Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2026-01-01 @ 6:22 PM
Study NCT ID:
NCT05288257
Status:
UNKNOWN
Last Update Posted:
2022-10-25
First Post:
2022-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mixed Method Study Protocol_Cognitive Non-technical Skills Learning Module for a Safe Laparoscopic Cholecystectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 217}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2023-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-24', 'studyFirstSubmitDate': '2022-02-08', 'studyFirstSubmitQcDate': '2022-03-10', 'lastUpdatePostDateStruct': {'date': '2022-10-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quantitative: Community Survey', 'timeFrame': 'February - March 2022', 'description': 'Survey data'}, {'measure': 'Qualitative: In Depth Interview', 'timeFrame': 'March - April 2022', 'description': 'Semi-structured interview data obtained from In Depth Interview'}, {'measure': 'Qualitative: Delphi Study', 'timeFrame': 'May 2022', 'description': 'Learning Module'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Safe Laparoscopic Cholecystectomy', 'Situation Awareness', 'Decision Making'], 'conditions': ['Learning Module', 'Cognitive Non-technical Skills']}, 'descriptionModule': {'briefSummary': "A mixed-methods sequential explanatory design study. The first quantitative phase will be an online survey to surgeons that includes questions related to their experience learning and performing laparoscopic cholecystectomy. The second qualitative phase will use depth interview to elaborate surgeon's experience regarding a safe laparoscopic cholecystectomy", 'detailedDescription': "Bile duct injuries from laparoscopic cholecystectomy remain a significant source of morbidity and are often the result of intraoperative errors in perception, judgment, and decision-making. Cognitive non-technical skills namely situation awareness and decision-making skills are essential in doing a safe laparoscopic cholecystectomy, as in any kind of surgery. Studies regarding cognitive non-technical skills and how to teach them are still lacking, especially in the field of surgery.\n\nWith this study, the investigators aim to formulate a comprehensive learning module for a safe laparoscopic cholecystectomy accomodating cognitive non-technical skills based on the surgeon's experience while learning and doing laparoscopic cholecystectomy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '25 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Surgeons and Surgical residents', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Surgeons and / or surgical residents\n* Complete all the required documents\n\nExclusion Criteria:\n\n* Refuse to participate in one or more parts of the study'}, 'identificationModule': {'nctId': 'NCT05288257', 'briefTitle': 'Mixed Method Study Protocol_Cognitive Non-technical Skills Learning Module for a Safe Laparoscopic Cholecystectomy', 'organization': {'class': 'OTHER', 'fullName': 'RSUP Fatmawati'}, 'officialTitle': 'The Role Cognitive Non-technical Skills Learning Module in Promoting A Safe Laparoscopic Cholecystectomy: Critical Analysis on Situation Awareness and Intraoperative Decision Making in the Prevention of Complications', 'orgStudyIdInfo': {'id': '22-01-0029'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Learning Module', 'type': 'BEHAVIORAL', 'otherNames': ['Safe Cholecystectomy'], 'description': 'Safe Cholecystectomy Learning Module'}]}, 'contactsLocationsModule': {'locations': [{'zip': '11480', 'city': 'Jakarta', 'state': 'DKI Jakarta', 'status': 'RECRUITING', 'country': 'Indonesia', 'contacts': [{'name': 'Adianto Nugroho, MD, FACS', 'role': 'CONTACT', 'email': 'kolesistektomi.aman@gmail.com', 'phone': '0217660608'}], 'facility': 'RSUP Fatmawati', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}], 'centralContacts': [{'name': 'Adianto Nugroho, MD, FACS', 'role': 'CONTACT', 'email': 'kolesistektomi.aman@gmail.com', 'phone': '0217660608'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RSUP Fatmawati', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Adianto Nugroho', 'investigatorAffiliation': 'RSUP Fatmawati'}}}}