RecruitingNCT06024109

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

Prospective, International, Randomized, Multicentric, Controlled Study on the Performance of SYMMCORA® Mid-term Unidirectional Barbed Suture Versus V-loc® Suture Material in Patients Undergoing Laparoscopic Total Hysterectomy


Sponsor

Aesculap AG

Enrollment

132 participants

Start Date

Mar 19, 2024

Study Type

OBSERVATIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria3

  • Females undergoing an elective, laparoscopic total hysterectomy
  • Age ≥ 18 years
  • Written informed consent

Exclusion Criteria6

  • 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

Interventions

DEVICEClosure 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).


Locations(2)

Klinikum Sachsenhausen der DGD

Frankfurt am Main, Hesse, Germany

Hospital Sant Joan de Déu de Manresa

Manresa, Barcelona, Spain

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NCT06024109


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