[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100344544":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":18,"studyPopulation":18,"armGroups":28,"interventions":39,"overallOfficials":47,"centralContacts":51,"locations":57,"responsibleParty":137,"collaborators":18,"id":139,"slug":18,"hasResults":140,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":144,"eligibilityCriteria":145,"healthyVolunteers":140,"sex":146,"minAge":147,"maxAge":148,"enrollmentInfo":149,"targetDuration":18,"studyType":152,"phases":153,"briefSummary":155,"conditions":156,"keywords":158,"overallStatus":60,"whyStopped":18,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":172},{"fullName":5,"class":6},"University Hospital, Lille","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"Composite criteria of success at 2 years follow-up","Composite criteria of success at 2 years follow-up: no symptom of vaginal bulge, no prolapse beyond the hymen (\\>0 cm), no reintervention for prolapse recurrence. Its advantage is that it considers only recurrences that are symptomatic or needing a reintervention. It is strongly linked with women satisfaction after prolapse surgery.","at 2 years after the intervention",[14],{"measure":15,"description":16,"timeFrame":17},"Anatomical results","Anatomical results will be based on clinical evaluation of patients at 2 years follow-up using the POP-Q system, with a specific evaluation of posterior vaginal wall with measures of the Bp point","at 2 years",null,{"allocation":20,"interventionModel":21,"interventionModelDescription":18,"primaryPurpose":22,"observationalModel":18,"timePerspective":18,"maskingInfo":23},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":24,"maskingDescription":18,"whoMasked":25},"DOUBLE",[26,27],"INVESTIGATOR","OUTCOMES_ASSESSOR",[29,34],{"label":30,"type":31,"description":18,"interventionNames":32},"Single-Anterior-Mesh, SAM","EXPERIMENTAL",[33],"Procedure: Single-Anterior-Mesh, SAM",{"label":35,"type":36,"description":18,"interventionNames":37},"Double-Mesh, DM","SHAM_COMPARATOR",[38],"Procedure: Double-Mesh, DM",[40,44],{"type":41,"name":30,"description":42,"armGroupLabels":43,"otherNames":18},"PROCEDURE","laparoscopic sacropexy is only performed with the anterior mes",[30],{"type":41,"name":35,"description":45,"armGroupLabels":46,"otherNames":18},"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",[35],[48],{"name":49,"affiliation":5,"role":50},"Jean-Philippe LUCOT, MD,PhD","PRINCIPAL_INVESTIGATOR",[52],{"name":49,"role":53,"phone":54,"phoneExt":55,"email":56},"CONTACT","(0)3 21 45 62","+33","lucot.jean-philippe@ghicl.net",[58,70,78,86,94,106,113,121,129],{"facility":59,"status":60,"city":61,"state":18,"zip":18,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":18},"Hopital Estaing","RECRUITING","Clermont-Ferrand","France","FR",{"type":65,"coordinates":66},"Point",[67,68],3.08682,45.77969,{"lat":68,"lon":67},{"facility":71,"status":60,"city":72,"state":18,"zip":18,"country":62,"countryCode":63,"cosmosGeoPoint":73,"geoPoint":77,"contacts":18},"Ch Dunkerque","Dunkirk",{"type":65,"coordinates":74},[75,76],2.37681,51.0344,{"lat":76,"lon":75},{"facility":79,"status":60,"city":80,"state":18,"zip":18,"country":62,"countryCode":63,"cosmosGeoPoint":81,"geoPoint":85,"contacts":18},"Hopital Saint-Louis - La Rochelle","La Rochelle",{"type":65,"coordinates":82},[83,84],-1.15222,46.16308,{"lat":84,"lon":83},{"facility":87,"status":60,"city":88,"state":18,"zip":18,"country":62,"countryCode":63,"cosmosGeoPoint":89,"geoPoint":93,"contacts":18},"Clinique Du Pre","Le Mans",{"type":65,"coordinates":90},[91,92],0.20251,48.0021,{"lat":92,"lon":91},{"facility":95,"status":60,"city":96,"state":18,"zip":97,"country":62,"countryCode":63,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"Hop Jeanne de Flandre Chu Lille","Lille","59037",{"type":65,"coordinates":99},[100,101],3.05512,50.63391,{"lat":101,"lon":100},[104],{"name":18,"role":53,"phone":105,"phoneExt":18,"email":18},"0320445962",{"facility":107,"status":60,"city":96,"state":18,"zip":97,"country":62,"countryCode":63,"cosmosGeoPoint":108,"geoPoint":110,"contacts":111},"Hopital Saint Vincent - Saint Antoine",{"type":65,"coordinates":109},[100,101],{"lat":101,"lon":100},[112],{"name":18,"role":53,"phone":105,"phoneExt":18,"email":18},{"facility":114,"status":60,"city":115,"state":18,"zip":18,"country":62,"countryCode":63,"cosmosGeoPoint":116,"geoPoint":120,"contacts":18},"Chu de Nice Hopital de L'Archet","Nice",{"type":65,"coordinates":117},[118,119],7.26608,43.70313,{"lat":119,"lon":118},{"facility":122,"status":60,"city":123,"state":18,"zip":18,"country":62,"countryCode":63,"cosmosGeoPoint":124,"geoPoint":128,"contacts":18},"Chu Nimes - Nimes","Nîmes",{"type":65,"coordinates":125},[126,127],4.35788,43.83665,{"lat":127,"lon":126},{"facility":130,"status":60,"city":131,"state":18,"zip":18,"country":62,"countryCode":63,"cosmosGeoPoint":132,"geoPoint":136,"contacts":18},"Chi Poissy St Germain Site de Poissy","Poissy",{"type":65,"coordinates":133},[134,135],2.04952,48.92902,{"lat":135,"lon":134},{"type":138,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","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":150,"type":151},834,"ESTIMATED","INTERVENTIONAL",[154],"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.",[157],"Urogenital Prolapse",[159,160,161,162],"Urogenital prolapse","laparoscopic sacropexy","mesh","medico-economic study","2026-05-20",{"date":165,"type":166},"2026-05-22","ACTUAL",{"date":168,"type":166},"2019-09-11",{"date":170,"type":151},"2026-12",{"name":5,"class":6},9]