[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"enterocele\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:enterocele":35},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,57],{"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":56},"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",1,{"id":58,"slug":59,"hasResults":11,"nctId":60,"briefTitle":61,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":64,"targetDuration":66,"studyType":67,"phases":4,"briefSummary":68,"conditions":69,"keywords":74,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":88},"100509817","multicenter-ventral-mesh-rectopexy-registry-collaborative-100509817","NCT05918367","Multicenter Ventral Mesh Rectopexy Registry Collaborative","M2R2","Inclusion Criteria:\n\n* Diagnosis of posterior pelvic organ prolaps planned for laparoscopie or robotic ventral mesh rectopexy with or without concomittant surgery.\n* All patients 18 years or older and are able to complete a written informed conscent are eligble for inclusion.\n\nExclusion Criteria:\n\n1. Inability to complete a written informed conscent\n2. Pregnant women\n3. No email adress available to send the questionnaires to\n4. Language barrier or impossiblity to fill in the questionnaires (at the discretion oft he treating physician)",{"count":65,"type":21},200,"5 Years","OBSERVATIONAL","The goal of this multicenter observational study is to collect data prospectively of patients with pelvic organ prolapse undergoing ventral mesh rectopexy (as well as rectoceles, entero-\u002Fsigmoidoceles\u002F intussusception\u002F rectal prolapse or combined) by laparoscopy or robotic surgery and to evaluate the longterm functional outcomes.\n\nSecondly complications (mesh erosions, recurrence, reoperations) are evaluated.\n\nFollowing main questions will be analysed - other can follow in consultation with the collaborative\n\n1. Is VMR the technique of choice for treatment of rectoceles? Functional results - recurrence - mesh related complications\n2. Has a perineal descent an impact on the functional outcome of ventral mesh rectopexy perfored for external rectal prolaps, internal rectal prolaps, rectocele, enterocele, sigmoidcele or combined pelvic organ prolapse?",[70,32,35,71,72,73],"Pelvic Organ Prolapse","Rectal Prolapse","Descending Perineum Syndrome","Surgery",[75,76,77,78],"Posterior pelvic organ prolapse","descending perineum","ventral mesh rectopexy","functional outcome","2023-10-23",{"date":81,"type":48},"2023-10-25",{"date":83,"type":48},"2023-09-25",{"date":85,"type":21},"2032-09-30",{"name":87,"class":55},"University Hospital, Antwerp",5]