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.
Females undergoing an elective, laparoscopic total hysterectomy
Age ≥ 18 years
Written informed consent
Emergency surgery
Open surgery
Patients undergone immunosuppressive drug treatment within the prior 6 months
Patients with hypersensitivity or allergy to the suture material.
Aesculap AG
Lead sponsor
B.Braun Surgical SA
Collaborator