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Comparison of Self-Locking Versus Traditional Sutures in Double-Layer Laparoscopic Vaginal Vault Closure After Hysterectomy (BI-SURE Trial)
Sponsor: Azienda Ospedaliero-Universitaria di Parma
Summary
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.
Official title: Comparison Between Double-Layer Self-Locking and Traditional Sutures in Post-Hysterectomy Laparoscopic Colporrhaphy: A Multicenter Pragmatic Randomized Controlled Trial
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
310
Start Date
2025-10-07
Completion Date
2027-01
Last Updated
2026-01-02
Healthy Volunteers
No
Interventions
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.
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.
Locations (5)
Department of Medicine and Surgery, University Hospital of Parma
Parma, Italy, Italy
Division of Oncologic Gynecology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, 40138 Bologna, Italy.
Bologna, Italy
Department of Obstetrics and Gynecology, Ospedale Santa Croce e Carle, Cuneo, Italy.
Cuneo, 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