Ignite Creation Date:
2025-12-24 @ 12:07 PM
Ignite Modification Date:
2026-03-29 @ 12:56 PM
Study NCT ID:
NCT00631761
Status:
COMPLETED
Last Update Posted:
2008-08-19
First Post:
2008-02-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Standardized Criteria to Judge Diagnostic Urethrocystoscopy Skills
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': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-08', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-08-18', 'studyFirstSubmitDate': '2008-02-27', 'studyFirstSubmitQcDate': '2008-03-07', 'lastUpdatePostDateStruct': {'date': '2008-08-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'measure competency and change in urethrocystoscopy skills', 'timeFrame': '2 months'}], 'secondaryOutcomes': [{'measure': 'Establish validity and reliability of measurement tools (OSATS) used to evaluate urethrocystoscopy skills', 'timeFrame': '2 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['urethrocystoscopy', 'cystoscopy', 'objective structured assessment of surgical skills (OSATS)'], 'conditions': ['Urethrocystoscopy Skills']}, 'referencesModule': {'references': [{'pmid': '17267826', 'type': 'BACKGROUND', 'citation': 'Siddighi S, Kleeman SD, Baggish MS, Rooney CM, Pauls RN, Karram MM. Effects of an educational workshop on performance of fourth-degree perineal laceration repair. Obstet Gynecol. 2007 Feb;109(2 Pt 1):289-94. doi: 10.1097/01.AOG.0000251499.18394.9f.'}]}, 'descriptionModule': {'briefSummary': 'Develop a tool to objectively quantify technical skills necessary to perform diagnostic cystoscopy (using Objective Structured Assessment of Technical Skills- OSATS).\n\nDevelop criteria by which surgeons skills in diagnostic cystoscopy can be evaluated or judged.\n\nDevelop an intervention (1.5 hour workshop) which can be replicated by other residency programs in order to enhance learning of diagnostic cystoscopy. The workshop should be adequate for practicing Gynecologists as well as they already have experience with diagnostic hysteroscopy which uses many of the same concepts.', 'detailedDescription': 'The OSATS and a written examination will be used to assess residents skills and knowledge pertinent to diagnostic urethrocystoscopy. All residents will be tested on anatomic replica of human bladder for baseline competency using the above tools. Then approximately half will be randomly selected to undergo an educational intervention (a workshop teaching diagnostic urethrocystoscopy). As we are interested in short-term acquisition, about a week later all residents will be retested using the same methods. Grades on the exam will be kept confidential.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All Obstetrics \\& Gynecology and Urology resident physicians training at the University of Cincinnati\n\nExclusion Criteria:\n\n* Any above resident with extensive training in cystoscopy'}, 'identificationModule': {'nctId': 'NCT00631761', 'briefTitle': 'Standardized Criteria to Judge Diagnostic Urethrocystoscopy Skills', 'organization': {'class': 'OTHER', 'fullName': 'University of Cincinnati'}, 'officialTitle': 'Standardized Criteria to Judge Diagnostic Urethrocystoscopy Skills', 'orgStudyIdInfo': {'id': 'Cystoscopy Project'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'The intervention group will view a 20 minute video, receive a 30 minute didactic lecture on urethrocystoscopy, and 30 minute coaching/practice performing diagnostic cystoscopy on anatomic replicas of the human bladder.', 'interventionNames': ['Other: educational workshop']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'The control group will be instructed to read a urethrocystoscopy textbook chapter at home', 'interventionNames': ['Other: no intervention (usual resident activities)']}], 'interventions': [{'name': 'educational workshop', 'type': 'OTHER', 'otherNames': ['Objective structured assessment of surgical skills (OSATS), diagnostic cystoscopy,', 'urethrocystoscopy skills intervention, objective evaluation of procedure skills intervention,', 'educational workshops, cystoscopy classes, cystoscopy certificate'], 'description': 'The intervention group will view a 20 minute video, receive a 30 minute didactic lecture on urethrocystoscopy, and 30 minute coaching/practice performing diagnostic cystoscopy on anatomic replicas.', 'armGroupLabels': ['1']}, {'name': 'no intervention (usual resident activities)', 'type': 'OTHER', 'description': 'usual activities', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45202', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Cincinnat', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Sam Siddighi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cincinnati'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cincinnati', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Sam Siddighi, MD', 'oldOrganization': 'University of Cincinnati'}}}}