Comparison of Self-Locking Versus Traditional Sutures in Double-Layer Laparoscopic Vaginal Vault Closure After Hysterectomy (BI-SURE Trial)
Recruiting
N/A
Interventional Study
Gynecologic Cancers
Vaginal Cuff Dehiscence
Postoperative Complications
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 310 (estimated)
- Sponsor
- Azienda Ospedaliero-Universitaria di Parma · Other
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About This Trial
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 controlle…
Trial Locations
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Eligibility Criteria
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 c…
Contacts