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| Name | Class |
|---|---|
| Miulli General Hospital | OTHER |
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This randomized controlled study is designed to test absorbable suture compared to non absorbable suture in laparoscopic sacral colpopexy in terms of anatomical correction of the prolapse, post-operative and long term morbidity, rate of recurrence, subjective satisfaction of the patient and rate of mesh erosion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Absorbable suture | Active Comparator | laparoscopic sacral colpopexy with absorbable suture |
|
| Non absorbable suture | Active Comparator | laparoscopic sacral colpopexy with non absorbable suture |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laparoscopic sacral colpopexy with absorbable suture | Procedure | laparoscopic sacral colpopexy to correct pelvic organ prolapse with anterior and posterior meshes with absorbable suture |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with anatomical correction of the prolapse | Anatomical correction of the prolapse evaluated by gynecological visit | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| rate mesh erosion | 1 year | |
| long term outcomes | development of nicturia, dysuria, obstructed defecation , urinary incontinence | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ospedale regionale Miulli | Acquaviva delle Fonti | Bari | 70021 | Italy |
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| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| laparoscopic sacral colpopexy with non absorbable suture | Procedure | laparoscopic sacral colpopexy to correct pelvic organ prolapse with anterior and posterior meshes with non absorbable suture |
|
| Rate of recurrence |
de novo anterior or central or posterior compartment prolapse |
| 1 year |