Randomized,Multicentric Study to Treat Prolapse After Hysterectomy With Amreich Procedure or Total Prolift Procedure
NCT ID: NCT00572702
Last Updated: 2009-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2007-01-31
2009-12-31
Brief Summary
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Detailed Description
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In the study we compare the techniques contemporary used - in the groups with or without mesh, in size relevant for the statistical evaluation
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
Patients with 3 compartment pelvic organ prolapse after hysterectomy, treated with Amreich-Richter procedure; it will be set randomly
Vaginal fixation Amreich-Richter
Descending vaginal cuff will be treated with fixation of the cuff on sacrospinous ligament
B
Patients with 3 compartment pelvic organ prolapse after hysterectomy, treated with total Prolift procedure; it will be set randomly
Prolift total
Descending vaginal cuff will be treated with insertion of site-specific mesh into the vesico-vaginal and recto-vaginal space
Interventions
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Vaginal fixation Amreich-Richter
Descending vaginal cuff will be treated with fixation of the cuff on sacrospinous ligament
Prolift total
Descending vaginal cuff will be treated with insertion of site-specific mesh into the vesico-vaginal and recto-vaginal space
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* age 18 and more
* subscribed informed consent
* objective symptoms of prolapse-POP-Q 3 and more according to ICS standards
* compliance of the patient
Exclusion Criteria
* history of radiotherapy in small pelvis
* patients suffering from any form of PID within inclusion process
* pregnancy
* lactation
* total eversion of uterus and vagina
* serious internal disorders
* history of recto- or vesico-vaginal fistula
* history of rejection of any artificial material
* symptoms of primary genuine stress urinary incontinence
* patients who were not able to subscribe the informed consent
* patients, who couldn´t be reached for further follow-up
18 Years
FEMALE
No
Sponsors
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Ministry of Health, Czech Republic
OTHER_GOV
Charles University, Czech Republic
OTHER
Responsible Party
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Inner Grant Agency, Ministry of Health, Czech republic
Principal Investigators
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Michael Halaska, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Charles University, Prague, Czech Republic
Locations
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Dpt. Obstetrics and gynecology, General Teaching Hospital
Prague, , Czechia
Institute for the care of mother and child
Prague, , Czechia
Dpt. of gynecology, Central military hospital
Prague, , Czechia
Dpt. Obstetrics and gynecology, Teaching hospital Bulovka
Prague, , Czechia
Dpt. of Obstetrics and gynecology, Bata hospital
Zlín, , Czechia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NR/9309-3 IGA
Identifier Type: -
Identifier Source: secondary_id
NR/9309-3 IGA
Identifier Type: -
Identifier Source: org_study_id
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