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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

132 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-19

Study Completion Date

2027-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Abnormal Uterine Bleeding Endometriosis Uterine Prolapse Uterine Cancer Ovarian Cancer Fallopian Tube Cancer Cervical Cancer Endometrial Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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SYMMCORA®

Barbed suture SYMMCORA® used for the vaginal cuff closure in female patients undergoing total laparoscopic 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).

Closure of the Vaginal Cuff after Total Hysterectomy

Intervention Type DEVICE

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).

V-Loc®

Barbed suture V-Loc® used for the vaginal cuff closure in female patients undergoing total laparoscopic 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).

Closure of the Vaginal Cuff after Total Hysterectomy

Intervention Type DEVICE

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).

Interventions

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Closure 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).

Intervention Type DEVICE

Other Intervention Names

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Suturing

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No