Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 10:41 PM
Study NCT ID:
NCT05741567
Status:
COMPLETED
Last Update Posted:
2023-02-23
First Post:
2023-02-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Transobturator Repair by Vaginal Plastron
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-14', 'studyFirstSubmitDate': '2023-02-14', 'studyFirstSubmitQcDate': '2023-02-14', 'lastUpdatePostDateStruct': {'date': '2023-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'failed prolapse correction', 'timeFrame': 'at 1 month after surgery', 'description': 'percentage of failed prolapse correction'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['anterior prolapse', 'transobturator repair', 'vaginal plastron'], 'conditions': ['Anterior Prolapse Surgery Using the Transobturator Repair by Vaginal Plastron']}, 'descriptionModule': {'briefSummary': "The autologous vaginal route consists of repairing the genital prolapse through the vagina using the patient's tissues without a prosthesis. Vaginal prostheses are actually currently prohibited in France \\[1, 2\\].\n\nThe autologous vaginal route is the quickest surgery and it can be done under spinal anesthesia, which constitutes arguments for offering it to elderly and fragile patients. The autologous vaginal approach gives functional and subjective results similar to promontofixation \\[2\\].\n\nThere are many surgical techniques that make it difficult to assess the recurrence rate in the literature. Autologous vaginal surgery provides a good degree of satisfaction for patients despite the risk of recurrence \\[3\\].\n\nWe propose to describe the results of the transobturator cystocele repair by vaginal plastron, a technique which seems reproducible and effective to us."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study covers all patients who underwent surgery using the transobturator repair by vaginal plastron for correction of anterior prolapse between September 2020 and October 2022.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women over 18\n* patient who underwent surgery using the transobturator repair by vaginal plastron for correction of anterior prolapse requiring surgical correction of stage equal to or greater than II in the POP-Q classification\n* intervention between September 2020 and October 2022\n* person having expressed his non-opposition\n\nExclusion Criteria:\n\n* inability to understand the information given\n* person deprived of liberty\n* person under guardianship'}, 'identificationModule': {'nctId': 'NCT05741567', 'acronym': 'CYSPTO', 'briefTitle': 'Transobturator Repair by Vaginal Plastron', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Transobturator Cystocele Repair by Vaginal Plastron', 'orgStudyIdInfo': {'id': '22-5083'}, 'secondaryIdInfos': [{'id': '69HCL22_1180', 'type': 'OTHER', 'domain': 'HCL'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'transobturator cystocele repair by vaginal plastron', 'description': 'patients who underwent surgery using the transobturator repair by vaginal plastron for correction of anterior prolapse', 'interventionNames': ['Procedure: correction of anterior prolapse']}], 'interventions': [{'name': 'correction of anterior prolapse', 'type': 'PROCEDURE', 'description': 'percentage of failed prolapse correction', 'armGroupLabels': ['transobturator cystocele repair by vaginal plastron']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69500', 'city': 'Lyon', 'state': 'BRON', 'country': 'France', 'facility': 'Hôpital Femme Mère Enfant', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}