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Study identifier: NCT07313839 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Gynecologic Cancers · Vaginal Cuff Dehiscence · Postoperative Complications  ·  Sponsor: Azienda Ospedaliero-Universitaria di Parma

PhaseNA
Planned participants310
Who can joinFemale, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Vito Andrea Capozzi  ·  0521704819  ·  vcapozzi@ao.pr.it

Always discuss trial participation with your own doctor first.

Locations (5)

Department of Medicine and Surgery, University Hospital of ParmaParma, Italy, ItalyRecruiting
Division of Oncologic Gynecology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, 40138 Bologna, Italy.Bologna, ItalyNot Yet Recruiting
Department of Obstetrics and Gynecology, Ospedale Santa Croce e Carle, Cuneo, Italy.Cuneo, ItalyRecruiting
Department of Gynecologic Oncology. Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.Milan, ItalyNot Yet Recruiting
Clinic of Obstetrics and Gynecology, "Santa Maria della Misericordia" University Hospital, Azienda Sanitaria Universitaria Friuli Centrale, Udine, Italy.Udine, ItalyNot Yet Recruiting

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Source record: clinicaltrials.gov/study/NCT07313839