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| ID | Type | Description | Link |
|---|---|---|---|
| NR/9309-3 IGA |
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| Name | Class |
|---|---|
| Ministry of Health, Czech Republic | OTHER_GOV |
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Head to Head comparison of perioperative complications and secondary the impact of operation techniques with or without mesh on patients suffering from pelvic organ prolapse on quality of life.
During the last decade a substantial progress in the detailed knowledge of morphology and function of different compartments of the female pelvic floor was achieved. The obtained informations were quickly implemented in the clinical practice especially in the application of special meshes and of novel techniques of their implantation. Their success rate was evaluated only in pilot companies supported studies. We do miss randomised studies not sponsored by company comparing different surgical techniques and their impact on the quality of life (QoL); the objective estimation of those consequences is for the longlasting effect of the surgery inevitable. The new methods bring also new complications which were not yet relevantly and objectively documented.
In the study we compare the techniques contemporary used - in the groups with or without mesh, in size relevant for the statistical evaluation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | Patients with 3 compartment pelvic organ prolapse after hysterectomy, treated with Amreich-Richter procedure; it will be set randomly |
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| B | Active Comparator | Patients with 3 compartment pelvic organ prolapse after hysterectomy, treated with total Prolift procedure; it will be set randomly |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaginal fixation Amreich-Richter | Procedure | Descending vaginal cuff will be treated with fixation of the cuff on sacrospinous ligament |
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| Measure | Description | Time Frame |
|---|---|---|
| The objective evaluation o perioperative complications and comparison of patients with pelvic organ prolapse treated with Amreich-Richter procedure or Prolift implants. | 3 month |
| Measure | Description | Time Frame |
|---|---|---|
| Ultrasound, urodynamics, clinical examinations, magnetic resonance imaging, validated QoL questionnaires | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Krcmar, MD | Contact | +420607675842 | xkrcmar@centrum.cz | |
| Kamil Svabik, MD | Contact | +420603583456 | kamil@svabik.cz |
| Name | Affiliation | Role |
|---|---|---|
| Michael Halaska, MD,PhD | Charles University, Prague, Czech Republic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dpt. Obstetrics and gynecology, General Teaching Hospital | Recruiting | Prague | 12800 | Czechia |
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| Prolift total | Procedure | Descending vaginal cuff will be treated with insertion of site-specific mesh into the vesico-vaginal and recto-vaginal space |
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| Institute for the care of mother and child | Recruiting | Prague | 147 10 | Czechia |
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| Dpt. of gynecology, Central military hospital | Recruiting | Prague | 169 02 | Czechia |
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| Dpt. Obstetrics and gynecology, Teaching hospital Bulovka | Recruiting | Prague | 18000 | Czechia |
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| Dpt. of Obstetrics and gynecology, Bata hospital | Recruiting | Zlín | 762 75 | Czechia |
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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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