Clinical trial NCT06720831: Role of Mesh in Laparoscopic Sacropexy Surgical Techniques for the Treatment of Female Genital Prolapse
Official title: Role of Mesh in Laparoscopic Sacropexy Surgical Techniques for the Treatment of Female Genital Prolapse
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Female Genital Prolapse
Keywords: prolapse
female genital
gynaecology
sacropexy
mesh
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2024-12-06
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.

Eligibility criteria: 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 outcomes:
measure: Recurrence rate of central pelvic organ prolapse
timeFrame: 24 months after surgery
Secondary outcomes:
measure: Recurrence rate of central pelvic organ prolapse in laparoscopic sacral hysteropexy, sacralcervicopexy and sacralcolpopexy
timeFrame: 24 months after surgery
measure: Rate of intraoperative and postoperative complications
timeFrame: During surgery and within 30 days
measure: Modification of symptoms after surgery
timeFrame: Before surgery and 24 months after surgery
measure: Changes in the disease framework
timeFrame: Before surgery and 24 months after surgery
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata di Verona
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Diego Raimondo, MD
role: PRINCIPAL_INVESTIGATOR
References: