Performance of SYMMCORA® vs. V-Loc® Suture Material in Patients Undergoing Laparoscopic Total Hysterectomy
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Females undergoing an elective, laparoscopic total hysterectomy * Age ≥ 18 years * Written informed consent Exclusion Criteria: * Emergency surgery * Open surgery * Patients undergone immunosuppressive drug treatment within the prior 6 months * Patients with hypersensitivity or allergy to the suture material. * Participation in another clinical study * Non-compliance of patient