Standardized Criteria to Judge Diagnostic Urethrocystoscopy Skills

August 18, 2008 updated by: University of Cincinnati

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

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ohio
      • Cincinnati, Ohio, United States, 45202
        • University of Cincinnat

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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.
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:
  • Objective structured assessment of surgical skills (OSATS), diagnostic cystoscopy,
  • urethrocystoscopy skills intervention, objective evaluation of procedure skills intervention,
  • educational workshops, cystoscopy classes, cystoscopy certificate
Placebo Comparator: 2
The control group will be instructed to read a urethrocystoscopy textbook chapter at home
usual activities

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
measure competency and change in urethrocystoscopy skills
Time Frame: 2 months
2 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Establish validity and reliability of measurement tools (OSATS) used to evaluate urethrocystoscopy skills
Time Frame: 2 months
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Sam Siddighi, MD, University of Cincinnati

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

February 27, 2008

First Submitted That Met QC Criteria

March 7, 2008

First Posted (Estimate)

March 10, 2008

Study Record Updates

Last Update Posted (Estimate)

August 19, 2008

Last Update Submitted That Met QC Criteria

August 18, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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