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Comparison of Self-Locking Versus Traditional Sutures in Double-Layer Laparoscopic Vaginal Vault Closure After Hysterectomy (BI-SURE Trial)

RECRUITINGN/ASponsored by Azienda Ospedaliero-Universitaria di Parma
Actively Recruiting
PhaseN/A
SponsorAzienda Ospedaliero-Universitaria di Parma
Started2025-10-07
Est. completion2027-01
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT07313839

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

Age: 18 Years+Sex: FEMALEHealthy volunteers accepted
Inclusion Criteria:

* Patients undergoing laparoscopic or robotically assisted hysterectomy for gynecologic malignant disease
* Age ≥ 18 years
* Ability to provide written informed consent

Exclusion Criteria:

* Laparotomic or vaginal hysterectomy
* Contraindication to laparoscopic vaginal vault closure

Conditions4

CancerGynecologic CancersPostoperative ComplicationsVaginal Cuff Dehiscence

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