Comparing two types of sutures for vaginal cuff closure in laparoscopic 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
This study is testing whether a new type of suture can close the vaginal cuff faster than a standard suture for women having laparoscopic hysterectomy, without causing more complications.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 132 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Aesculap AG Industry-sponsored |
| Locations | 2 sites (Frankfurt am Main, Hesse and 1 other locations) |
| Trial ID | NCT06024109 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the performance of SYMMCORA®, a new unidirectional barbed suture, against the conventional V-Loc® suture material in patients undergoing laparoscopic total hysterectomy. The primary focus is to evaluate which suture allows for a quicker closure of the vaginal cuff without increasing complication rates. The study will be conducted in a routine clinical setting, with participants randomly assigned to one of the two suture groups. Both sutures are CE-marked and will be used as intended, ensuring no additional invasive measures or burdens on the patients.
Who should consider this trial
Good fit: Ideal candidates are females aged 18 and older who are scheduled for an elective laparoscopic total hysterectomy.
Not a fit: Patients undergoing emergency or open surgeries, or those with allergies to the suture materials, will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to faster surgical procedures and improved recovery times for patients undergoing laparoscopic hysterectomy.
How similar studies have performed: Previous studies have shown promising results with similar suture materials, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Frankfurt am Main, Hesse and 1 other locations
- Klinikum Sachsenhausen der DGD — Frankfurt am Main, Hesse, Germany (Recruiting)
- Hospital Sant Joan de Déu de Manresa — Manresa, Barcelona, Spain (Recruiting)
Study contacts
- Principal investigator: Amadeus Hornemann, Prof. Dr. — Klinikum Sachsenhausen der DGD
- Study coordinator: Petra Baumann
- Email: petra.baumann@aesculap.de
- Phone: +49746195
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.