Ignite Creation Date:
2025-12-24 @ 4:30 PM
Ignite Modification Date:
2026-01-05 @ 1:55 AM
Study NCT ID:
NCT06482866
Status:
COMPLETED
Last Update Posted:
2024-07-01
First Post:
2024-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Synechie Afrer Rhinosug. Proc. 2024
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 243}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-06-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-06-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-26', 'studyFirstSubmitDate': '2024-06-26', 'studyFirstSubmitQcDate': '2024-06-26', 'lastUpdatePostDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Synechie', 'timeFrame': 'Between 2 weeks to 12 month', 'description': 'Intranasal synechiae after rhino nasal procedures'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Complication of Surgical Procedure']}, 'descriptionModule': {'briefSummary': 'Analyze the factors influencing the development of intranasal adhesions (synechiae), with particular emphasis on the use of nasal septal separators, and to suggest a solution to reduce this complication in the future.\n\nAnalyze of the medical documentation. It was not an experimental examination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who were operated in Polish hospital (Gorzów Wlkp).', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* septo or septoconchoplasty\n\nExclusion Criteria:\n\n* incompleted documentation'}, 'identificationModule': {'nctId': 'NCT06482866', 'briefTitle': 'Synechie Afrer Rhinosug. Proc. 2024', 'organization': {'class': 'OTHER', 'fullName': 'Multidisciplinary Regional Hospital in Gorzow'}, 'officialTitle': 'Risk Factors Leading to the Formation of Intranasal Synechiae in Patients After Endonasal Surgery', 'orgStudyIdInfo': {'id': 'SYNECHIE2024'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control group', 'description': "Patients underwent septoconchoplasty with or without turbionplasty. Surgeons didn't use nasal splits.", 'interventionNames': ["Other: Cottle's septoplasty and radiocoagulation conchoplasty"]}, {'label': 'Study group', 'description': 'Patients underwent septoconchoplasty with or without turbionplasty. Surgeons used nasal splits.', 'interventionNames': ["Other: Cottle's septoplasty and radiocoagulation conchoplasty"]}], 'interventions': [{'name': "Cottle's septoplasty and radiocoagulation conchoplasty", 'type': 'OTHER', 'description': "Cottle's septoplasty and radiocoagulation conchoplasty Study group - added nasal splits; Control group - nasal splits weren't used.", 'armGroupLabels': ['Control group', 'Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66-400', 'city': 'Gorzów Wielkopolski', 'state': 'Woj. Lubuskie', 'country': 'Poland', 'facility': 'Multidisciplinary Regional Hospital', 'geoPoint': {'lat': 52.73371, 'lon': 15.22505}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Publication of results in open access magazine'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mateusz Jan Stępiński', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Lek.', 'investigatorFullName': 'Mateusz Jan Stępiński', 'investigatorAffiliation': 'Multidisciplinary Regional Hospital in Gorzow'}}}}