Performance of SYMMCORA4 Mid-term Unidirectional Barbed Suture Versus V-Loc4 Suture in Laparoscopic Total Hysterectomy

What this Trial Is About

Researchers are evaluating the performance of a new unidirectional barbed suture called SYMMCORA4 in comparison to conventional suture material during vaginal cuff closure in laparoscopic total hysterectomy surgeries in female patients. The study aims to determine if SYMMCORA4 can reduce the time needed for vaginal cuff closure without increasing complication rates. Additionally, the study compares SYMMCORA4 against another barbed suture, V-Loc4, to assess which allows faster closure. Participants will be randomly assigned to one of two groups: one using the SYMMCORA4 suture and the other using the V-Loc4 suture for vaginal cuff closure during their laparoscopic total hysterectomy. Both sutures are approved for use and will be applied according to standard clinical practice and manufacturer instructions. There are no additional invasive procedures or burdens placed on patients beyond routine surgical care. During the study, researchers will measure the time to close the vaginal cuff during surgery as the primary outcome. They will also track early and longer-term complications, device performance, patient satisfaction, sexual function, pain levels, health status, and length of hospital stay up to six months after surgery. Safety and handling assessments of the sutures will be conducted intraoperatively. Participation lasts from surgery through follow-up visits at discharge, 6-8 weeks, and 6 months postoperatively.

Performance of SYMMCORA® vs. V-Loc® Suture Material in Patients Undergoing Laparoscopic Total Hysterectomy