Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-25 @ 5:32 PM
Study NCT ID:
NCT04791904
Status:
COMPLETED
Last Update Posted:
2022-08-24
First Post:
2021-03-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Predictive Factors for Cranioplasty Complications - A Decade Experience
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': 168}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-20', 'studyFirstSubmitDate': '2021-03-06', 'studyFirstSubmitQcDate': '2021-03-09', 'lastUpdatePostDateStruct': {'date': '2022-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surgical Complications', 'timeFrame': '6 months', 'description': 'Complications after cranioplasty - symptomatic hemorrhage, infection, re-intervention.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cranioplasty', 'Surgery Complications', 'Decompressive Craniectomy'], 'conditions': ['Decompressive Craniectomy and Cranioplasty']}, 'descriptionModule': {'briefSummary': 'This is a single-center, observational retrospective study. This study aims to identify predictive factors of complications for patients submitted to cranioplasty after decompressive craniectomy for all types of etiologies.\n\nAll patients submitted to cranioplasty since 2008 will be analyzed.', 'detailedDescription': "Patients submitted to cranioplasty since 2008 to 2019 will be retrospectively analyzed.\n\nWill be considered for analysis all cases treated after decompressive craniectomy. Will be excluded patients with incomplete clinical or imaging records.\n\nMain factors determined as a possible influence on complications after cranioplasty will be recorded focusing on patients characteristics, craniectomy characteristics, surgical timing, and cranioplasty materials.\n\nPatients' records will be review by two investigators and data will be verified by a third investigator. records will be anonymously recorded."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients submitted to cranioplasty after decompressive craniectomy between 1 of January of 2008 and 21 of December of 2019.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cranioplasty surgery\n* Previous decompressive craniectomy\n\nExclusion Criteria:\n\n* Incomplete records (Clinical and Imaging) since craniectomy to 6 months after cranioplasty.\n* More than one decompressive craniectomy'}, 'identificationModule': {'nctId': 'NCT04791904', 'briefTitle': 'Predictive Factors for Cranioplasty Complications - A Decade Experience', 'organization': {'class': 'OTHER', 'fullName': 'Universidade do Porto'}, 'officialTitle': 'Predictive Factors for Cranioplasty Complications - A Decade Experience', 'orgStudyIdInfo': {'id': '202101'}}, 'contactsLocationsModule': {'locations': [{'city': 'Porto', 'country': 'Portugal', 'facility': 'Centro Hospitalar Universitário de São João', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}], 'overallOfficials': [{'name': 'Pedro Silva, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Porto, Medicine Faculty'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade do Porto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ana Filipa Vaz Ferreira', 'investigatorAffiliation': 'Universidade do Porto'}}}}