[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100352985":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":11,"locations":29,"responsibleParty":193,"collaborators":11,"id":195,"slug":196,"hasResults":197,"nctId":198,"briefTitle":199,"officialTitle":199,"acronym":200,"eligibilityCriteria":201,"healthyVolunteers":197,"sex":202,"minAge":203,"maxAge":11,"enrollmentInfo":204,"targetDuration":11,"studyType":207,"phases":208,"briefSummary":210,"conditions":211,"keywords":213,"overallStatus":32,"whyStopped":11,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":226},{"fullName":5,"class":6},"University Hospital, Limoges","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A","ACTIVE_COMPARATOR",null,[13],"Procedure: Anterior colporraphy",{"label":15,"type":16,"description":11,"interventionNames":17},"Arm B","EXPERIMENTAL",[18],"Procedure: vaginal patch plastron",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"PROCEDURE","Anterior colporraphy","It will be delimitate a rectangular vaginal strip which will be isolated from the anterior colpocele. The superior edge of the strip is placed 2 cm from the urethral orifice. After lateral vesico-vaginal dissection, the paravesical fossae will be wide opened to repair the tendinous arches. The vaginal plastron will be fixed to the tendinous arch of the pelvic fascia by 3 lateral stitches (anterior\u002F lateral\u002F posterior) on each side of the plastron. After, the plastron will be tensioning and the cystocele will be suspended. The closure of the vaginal wall will end the procedure.",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"vaginal patch plastron","It will be make a midline incision of the anterior vaginal wall from the urethrovesical junction to the vaginal apex or anterior fornix. The vaginal epithelium will be separated from the underlying fibromuscular layer (Halban Fascia) after the midline incision. Midline plication of the fibromuscular layer will be obtained by interrupted horizontal stiches. The closure of the vaginal wall will end the procedure.",[15],[30,57,75,89,105,128,142,163,180],{"facility":31,"status":32,"city":33,"state":11,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"CHU de Bordeaux","RECRUITING","Bordeaux","33000","France","FR",{"type":38,"coordinates":39},"Point",[40,41],-0.58046,44.84124,{"lat":41,"lon":40},[44,48,50,53,55],{"name":45,"role":46,"phone":11,"phoneExt":11,"email":47},"Claude HOCKE, MD","CONTACT","claude.hocke@chu-bordeaux.fr",{"name":45,"role":49,"phone":11,"phoneExt":11,"email":11},"PRINCIPAL_INVESTIGATOR",{"name":51,"role":52,"phone":11,"phoneExt":11,"email":11},"Mathilde CORET, MD","SUB_INVESTIGATOR",{"name":54,"role":52,"phone":11,"phoneExt":11,"email":11},"Jean-Luc BRUN, MD",{"name":56,"role":52,"phone":11,"phoneExt":11,"email":11},"Géraldine CHAUVIN, MD",{"facility":58,"status":32,"city":59,"state":11,"zip":60,"country":35,"countryCode":36,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"CH de Brive","Brive-la-Gaillarde","19100",{"type":38,"coordinates":62},[63,64],1.53326,45.1589,{"lat":64,"lon":63},[67,70,71,73],{"name":68,"role":46,"phone":11,"phoneExt":11,"email":69},"Christelle MESNARD, MD","mesnardc@yahoo.fr",{"name":68,"role":49,"phone":11,"phoneExt":11,"email":11},{"name":72,"role":52,"phone":11,"phoneExt":11,"email":11},"Tristan GAUTHIER, MD",{"name":74,"role":52,"phone":11,"phoneExt":11,"email":11},"Dimitrios HARISIS, MD",{"facility":76,"status":32,"city":77,"state":11,"zip":78,"country":35,"countryCode":36,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"CHU de Clermont Ferrand","Clermont-Ferrand","63100",{"type":38,"coordinates":80},[81,82],3.08682,45.77969,{"lat":82,"lon":81},[85,88],{"name":86,"role":46,"phone":11,"phoneExt":11,"email":87},"Sandrine CAMPAGNE, MD","scampagne-loiseau@chu-clermontferrand.fr",{"name":86,"role":49,"phone":11,"phoneExt":11,"email":11},{"facility":90,"status":32,"city":91,"state":11,"zip":92,"country":35,"countryCode":36,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"CH de Gueret","Guéret","23000",{"type":38,"coordinates":94},[95,96],1.87166,46.17185,{"lat":96,"lon":95},[99,102,103],{"name":100,"role":46,"phone":11,"phoneExt":11,"email":101},"Yves AUBARD, MD","yves.aubard@chu-limoges.fr",{"name":100,"role":49,"phone":11,"phoneExt":11,"email":11},{"name":104,"role":52,"phone":11,"phoneExt":11,"email":11},"Aymeline LACORRE, MD",{"facility":106,"status":32,"city":107,"state":11,"zip":108,"country":35,"countryCode":36,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"CHU de