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

NCT07313839 | Recruiting

• 1 other identifier: 415/2024/DISP/AOUPR
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Vaginal Cuff Dehiscence; Postoperative Complications; Gynecologic Cancers

Keywords

Laparoscopic hysterectomy; Vaginal vault closure; Colporrhaphy; Self-locking suture; Barbed suture; Polyglactin 910; Gynecologic oncology; Postoperative complications; Randomized controlled trial

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Postoperative pain intensity

  At 1 month and 3 months after surgery

• Early postoperative composite complication rate

  Within 1 month after surgery

Study Arms (2)

Self-Locking Suture Group

EXPERIMENTAL

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

Traditional Suture Group

ACTIVE COMPARATOR

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

Interventions

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.

Self-Locking Suture Group

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.

Traditional Suture Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Laparotomic or vaginal hysterectomy
• Contraindication to laparoscopic vaginal vault closure

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria di Parma: lead

Study Sites (5)

Department of Medicine and Surgery, University Hospital of Parma

Parma, Italy, 43125, Italy

RECRUITING

Division of Oncologic Gynecology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, 40138 Bologna, Italy.

Bologna, Italy

NOT YET RECRUITING

Department of Obstetrics and Gynecology, Ospedale Santa Croce e Carle, Cuneo, Italy.

Cuneo, Italy

RECRUITING

Department of Gynecologic Oncology. Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.

Milan, Italy

NOT YET RECRUITING

Clinic of Obstetrics and Gynecology, "Santa Maria della Misericordia" University Hospital, Azienda Sanitaria Universitaria Friuli Centrale, Udine, Italy.

Udine, Italy

NOT YET RECRUITING

MeSH Terms

Conditions

Postoperative Complications

Interventions

Polyglactin 910

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Polyesters; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Central Study Contacts

Vito Andrea Capozzi

CONTACT

0521704819; vcapozzi@ao.pr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vito Andrea Capozzi, M.D. Department of Medicine and Surgery University Hospital of Parma, Parma, Italy

Model Details: 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.

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: January 2, 2026
• Study Start: October 7, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (5)