Comparison of Self-Locking Versus Traditional Sutures in Double-Layer Laparoscopic Vaginal Vault Closure After Hysterectomy (BI-SURE Trial)
Recruiting now · Not applicable
Conditions studied: Gynecologic Cancers, Vaginal Cuff Dehiscence, Postoperative Complications
In brief
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. The 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.
Key facts
- Study ID
- NCT07313839
- Run by
- Azienda Ospedaliero-Universitaria di Parma
- People needed
- 310
- Starts
- 2025-10-07
- Expected to finish
- 2027-01-01
- Last updated by the study team
- 2026-06-17
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Patients undergoing laparoscopic or robotically assisted hysterectomy for gynecologic malignant disease
- Age ≥ 18 years
- Ability to provide written informed consent
You may not qualify if…
- Laparotomic or vaginal hysterectomy
- Contraindication to laparoscopic vaginal vault closure
Where it is running
- Department of Medicine and Surgery, University Hospital of Parma — Parma, Italy, Italy (enrolling)
- Department of Obstetrics and Gynecology, Ospedale Santa Croce e Carle, Cuneo, Italy. — Cuneo, Italy (enrolling)
- Division of Oncologic Gynecology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, 40138 Bologna, Italy. — Bologna, Italy
- Department of Gynecologic Oncology. Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy. — Milan, Italy
- Clinic of Obstetrics and Gynecology, "Santa Maria della Misericordia" University Hospital, Azienda Sanitaria Universitaria Friuli Centrale, Udine, Italy. — Udine, Italy
Full record on ClinicalTrials.gov
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