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.
Patients undergoing laparoscopic or robotically assisted hysterectomy for gynecologic malignant disease
Age ≥ 18 years
Ability to provide written informed consent
Laparotomic or vaginal hysterectomy
Contraindication to laparoscopic vaginal vault closure