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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Study summary

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

Primary outcome measure(s)

• Vaginal cuff dehiscence rate — Within 3 months after surgery
  Proportion of participants experiencing vaginal cuff dehiscence requiring surgical reintervention after laparoscopic hysterectomy.
• Vaginal cuff infection rate — Within 3 months after surgery
  Proportion of participants developing vaginal cuff infection, defined as abnormal vaginal discharge with or without fever, leukocytosis, and/or local tenderness, requiring antibiotic therapy.
• Postoperative bleeding rate — Within 3 months after surgery
  Proportion of participants experiencing postoperative vaginal cuff bleeding requiring hemostatic treatment.

Trial sites (5)

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