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

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

Study Overview

• Status: Recruiting
• Conditions: Postoperative Complications; Vaginal Cuff Dehiscence; Gynecologic Cancers
• Intervention / Treatment: Procedure: Double-Layer Vaginal Vault Closure with Self-Locking Suture; Procedure: Double-Layer Vaginal Vault Closure with Polyglactin 910

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.

• Study Type: Interventional
• Enrollment (Estimated): 310
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vito Andrea Capozzi; Phone Number: 0521704819; Email: vcapozzi@ao.pr.it

Study Locations

• Italy
  • Bologna, Italy
    • Not yet recruiting
    • Division of Oncologic Gynecology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, 40138 Bologna, Italy.
    • Contact: De Iaco; Email: pierandrea.deiaco@unibo.it
  • Cuneo, Italy
    • Recruiting
    • Department of Obstetrics and Gynecology, Ospedale Santa Croce e Carle, Cuneo, Italy.
    • Contact: Puppo; Email: puppoand@hotmail.com
  • Milan, Italy
    • Not yet recruiting
    • Department of Gynecologic Oncology. Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.
    • Contact: Bogani; Email: bogani.giorgio@gmail.com
  • Udine, Italy
    • Not yet recruiting
    • Clinic of Obstetrics and Gynecology, "Santa Maria della Misericordia" University Hospital, Azienda Sanitaria Universitaria Friuli Centrale, Udine, Italy.
    • Contact: Vizzielli; Email: giuseppevizzielli@yahoo.it
  • Italy
    • Parma, Italy, Italy, 43125
      • Recruiting
      • Department of Medicine and Surgery, University Hospital of Parma
      • Contact: Capozzi; Phone Number: 0521704819; Email: vcapozzi@ao.pr.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vaginal cuff dehiscence rate	Proportion of participants experiencing vaginal cuff dehiscence requiring surgical reintervention after laparoscopic hysterectomy.	Within 3 months after surgery
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.	Within 3 months after surgery
Postoperative bleeding rate	Proportion of participants experiencing postoperative vaginal cuff bleeding requiring hemostatic treatment.	Within 3 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain intensity	Postoperative pain assessed using the Visual Analogue Scale (VAS).	At 1 month and 3 months after surgery
Early postoperative composite complication rate	Proportion of participants experiencing vaginal cuff dehiscence, infection, or bleeding before the initiation of adjuvant therapy.	Within 1 month after surgery

Collaborators and Investigators

• Sponsor: Azienda Ospedaliero-Universitaria di Parma

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: December 18, 2025
• First Submitted That Met QC Criteria: December 18, 2025
• First Posted (Estimated): January 2, 2026

Study Record Updates

• Last Update Posted (Estimated): January 2, 2026
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Postoperative complications; Laparoscopic hysterectomy; Polyglactin 910; Barbed suture; Colporrhaphy; Gynecologic oncology; Vaginal vault closure; Self-locking suture
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Polyesters; Polyglactin 910
• Other Study ID Numbers: 415/2024/DISP/AOUPR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared because the study is conducted within a hospital-based academic setting and no data repository has been designated for public data release. Data will be stored securely at the sponsor institution and will be accessible only to authorized study personnel in compliance with applicable privacy regulations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes