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

Recruiting

• Conditions: Female Genital Prolapse

• Registration Number: NCT06720831
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2024-10
• Study Start: 2024-12
• Study First Submitted: 2024-12-03
• Study First Submitted QC: 2024-12-03
• Last Update Submitted: 2024-12-03
• Study First Posted: 2024-12-06
• Last Update Posted: 2024-12-06
• Primary Completion: 2025-01
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 160

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Recurrence rate of central pelvic organ prolapse in laparoscopic sacral hysteropexy, sacralcervicopexy and sacralcolpopexy	24 months after surgery	The rate of pelvic organ prolapse recurrence in patients treated with mesh (group 1) and without (group 2) in the laparoscopic sacral hysteropexy, sacralcervicopexy and sacralcolpopexy
Rate of intraoperative and postoperative complications	During surgery and within 30 days	Evaluation of intraoperative and postoperative complications according to the Clavien-Dindo classification
Modification of symptoms after surgery	Before surgery and 24 months after surgery	Change in pre- and post-operative symptomatology assessed through the completion of a questionnaire
Changes in the disease framework	Before surgery and 24 months after surgery	Change in the disease framework of pelvic organ prolapse according to the POP-Q classification assessed before and after surgery

Trial Locations

Locations (2)

IRCCS Azienda Ospedaliero-Universitaria di Bologna; 🇮🇹 Bologna, Italy

Azienda Ospedaliera Universitaria Integrata di Verona; 🇮🇹 Verona, Italy