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

Last updated: May 12, 2025
Sponsor: Aesculap AG
Overall Status: Active - Recruiting

Phase

N/A

Condition

Uterine Cancer

Endometriosis

Endometrial Cancer

Treatment

Closure of the Vaginal Cuff after Total Hysterectomy

Clinical Study ID

NCT06024109
AAG-O-H-2001
  • Ages > 18
  • Female

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 Criteria

Inclusion

Inclusion Criteria:

  • Females undergoing an elective, laparoscopic total hysterectomy

  • Age ≥ 18 years

  • Written informed consent

Exclusion

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

Study Design

Total Participants: 132
Treatment Group(s): 1
Primary Treatment: Closure of the Vaginal Cuff after Total Hysterectomy
Phase:
Study Start date:
March 19, 2024
Estimated Completion Date:
January 31, 2027

Connect with a study center

  • Klinikum Sachsenhausen der DGD

    Frankfurt/Main, Hessen 60594
    Germany

    Active - Recruiting

  • Hospital Sant Joan de Déu de Manresa

    Manresa, Barcelona 08243
    Spain

    Active - Recruiting

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