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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

310 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-07

Study Completion Date

2027-01-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Gynecologic Cancers Vaginal Cuff Dehiscence Postoperative Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a multicenter, pragmatic, randomized controlled trial with a parallel assignment design. Eligible patients will be randomized in a 1:1 ratio to receive either double-layer self-locking sutures or double-layer traditional Polyglactin 910 sutures for laparoscopic vaginal vault closure following hysterectomy for gynecologic malignancy. The study is triple-blinded, with participants, outcome assessors, and statisticians masked to treatment allocation.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Self-Locking Suture Group

Participants randomized to this arm will undergo laparoscopic vaginal vault closure after hysterectomy using a double-layer continuous suturing technique performed with a self-locking (barbed) suture, according to current clinical practice.

Group Type EXPERIMENTAL

Double-Layer Vaginal Vault Closure with Self-Locking Suture

Intervention Type PROCEDURE

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

Traditional Suture Group

Participants randomized to this arm will undergo laparoscopic vaginal vault closure after hysterectomy using a double-layer continuous suturing technique performed with traditional braided Polyglactin 910 suture, according to current clinical practice.

Group Type ACTIVE_COMPARATOR

Double-Layer Vaginal Vault Closure with Polyglactin 910

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing laparoscopic or robotically assisted hysterectomy for gynecologic malignant disease
* Age ≥ 18 years
* Ability to provide written informed consent