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.