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

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status: Enrolling

Conditions: Female Genital Prolapse

Study type: Observational

Funder types: Other

Identifiers

NCT06720831

SACROMESH

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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