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

Last updated: December 3, 2024
Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT06720831
SACROMESH
  • Ages 18-80
  • Female

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 Criteria

Inclusion

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

Exclusion Criteria:

  • Age > 80 years

  • Previous genital prolapse surgery

Study Design

Total Participants: 160
Study Start date:
December 01, 2024
Estimated Completion Date:
March 31, 2025

Study Description

There is a lack of data in the literature comparing sacroplexing with the use of mesh with sacroplexing performed without the use of mesh in terms of recurrence, improvement in symptoms, and restoration of normal pelvic organ prolapse relationships. The objective of this study is to determine 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 who underwent laparoscopic sacroplasty with mesh (group 1) and without mesh (group 2). The study may provide information on the impact of mesh in laparoscopic surgery for the correction of central pelvic organ prolapse.

Connect with a study center

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    Bologna, 40138
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Universitaria Integrata di Verona

    Verona, 37126
    Italy

    Site Not Available

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