[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100547204":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":26,"centralContacts":31,"locations":38,"responsibleParty":54,"collaborators":56,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":26,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":26,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":26,"overallStatus":40,"whyStopped":26,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Hospital Mutua de Terrassa","OTHER",[8,13,17],{"label":9,"type":10,"description":9,"interventionNames":11},"Vaginal hysterectomy plus anterior colporrhaphy","SHAM_COMPARATOR",[12],"Procedure: Vaginal hysterectomy plus anterior colporrhaphy",{"label":14,"type":10,"description":14,"interventionNames":15},"Vaginal hysterectomy plus sacrospinous fixation with Anchorsure® device",[16],"Procedure: Vaginal hysterectomy plus sacrospinous fixation with Anchorsure® device",{"label":18,"type":19,"description":18,"interventionNames":20},"Vaginal hysterectomy plus matrix reinforcement and sacrospinous fixation with Anchorsure® device","EXPERIMENTAL",[21],"Procedure: Vaginal hysterectomy plus matrix reinforcement and sacrospinous fixation with Anchorsure® device",[23,27,29],{"type":24,"name":18,"description":18,"armGroupLabels":25,"otherNames":26},"PROCEDURE",[18],null,{"type":24,"name":9,"description":9,"armGroupLabels":28,"otherNames":26},[9],{"type":24,"name":14,"description":14,"armGroupLabels":30,"otherNames":26},[14],[32,36],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":26},"Gerard Molina","CONTACT","+34937365050",{"name":37,"role":34,"phone":35,"phoneExt":26,"email":26},"Pilar Arcusa",[39],{"facility":5,"status":40,"city":41,"state":26,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"RECRUITING","Terrassa","08221","Spain","ES",{"type":46,"coordinates":47},"Point",[48,49],2.01667,41.56667,{"lat":49,"lon":48},[52],{"name":33,"role":34,"phone":53,"phoneExt":26,"email":26},"937365050",{"type":55,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[57,59,61],{"name":58,"class":6},"Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau",{"name":60,"class":6},"Germans Trias i Pujol Hospital",{"name":62,"class":6},"Hospital Arnau de Vilanova","100547204","phase-2-transvaginal-human-acellular-dermal-matrix-for-prolapse-treatment-100547204",false,"NCT06404931","Transvaginal Human Acellular Dermal Matrix for Prolapse Treatment","Transvaginal Human Acellular Dermal Matrix and Sacrospinous Fixation for Anterior and Apical Prolapse Treatment in Patients With Hiatal Ballooning or Levator Ani Injury: a Randomized Pilot Trial","Inclusion Criteria:\n\n* Women with symptomatic POP with indication of vaginal surgery.\n* Women with hiatal ballooning or levator ani injury evaluated by 3D pelvic floor ultrasound.\n* Women ≥18 years old.\n* Women wishing to complete a 36-month follow-up.\n* Understand and accept the study procedures and sign the informed consent.\n\nExclusion Criteria:\n\n* Women with previous pelvic floor or prolapse surgery\n* Women with POP grade IV\n* Women with chronic pelvic pain.\n* Not being able to understand the nature of the study and\u002For the procedures to be followed.\n* Not signing the informed consent","FEMALE","18 Years","100 Years",{"count":74,"type":75},90,"ESTIMATED","INTERVENTIONAL",[78],"PHASE2","This is a randomised study in which we compare the effectiveness of three different procedures in mending symptomatic anterior and apical prolapse in patients who are candidates to receive surgery.\n\nThey will be randomly assigned in a ratio 1:1:1 to three different groups who will have assigned three different kinds of surgery. In the patients of the first group a classic vaginal hysterectomy with anterior colporrhaphy will be practised. Patients who belong to group two will undergo a vaginal hysterectomy followed by placement of an acellular dermal matrix from cadaveric donors (hADM) for anterior reinforcement and sacrospinous fixation with Anchorsure® device (Neomedic trade mark (TM) International, Spain). Finally, patients from group three will have vaginal hysterectomy followed by sacrospinous fixation with Anchorsure® alone .\n\nPatients will be followed-up at 4 weeks, 6 months, 12 months and annually till 36 months to evaluate relapses and possible complications.",[81,82,83],"Prolapse; Female","Prolapse Genital","Prolapse Uterovaginal","2025-01-15",{"date":86,"type":87},"2025-01-17","ACTUAL",{"date":89,"type":87},"2024-07-01",{"date":91,"type":75},"2026-01-01",{"name":5,"class":6},1]