Gynecologic Cancers, Postoperative Complications, Vaginal Cuff Dehiscence
Conditions
Keywords
Laparoscopic hysterectomy, Vaginal vault closure, Colporrhaphy, Self-locking suture, Barbed suture, Polyglactin 910, Gynecologic oncology, Postoperative complications, Randomized controlled trial
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.
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.
Interventions
PROCEDUREDouble-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.
PROCEDUREDouble-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.
Sponsors
Azienda Ospedaliero-Universitaria di Parma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vaginal cuff dehiscence rate | Within 3 months after surgery | Proportion of participants experiencing vaginal cuff dehiscence requiring surgical reintervention after laparoscopic hysterectomy. |
| Vaginal cuff infection rate | 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. |
| Postoperative bleeding rate | Within 3 months after surgery | Proportion of participants experiencing postoperative vaginal cuff bleeding requiring hemostatic treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain intensity | At 1 month and 3 months after surgery | Postoperative pain assessed using the Visual Analogue Scale (VAS). |
| Early postoperative composite complication rate | Within 1 month after surgery | Proportion of participants experiencing vaginal cuff dehiscence, infection, or bleeding before the initiation of adjuvant therapy. |
Countries
Italy
Contacts
CONTACTVito Andrea Capozzi
Outcome results
None listed