Study Comparing Double-Layer Self-Locking and Traditional Sutures for Laparoscopic Vaginal Vault Closure After Hysterectomy in Gynecologic Cancer Patients

What this Trial Is About

Researchers are evaluating the best suture technique for closing the vaginal vault after laparoscopic or robotic hysterectomy in patients treated for gynecologic cancers. The study compares two methodsdouble-layer self-locking sutures and traditional double-layer Polyglactin 910 suturesto understand their effects on postoperative complications such as vaginal cuff dehiscence, infection, and bleeding. This multicenter randomized controlled trial aims to improve surgical outcomes and safety within three months after surgery. Participants are randomly assigned to receive one of two laparoscopic vaginal vault closure procedures following hysterectomy a double-layer continuous suturing with self-locking barbed sutures or with traditional braided Polyglactin 910 sutures. Both techniques follow current clinical practice standards. The trial monitors participants for up to three months post-surgery to compare rates of vaginal cuff-related complications and postoperative pain. Throughout the study, participants undergo assessments to track outcomes such as vaginal cuff dehiscence, infection, bleeding, and pain intensity at one and three months after surgery. Early postoperative complications within the first month are also recorded. The trial involves follow-up visits during this period to carefully monitor safety and effectiveness of each suturing technique. Participation duration lasts approximately three months from surgery to outcome evaluation.

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