Ignite Creation Date:
2025-12-24 @ 3:30 PM
Ignite Modification Date:
2025-12-26 @ 1:56 PM
Study NCT ID:
NCT00311792
Status:
COMPLETED
Last Update Posted:
2007-08-30
First Post:
2006-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transfer of Skills From VR-Trainer to Operation Room
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-08', 'completionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-08-29', 'studyFirstSubmitDate': '2006-04-05', 'studyFirstSubmitQcDate': '2006-04-05', 'lastUpdatePostDateStruct': {'date': '2007-08-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-04-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rating Scale Score', 'timeFrame': '1 day'}], 'secondaryOutcomes': [{'measure': 'Time used to perform operation', 'timeFrame': '1 day'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['training', 'teaching', 'curriculum'], 'conditions': ['Clinical Competence']}, 'referencesModule': {'references': [{'pmid': '16147767', 'type': 'BACKGROUND', 'citation': 'Issenberg SB, McGaghie WC, Petrusa ER, Lee Gordon D, Scalese RJ. Features and uses of high-fidelity medical simulations that lead to effective learning: a BEME systematic review. Med Teach. 2005 Jan;27(1):10-28. doi: 10.1080/01421590500046924.'}, {'pmid': '19443914', 'type': 'DERIVED', 'citation': 'Larsen CR, Soerensen JL, Grantcharov TP, Dalsgaard T, Schouenborg L, Ottosen C, Schroeder TV, Ottesen BS. Effect of virtual reality training on laparoscopic surgery: randomised controlled trial. BMJ. 2009 May 14;338:b1802. doi: 10.1136/bmj.b1802.'}]}, 'descriptionModule': {'briefSummary': 'The purpose is to determine if skills obtained by training in the laparoscopic virtual reality simulator LapSimGyn can be transferred to a real laparoscopic operation measured as improved score in a technical skills assessment.', 'detailedDescription': 'The purpose is to determine if skills obtained by training in the laparoscopic virtual reality simulator LapSimGyn can be transferred to a real laparoscopic operation measured as improved score in a technical skills assessment. Design: prospective randomized double blinded intervention study.\n\nSubjects:Younger gynaecologists (Postgraduate year 2-8) Half are having conventional training the other half is undergoing virtual reality simulator training before performing their first laparoscopic salpingectomy.\n\nOutcome is measured by blinded video evaluation with criteria. The criteria is defined in the previous validated scoring system Objective Structured Assessment of Technical Skills (OSATS)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gyn/obs trainee 1.-2. year, with no experience from advanced laparoscopy\n\nExclusion Criteria:\n\n* Advanced laparoscopic experience\n* Previous training in simulator'}, 'identificationModule': {'nctId': 'NCT00311792', 'briefTitle': 'Transfer of Skills From VR-Trainer to Operation Room', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Transfer of Skills From LapSimGyn VR-Simulator to a Laparoscopic Salpingectomy', 'orgStudyIdInfo': {'id': 'KF 01283756'}, 'secondaryIdInfos': [{'id': '959587647'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Simulator training', 'interventionNames': ['Behavioral: LapSimGyn training until expert proficiency level is reached']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Traditional Clinical education at operating room', 'interventionNames': ['Behavioral: Traditional clinical education']}], 'interventions': [{'name': 'LapSimGyn training until expert proficiency level is reached', 'type': 'BEHAVIORAL', 'description': 'Two consecutive simulations reaching predefined expert level', 'armGroupLabels': ['1']}, {'name': 'Traditional clinical education', 'type': 'BEHAVIORAL', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Bent Ottesen, MD Dr.Sci', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Rigshospitalet, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}}}}