[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100549201":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":38,"locations":47,"responsibleParty":64,"collaborators":67,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":72,"sex":78,"minAge":79,"maxAge":43,"enrollmentInfo":80,"targetDuration":43,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":99,"overallStatus":49,"whyStopped":43,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Meander Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Polypropylene mesh","ACTIVE_COMPARATOR","Polypropylene mesh (Prolene, PMN3, Ethicon Inc Johnson \\& Johnson, Amersfoort, The Netherlands; weight 78 g\u002Fm2)",[13],"Procedure: Minimal invasive abdominal prolapse surgery using Polypropylene mesh",{"label":15,"type":16,"description":17,"interventionNames":18},"OviTex 1S permanent mesh","EXPERIMENTAL","OviTex Reinforced BioScaffold, Permanent Polymer composed of ovine (sheep) forestomach extracellular matrix (ECM) and polypropylene.",[19],"Procedure: Minimal invasive abdominal prolapse surgery using OviTex 1S permanent mesh",[21,29],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Minimal invasive abdominal prolapse surgery using Polypropylene mesh","All procedures will be performed with robotic assistance of the da Vinci Si-HD (intuitive Surgical, Inc, Sunnyvale, CA).",[9],[27,28],"Ventral mesh rectopexy","Sacrocolporectopexy",{"type":22,"name":30,"description":24,"armGroupLabels":31,"otherNames":32},"Minimal invasive abdominal prolapse surgery using OviTex 1S permanent mesh",[15],[27,28],[34],{"name":35,"affiliation":36,"role":37},"Esther Consten, Prof.dr","Meander Medisch Centrum","PRINCIPAL_INVESTIGATOR",[39,45],{"name":40,"role":41,"phone":42,"phoneExt":43,"email":44},"Marije Boom, drs.","CONTACT","+ 31 33 850 1716",null,"ma.boom@meandermc.nl",{"name":35,"role":41,"phone":43,"phoneExt":43,"email":46},"ecj.consten@meandermc.nl",[48],{"facility":36,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"RECRUITING","Amersfoort","Utrecht","3813TZ","Netherlands","NL",{"type":56,"coordinates":57},"Point",[58,59],5.3875,52.155,{"lat":59,"lon":58},[62],{"name":40,"role":41,"phone":63,"phoneExt":43,"email":44},"+31 33 850 1716",{"type":37,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"Esther Consten","Clinical Professor",[68],{"name":69,"class":6},"Health Holland","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":81,"type":82},184,"ESTIMATED","INTERVENTIONAL",[85],"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.",[88,89,90,91,92,93,94,95,96,97,98],"Colorectal Disorders","Prolapse","Prolapse Rectal","Prolapse Genital","Prolapse Pelvic","Rectocele","Prolapse Uterus","Cystocele","Enterocele","Prolapse Bladder","Prolapse; Cervix",[89,100,101,102,103,104],"Abdominal prolapse Surgery","Biological mesh","OviTex","VMR","sacrocolporectopexy","2025-12-31",{"date":107,"type":108},"2026-01-02","ACTUAL",{"date":110,"type":108},"2023-12-06",{"date":112,"type":82},"2027-07-01",{"name":5,"class":6},1]