Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-26 @ 4:48 AM
Study NCT ID:
NCT06951360
Status:
WITHDRAWN
Last Update Posted:
2025-04-30
First Post:
2022-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Workload Evaluation (Via NASA Task Load Index) of Robotic Assisted and Laparoscopic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073397', 'term': 'Occupational Stress'}], 'ancestors': [{'id': 'D009784', 'term': 'Occupational Diseases'}, {'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'No multicenter recriutiment feasible', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2022-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-26', 'studyFirstSubmitDate': '2022-05-22', 'studyFirstSubmitQcDate': '2025-04-26', 'lastUpdatePostDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall workload', 'timeFrame': '5 years', 'description': 'NASA Task Load overall workload'}, {'measure': 'surgical expertise', 'timeFrame': '5 years', 'description': 'surgical experience counting numbers of open, laparoscopic, robotic procedures and years of surgical practice'}], 'secondaryOutcomes': [{'measure': 'NASA Task Load Index subscales', 'timeFrame': '5 years', 'description': 'mental, physical, temporal demand, performance, effort, frustration'}, {'measure': "procedure's difficulty level", 'timeFrame': '5 years', 'description': 'additional question to evaluate the variation of difficulty of the performed procedure to expected level of difficulty; 3 levels'}, {'measure': 'patient factors', 'timeFrame': '5 years', 'description': 'age, sex, BMI, preexisting illnesses/diseases using CCI (Charlson Comorbidity Index), previous operations, ASA'}, {'measure': 'procedure characteristics', 'timeFrame': '5 years', 'description': 'indication, performed operation, intraoperative complications using Clavien-Dindo classification, operation duration, blood loss'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Workplace Stress']}, 'referencesModule': {'references': [{'pmid': '21330339', 'type': 'BACKGROUND', 'citation': 'Quan H, Li B, Couris CM, Fushimi K, Graham P, Hider P, Januel JM, Sundararajan V. Updating and validating the Charlson comorbidity index and score for risk adjustment in hospital discharge abstracts using data from 6 countries. Am J Epidemiol. 2011 Mar 15;173(6):676-82. doi: 10.1093/aje/kwq433. Epub 2011 Feb 17.'}, {'pmid': '30247331', 'type': 'BACKGROUND', 'citation': 'Lowndes BR, Forsyth KL, Blocker RC, Dean PG, Truty MJ, Heller SF, Blackmon S, Hallbeck MS, Nelson H. NASA-TLX Assessment of Surgeon Workload Variation Across Specialties. Ann Surg. 2020 Apr;271(4):686-692. doi: 10.1097/SLA.0000000000003058.'}]}, 'descriptionModule': {'briefSummary': 'workload evaluation (via NASA Task Load Index) of robotic- assisted and laparoscopic surgery', 'detailedDescription': 'evaluation of individual and overall workload during robotic visceral surgeries using NASA Task Load Index and one additional question referring to difficulty level of the operation in comparison with laparoscopic procedures'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '* involved medical stuff (surgeons, OR nurses, further professions)\n* patients undergoing laparoscopic and robotic procedures fulfilling the inclusion criterias', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* robotic and laparoscopic procedures\n\nExclusion Criteria:\n\n* decline of participation (patients, medical stuff)\n* paparoscopic appendectomies, laparoscopic cholecystectomies'}, 'identificationModule': {'nctId': 'NCT06951360', 'acronym': 'ENERGY', 'briefTitle': 'Workload Evaluation (Via NASA Task Load Index) of Robotic Assisted and Laparoscopic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Otto-von-Guericke University Magdeburg'}, 'officialTitle': 'ENERGY Study - Workload Evaluation (Via NASA Task Load Index) of Robotic Assisted and Laparoscopic Surgery', 'orgStudyIdInfo': {'id': 'ENERGY study'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'robotic procedures', 'description': 'residents, specialists and experts performing robotic visceral surgeries', 'interventionNames': ['Procedure: ENERGY questionnaire']}, {'label': 'laparoscopic procedures', 'description': 'residents, specialists and experts performing laparoscopic visceral surgeries', 'interventionNames': ['Procedure: ENERGY questionnaire']}], 'interventions': [{'name': 'ENERGY questionnaire', 'type': 'PROCEDURE', 'description': 'Questionnaire including NASA Task Load Index, difficulty level of operation, patient and operation factors', 'armGroupLabels': ['laparoscopic procedures', 'robotic procedures']}]}, 'contactsLocationsModule': {'locations': [{'zip': '39120', 'city': 'Magdeburg', 'state': 'Saxony-Anhalt', 'country': 'Germany', 'facility': 'Otto-von-Guericke University Magdeburg', 'geoPoint': {'lat': 52.13129, 'lon': 11.63189}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Otto-von-Guericke University Magdeburg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. med.', 'investigatorFullName': 'Jessica Stockheim', 'investigatorAffiliation': 'Otto-von-Guericke University Magdeburg'}}}}