Actively Recruiting
Evaluation of Synthetic Glue Versus Standard Sutures for Mesh Fixation in Laparoscopic Sacrocolpopexy for Apical Prolapse
Led by Brno University Hospital · Updated on 2025-03-20
40
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effect of a synthetic cyanoacrylate-based tissue adhesive for implant fixation during laparoscopic sacrocolpopexy, a standard treatment for apical prolapse. This condition involves pelvic organ descent of grade 2 or higher. The study aims to compare the adhesive method with traditional suturing to see if it reduces implant fixation time, overall surgery duration, and postoperative complications while also assessing cost-effectiveness. This randomized prospective study includes adult women aged 18 to 75 years and excludes those with uterine preservation requests, prior hysterectomy, or uterine malignancies. Participants will be divided into two groups: one where the mesh implant is fixed to the vaginal walls using cyanoacrylate adhesive combined with non-absorbable sutures, and another using the standard method with absorbable and non-absorbable sutures. Both groups undergo a supracervical hysterectomy performed in a standard manner before implant fixation. The study will evaluate differences in fixation time, total operation time, and postoperative outcomes including pain and complications over follow-up periods. During the study, researchers will use questionnaires such as the POPQ for anatomical assessment and PFDI-20 to measure discomfort, along with pain evaluation using the VAS scale. Outcomes like prolapse recurrence, quality of life, sexual function, and mesh-related complications will be tracked up to 12 months post-surgery. Cost-effectiveness will also be analyzed based on hospital reports. The trial aims to reduce fixation time by at least 20 minutes, providing important data on this adhesive method compared to traditional sutures in laparoscopic sacrocolpopexy.
CONDITIONS
Brief Title
Evaluation of the Use of Synthetic Glue for Mesh Fixation in Laparoscopic Sacrocolpopexy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Sufficient knowledge of the Czech language
- Pelvic organ prolapse of stage 2 or higher according to POPQ classification
- Patients indicated for laparoscopic sacrocolpopexy with concomitant supracervical hysterectomy
- Female participants aged 18 to 75 years
You will not qualify if you...
- Patients requesting uterine preservation
- Patients with previous hysterectomy
- Patients with premalignancy or malignancy of the female reproductive organs
- Patients undergoing concomitant urethropexy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo laparoscopic sacrocolpopexy with mesh fixation using either synthetic glue or standard sutures, followed by immediate post-operative care.
1 surgery visit
Duration - 12 months
Participants are monitored for peri- and post-operative complications, pain intensity, and recovery over a 12-month period.
Visits at 6, 24, and 48 hours after surgery and additional visits up to 12 months
Trial Site Locations
Total: 1 location
1
Brno University Hospital
Brno, Czech Republic, Czechia, 62500
Actively Recruiting
Research Team
S
Samuel Tvarozek, MD
M
Martina Szypulová, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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