Female Genital Prolapse
Conditions
Keywords
prolapse, female genital, gynaecology, sacropexy, 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.
Interventions
None listed
Sponsors
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Italy
Contacts
Primary ContactDiego Raimondo, MD
Backup ContactManuela Maletta, MD
Outcome results
None listed