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

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.

Study Overview

• Status: Recruiting
• Conditions: Female Genital Prolapse

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 Type: Observational
• Enrollment (Estimated): 160

Contacts and Locations

• Study Contact: Name: Diego Raimondo, MD; Phone Number: +393290636618; Email: die.raimondo@gmail.com
• Study Contact Backup: Name: Manuela Maletta, MD; Email: manuela.maletta@studio.unibo.it

Study Locations

• Italy
  • Bologna, Italy, 40138
    • Recruiting
    • IRCCS Azienda Ospedaliero-Universitaria di Bologna
    • Contact: Diego Raimondo, MD; Phone Number: +393290636618; Email: die.raimondo@gmail.com
  • Verona, Italy, 37126
    • Not yet recruiting
    • Azienda Ospedaliera Universitaria Integrata di Verona
    • Contact: Stefano Scarperi, MD; Phone Number: +393207081860; Email: stefano.scarperi@aovr.veneto.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with genital prolapse stage ≥ 2 according to the POP-Q classification undergoing laparoscopic sacroplexxy with mesh and laparoscopic sacropexy without mesh

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence rate of central pelvic organ prolapse	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	24 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence rate of central pelvic organ prolapse in laparoscopic sacral hysteropexy, sacralcervicopexy and sacralcolpopexy	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	24 months after surgery
Rate of intraoperative and postoperative complications	Evaluation of intraoperative and postoperative complications according to the Clavien-Dindo classification	During surgery and within 30 days
Modification of symptoms after surgery	Change in pre- and post-operative symptomatology assessed through the completion of a questionnaire	Before surgery and 24 months after surgery
Changes in the disease framework	Change in the disease framework of pelvic organ prolapse according to the POP-Q classification assessed before and after surgery	Before surgery and 24 months after surgery

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Investigators: Principal Investigator: Diego Raimondo, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: December 3, 2024
• First Submitted That Met QC Criteria: December 3, 2024
• First Posted (Estimated): December 6, 2024

Study Record Updates

• Last Update Posted (Estimated): December 6, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: prolapse; mesh; sacropexy; gynaecology; female genital
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathological Conditions, Anatomical; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Prolapse; Genital Diseases, Female
• Other Study ID Numbers: SACROMESH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No