Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2026-01-02 @ 9:03 AM
Study NCT ID:
NCT02069951
Status:
COMPLETED
Last Update Posted:
2015-05-12
First Post:
2014-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Procedure-to-procedure Transfer Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-09', 'studyFirstSubmitDate': '2014-02-20', 'studyFirstSubmitQcDate': '2014-02-20', 'lastUpdatePostDateStruct': {'date': '2015-05-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Subjective Mental Effort Question score after the 1st repetition', 'timeFrame': 'Up to 26 weeks', 'description': 'To score the level of stress, all the participants will be required to the Subjective Mental Effort Questionnaire after the first repetition of a procedural module. The SMEQ is a cognitive workload questionnaire with a scale of 0 to 150 points'}, {'measure': 'Motor skills performance parameters', 'timeFrame': 'Up to 26 weeks', 'description': '1. The total path length (cumulative distance tip movement for both the right and left instrument) for the first attempt on procedural module B will be compared for the intervention and the control group.\n2. The total angular path (cumulative angular degrees for both the right and left instrument) for the first attempt on procedural module B will be compared for the intervention and the control group.\n3. The total procedure time for the first attempt on procedural module B will be compared for the intervention and the control group.'}], 'primaryOutcomes': [{'measure': 'The number of repetitions needed to reach a predefined proficiency level for a procedural module on a simulator', 'timeFrame': 'Up to 26 weeks', 'description': 'The number of repetitions needed to reach a predefined proficiency level for a procedural module (a laparoscopic salpingectomy) on the simulator.'}], 'secondaryOutcomes': [{'measure': 'The effective training time on the simulator (minutes) needed to reach the predefined proficiency level for a procedural module.', 'timeFrame': 'Up to 26 weeks', 'description': 'The effective training time on the simulator (minutes) needed to reach a predefined proficiency level for a procedural module (a laparoscopic salpingectomy) on the simulator.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Laparoscopy', 'Training', 'Simulator'], 'conditions': ['Surgery']}, 'referencesModule': {'references': [{'pmid': '26511775', 'type': 'DERIVED', 'citation': 'Bjerrum F, Sorensen JL, Konge L, Rosthoj S, Lindschou J, Ottesen B, Strandbygaard J. Randomized trial to examine procedure-to-procedure transfer in laparoscopic simulator training. Br J Surg. 2016 Jan;103(1):44-50. doi: 10.1002/bjs.9966. Epub 2015 Oct 29.'}, {'pmid': '25304939', 'type': 'DERIVED', 'citation': 'Bjerrum F, Sorensen JL, Konge L, Lindschou J, Rosthoj S, Ottesen B, Strandbygaard J. Procedural specificity in laparoscopic simulator training: protocol for a randomised educational superiority trial. BMC Med Educ. 2014 Oct 10;14:215. doi: 10.1186/1472-6920-14-215.'}], 'seeAlsoLinks': [{'url': 'http://www.rigshospitalet.dk/RHenglish/Menu/Departments+and+Clinics/Juliane+Marie+Centre/Research/Simulation+unit+JMC/Simulation+Unit+JMC.htm', 'label': 'JMC Simulation Unit'}]}, 'descriptionModule': {'briefSummary': 'Surgical training programs using virtual reality simulators often only use basic skills training and the use of procedural training is very limited. Procedural training differs from basic skills training by requiring integration of isolated skills and decision making and planning components. However, it is unknown if it is necessary to practice all procedures before operating on actual patients or whether it is simply a matter of learning psychomotor skills and if these skills are transferable between different tasks.\n\nThe main hypothesis is that practicing a laparoscopic procedure on a simulator makes it easier to reach proficiency on a different laparoscopic procedure on the simulator because participants have already practiced the integration of isolated skills.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Medical students enrolled at The Faculty of Health Science, University of Copenhagen.\n* Obtained the bachelor degree in medicine.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Previous participation in trials involving laparoscopic training.\n* Experience with laparoscopy surgery (having performed minimum one laparoscopic procedure as primary surgeon, including supervised procedures).\n* No informed consent.\n* Does not speak Danish on a conversational level.'}, 'identificationModule': {'nctId': 'NCT02069951', 'briefTitle': 'Procedure-to-procedure Transfer Trial', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'A Randomised Educational Trial of Practicing One Versus Two Laparoscopic Procedural Modules in Simulator Training for Novices on Procedure-to-procedure Transferability', 'orgStudyIdInfo': {'id': '102169'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Practice two procedures on a simulator', 'description': 'All participants start by practicing a series of six basic skills modules until they reach a predefined proficiency level for each module. For all of the basic skills exercises proficiency is reached when the participants have passed the proficiency level for all exercises.\n\nParticipants randomised to the intervention group will practice two procedures on a simulator. First a procedural module A (a laparoscopic appendectomy) to a predefined proficiency level. Upon reaching proficiency for procedural module A the participants will practice procedural module B (a laparoscopic salpingectomy) to a predefined proficiency level.', 'interventionNames': ['Other: Practice a procedural module on a simulator']}, {'type': 'NO_INTERVENTION', 'label': 'Practice one procedure on a simulator', 'description': 'All participants start by practicing a series of six basic skills modules until they reach a predefined proficiency level for each module. For all of the basic skills exercises proficiency is reached when the participants have passed the proficiency level for all exercises. Each exercise has to be passed twice within five consecutive attempts.\n\nParticipants randomised to the control group will practice procedural module B (a laparoscopic salpingectomy) to a predefined proficiency level.'}], 'interventions': [{'name': 'Practice a procedural module on a simulator', 'type': 'OTHER', 'armGroupLabels': ['Practice two procedures on a simulator']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DK2100', 'city': 'Copenhagen', 'state': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Flemming Bjerrum, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rigshospitalet, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'Copenhagen University Hospital, Denmark', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Flemming Bjerrum', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}