[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617070":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":103,"collaborators":26,"id":106,"slug":107,"hasResults":108,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":108,"sex":114,"minAge":115,"maxAge":26,"enrollmentInfo":116,"targetDuration":26,"studyType":119,"phases":120,"briefSummary":122,"conditions":123,"keywords":127,"overallStatus":40,"whyStopped":26,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":146},{"fullName":5,"class":6},"Azienda Ospedaliero-Universitaria di Parma","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Self-Locking Suture Group","EXPERIMENTAL","Participants randomized to this arm will undergo laparoscopic vaginal vault closure after hysterectomy using a double-layer continuous suturing technique performed with a self-locking (barbed) suture, according to current clinical practice.",[13],"Procedure: Double-Layer Vaginal Vault Closure with Self-Locking Suture",{"label":15,"type":16,"description":17,"interventionNames":18},"Traditional Suture Group","ACTIVE_COMPARATOR","Participants randomized to this arm will undergo laparoscopic vaginal vault closure after hysterectomy using a double-layer continuous suturing technique performed with traditional braided Polyglactin 910 suture, according to current clinical practice.",[19],"Procedure: Double-Layer Vaginal Vault Closure with Polyglactin 910",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Double-Layer Vaginal Vault Closure with Self-Locking Suture","Laparoscopic vaginal vault closure performed using a double-layer continuous suturing technique with a self-locking (barbed) suture following hysterectomy.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Double-Layer Vaginal Vault Closure with Polyglactin 910","Laparoscopic vaginal vault closure performed using a double-layer continuous suturing technique with traditional braided Polyglactin 910 suture following hysterectomy.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Vito Andrea Capozzi","CONTACT","0521704819","vcapozzi@ao.pr.it",[38,54,67,79,91],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":42,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Department of Medicine and Surgery, University Hospital of Parma","RECRUITING","Parma","Italy","43125","IT",{"type":46,"coordinates":47},"Point",[48,49],10.32618,44.79935,{"lat":49,"lon":48},[52],{"name":53,"role":34,"phone":35,"phoneExt":26,"email":36},"Capozzi",{"facility":55,"status":56,"city":57,"state":26,"zip":26,"country":42,"countryCode":44,"cosmosGeoPoint":58,"geoPoint":62,"contacts":63},"Division of Oncologic Gynecology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, 40138 Bologna, Italy.","NOT_YET_RECRUITING","Bologna",{"type":46,"coordinates":59},[60,61],11.33875,44.49381,{"lat":61,"lon":60},[64],{"name":65,"role":34,"phone":26,"phoneExt":26,"email":66},"De Iaco","pierandrea.deiaco@unibo.it",{"facility":68,"status":40,"city":69,"state":26,"zip":26,"country":42,"countryCode":44,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"Department of Obstetrics and Gynecology, Ospedale Santa Croce e Carle, Cuneo, Italy.","Cuneo",{"type":46,"coordinates":71},[72,73],7.54828,44.39071,{"lat":73,"lon":72},[76],{"name":77,"role":34,"phone":26,"phoneExt":26,"email":78},"Puppo","puppoand@hotmail.com",{"facility":80,"status":56,"city":81,"state":26,"zip":26,"country":42,"countryCode":44,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"Department of Gynecologic Oncology. Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.","Milan",{"type":46,"coordinates":83},[84,85],12.59836,42.78235,{"lat":85,"lon":84},[88],{"name":89,"role":34,"phone":26,"phoneExt":26,"email":90},"Bogani","bogani.giorgio@gmail.com",{"facility":92,"status":56,"city":93,"state":26,"zip":26,"country":42,"countryCode":44,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"Clinic of Obstetrics and Gynecology, \"Santa Maria della Misericordia\" University Hospital, Azienda Sanitaria Universitaria Friuli Centrale, Udine, Italy.","Udine",{"type":46,"coordinates":95},[96,97],13.23715,46.0693,{"lat":97,"lon":96},[100],{"name":101,"role":34,"phone":26,"phoneExt":26,"email":102},"Vizzielli","giuseppevizzielli@yahoo.it",{"type":104,"investigatorFullName":33,"investigatorTitle":105,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Principal Investigator","100617070","comparison-of-self-locking-versus-traditional-sutures-in-double-layer-laparoscopic-vaginal-vault-closure-after-hysterectomy-bi-sure-trial-100617070",false,"NCT07313839","Comparison of Self-Locking Versus Traditional Sutures in Double-Layer Laparoscopic Vaginal Vault Closure After Hysterectomy (BI-SURE Trial)","Comparison Between Double-Layer Self-Locking and Traditional Sutures in Post-Hysterectomy Laparoscopic Colporrhaphy: A Multicenter Pragmatic Randomized Controlled Trial","BI-SURE","Inclusion Criteria:\n\n* Patients undergoing laparoscopic or robotically assisted hysterectomy for gynecologic malignant disease\n* Age ≥ 18 years\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Laparotomic or vaginal hysterectomy\n* Contraindication to laparoscopic vaginal vault closure","FEMALE","18 Years",{"count":117,"type":118},310,"ESTIMATED","INTERVENTIONAL",[121],"NA","Vaginal vault closure after laparoscopic or robotic hysterectomy may be associated with postoperative complications such as vaginal cuff dehiscence, infection, and bleeding. The optimal suture material and technique for laparoscopic colporrhaphy, particularly in patients undergoing surgery for gynecologic malignancies, remain controversial.\n\nThe BI-SURE trial is a multicenter, randomized controlled study designed to compare double-layer self-locking sutures versus double-layer traditional Polyglactin 910 sutures for laparoscopic vaginal vault closure after hysterectomy. The study aims to evaluate postoperative effectiveness and safety within three months after surgery.",[124,125,126],"Gynecologic Cancers","Vaginal Cuff Dehiscence","Postoperative Complications",[128,129,130,131,132,133,134,135,136],"Laparoscopic hysterectomy","Vaginal vault closure","Colporrhaphy","Self-locking suture","Barbed suture","Polyglactin 910","Gynecologic oncology","Postoperative complications","Randomized controlled trial","2026-06-16",{"date":139,"type":140},"2026-06-17","ACTUAL",{"date":142,"type":140},"2025-10-07",{"date":144,"type":118},"2027-01",{"name":5,"class":6},5]