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

Recruitingn/aAges 18 Years - anyFemaleAesculap AG
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Females undergoing an elective, laparoscopic total hysterectomy * Age ≥ 18 years * Written informed consent 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
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What it tests

  • Closure of the Vaginal Cuff after Total Hysterectomy
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Where

2 sites
Klinikum Sachsenhausen der DGD
Frankfurt am Main, Germany
Hospital Sant Joan de Déu de Manresa
Manresa, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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