Comparison Between Double-Layer Self-Locking and Traditional Sutures in Post-Hysterectomy Laparoscopic Colporrhaphy: A Multicenter Pragmatic Randomized Controlled Trial

What this Trial Is About

Researchers are evaluating the best suture material and technique for closing the vaginal vault after laparoscopic or robotic hysterectomy in patients treated for gynecologic cancers. This study focuses on comparing double-layer self-locking sutures with traditional double-layer Polyglactin 910 sutures. The goal is to assess postoperative complications such as vaginal cuff dehiscence, infection, and bleeding within three months after surgery. Participants will be randomly assigned to receive one of two suturing methods during their laparoscopic vaginal vault closure following hysterectomy. One group will have a double-layer continuous closure using self-locking (barbed) sutures, while the other group will have the same closure technique using traditional braided Polyglactin 910 sutures. Both procedures follow current clinical standards and are performed after surgery for gynecologic malignancies. During the study, researchers will monitor participants for up to three months after surgery to evaluate the rates of vaginal cuff-related complications and postoperative bleeding. They will also assess pain levels at one and three months post-surgery and track early composite complications within the first month. This includes clinical evaluations and follow-ups to determine safety and effectiveness of the suturing methods.

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