Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Miulli General Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
This randomized controlled study is designed to test the non inferiority of no attachment of posterior mesh compared to fixation of posterior mesh to the vagina in laparoscopic sacral colpopexy in terms of anatomical correction of the prolapse, post-operative and long term morbidity and rate of recurrence.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| posterior mesh no attachment | Active Comparator | laparoscopic sacral colpopexy with no fixation of posterior mesh |
|
| posterior mesh attachment | Active Comparator | laparoscopic sacral colpopexy with fixation of posterior mesh by suture |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laparoscopic sacral colpopexy with posterior mesh no attachment | Procedure | pelvic organ prolapse correction with laparoscopic sacralcolpopexy with no attachement of posterior mesh |
| Measure | Description | Time Frame |
|---|---|---|
| correction of pelvic organ prolapse | number of women with correction of prolapse mesured in S POP-Q stage during FU visit | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| rate of recurrence | number of women with de novo anterior or posterior or central prolapse | 1 year |
| long term outcomes | number of women with nicturia, dysuria, obstructed defecation , urinary incontinence, pelvic pain |
Not provided
Inclusion Criteria:
-patients who required surgical treatment for symptomatic pelvic organ prolapse stage ≥ 2 with or without stress urinary incontinence
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maurizio Guido | Contact | 3393894243 | maurizioguido@libero.it |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ospedale regionale Miulli | Recruiting | Acquaviva delle Fonti | Bari | 70021 | Italy |
Not provided
| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| laparoscopic sacral colpopexy with posterior mesh attachment | Procedure | pelvic organ prolapse correction with laparoscopic sacralcolpopexy with the attachement of posterior mesh to vagina |
|
| 1 year |