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Clinical Trials in Italy / NCT06720831
Recruiting Observational

Role of Mesh in Laparoscopic Sacropexy Surgical Techniques for the Treatment of Female Genital Prolapse

NCT06720831 · tracked via the Priya Life Science Italy tracker
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Phase
Observational
Started
2024-12
Last updated
2024-12-06

Condition(s) studied

Female Genital Prolapse

Study summary

This study aims to determine the rate of recurrence of central pelvic organ prolapse in patients who have undergone surgery (sacropexy with and without mesh) for the same pathology.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Recurrence rate of central pelvic organ prolapse — 24 months after surgery
    The rate of recurrence of central pelvic organ prolapse in patients with a clinical diagnosis of genital prolapse stage ≥ 2 according to the POP-Q classification, undergoing sacroplasty with and without mesh

Trial sites (2)

FacilityCityRegionStatus
IRCCS Azienda Ospedaliero-Universitaria di Bologna Bologna Bologna Recruiting
Azienda Ospedaliera Universitaria Integrata di Verona Verona Verona Not Yet Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06720831 on ClinicalTrials.gov ↗ ← All trials in Italy