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

The aim of this study is to show the superiority of the new unidirectional barbed suture (SYMMCORA® mid-term, unidirectional) to conventional suture material in terms of time to perform the vaginal cuff closure during gynecologic surgeries without an increase in the complication rate. Secondly, the superiority of SYMMCORA®, mid-term unidirectional compared to the V-Loc®, unidirectional will be assessed regarding the mean time to close the vaginal cuff. The study will be performed in routine clinical setting, the only difference will be the randomization into two different suture groups. Both suture materials which will be applied to approximate the vaginal cuff are approved and carrying the CE-marks. Additionally, both sutures will be applied in their intended use. Neither additional invasive measures nor additional burden in regard to the patient will be performed.

NCT Number	NCT06024109
Lead Sponsor	Aesculap AG Collaborators: B.Braun Surgical SA
Conditions	Abnormal Uterine Bleeding, Endometriosis, Uterine Prolapse, Uterine Cancer, Ovarian Cancer, Fallopian Tube Cancer, Cervical Cancer, Endometrial Cancer
Enrollment	132 participants
Start Date	2024-03-19
Primary Completion	2027-01 (estimated)
Study Completion	2027-08 (estimated)
Updated on ClinicalTrials.gov	2026-06-02