Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-28 @ 5:11 AM
Study NCT ID:
NCT05834504
Status:
COMPLETED
Last Update Posted:
2023-04-28
First Post:
2022-08-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exploring the Intervals in Distributed Laparoscopic Skills Training
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-03-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-26', 'studyFirstSubmitDate': '2022-08-22', 'studyFirstSubmitQcDate': '2023-04-26', 'lastUpdatePostDateStruct': {'date': '2023-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to proficiency', 'timeFrame': '6 months', 'description': 'The total effective training time (minutes) to reach the predefined proficiency level for both the four basic skills and the salpingectomy module.'}], 'secondaryOutcomes': [{'measure': 'Retention test', 'timeFrame': '6 months', 'description': 'The total effective training time (minutes) to reach the predefined proficiency level for both the four basic skills and the salpingectomy module after 3-5 weeks without laparoscopic training from the last training session.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Skills Acquisition', 'Simulation', 'Laparoscopy']}, 'descriptionModule': {'briefSummary': 'The objective of this trial is to investigate if short intervals (1-2 days) between training sessions are more efficient than practicing with longer intervals (6-8 days) between sessions during proficiency-based laparoscopic simulator training. Our hypothesis is that just 1-2 days of break between sessions is optimal for the acquisition of laparoscopic skills and that a shorter interval between sessions is optimal for training.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n\\- Master's degree medical students, enrolled at a Danish University.\n\nExclusion Criteria:\n\n* Medical students that have participated in prior studies or similar involving laparoscopic training.\n* Performing laparoscopy surgery between the intervention and the retention test 3-5 weeks after.\n* No informed consent.\n* Does not speak Danish on a conversational level.\n* Any disability or injury regarding eyesight and mobility."}, 'identificationModule': {'nctId': 'NCT05834504', 'acronym': 'DPiLS', 'briefTitle': 'Exploring the Intervals in Distributed Laparoscopic Skills Training', 'organization': {'class': 'OTHER', 'fullName': 'Copenhagen Academy for Medical Education and Simulation'}, 'officialTitle': 'Exploring the Intervals in Distributed Laparoscopic Skills Training', 'orgStudyIdInfo': {'id': 'DPiLS trial'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'The control group will practice four basic skills and one procedural module on the Laparoscopic "Lapsim" Virtual Reality Simulator. They will practice with 6-8 days of break in between training sessions until proficiency level is achieved.'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'The intervention group will practice four basic skills and one procedural module on the Laparoscopic "Lapsim" Virtual Reality Simulator. They will practice with 1-2 days of break in between training sessions until proficiency level is achieved.', 'interventionNames': ['Other: Short distributed training (1-2 days)']}], 'interventions': [{'name': 'Short distributed training (1-2 days)', 'type': 'OTHER', 'description': 'The intervention group will practice four basic skills and one procedural module on the Laparoscopic "Lapsim" Virtual Reality Simulator. They will practice with 1-2 days of break in between training sessions until proficiency level is achieved.', 'armGroupLabels': ['Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'state': 'Capital Region', 'country': 'Denmark', 'facility': 'Copenhagen Academy For Medical Education and Simulation (Cames)', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Flemming Bjerrum, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Copenhagen Academy for Medical Education and Simulation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Copenhagen Academy for Medical Education and Simulation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Hai-Yen Tang', 'investigatorAffiliation': 'Copenhagen Academy for Medical Education and Simulation'}}}}