Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-26 @ 12:52 AM
Study NCT ID:
NCT05579834
Status:
COMPLETED
Last Update Posted:
2022-10-14
First Post:
2022-10-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hemothorax Caused by Posterior Correction Surgery for Spinal Deformity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006491', 'term': 'Hemothorax'}], 'ancestors': [{'id': 'D010995', 'term': 'Pleural Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-07-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-11', 'studyFirstSubmitDate': '2022-10-11', 'studyFirstSubmitQcDate': '2022-10-11', 'lastUpdatePostDateStruct': {'date': '2022-10-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'hemothorax', 'timeFrame': '2016-2021', 'description': 'hemothorax caused by posterior correction surgery for spinal deformity'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['spinal deformity', 'posterior correction surgery', 'hemothorax'], 'conditions': ['Spinal Deformity', 'Hemothorax Postoperative']}, 'descriptionModule': {'briefSummary': 'Owing to the development of instruments and surgical techniques, the number of spinal deformity correction surgeries has increased significantly. The incidence of hemothorax due to posterior correction surgery for spinal deformity is reported to be as low as 0.1%, and the vast majority of these cases were treated through observation without additional intervention. However, if hemothorax that occurs is missed, it can result in increased mortality and morbidity. Furthermore, there is a paucity of data on management of hemothorax caused by posterior correction surgery. The aim of this retrospective study is to evaluate our cases of hemothorax after posterior correction surgery for spinal deformity.', 'detailedDescription': 'We retrospectively reviewed medical records of all pediatric patients who underwent posterior correction surgery from 2016 to 2021.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Year', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Children who underwent posterior correction surgery for spinal deformities (age range 1-18 years)', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children who underwent posterior correction surgery for spinal deformities (age range 1-18 years)\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT05579834', 'briefTitle': 'Hemothorax Caused by Posterior Correction Surgery for Spinal Deformity', 'organization': {'class': 'OTHER', 'fullName': 'Gazi University'}, 'officialTitle': 'Perioperative Management in Terms of Hemothorax Caused by Posterior Correction', 'orgStudyIdInfo': {'id': 'GU-260121-02'}}, 'armsInterventionsModule': {'interventions': [{'name': 'posterior correction surgery', 'type': 'PROCEDURE', 'description': 'Cases of hemothorax developing after posterior correction surgery for spinal deformities'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06560', 'city': 'Ankara', 'state': 'None Selected', 'country': 'Turkey (Türkiye)', 'facility': 'Gazi Üniversitesi', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gazi University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Asst.Prof.', 'investigatorFullName': 'Cem KAYA', 'investigatorAffiliation': 'Gazi University'}}}}