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Virtual Temporal Bone Surgery: Defining and Translating Metrics

This study has been completed.
Sponsor:
Collaborators:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Ohio State University
Information provided by (Responsible Party):
Gregory Wiet, Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT01493765
First received: December 13, 2011
Last updated: January 30, 2017
Last verified: January 2017
  Purpose
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.

Condition Intervention
Focus: Otologic Surgery Training
Other: Simulator training with expert scoring

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Prospective
Official Title: Virtual Temporal Bone Surgery: Defining and Translating Metrics

Resource links provided by NLM:


Further study details as provided by Nationwide Children's Hospital:

Primary Outcome Measures:
  • 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.


Enrollment: 96
Study Start Date: July 2013
Study Completion Date: July 1, 2016
Primary Completion Date: July 1, 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Other: Simulator training with expert scoring
Residents will be trained using surgical simulation

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.

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Novice otology surgeons
Criteria

Inclusion Criteria:

  • Specific knowledge of otologic surgery.

Exclusion Criteria:

  • request not to participate
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01493765

Locations
United States, California
UC Irvine
Irvine, California, United States, 92868
Stanford
Palo Alto, California, United States, 94305
United States, Iowa
Iowa
Iowa City, Iowa, United States, 52242
United States, Michigan
Henry Ford
Detroit, Michigan, United States, 28322
United States, Mississippi
Mississippi
Jackson, Mississippi, United States, 39216
United States, New York
Albert Einstein
Bronx, New York, United States, 10467
United States, North Carolina
Duke
Durham, North Carolina, United States, 27710
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
United States, Texas
UT Southwestern
Dallas, Texas, United States, 75390
Baylor
Houston, Texas, United States, 77030
Sponsors and Collaborators
Nationwide Children's Hospital
National Institute on Deafness and Other Communication Disorders (NIDCD)
Ohio State University
  More Information

Responsible Party: Gregory Wiet, Associate Professor of Otolaryngology and Biomedical Informatics, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01493765     History of Changes
Other Study ID Numbers: R01DC011321-01A1 
Study First Received: December 13, 2011
Last Updated: January 30, 2017

Additional relevant MeSH terms:
Metronidazole
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on February 24, 2017