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| Name | Class |
|---|---|
| Spaarne Gasthuis | OTHER |
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The goal of this study is to evaluate whether adding perineoplasty is, in comparison to performing vaginal prolapse surgery without adding perineoplasty, superior with respect to efficacy and cost-effectiveness and non-inferior with respect to morbidity, in patients undergoing vaginal surgical correction of pelvic organ prolapse at 24 months after surgery.
Preoperative measurements, performed at baseline:
Postoperative measurements:
Extra follow up:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Operative procedure; standard treatment | Vaginal level I and/or level II repair will be performed as usual (eg anterior and/or posterior colporrhaphy, sacrospinous fixation etc.) without perineoplasty as decided by surgeon and patient. This procedure is considered as the control group. | ||
| Operative procedure; standard treatment including level III repair | Vaginal level I and/or level II repair will be performed as usual, but now including perineoplasty (level III repair) as decided by surgeon and patient. The decision of a perineoplasty to vaginal level I and/or level II repair is based on a shared decision made by surgeon together with the patient. The considerations upon which this decision has been established in a consensus meeting of Dutch urogynecologists and will be collected by a questionnaire, This group is considered as the 'intervention' group. |
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| Measure | Description | Time Frame |
|---|---|---|
| Surgical success | composite outcome defined as meeting the 3 following conditions: [1] "much improved" or "improved" in response to the patient global impression of improvement questionnaire, [2] no re-intervention performed in the same compartment within the first 12 months after index surgery, [3] no stage 2 or more POP in the operated compartment. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Morbidity | complications and re-interventions due to complications, pain | 24 months |
| Effectiveness | disease specific and general quality of life |
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Inclusion Criteria:
Exclusion Criteria:
female organs
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Patients indicated for vaginal pelvic organ prolapse surgery.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spaarne Gasthuis | Haarlem | Netherlands | ||||
| Bergman Clinics |
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| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| D011391 | Prolapse |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 24 months |
| Anatomical outcomes | 24 months |
| Societal costs | 24 months |
| Hilversum |
| 1213PA |
| Netherlands |