- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00631761
Standardized Criteria to Judge Diagnostic Urethrocystoscopy Skills
Develop a tool to objectively quantify technical skills necessary to perform diagnostic cystoscopy (using Objective Structured Assessment of Technical Skills- OSATS).
Develop criteria by which surgeons skills in diagnostic cystoscopy can be evaluated or judged.
Develop 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ohio
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Cincinnati, Ohio, United States, 45202
- University of Cincinnat
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All Obstetrics & Gynecology and Urology resident physicians training at the University of Cincinnati
Exclusion Criteria:
- Any above resident with extensive training in cystoscopy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: 1
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.
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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.
Other Names:
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Placebo Comparator: 2
The control group will be instructed to read a urethrocystoscopy textbook chapter at home
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usual activities
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
measure competency and change in urethrocystoscopy skills
Time Frame: 2 months
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2 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Establish validity and reliability of measurement tools (OSATS) used to evaluate urethrocystoscopy skills
Time Frame: 2 months
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2 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sam Siddighi, MD, University of Cincinnati
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Cystoscopy Project
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