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

ConditionsGynecologic CancersVaginal Cuff DehiscencePostoperative Complications
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorAzienda Ospedaliero-Universitaria di Parma

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 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients undergoing laparoscopic or robotically assisted hysterectomy for gynecologic malignant disease

Age ≥ 18 years

Ability to provide written informed consent

Disqualifiers

Laparotomic or vaginal hysterectomy

Contraindication to laparoscopic vaginal vault closure

Trial design

Design model

Parallel

Treatments tested in this trial

  • Double-Layer Vaginal Vault Closure with Self-Locking Suture

    Procedure/Surgery

    Laparoscopic vaginal vault closure performed using a double-layer continuous suturing technique with a self-locking (barbed) suture following hysterectomy.

  • Double-Layer Vaginal Vault Closure with Polyglactin 910

    Procedure/Surgery

    Laparoscopic vaginal vault closure performed using a double-layer continuous suturing technique with traditional braided Polyglactin 910 suture following hysterectomy.

Treatment groups

310 Participants
are divided into 2 treatment groups
Group A: Self-Locking Suture GroupExperimental treatment 1 intervention
Group B: Traditional Suture GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Vaginal cuff dehiscence rate

Proportion of participants experiencing vaginal cuff dehiscence requiring surgical reintervention after laparoscopic hysterectomy.

Time frame
Within 3 months after surgery
2

Vaginal cuff infection rate

Proportion of participants developing vaginal cuff infection, defined as abnormal vaginal discharge with or without fever, leukocytosis, and/or local tenderness, requiring antibiotic therapy.

Time frame
Within 3 months after surgery
3

Postoperative bleeding rate

Proportion of participants experiencing postoperative vaginal cuff bleeding requiring hemostatic treatment.

Time frame
Within 3 months after surgery

Secondary outcomes

1

Postoperative pain intensity

Postoperative pain assessed using the Visual Analogue Scale (VAS).

Time frame
At 1 month and 3 months after surgery
2

Early postoperative composite complication rate

Proportion of participants experiencing vaginal cuff dehiscence, infection, or bleeding before the initiation of adjuvant therapy.

Time frame
Within 1 month after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Azienda Ospedaliero-Universitaria di Parma

Lead sponsor

Source ClinicalTrials.gov
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