Limoges","Limoges","87000",{"type":38,"coordinates":110},[111,112],1.24759,45.83362,{"lat":112,"lon":111},[115,117,119,120,121,122,124,126],{"name":104,"role":46,"phone":11,"phoneExt":11,"email":116},"aymeline.lacorre@chu-limoges.fr",{"name":72,"role":46,"phone":11,"phoneExt":11,"email":118},"tristan.gauthier@chu-limoges.fr",{"name":104,"role":49,"phone":11,"phoneExt":11,"email":11},{"name":72,"role":52,"phone":11,"phoneExt":11,"email":11},{"name":100,"role":52,"phone":11,"phoneExt":11,"email":11},{"name":123,"role":52,"phone":11,"phoneExt":11,"email":11},"Hugues CALY, MD",{"name":125,"role":52,"phone":11,"phoneExt":11,"email":11},"Maxime LEGROS, MD",{"name":127,"role":52,"phone":11,"phoneExt":11,"email":11},"François MARGUERITTE, MD",{"facility":129,"status":32,"city":130,"state":11,"zip":131,"country":35,"countryCode":36,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"CHU de Saint-Etienne","Saint-Etienne","42000",{"type":38,"coordinates":133},[134,135],4.39,45.43389,{"lat":135,"lon":134},[138,141],{"name":139,"role":46,"phone":11,"phoneExt":11,"email":140},"Céline CHAULEUR, MD","celine.chauleur@chu-st-etienne.fr",{"name":139,"role":49,"phone":11,"phoneExt":11,"email":11},{"facility":143,"status":32,"city":144,"state":11,"zip":145,"country":35,"countryCode":36,"cosmosGeoPoint":146,"geoPoint":150,"contacts":151},"CHU de Toulouse - Paule de Viguier","Toulouse","31059",{"type":38,"coordinates":147},[148,149],1.44367,43.60426,{"lat":149,"lon":148},[152,155,157,159,161],{"name":153,"role":46,"phone":11,"phoneExt":11,"email":154},"Hélène POL, MD","helene.pol@chu-toulouse.fr",{"name":156,"role":49,"phone":11,"phoneExt":11,"email":11},"Fabien VIDAL, MD",{"name":158,"role":52,"phone":11,"phoneExt":11,"email":11},"Yann TANGUY LE GAC, MD",{"name":160,"role":52,"phone":11,"phoneExt":11,"email":11},"Géraldine CARTRON, MD",{"name":162,"role":52,"phone":11,"phoneExt":11,"email":11},"Martin BAUJAT, MD",{"facility":164,"status":32,"city":144,"state":11,"zip":165,"country":35,"countryCode":36,"cosmosGeoPoint":166,"geoPoint":168,"contacts":169},"CHU de Toulouse - Rangueil","31400",{"type":38,"coordinates":167},[148,149],{"lat":149,"lon":148},[170,173,174,176,178],{"name":171,"role":46,"phone":11,"phoneExt":11,"email":172},"Elodie CHANTALAT, MD","chantalat.e@chu-toulouse.fr",{"name":171,"role":49,"phone":11,"phoneExt":11,"email":11},{"name":175,"role":52,"phone":11,"phoneExt":11,"email":11},"Jacques RIMAILHO, MD",{"name":177,"role":52,"phone":11,"phoneExt":11,"email":11},"Stéphanie MOTTON, MD",{"name":179,"role":52,"phone":11,"phoneExt":11,"email":11},"Marc SOULE-THOLY, MD",{"facility":181,"status":32,"city":182,"state":11,"zip":183,"country":35,"countryCode":36,"cosmosGeoPoint":184,"geoPoint":188,"contacts":189},"CH de Tulle","Tulle","19000",{"type":38,"coordinates":185},[186,187],1.77233,45.26582,{"lat":187,"lon":186},[190],{"name":191,"role":46,"phone":11,"phoneExt":11,"email":192},"François SIEGERTH, MD","FSIEGERTH@ch-tulle.fr",{"type":194,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100352985","vaginal-native-tissues-repair-for-pelvic-organ-prolapse-100352985",false,"NCT03875989","Vaginal Native Tissues Repair for Pelvic Organ Prolapse","TAPP","Inclusion Criteria:\n\n* Patient at 50 years of age or older\n* Symptomatic primary prolapse of the anterior vaginal wall defined by Aa and\u002For Ba points ≥0 according to the POP-Q system\n* A positive response to the question \"Do you usually have a bulge or something falling out that you can see or feel in your vaginal area?\" (question 3 of the PFDI-20)\n* Able to give informed consent\n* Performans Status score ≤ 2\n\nExclusion Criteria:\n\n* Patient with need for surgical treatment for myorraphy of levator ani muscles\n* Patient with previous surgical cystocele repair.\n* Patient with evolving gynaecologic cancer.\n* Pregnancy or wish for future pregnancy, lactating woman.\n* Inability to participate in study follow-up or to provide informed consent.\n* Lack of social insurance .","FEMALE","50 Years",{"count":205,"type":206},214,"ESTIMATED","INTERVENTIONAL",[209],"NA","The aim of the study is to assess at one year the effectiveness of the vaginal patch plastron in comparison of the anterior colporraphy through a combined definition of success: anatomic and functional.",[212],"Prolapse, Vaginal",[214,215,216],"Prolapse","Vaginal native tissues repair","Pelvic organ","2023-08-28",{"date":219,"type":220},"2023-08-29","ACTUAL",{"date":222,"type":220},"2019-09-27",{"date":224,"type":206},"2028-03-27",{"name":5,"class":6},9]