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NCT Number: NCT07313839

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

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Key information

Conditions

Gynecologic Cancers Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Vaginal Cuff Dehiscence

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Medicine and Surgery, University Hospital of Parma, Parma, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Double-Layer Vaginal Vault Closure with Self-Locking Suture

Procedure

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

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

Primary outcomes

  1. Vaginal cuff dehiscence rate

    Time frame: Within 3 months after surgery

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

  2. Vaginal cuff infection rate

    Time frame: 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.

  3. Postoperative bleeding rate

    Time frame: Within 3 months after surgery

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

Secondary outcomes

  1. Postoperative pain intensity

    Time frame: At 1 month and 3 months after surgery

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

  2. Early postoperative composite complication rate

    Time frame: Within 1 month after surgery

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

Study contacts

Contact information is provided by the study sponsor or research team.

Vito Andrea Capozzi

CONTACT

[email protected]

0521704819

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero-Universitaria di Parma

Other

Registry information

Official study title

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

Acronym: BI-SURE

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 2, 2026
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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