Clinical trial · Interventional
Comparison of Self-Locking Versus Traditional Sutures in Double-Layer Laparoscopic Vaginal Vault Closure After Hysterectomy (BI-SURE Trial)
Comparison Between Double-Layer Self-Locking and Traditional Sutures in Post-Hysterectomy Laparoscopic Colporrhaphy: A Multicenter Pragmatic Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gynecologic Cancers | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
| Postoperative Complications | — | UNRESOLVED | — |
| Vaginal Cuff Dehiscence | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Double-Layer Vaginal Vault Closure with Polyglactin 910 | Procedure | — | UNRESOLVED |
| Double-Layer Vaginal Vault Closure with Self-Locking Suture | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Self-Locking Suture Group
- description
- 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.
- interventionNames
- Procedure: Double-Layer Vaginal Vault Closure with Self-Locking Suture
- type
- ACTIVE_COMPARATOR
- label
- Traditional Suture Group
- description
- 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.
- interventionNames
- Procedure: Double-Layer Vaginal Vault Closure with Polyglactin 910
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available