[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"urogenital-prolapse\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:urogenital-prolapse":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"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":21,"type":22},834,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28],"Urogenital Prolapse",[30,31,32,33],"Urogenital prolapse","laparoscopic sacropexy","mesh","medico-economic study","RECRUITING","2026-05-20",{"date":37,"type":38},"2026-05-22","ACTUAL",{"date":40,"type":38},"2019-09-11",{"date":42,"type":22},"2026-12",{"name":44,"class":45},"University Hospital, Lille","OTHER",9]