Ignite Creation Date:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2026-04-09 @ 2:59 PM
Study NCT ID:
NCT00591435
Status:
COMPLETED
Last Update Posted:
2010-03-24
First Post:
2007-12-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Resident Training on Intra-operative Workflow
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': 600}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-11', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-03-23', 'studyFirstSubmitDate': '2007-12-28', 'studyFirstSubmitQcDate': '2007-12-28', 'lastUpdatePostDateStruct': {'date': '2010-03-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anaesthesia and procedural related time intervals', 'timeFrame': 'All events will be recorded intraoperativly'}], 'secondaryOutcomes': [{'measure': 'OR costs are calculated as $ 15.00 per minute, additional costs due to increase of time intervals will be analyzed', 'timeFrame': 'All data will be recorded intraoperaitvly'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Anesthesia', 'Surgery', 'Education', 'Economics'], 'conditions': ['Intraoperative Workflow', 'Anesthesia and Procedure Related Time Intervals']}, 'descriptionModule': {'briefSummary': 'Anaesthesia and surgery related time intervals of three standard operations are compared depending on whether residents or consultants are performing anaesthesia and surgery.\n\nHypothesis: Perioperative workflow is influenced by state of education, time intervals reflecting anaesthesia as well as surgical performance increase due to resident training. Therefore, costs of perioperative care increase as well.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy subjects scheduled for one of the three defined procedures (defined by German Diagnose Related Groups ID) under general or regional anesthesia', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy subjects scheduled for one of the three defined procedures (defined by German Diagnose Related Groups ID) under general or regional anesthesia\n\nExclusion Criteria:\n\n* Patient's refusal of data collection, emergency procedures, change of physician in charge (resident to consultant or the other way around) of anesthesia or surgical team"}, 'identificationModule': {'nctId': 'NCT00591435', 'briefTitle': 'Influence of Resident Training on Intra-operative Workflow', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Schleswig-Holstein'}, 'officialTitle': 'Resident Training Affects Intra-Operative Workflow and Costs', 'orgStudyIdInfo': {'id': 'UKSH_Hanss'}, 'secondaryIdInfos': [{'id': 'IRB: A138/07'}]}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': '200 laparoscopic cholecystectomies will be included, consultant cases will be compared to resident cases', 'interventionNames': ['Other: Comparison of performance of consultants versus residents']}, {'label': '2', 'description': '200 laparoscopic pelviscopies will be included, consultant cases will be compared to resident cases', 'interventionNames': ['Other: Comparison of performance of consultants versus residents']}, {'label': '3', 'description': '200 transurethral resection of urinary bladder or prostate gland will be included, consultant cases will be compared to resident cases', 'interventionNames': ['Other: Comparison of performance of consultants versus residents']}], 'interventions': [{'name': 'Comparison of performance of consultants versus residents', 'type': 'OTHER', 'description': 'Anesthesia as well as surgical workflow will be analysed. Performance of consultants will be compared to residents', 'armGroupLabels': ['1', '2', '3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '24105', 'city': 'Kiel', 'state': 'Schleswig-Holstein', 'country': 'Germany', 'facility': 'University Hospital Schleswig-Holstein, Campus Kiel', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}], 'overallOfficials': [{'name': 'Jens Scholz, MD, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anaesthesiology and Intenisve Care Medicine, University Hospital Schleswig-Holstein, Campus Kiel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Schleswig-Holstein', 'class': 'OTHER'}, 'collaborators': [{'name': 'Department of Anaesthesiology and Intensive Care Medicine', 'class': 'AMBIG'}], 'responsibleParty': {'oldNameTitle': 'Jens Scholz, Professor of Anaesthesiology, Chair of the Department of Anaesthesiology and Intensive Care Medicine'}}}}