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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.
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.
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with genital prolapse stage ≥ 2 according to the POP-Q classification undergoing laparoscopic sacroplexxy with mesh and laparoscopic sacropexy without mesh
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Diego Raimondo, MD | Contact | +393290636618 | die.raimondo@gmail.com | |
| Manuela Maletta, MD | Contact | manuela.maletta@studio.unibo.it |
| Name | Affiliation | Role |
|---|---|---|
| Diego Raimondo, MD | IRCCS Azienda Ospedaliero-Universitaria di Bologna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Azienda Ospedaliero-Universitaria di Bologna | Recruiting | Bologna | Bologna | 40138 | Italy |
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| ID | Term |
|---|---|
| D011391 | Prolapse |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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 |
| Azienda Ospedaliera Universitaria Integrata di Verona | Not yet recruiting | Verona | Verona | 37126 | Italy |
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