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

Plain Language Summary

Simplified for easier understanding

This study is comparing two types of dissolving stitches (sutures) used to close wounds during laparoscopic (minimally invasive) hysterectomy surgery — SYMMCORA and V-Loc. The goal is to see which suture performs better in terms of healing, ease of use, and patient outcomes. **You may be eligible if...** - You are a woman aged 18 or older - You are scheduled for a planned (non-emergency) laparoscopic total hysterectomy **You may NOT be eligible if...** - You need emergency surgery - You require open (non-laparoscopic) surgery - You have taken immunosuppressant drugs in the past 6 months - You have an allergy to the suture materials being tested - You are already participating in another clinical study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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