Centre Hospitalier Emile Roux","Le Puy-en-Velay","43012",{"type":64,"coordinates":88},[89,90],3.88523,45.04366,{"lat":90,"lon":89},[93],{"name":94,"role":48,"phone":13,"phoneExt":13,"email":13},"Luis Matias BRUNA",{"facility":96,"status":59,"city":97,"state":13,"zip":98,"country":61,"countryCode":62,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"CHU Nantes","Nantes","44000",{"type":64,"coordinates":100},[101,102],-1.55336,47.21725,{"lat":102,"lon":101},[105],{"name":106,"role":48,"phone":13,"phoneExt":13,"email":13},"Claire BLANCHARD, Dr",{"facility":108,"status":59,"city":97,"state":13,"zip":109,"country":61,"countryCode":62,"cosmosGeoPoint":110,"geoPoint":112,"contacts":113},"Clinique Jules Verne","44300",{"type":64,"coordinates":111},[101,102],{"lat":102,"lon":101},[114],{"name":115,"role":48,"phone":13,"phoneExt":13,"email":13},"Laurent POTIRON",{"facility":117,"status":59,"city":118,"state":13,"zip":13,"country":61,"countryCode":62,"cosmosGeoPoint":119,"geoPoint":123,"contacts":124},"Centre Hospitalier Régional et Universitaire d'Orléans","Orléans",{"type":64,"coordinates":120},[121,122],1.90407,47.90248,{"lat":122,"lon":121},[125],{"name":126,"role":48,"phone":13,"phoneExt":13,"email":13},"Adel ABOU-MRAD, Dr",{"facility":128,"status":59,"city":129,"state":13,"zip":130,"country":61,"countryCode":62,"cosmosGeoPoint":131,"geoPoint":135,"contacts":136},"Hopital Pontchaillou","Rennes","35000",{"type":64,"coordinates":132},[133,134],-1.67431,48.11109,{"lat":134,"lon":133},[137],{"name":138,"role":48,"phone":13,"phoneExt":13,"email":13},"Marie LIVIN, Dr",{"facility":140,"status":141,"city":129,"state":13,"zip":13,"country":61,"countryCode":62,"cosmosGeoPoint":142,"geoPoint":144,"contacts":145},"Clinique Mutualiste de la Sagesse","NOT_YET_RECRUITING",{"type":64,"coordinates":143},[133,134],{"lat":134,"lon":133},[146],{"name":147,"role":48,"phone":13,"phoneExt":13,"email":13},"Damien BERGEAT, Dr",{"facility":149,"status":59,"city":150,"state":13,"zip":151,"country":61,"countryCode":62,"cosmosGeoPoint":152,"geoPoint":156,"contacts":157},"Clinique Santé Atlantique","Saint-Herblain","44800",{"type":64,"coordinates":153},[154,155],-1.651,47.21154,{"lat":155,"lon":154},[158],{"name":159,"role":48,"phone":13,"phoneExt":13,"email":13},"Antoine SINA, Dr",{"type":161,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","100438851",false,"NCT04994665","Evaluation of Omentopexy on Gastro-oesophageal Reflux Following Sleeve Gastrectomy","Sleevepexie","Inclusion Criteria:\n\n* Patient ≥ 18 years old,\n* Patient to be operated in first intention of a sleeve gastrectomy\n* Initial BMI between 35Kg\u002Fm² and 40 Kg\u002Fm² associated with at least one severe comorbidity likely to be improved after surgery according to HAS recommendations.\n\nOR initial BMI ≥ 40 Kg\u002Fm².\n\n* Multidisciplinary follow-up of at least 6 months before surgery\n* Validation of the surgical intervention in a multidisciplinary consultation meeting\n* Certificate of no contraindication by a psychiatrist\n* Patient who has the capacity to understand the protocol and has given consent to participate in the research,\n* Patient with social security coverage.\n\nExclusion Criteria:\n\n* Eating disorder or mental disorder\n* Misunderstanding of the protocol\n* Psychiatric contraindication\n* Initial BMI \\\u003C35Kg\u002Fm².\n* Initial BMI between 35Kg\u002Fm² and 40 Kg\u002Fm² without comorbidities.\n* Esophagitis of grade B and above on the Oeso-Gastro-Duodenal Fibroscopy\n* CARLSSON score (score ≥ 4) preoperatively\n* Presence of a Proton-Pump Inhibitors treatment\n* Patient to have a 2-stage surgery (first sleeve gastrectomy then gastric bypass or Single Anastomosis Duodeno-Ileal bypass)\n* Patient participating in another interventional clinical research protocol involving a drug or medical device\n* Patient who are pregnant, breastfeeding, or who have the potential to become pregnant without effective contraception at the time of inclusion and up to 24 months after surgery\n* Patient under guardianship, curators or legal protection,P","ALL","18 Years",{"count":171,"type":172},526,"ESTIMATED","INTERVENTIONAL",[175],"NA","The aim of the study is to assess impact of omentopexy on de novo gastro-oesophageal reflux disease (GERD) after sleeve gastrectomy.\n\nThis will be assess 2 years postoperatively. This study is a prospective, multicentric, randomized trial. Five hundred twenty six patients should be included with 263 in each arm. First arm will include patients who have a sleeve gastrectomy. The second arm will include patients who have sleeve gastrectomy with omentopexy.\n\nTwo years after surgery , it will be collected a CARLSSON score and BAROS score (quality of life).\n\nThe main objective is to show that omentopexy decreases the rate of de novo GERD after sleeve gastrectomy at 2 years postoperatively without the use of Proton-Pump Inhibitors (PPIs)",[178],"Obesity",[38,180,181],"omentopexy","gastro-oesophageal disease","2025-09-18",{"date":184,"type":185},"2025-09-23","ACTUAL",{"date":187,"type":185},"2021-12-07",{"date":189,"type":172},"2028-11-01",{"name":5,"class":6},9]