Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 9:58 PM
Study NCT ID:
NCT04926558
Status:
RECRUITING
Last Update Posted:
2024-06-07
First Post:
2021-03-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
TROMS (Trainee Reported Outcome Measurement): the New Era of Surgical Evaluation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-05', 'studyFirstSubmitDate': '2021-03-24', 'studyFirstSubmitQcDate': '2021-06-08', 'lastUpdatePostDateStruct': {'date': '2024-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of surgical skills achieved by residents', 'timeFrame': '5 years', 'description': 'Surgical performance will be evaluated in a random assigned operation by mentors using an specific OPRS (Operative Performance Rating System)'}], 'secondaryOutcomes': [{'measure': 'Trainee reported outcomes measurements', 'timeFrame': '5 years', 'description': 'Using a specific scale, we aim to measure the satisfaction perceived by our surgical residents concerning their training'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['TROMS', 'PROMS', 'surgical assessment', 'learning curve', 'OSATS', 'MIR'], 'conditions': ['Surgical Procedure, Unspecified']}, 'descriptionModule': {'briefSummary': 'TROMS (trainee reported outcome assessment): assessment of surgical training of residents in general surgery'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'all surgical residents of HMar', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\nAll surgical residents in the department of general and digestive surgery\n\nExclusion criteria:\n\nNot applicable'}, 'identificationModule': {'nctId': 'NCT04926558', 'acronym': 'TROMS', 'briefTitle': 'TROMS (Trainee Reported Outcome Measurement): the New Era of Surgical Evaluation', 'organization': {'class': 'OTHER', 'fullName': 'Hospital del Mar'}, 'officialTitle': 'TROMS (Trainee Reported Outcome Measurement): the New Era of Surgical Evaluation', 'orgStudyIdInfo': {'id': 'HMar2021'}}, 'contactsLocationsModule': {'locations': [{'zip': '08019', 'city': 'Barcelona', 'state': 'Catalonia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Patricia Sánchez-Velázquez, MD PhD FEBS', 'role': 'CONTACT', 'email': 'Psanchezvelazquez@psmar.cat', 'phone': '+34932483207'}], 'facility': 'Parc de Salut Mar de Barcelona- Hospital del Mar', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital del Mar', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical investigator', 'investigatorFullName': 'Patricia Sanchez Velazquez', 'investigatorAffiliation': 'Hospital del Mar'}}}}