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
Azienda Ospedaliero-Universitaria di Parma
310 participants
Oct 7, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- Patients undergoing laparoscopic or robotically assisted hysterectomy for gynecologic malignant disease
- Age ≥ 18 years
- Ability to provide written informed consent
Exclusion Criteria2
- Laparotomic or vaginal hysterectomy
- Contraindication to laparoscopic vaginal vault closure
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Interventions
Laparoscopic vaginal vault closure performed using a double-layer continuous suturing technique with a self-locking (barbed) suture following hysterectomy.
Laparoscopic vaginal vault closure performed using a double-layer continuous suturing technique with traditional braided Polyglactin 910 suture following hysterectomy.
Locations(5)
View Full Details on ClinicalTrials.gov
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NCT07313839