Actively Recruiting
Performance of SYMMCORA® vs. V-Loc® Suture Material in Patients Undergoing Laparoscopic Total Hysterectomy
Led by Aesculap AG · Updated on 2025-05-13
132
Participants Needed
2
Research Sites
145 weeks
Total Duration
On this page
Sponsors
A
Aesculap AG
Lead Sponsor
B
B.Braun Surgical SA
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Performance of SYMMCORA® vs. V-Loc® Suture Material in Patients Undergoing Laparoscopic Total Hysterectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients undergoing elective laparoscopic total hysterectomy
- Age 18 years or older
- Able to give written informed consent
You will not qualify if you...
- Emergency surgery
- Open surgery
- Use of immunosuppressive drugs within the prior 6 months
- Allergy or hypersensitivity to the suture materials
- Participation in another clinical study
- Patient non-compliance
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Klinikum Sachsenhausen der DGD
Frankfurt am Main, Hesse, Germany, 60594
Actively Recruiting
2
Hospital Sant Joan de Déu de Manresa
Manresa, Barcelona, Spain, 08243
Actively Recruiting
Research Team
P
Petra Baumann
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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