[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"vaginal-cuff-dehiscence\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:vaginal-cuff-dehiscence":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":30,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"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":20,"type":21},310,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29],"Gynecologic Cancers","Vaginal Cuff Dehiscence","Postoperative Complications",[31,32,33,34,35,36,37,38,39],"Laparoscopic hysterectomy","Vaginal vault closure","Colporrhaphy","Self-locking suture","Barbed suture","Polyglactin 910","Gynecologic oncology","Postoperative complications","Randomized controlled trial","RECRUITING","2026-06-16",{"date":43,"type":44},"2026-06-17","ACTUAL",{"date":46,"type":44},"2025-10-07",{"date":48,"type":21},"2027-01",{"name":50,"class":51},"Azienda Ospedaliero-Universitaria di Parma","OTHER",5]