Actively Recruiting
Comparison of Self-Locking Versus Traditional Sutures in Double-Layer Laparoscopic Vaginal Vault Closure After Hysterectomy (BI-SURE Trial)
Led by Azienda Ospedaliero-Universitaria di Parma · Updated on 2026-01-02
310
Participants Needed
5
Research Sites
64 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Comparison of Self-Locking Versus Traditional Sutures in Double-Layer Laparoscopic Vaginal Vault Closure After Hysterectomy (BI-SURE Trial)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients undergoing laparoscopic or robotically assisted hysterectomy for gynecologic malignant disease
- Age e 18 years
- Ability to provide written informed consent
You will not qualify if you...
- Laparotomic or vaginal hysterectomy
- Contraindication to laparoscopic vaginal vault closure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Department of Medicine and Surgery, University Hospital of Parma
Parma, Italy, Italy, 43125
Actively Recruiting
2
Division of Oncologic Gynecology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, 40138 Bologna, Italy.
Bologna, Italy
Not Yet Recruiting
3
Department of Obstetrics and Gynecology, Ospedale Santa Croce e Carle, Cuneo, Italy.
Cuneo, Italy
Actively Recruiting
4
Department of Gynecologic Oncology. Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.
Milan, Italy
Not Yet Recruiting
5
Clinic of Obstetrics and Gynecology, "Santa Maria della Misericordia" University Hospital, Azienda Sanitaria Universitaria Friuli Centrale, Udine, Italy.
Udine, Italy
Not Yet Recruiting
Research Team
V
Vito Andrea Capozzi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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