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

Condition(s) studied

Investigational drug(s) / intervention(s)

Closure of the Vaginal Cuff after Total Hysterectomy: Closure of the vaginal cuff in patients undergoing laparoscopic total hysterectomy. The product under investigation and the comparator suture material will be used in routine clinical practice and according to the Instructions for Use (IfU).

Study 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

Primary outcome measure(s)

• Suturing time to close the vaginal cuff — intraoperatively
  Measured in Minutes. Time to perform the vaginal cuff closure after laparoscopic total hysterectomy using a stop watch. Time starts when the needle passes the first time the tissue and ends after completion of the wound closure (cut of the needle from the thread).

Trial sites (2)

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