Virtual Temporal Bone Surgery: Defining and Translating Metrics

January 30, 2017 updated by: Gregory Wiet, Nationwide Children's Hospital
The goal of this project is to improve the efficiency of training and assessment of technical skill in surgical treatment of otologic disease. Through previous funding, we have developed an intuitive virtual simulation environment to be used as an adjuvant for teaching temporal bone surgery. Using direct-volume visualization techniques with integrated stereoscopic display, haptic (force) feedback, and aural simulation, we have achieved a straightforward, low-cost learning environment ready for translation into a practical training and assessment tool. This application challenges and seeks to shift current practice in clinical training by translating the simulation environment into a vehicle for curriculum development, technical skills assessment, and dissemination. The intent is to provide more accessible, inexpensive, safe, and deliberate practice with objective and continuous quantitative, objective assessment in the early stages of training.

Study Overview

Status

Completed

Detailed Description

The aims of this research include: 1) definition of standardized metrics for otological surgical techniques, 2) the translation of those standards into objective criteria for use in a computer synthesized surgical environment, and 3) the correlation between expert evaluation and computer automated assessment of resident proficiency.

The interactions will be computer-based and include:

Experts will learn to use the system so that they can evaluate the quality of translation of metrics to the simulation environment.

Evaluations will be in the form of anonymous web-based surveys. Experts serve as a focus group.

Residents will use the simulation environment to perform surgical procedures on virtual specimens. Residents will then evaluate the quality of the simulation environment via anonymous web-based surveys.

Experts will use the simulation environment to evaluate and rate the residents performance.

The computer environment will be used to automatically assess and rate the residents performance.

Expert and computer assessment will be compared.

Study Type

Observational

Enrollment (Actual)

96

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

    • California
      • Irvine, California, United States, 92868
        • UC Irvine
      • Palo Alto, California, United States, 94305
        • Stanford
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Iowa
    • Michigan
      • Detroit, Michigan, United States, 28322
        • Henry Ford
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Mississippi
    • New York
      • Bronx, New York, United States, 10467
        • Albert Einstein
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern
      • Houston, Texas, United States, 77030
        • Baylor

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Novice otology surgeons

Description

Inclusion Criteria:

  • Specific knowledge of otologic surgery.

Exclusion Criteria:

  • request not to participate

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Benchmarking
All resident study subjects will drill virtual temporal bones within the computer based system. The performance data will be used to validate the rating metrics and computer scoring process.
Residents will be trained using surgical simulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance on a set of validated metrics for temporal bone surgery.
Time Frame: one year
A collection of metrics designed to measure technical performance during a mastoidectomy will be validated by expert survey. These metrics will be translated to an automated system within the surgical simulation system. Resident subjects will be asked to perform the surgical procedure (mastoidectomy) within the simulation. Experts will then rate the playback of the performances using the validated metrics. These results will be compared to the automated scoring system. A conclusion will be drawn about the accuracy of the automated process compared to the expert rated process.
one year

Collaborators and Investigators

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

July 1, 2013

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

December 13, 2011

First Submitted That Met QC Criteria

December 14, 2011

First Posted (Estimate)

December 16, 2011

Study Record Updates

Last Update Posted (Estimate)

January 31, 2017

Last Update Submitted That Met QC Criteria

January 30, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • R01DC011321-01A1 (U.S. NIH Grant/Contract)

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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