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Recruiting NCT07313839

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

No phase Interventional Gynecologic Cancers Vaginal Cuff Dehiscence Postoperative Complications

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Double-Layer Vaginal Vault Closure with Self-Locking Suture, Double-Layer Vaginal Vault Closure with Polyglactin 910.
Who it may be relevant to
Registry conditions: Gynecologic Cancers, Vaginal Cuff Dehiscence, Postoperative Complications. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Comparison Between Double-Layer Self-Locking and Traditional Sutures in Post-Hysterectomy Laparoscopic Colporrhaphy: A Multicenter Pragmatic Randomized Controlled Trial

Overview

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.

Detailed description

Laparoscopic and robotic hysterectomy represent standard surgical approaches for the treatment of gynecologic malignancies but are associated with a higher risk of vaginal vault complications compared with open or vaginal surgery. Although uncommon, postoperative complications such as vaginal cuff dehiscence, infection, and bleeding may lead to significant morbidity and require additional medical or surgical interventions.

Vaginal vault closure can be performed using different suturing techniques and materials. Traditional braided sutures, such as Polyglactin 910, are widely used in clinical practice, while self-locking (barbed) sutures have been introduced to facilitate laparoscopic suturing by maintaining tissue approximation without the need for knots. Evidence comparing these sutures is limited, particularly for double-layer closure techniques and in patients treated for gynecologic malignancies.

The BI-SURE trial is a multicenter, pragmatic, randomized controlled trial designed to compare double-layer self-locking sutures versus double-layer traditional Polyglactin 910 sutures for laparoscopic vaginal vault closure following hysterectomy for malignant gynecologic disease. Eligible patients will be randomized in a 1:1 ratio. Postoperative outcomes will be assessed up to three months after surgery, including vaginal cuff-related complications and postoperative pain.

Interventions

  • Procedure Double-Layer Vaginal Vault Closure with Self-Locking Suture
    Laparoscopic vaginal vault closure performed using a double-layer continuous suturing technique with a self-locking (barbed) suture following hysterectomy.
  • Procedure Double-Layer Vaginal Vault Closure with Polyglactin 910
    Laparoscopic vaginal vault closure performed using a double-layer continuous suturing technique with traditional braided Polyglactin 910 suture following hysterectomy.

Primary outcome measures

  • Vaginal cuff dehiscence rate [Time frame: Within 3 months after surgery]
  • Vaginal cuff infection rate [Time frame: Within 3 months after surgery]
  • Postoperative bleeding rate [Time frame: Within 3 months after surgery]
Secondary outcome measures (2)
  • Postoperative pain intensity [Time frame: At 1 month and 3 months after surgery]
  • Early postoperative composite complication rate [Time frame: Within 1 month after surgery]

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 closure

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Italy · 5 centers
  • Department of Medicine and Surgery, University Hospital of Parma — Parma
  • Division of Oncologic Gynecology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, 4013 — Bologna
  • Department of Obstetrics and Gynecology, Ospedale Santa Croce e Carle, Cuneo, Italy. — Cuneo
  • Department of Gynecologic Oncology. Fondazione IRCCS Istituto Nazionale dei Tumori di Mila — Milan
  • Clinic of Obstetrics and Gynecology, "Santa Maria della Misericordia" University Hospital, — Udine

Identifiers

NCT: NCT07313839 · 415/2024/DISP/AOUPR

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