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

Sponsor
Aesculap AG
Study ID
NCT06024109
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Closure of the Vaginal Cuff after Total Hysterectomy — DEVICE
    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 Details

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.

Key Dates

First listed
Sep 6, 2023
Start date
Mar 19, 2024
Status verified
Jun 2026
Primary completion
Jan 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
132 participants (estimated)

Arms

  • Arm: SYMMCORA®
    Barbed suture SYMMCORA® used for the vaginal cuff closure in female patients undergoing total laparoscopic 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).
  • Arm: V-Loc®
    Barbed suture V-Loc® used for the vaginal cuff closure in female patients undergoing total laparoscopic 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).

Primary Outcome Measure

Suturing time to close the vaginal cuff [ Time Frame: intraoperatively ]

Central Contacts

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