[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100344544":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":31,"locations":37,"responsibleParty":117,"collaborators":11,"id":119,"slug":120,"hasResults":121,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":125,"eligibilityCriteria":126,"healthyVolunteers":121,"sex":127,"minAge":128,"maxAge":129,"enrollmentInfo":130,"targetDuration":11,"studyType":133,"phases":134,"briefSummary":136,"conditions":137,"keywords":139,"overallStatus":40,"whyStopped":11,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":153},{"fullName":5,"class":6},"University Hospital, Lille","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Single-Anterior-Mesh, SAM","EXPERIMENTAL",null,[13],"Procedure: Single-Anterior-Mesh, SAM",{"label":15,"type":16,"description":11,"interventionNames":17},"Double-Mesh, DM","SHAM_COMPARATOR",[18],"Procedure: Double-Mesh, DM",[20,24],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":11},"PROCEDURE","laparoscopic sacropexy is only performed with the anterior mes",[9],{"type":21,"name":15,"description":25,"armGroupLabels":26,"otherNames":11},"laparoscopic sacropexy is performed using two synthetic non-absorbable meshes, both sutured to the promontory (Double-Mesh, DM): one mesh is placed in the vesicovaginal space and sutured to the uterine cervix or vaginal apex, and one mesh is placed in the rectovaginal space",[15],[28],{"name":29,"affiliation":5,"role":30},"Jean-Philippe LUCOT, MD,PhD","PRINCIPAL_INVESTIGATOR",[32],{"name":29,"role":33,"phone":34,"phoneExt":35,"email":36},"CONTACT","(0)3 21 45 62","+33","lucot.jean-philippe@ghicl.net",[38,50,58,66,74,86,93,101,109],{"facility":39,"status":40,"city":41,"state":11,"zip":11,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":11},"Hopital Estaing","RECRUITING","Clermont-Ferrand","France","FR",{"type":45,"coordinates":46},"Point",[47,48],3.08682,45.77969,{"lat":48,"lon":47},{"facility":51,"status":40,"city":52,"state":11,"zip":11,"country":42,"countryCode":43,"cosmosGeoPoint":53,"geoPoint":57,"contacts":11},"Ch Dunkerque","Dunkirk",{"type":45,"coordinates":54},[55,56],2.37681,51.0344,{"lat":56,"lon":55},{"facility":59,"status":40,"city":60,"state":11,"zip":11,"country":42,"countryCode":43,"cosmosGeoPoint":61,"geoPoint":65,"contacts":11},"Hopital Saint-Louis - La Rochelle","La Rochelle",{"type":45,"coordinates":62},[63,64],-1.15222,46.16308,{"lat":64,"lon":63},{"facility":67,"status":40,"city":68,"state":11,"zip":11,"country":42,"countryCode":43,"cosmosGeoPoint":69,"geoPoint":73,"contacts":11},"Clinique Du Pre","Le Mans",{"type":45,"coordinates":70},[71,72],0.20251,48.0021,{"lat":72,"lon":71},{"facility":75,"status":40,"city":76,"state":11,"zip":77,"country":42,"countryCode":43,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"Hop Jeanne de Flandre Chu Lille","Lille","59037",{"type":45,"coordinates":79},[80,81],3.05512,50.63391,{"lat":81,"lon":80},[84],{"name":11,"role":33,"phone":85,"phoneExt":11,"email":11},"0320445962",{"facility":87,"status":40,"city":76,"state":11,"zip":77,"country":42,"countryCode":43,"cosmosGeoPoint":88,"geoPoint":90,"contacts":91},"Hopital Saint Vincent - Saint Antoine",{"type":45,"coordinates":89},[80,81],{"lat":81,"lon":80},[92],{"name":11,"role":33,"phone":85,"phoneExt":11,"email":11},{"facility":94,"status":40,"city":95,"state":11,"zip":11,"country":42,"countryCode":43,"cosmosGeoPoint":96,"geoPoint":100,"contacts":11},"Chu de Nice Hopital de L'Archet","Nice",{"type":45,"coordinates":97},[98,99],7.26608,43.70313,{"lat":99,"lon":98},{"facility":102,"status":40,"city":103,"state":11,"zip":11,"country":42,"countryCode":43,"cosmosGeoPoint":104,"geoPoint":108,"contacts":11},"Chu Nimes - Nimes","Nîmes",{"type":45,"coordinates":105},[106,107],4.35788,43.83665,{"lat":107,"lon":106},{"facility":110,"status":40,"city":111,"state":11,"zip":11,"country":42,"countryCode":43,"cosmosGeoPoint":112,"geoPoint":116,"contacts":11},"Chi Poissy St Germain Site de Poissy","Poissy",{"type":45,"coordinates":113},[114,115],2.04952,48.92902,{"lat":115,"lon":114},{"type":118,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100344544","laparoscopic-preventive-prerectal-mesh-100344544",false,"NCT03766048","LAparoscopic Preventive PRErectal Mesh","Non-inferiority Randomized Double Blind Controlled Trial Comparing Results of Laparoscopic Sacrocolpopexy With or Without Preventive Prerectal Mesh in Women Operated for Urogenital Prolapse Without Significant Posterior Vaginal Wall Prolapse","LAPREM","Inclusion Criteria:\n\n* Women with a urogenital prolapse (anterior wall and\u002For uterus or vaginal apex) stage = 2 (Ba and\u002For C points ≥ - 1 cm using the POP-Q system),\n* without significant posterior vaginal wall prolapse (Bp \\\u003C -1 cm when apical prolapse is reduced using a retractor leaving the posterior vaginal wall free),\n\nExclusion Criteria:\n\n* Previous surgical repair for Pelvic Organ Prolapse\n* Any associated prolapse requiring any non-authorized additional surgical repair (Authorized additional surgical procedures are hysterectomy, ovariectomy, adnexectomy, salpingectomy, myomectomy, or suburethral vaginal tape.)\n* Wish for future pregnancy\n* Lack of health insurance\n* Woman not reading French or unable to consent\n* Woman under law protection","FEMALE","40 Years","75 Years",{"count":131,"type":132},834,"ESTIMATED","INTERVENTIONAL",[135],"NA","Urogenital prolapse is a frequent and invalidating pathology in women, involving the anterior vaginal wall and the uterus in most cases. Posterior vaginal wall prolapse is present in only 50% of cases. Surgery is an option for women with troublesome prolapse. A woman's lifetime risk of undergoing surgery for pelvic organ prolapse (POP) surgery by the age of 80 is around 19%. Laparoscopic sacrocolpopexy (LS) with synthetic non-absorbable mesh is considered the gold standard, with a composite success rate of 85% at one year (Prospere study). Based on early experience and historical habits, a prerectal mesh was used to be systematically placed in the rectovaginal space, in addition to the anterior and apical mesh placed in the vesicovaginal space, in order to prevent de-novo posterior prolapse (reported rates up to 33%).\n\nThe benefit of preventive prerectal mesh is questionned on the basis of a single retrospective study comparing 68 LS with double-mesh (anterior \\& posterior, DM) to 32 LS with a single anterior mesh (SAM): posterior recurrence rates were respectively 5.9 vs. 31.3% (p\\\u003C0,01), and total recurrence rates 16.2 vs. 43.8% (p\\\u003C0.01). However, as this difference was not significant in the subgroup of patients without associated cervicocystopexy, the authors concluded that the risk of posterior failure was only due to the cervicocystopexy itself (anti-urinary incontinence procedure which has been abandoned since).\n\nOn the other hand, a prerectal mesh increases the risk for specific complications: rectal injury (up to 3%), anal pain (up to 25%), mesh exposition (up to 2%). Furthermore the posterior mesh increases the procedure by a minimum of 30 minutes (Robolaps study, unpublished data). The rate of de-novo obstructed defecation after LS with prerectal mesh is reported up to 25%. It could be explained by the mesh itself, but also by nerve injuries during the dissection of the rectovaginal space and rectal stalks.",[138],"Urogenital Prolapse",[140,141,142,143],"Urogenital prolapse","laparoscopic sacropexy","mesh","medico-economic study","2026-05-20",{"date":146,"type":147},"2026-05-22","ACTUAL",{"date":149,"type":147},"2019-09-11",{"date":151,"type":132},"2026-12",{"name":5,"class":6},9]