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

RecruitingNAAges 18 Years - anyFemaleAzienda Ospedaliero-Universitaria di Parma
NCT07313839 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Double-Layer Vaginal Vault Closure with Self-Locking Suture
  • Double-Layer Vaginal Vault Closure with Polyglactin 910
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Where

5 sites
Department of Medicine and Surgery, University Hospital of Parma
Parma, Italy
Division of Oncologic Gynecology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, 40138 Bologna, Italy.
Bologna, Italy
Department of Obstetrics and Gynecology, Ospedale Santa Croce e Carle, Cuneo, Italy.
Cuneo, Italy
Department of Gynecologic Oncology. Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.
Milan, Italy
Clinic of Obstetrics and Gynecology, "Santa Maria della Misericordia" University Hospital, Azienda Sanitaria Universitaria Friuli Centrale, Udine, Italy.
Udine, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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