Ignite Creation Date:
2025-12-26 @ 1:17 PM
Ignite Modification Date:
2025-12-31 @ 6:56 PM
Study NCT ID:
NCT01628406
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-12-14
First Post:
2012-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient Registry of the Neurosurgery Department
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18000}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-07', 'studyFirstSubmitDate': '2012-06-21', 'studyFirstSubmitQcDate': '2012-06-25', 'lastUpdatePostDateStruct': {'date': '2023-12-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-06-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'neurological outcome', 'timeFrame': '1 year', 'description': 'validated scales like KPSS or NIHSS'}, {'measure': 'social outcome', 'timeFrame': '1 year', 'description': 'e.g. activity of daily living, employment status'}]}, 'conditionsModule': {'conditions': ['Patients Treated at the Neurosurgery Department']}, 'referencesModule': {'references': [{'pmid': '36248111', 'type': 'RESULT', 'citation': 'Sarnthein J, Staartjes VE, Regli L; Neurosurgery-Registry consortium. Neurosurgery outcomes and complications in a monocentric 7-year patient registry. Brain Spine. 2022 Jan 19;2:100860. doi: 10.1016/j.bas.2022.100860. eCollection 2022.'}, {'pmid': '39445855', 'type': 'DERIVED', 'citation': 'Staartjes VE, Serra C, Regli L. In Reply: Safety and Effectiveness of an Enhanced Recovery Protocol in Patients Undergoing Burr Hole Evacuation for Chronic Subdural Hematoma. Neurosurgery. 2025 Jan 1;96(1):e16-e17. doi: 10.1227/neu.0000000000003235. Epub 2024 Oct 24. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The investigators record all indications, treatments and outcomes from patients treated at the Neurosurgery Department.\n\n* Trial with surgical intervention'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients treated at the Neurosurgery Department', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\nAll patients treated at the Neurosurgery Department\n\nExclusion criteria:\n\nNone'}, 'identificationModule': {'nctId': 'NCT01628406', 'acronym': 'patregNCH', 'briefTitle': 'Patient Registry of the Neurosurgery Department', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Patient Registry of the Neurosurgery Department.', 'orgStudyIdInfo': {'id': 'patregNCH'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients treated at the neurosurgery department', 'description': 'Patients treated at the neurosurgery department', 'interventionNames': ['Procedure: Treatment at the neurosurgery departement']}], 'interventions': [{'name': 'Treatment at the neurosurgery departement', 'type': 'PROCEDURE', 'description': 'Treatment at the neurosurgery departement', 'armGroupLabels': ['Patients treated at the neurosurgery department']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': 'University Hospital Zurich, Neurosurgery', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Johannes Sarnthein, Prof Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Zurich, Division of Neurosurgery'}, {'name': 'Luca Regli, Prof Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Zurich, Division of Neurosurgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}