[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100554122":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":28,"locations":38,"responsibleParty":54,"collaborators":11,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":11,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":11,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":41,"whyStopped":11,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Saint Petersburg State University, Russia","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Sacrospinous hysteropexy with the synthetic mesh, vaginal flap and anterior colporrhaphy","ACTIVE_COMPARATOR",null,[13],"Procedure: Sacrospinous hysteropexy with the synthetic mesh, vaginal flap and anterior colporrhaphy",{"label":15,"type":10,"description":11,"interventionNames":16},"Sacrospinous hysteropexy with the synthetic mesh and anterior colporrhaphy",[17],"Procedure: Sacrospinous hysteropexy with the synthetic mesh and anterior colporrhaphy",[19,22],{"type":20,"name":9,"description":9,"armGroupLabels":21,"otherNames":11},"PROCEDURE",[9],{"type":20,"name":15,"description":15,"armGroupLabels":23,"otherNames":11},[15],[25],{"name":26,"affiliation":5,"role":27},"Dmitry Shkarupa, MD, PhD","STUDY_CHAIR",[29,34],{"name":30,"role":31,"phone":32,"phoneExt":11,"email":33},"Denis Suchkov, MD","CONTACT","+79995218976","denis.urolog@yandex.ru",{"name":35,"role":31,"phone":36,"phoneExt":11,"email":37},"Rustam Shakhaliev, MD","+79312368664","rustam.shahaliev@gmail.com",[39],{"facility":40,"status":41,"city":42,"state":11,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Saint-Petersburg State University Hospital","RECRUITING","Saint Petersburg","190103","Russia","RU",{"type":47,"coordinates":48},"Point",[49,50],30.31413,59.93863,{"lat":50,"lon":49},[53],{"name":30,"role":31,"phone":32,"phoneExt":11,"email":33},{"type":55,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Shkarupa Dmitry","MD, PhD; Director, St. Petersburg State University Hospital","100554122","the-influence-of-using-vascularized-vaginal-flap-on-the-efficacy-of-mesh-augmented-sacrospinous-hysteropexy-100554122",false,"NCT06494982","The Influence of Using Vascularized Vaginal Flap on the Efficacy of Mesh-augmented Sacrospinous Hysteropexy","The Influence of Augmentation of the Anterior Vaginal Wall With a Vascularized Flap on the Effectiveness of Mesh-augmented Sacrospinous Hysteropexy and Anterior Subfascial Colporrhaphy During Reconstruction of the Pelvic Floor for POP","Inclusion Criteria:\n\n* The subject is a woman with anterior and apical compartment pelvic organ prolapse\n* The age of a subject is 45-80 years\n* Leading point of prolapse is at the level of the hymen or distal to the hymen (Ba, C\\>=1 according to POP-Q classification)\n* The subject gave written consent to participate in the study\n* The subject is able to evaluate the risks of the treatment and make an independent decision on participation in the study\n* The subject is able to fill up validated questionnaires and come to the control visit after the surgery\n\nExclusion Criteria:\n\n* The subject has an active urinary tract infection or skin infection in the region of surgery or acute infectious disease\n* The subject had prior hysterectomy\n* The subject has previously diagnosed or currently active cancer\n* The subject has chronic pelvic pain\n* The subject has cervical elongation\n* The subject has gynecological diseases (recurrent uterine bleeding, endometrial hyperplasia, the presence of atypical cells in cervical smears, adenomyosis, multiple uterine myoma)\n* The subject is planning pregnancy\n* The subject is unable to visit postoperative check-ups\n* Refusal from participation.","FEMALE","45 Years","80 Years",{"count":69,"type":70},60,"ESTIMATED","INTERVENTIONAL",[73],"NA","This is a prospective randomized controlled trial designed to compare the effectiveness and safety of two methods of pelvic floor reconstruction in patients with pelvic organ prolapse (POP): sacrospinous hysteropexy (SSHP) with synthetic mesh, vascularized anterior vaginal wall flap, anterior colporrhaphy, and sacrospinous hysteropexy with synthetic mesh. , anterior colporrhaphy, as well as the impact of surgery on quality of life.",[76],"Pelvic Organ Prolapse",[78,79,80,81,82],"pelvic organ prolapse","vaginal repair","vaginal mesh","sacrospinous fixation","vaginal flap","2024-07-02",{"date":85,"type":86},"2024-07-10","ACTUAL",{"date":88,"type":86},"2024-05-01",{"date":90,"type":70},"2025-10-01",{"name":5,"class":6},1]