[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100438851":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":42,"responsibleParty":146,"collaborators":26,"id":148,"slug":149,"hasResults":150,"nctId":151,"briefTitle":152,"officialTitle":152,"acronym":153,"eligibilityCriteria":154,"healthyVolunteers":150,"sex":155,"minAge":156,"maxAge":26,"enrollmentInfo":157,"targetDuration":26,"studyType":160,"phases":161,"briefSummary":163,"conditions":164,"keywords":166,"overallStatus":45,"whyStopped":26,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":178},{"fullName":5,"class":6},"Centre Hospitalier Departemental Vendee","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Sleeve gastrectomy","ACTIVE_COMPARATOR","realization of a sleeve gastrectomy alone",[13],"Procedure: sleeve gastrectomy",{"label":15,"type":16,"description":17,"interventionNames":18},"sleeve gastrectomy with omentopexy","EXPERIMENTAL","realization of a sleeve gastrectomy followed by an omentopexy",[19],"Procedure: sleeve gastrectomy with omentopexy",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","sleeve gastrectomy","The sleeve gastrectomy is a surgical weight-loss procedure, about 80% of the stomach is removed",[9],null,{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"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",[15],[31],{"name":32,"affiliation":33,"role":34},"Emeric Abet, Dr","CHD Vendée","PRINCIPAL_INVESTIGATOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":40,"email":41},"Agnès Dorion","CONTACT","251446380","+33","agnes.dorion@chd-vendee.fr",[43,58,69,81,93,102,113,125,134],{"facility":44,"status":45,"city":46,"state":26,"zip":26,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"CH de la Cote Basque","RECRUITING","Bayonne","France","FR",{"type":50,"coordinates":51},"Point",[52,53],-1.473,43.49316,{"lat":53,"lon":52},[56],{"name":57,"role":34,"phone":26,"phoneExt":26,"email":26},"Renaud GONTIER, Dr",{"facility":33,"status":45,"city":59,"state":26,"zip":60,"country":47,"countryCode":48,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"La Roche-sur-Yon","85000",{"type":50,"coordinates":62},[63,64],-1.42757,46.66974,{"lat":64,"lon":63},[67],{"name":68,"role":34,"phone":26,"phoneExt":26,"email":26},"Emeric ABET, Dr",{"facility":70,"status":45,"city":71,"state":26,"zip":72,"country":47,"countryCode":48,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"Centre Hospitalier Emile Roux","Le 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d'Orléans","Orléans",{"type":50,"coordinates":106},[107,108],1.90407,47.90248,{"lat":108,"lon":107},[111],{"name":112,"role":34,"phone":26,"phoneExt":26,"email":26},"Adel ABOU-MRAD, Dr",{"facility":114,"status":45,"city":115,"state":26,"zip":116,"country":47,"countryCode":48,"cosmosGeoPoint":117,"geoPoint":121,"contacts":122},"Hopital Pontchaillou","Rennes","35000",{"type":50,"coordinates":118},[119,120],-1.67431,48.11109,{"lat":120,"lon":119},[123],{"name":124,"role":34,"phone":26,"phoneExt":26,"email":26},"Marie LIVIN, Dr",{"facility":126,"status":127,"city":115,"state":26,"zip":26,"country":47,"countryCode":48,"cosmosGeoPoint":128,"geoPoint":130,"contacts":131},"Clinique Mutualiste de la Sagesse","NOT_YET_RECRUITING",{"type":50,"coordinates":129},[119,120],{"lat":120,"lon":119},[132],{"name":133,"role":34,"phone":26,"phoneExt":26,"email":26},"Damien BERGEAT, Dr",{"facility":135,"status":45,"city":136,"state":26,"zip":137,"country":47,"countryCode":48,"cosmosGeoPoint":138,"geoPoint":142,"contacts":143},"Clinique Santé Atlantique","Saint-Herblain","44800",{"type":50,"coordinates":139},[140,141],-1.651,47.21154,{"lat":141,"lon":140},[144],{"name":145,"role":34,"phone":26,"phoneExt":26,"email":26},"Antoine SINA, Dr",{"type":147,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100438851","evaluation-of-omentopexy-on-gastro-oesophageal-reflux-following-sleeve-gastrectomy-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":158,"type":159},526,"ESTIMATED","INTERVENTIONAL",[162],"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)",[165],"Obesity",[23,167,168],"omentopexy","gastro-oesophageal disease","2025-09-18",{"date":171,"type":172},"2025-09-23","ACTUAL",{"date":174,"type":172},"2021-12-07",{"date":176,"type":159},"2028-11-01",{"name":5,"class":6},9]