[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"prolapse-rectal\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:prolapse-rectal":56},{"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":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":38,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":5},"100549201","biological-ovitex-versus-synthetic-graft-in-robotic-prolapse-surgery-100549201",false,"NCT06430931","Biological OviTex Versus Synthetic Graft in Robotic Prolapse Surgery","Biological OviTex Versus Synthetic Graft in Robotic Prolapse Surgery: a Multicentre, Phase 11-111, Partially Randomised Patient Preference Trial","ProTex","Inclusion Criteria:\n\n* Indication for VMR or SCR set by the treating surgeon\u002Fgynecologist in accordance to the current guidelines on rectal and pelvic prolapse;\n* Counselled for therapeutic options and given informed consent for VMR or SCR;\n* Counselled for different types of mesh (OviTex or Prolene) and randomisation;\n* Written informed consent for randomisation, OviTex implant or Prolene;\n* Written informed consent for observational data collection.\n\nExclusion Criteria:\n\n* Mentally incompetent patients (unable to fulfil questionnaires).\n* Allergy to ovine rumen.\n* A medical history of pelvic radiation therapy.\n* Scheduled for a redo-rectopexy.\n* A medical history of previously implanted pelvic floor meshes or native tissue.\n* Language barrier","ALL","18 Years",{"count":20,"type":21},184,"ESTIMATED","INTERVENTIONAL",[24],"NA","This prospective study aims to assess the efficacy of the OviTex 1S permanent mesh in pelvic floor surgery in comparison with the current standard polypropylene mesh.",[27,28,29,30,31,32,33,34,35,36,37],"Colorectal Disorders","Prolapse","Prolapse Rectal","Prolapse Genital","Prolapse Pelvic","Rectocele","Prolapse Uterus","Cystocele","Enterocele","Prolapse Bladder","Prolapse; Cervix",[28,39,40,41,42,43],"Abdominal prolapse Surgery","Biological mesh","OviTex","VMR","sacrocolporectopexy","RECRUITING","2025-12-31",{"date":47,"type":48},"2026-01-02","ACTUAL",{"date":50,"type":48},"2023-12-06",{"date":52,"type":21},"2027-07-01",{"name":54,"class":55},"Meander Medical Center","OTHER","Prolapse, Rectal"]