Evaluating the use of mesh in laparoscopic surgery for female genital prolapse
Role of Mesh in Laparoscopic Sacropexy Surgical Techniques for the Treatment of Female Genital Prolapse
This study is testing whether using mesh in laparoscopic surgery helps women with pelvic organ prolapse have better outcomes and lower chances of their condition coming back compared to surgery without mesh.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 160 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Female |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 2 sites (Bologna, Bologna and 1 other locations) |
| Trial ID | NCT06720831 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare the recurrence rates of central pelvic organ prolapse in women who have undergone laparoscopic sacropexy with and without the use of mesh. It focuses on patients diagnosed with genital prolapse stage ≥ 2 according to the POP-Q classification. The study will assess the impact of mesh on surgical outcomes, including symptom improvement and restoration of normal pelvic organ relationships, over a follow-up period of 24 months. By analyzing these two surgical techniques, the study seeks to fill a gap in existing literature regarding the effectiveness of mesh in this context.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 to 80 years with a clinical diagnosis of genital prolapse stage ≥ 2 who are undergoing laparoscopic sacropexy.
Not a fit: Patients over the age of 80 or those who have previously undergone genital prolapse surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the optimal surgical approach for treating female genital prolapse, potentially improving patient outcomes.
How similar studies have performed: While there is limited data comparing the use of mesh in laparoscopic sacropexy, this study aims to address a significant gap in the literature, suggesting a novel approach to understanding this surgical technique.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Clinical diagnosis of genital prolapse stage ≥ 2 according to POP-Q classification * Surgical treatment of laparoscopic sacropexy by mesh (group 1) and without (group 2) in female patients * Acquisition of informed consent * At least one follow-up evaluation at 24 months Exclusion Criteria: * Age \> 80 years * Previous genital prolapse surgery
Where this trial is running
Bologna, Bologna and 1 other locations
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Bologna, Italy (Recruiting)
- Azienda Ospedaliera Universitaria Integrata di Verona — Verona, Verona, Italy (Not_yet_recruiting)
Study contacts
- Principal investigator: Diego Raimondo, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Diego Raimondo, MD
- Email: die.raimondo@gmail.com
- Phone: +393290636618
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.