About this trial

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

Qualifiers

Females undergoing an elective, laparoscopic total hysterectomy

Age ≥ 18 years

Written informed consent

Disqualifiers

Emergency surgery

Open surgery

Patients undergone immunosuppressive drug treatment within the prior 6 months

Patients with hypersensitivity or allergy to the suture material.

Trial design

Treatments tested in this trial

  • Closure of the Vaginal Cuff after Total Hysterectomy

Treatment groups

132 Participants
are divided into 2 treatment groups

Locations

2
Germany
Klinikum Sachsenhausen der DGD60594, Frankfurt am MainHesse, Germany
Spain
Hospital Sant Joan de Déu de Manresa08243, ManresaBarcelona, Spain

Sponsors and collaborators

Aesculap AG

Lead sponsor

B.Braun Surgical SA

Collaborator