Using synthetic glue for mesh fixation in laparoscopic surgery for pelvic organ prolapse
Evaluation of the Use of Synthetic Glue for Mesh Fixation in Laparoscopic Sacrocolpopexy
This study is testing if a special glue can help fix mesh faster during surgery for pelvic organ prolapse, making the procedure easier and safer for patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Brno University Hospital Academic / other |
| Locations | 1 site (Brno, Czech Republic) |
| Trial ID | NCT06872983 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of cyanoacrylate adhesive in laparoscopic sacrocolpopexy, a minimally invasive procedure for treating apical prolapse. The goal is to reduce the operative time, which often exceeds 180 minutes due to the complexity of the surgery. By comparing traditional suture fixation methods with cyanoacrylate adhesives, the study aims to determine if the latter can decrease fixation time and potentially lower the risk of postoperative complications. The trial will involve patients who meet specific criteria related to pelvic organ prolapse severity and surgical indications.
Who should consider this trial
Good fit: Ideal candidates are women with pelvic organ prolapse of second stage or higher who are indicated for laparoscopic sacropexy.
Not a fit: Patients requesting uterine preservation or those with previous hysterectomy or malignancies of the female reproductive organs may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to shorter surgical times and reduced complications for patients undergoing laparoscopic sacrocolpopexy.
How similar studies have performed: There are limited studies on the use of cyanoacrylate adhesives for implant fixation, indicating this approach may be novel or underexplored.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Sufficient knowledge of the Czech language * Pelvic organs prolapse of second stage or higher according to POPQ classification (POPQ ≥ 2) * Patients indicated for laparoscopic sacropexy - sacrocervicopexy with concomitant supracervical hysterectomy Exclusion Criteria: * Patients requesting uterine preservation * Patients with previous hysterectomy * Patients with premalignancy or malignancy of the female reproductive organs * Concomitant urethropexy
Where this trial is running
Brno, Czech Republic
- Brno University Hospital — Brno, Czech Republic, Czechia (Recruiting)
Study contacts
- Principal investigator: Samuel Tvarozek, MD — Department of Obstetrics and Gynecology, University Hospital Brno, Brno, Czech Republic
- Study coordinator: Samuel Tvarozek, MD
- Email: tvarozek.samuel@fnbrno.cz
- Phone: +420532238207
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.