Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2026-02-25 @ 3:35 AM
Study NCT ID:
NCT00572702
Status:
UNKNOWN
Last Update Posted:
2009-08-03
First Post:
2007-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized,Multicentric Study to Treat Prolapse After Hysterectomy With Amreich Procedure or Total Prolift Procedure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056887', 'term': 'Pelvic Organ Prolapse'}], 'ancestors': [{'id': 'D011391', 'term': 'Prolapse'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'completionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-07-31', 'studyFirstSubmitDate': '2007-12-12', 'studyFirstSubmitQcDate': '2007-12-12', 'lastUpdatePostDateStruct': {'date': '2009-08-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The objective evaluation o perioperative complications and comparison of patients with pelvic organ prolapse treated with Amreich-Richter procedure or Prolift implants.', 'timeFrame': '3 month'}], 'secondaryOutcomes': [{'measure': 'Ultrasound, urodynamics, clinical examinations, magnetic resonance imaging, validated QoL questionnaires', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Biocompatible Materials', 'Female', 'Humans', 'Pelvic Floor', 'Polypropylenes', 'Prostheses and Implants', 'Surgical Mesh', 'Uterine Prolapse/*therapy'], 'conditions': ['Pelvic Organ Prolapse']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nIn the study we compare the techniques contemporary used - in the groups with or without mesh, in size relevant for the statistical evaluation'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* female sex\n* age 18 and more\n* subscribed informed consent\n* objective symptoms of prolapse-POP-Q 3 and more according to ICS standards\n* compliance of the patient\n\nExclusion Criteria:\n\n* patients with evidence of malignant lesion in small pelvis\n* history of radiotherapy in small pelvis\n* patients suffering from any form of PID within inclusion process\n* pregnancy\n* lactation\n* total eversion of uterus and vagina\n* serious internal disorders\n* history of recto- or vesico-vaginal fistula\n* history of rejection of any artificial material\n* symptoms of primary genuine stress urinary incontinence\n* patients who were not able to subscribe the informed consent\n* patients, who couldn´t be reached for further follow-up'}, 'identificationModule': {'nctId': 'NCT00572702', 'briefTitle': 'Randomized,Multicentric Study to Treat Prolapse After Hysterectomy With Amreich Procedure or Total Prolift Procedure', 'organization': {'class': 'OTHER', 'fullName': 'Charles University, Czech Republic'}, 'officialTitle': 'Open, Randomized, Prospective, Comparative, Multicentric to Treat Prolapse of Vaginal Cuff After Hysterectomy With Amreich Procedure or Total Prolift Procedure', 'orgStudyIdInfo': {'id': 'NR/9309-3 IGA'}, 'secondaryIdInfos': [{'id': 'NR/9309-3 IGA'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A', 'description': 'Patients with 3 compartment pelvic organ prolapse after hysterectomy, treated with Amreich-Richter procedure; it will be set randomly', 'interventionNames': ['Procedure: Vaginal fixation Amreich-Richter']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'description': 'Patients with 3 compartment pelvic organ prolapse after hysterectomy, treated with total Prolift procedure; it will be set randomly', 'interventionNames': ['Procedure: Prolift total']}], 'interventions': [{'name': 'Vaginal fixation Amreich-Richter', 'type': 'PROCEDURE', 'description': 'Descending vaginal cuff will be treated with fixation of the cuff on sacrospinous ligament', 'armGroupLabels': ['A']}, {'name': 'Prolift total', 'type': 'PROCEDURE', 'otherNames': ['Prolift total - polypropylen mesh'], 'description': 'Descending vaginal cuff will be treated with insertion of site-specific mesh into the vesico-vaginal and recto-vaginal space', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12800', 'city': 'Prague', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Kamil Svabik, MD.', 'role': 'CONTACT', 'email': 'kamil@svabik.cz', 'phone': '+420603583456'}], 'facility': 'Dpt. Obstetrics and gynecology, General Teaching Hospital', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '147 10', 'city': 'Prague', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Ladislav Krofta, MD.,PhD.', 'role': 'CONTACT', 'email': 'ladislav.krofta@post.cz', 'phone': '+420604480886'}], 'facility': 'Institute for the care of mother and child', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '169 02', 'city': 'Prague', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Tomas Rittstein, MD.', 'role': 'CONTACT', 'email': 'urogyn@volny.cz', 'phone': '+420606369793'}], 'facility': 'Dpt. of gynecology, Central military hospital', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '18000', 'city': 'Prague', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Michal Krcmar, MD.', 'role': 'CONTACT', 'email': 'xkrcmar@centrum.cz', 'phone': '+420607675842'}], 'facility': 'Dpt. Obstetrics and gynecology, Teaching hospital Bulovka', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '762 75', 'city': 'Zlín', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Zdenek Adamik, MD., PhD.', 'role': 'CONTACT', 'email': 'adamik@mediclub.cz', 'phone': '+420603241176'}], 'facility': 'Dpt. of Obstetrics and gynecology, Bata hospital', 'geoPoint': {'lat': 49.22645, 'lon': 17.67065}}], 'centralContacts': [{'name': 'Michael Krcmar, MD', 'role': 'CONTACT', 'email': 'xkrcmar@centrum.cz', 'phone': '+420607675842'}, {'name': 'Kamil Svabik, MD', 'role': 'CONTACT', 'email': 'kamil@svabik.cz', 'phone': '+420603583456'}], 'overallOfficials': [{'name': 'Michael Halaska, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charles University, Prague, Czech Republic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charles University, Czech Republic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, Czech Republic', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'prof. Michael Halaska, MD., PhD.', 'oldOrganization': 'Inner Grant Agency, Ministry of Health, Czech republic'}}}}