Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-28 @ 10:39 PM
Study NCT ID:
NCT01343069
Status:
WITHDRAWN
Last Update Posted:
2015-05-05
First Post:
2011-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Improvement and Checklist Application
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Italy']}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'insufficient quality of data', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2012-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-05-04', 'studyFirstSubmitDate': '2011-04-26', 'studyFirstSubmitQcDate': '2011-04-26', 'lastUpdatePostDateStruct': {'date': '2015-05-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of complications after elective surgery', 'timeFrame': 'within 30 days', 'description': 'comparison of number of complications in the two study arms before and after introduction of the checklist'}], 'secondaryOutcomes': [{'measure': 'mortality', 'timeFrame': '30 days', 'description': 'evaluation of 30-days mortality'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['safety', 'team', 'team performance', 'surgery', 'outcome'], 'conditions': ['Complications', 'Outcome']}, 'descriptionModule': {'briefSummary': 'The study investigates the impact of the introduction of a surgical checklist on the incidence of complications and mortality within 30 days after surgery in patients scheduled for elective non-cardiac surgery. Patients scheduled for elective surgical procedures lasting longer than 20 minutes at are eligible. Surgery is performed in a single tertiary care center. Study design is an open trial before and after intervention (implementation of the checklist "safe surgery saves lifes").'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* elective surgery in general or regional anesthesia lasting \\> 15 min\n\nExclusion Criteria:\n\n* urgent surgery'}, 'identificationModule': {'nctId': 'NCT01343069', 'acronym': 'SICA', 'briefTitle': 'Safety Improvement and Checklist Application', 'organization': {'class': 'OTHER', 'fullName': 'Regional Hospital of Bolzano'}, 'officialTitle': 'Safety Analysis in Regard to the Introduction of Surgical Checklists in the Operation Rooms in a Tertiary Care Center', 'orgStudyIdInfo': {'id': 'check4outcome2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'before surgical checklist'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'after implementation surgical checklist', 'interventionNames': ['Procedure: implementation surgical checklist']}], 'interventions': [{'name': 'implementation surgical checklist', 'type': 'PROCEDURE', 'description': 'a checklist according to the suggestions raised by the WHO is implementated', 'armGroupLabels': ['after implementation surgical checklist']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Matthias Bock, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Central Hospital Bolzano Italy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regional Hospital of Bolzano', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Safety Analysis in Regard to the Introduction of Surgical Checklists in the Operation Rooms in a Tertiary Care Center', 'investigatorFullName': 'Matthias Bock', 'investigatorAffiliation': 'Regional Hospital of Bolzano'}}}}