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Validation/Dissemination Of A Temporal Bone Dissection Simulator

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ClinicalTrials.gov Identifier: NCT00887185
Recruitment Status : Completed
First Posted : April 23, 2009
Last Update Posted : September 27, 2011
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Designed to test the efficacy of a computer based virtual simulation for teaching ear surgery.

Condition or disease Intervention/treatment Phase
Computer Simulation Education Other: Simulator training for temporal bone surgery Phase 2

Detailed Description:
This research is designed to test the efficacy of a computer based virtual simulation for teaching ear surgery. Subjects will be randomized to training in the usual fashion and training in the simulation environment. Subjects performance will be tested in a standard fashion by dissecting cadaveric temporal bones (human ears) before and after training. The subjects will also perform a dissection in the virtual environment before and after training. The results will be tabulated to compare the different training arms. There is minimal risk associated with the projects and is limited to exposure to cadaveric material. Current training techniques utilize cadaveric material so exposure to this type of material is already a part of the standard training process and this study should not constitute an increased risk beyond what is encountered during their regular training. Demographic information will be obtained for each of the study subject on age, sex, information regarding previous otologic training, year of training and prior experience using computers. The anticipated benefits to society will be that future otologic surgeons can obtain operative experience in a controlled and non threatening environment. They will have access to a greater number of variations in pathology. This will allow each novice surgeon to obtain significantly more experience outside the operating room prior to working with live patients. This will result in less risk to the patient and better trained ear surgeons.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Validation/Dissemination Of A Temporal Bone Dissection Simulator
Study Start Date : October 2006
Primary Completion Date : August 2011
Study Completion Date : August 2011
Arms and Interventions

Arm Intervention/treatment
Active Comparator: 1 - Traditional training
Temporal bone dissection training in cadaveric laboratory. Subjects are provided 2 cadaveric temporal bones and asked to spend 2 weeks practicing the surgical technique of complete mastoidectomy with facial recess approach.
Other: Simulator training for temporal bone surgery
Subjects in experimental arm are asked to spend 2 weeks practicing temporal bone surgical procedures using a computer simulation.
Other Names:
  • Simulator training
  • Surgical training
Experimental: 2 Simulator training
Subjects perform temporal bone surgical dissection training on a simulator.
Other: Simulator training for temporal bone surgery
Subjects in experimental arm are asked to spend 2 weeks practicing temporal bone surgical procedures using a computer simulation.
Other Names:
  • Simulator training
  • Surgical training


Outcome Measures

Primary Outcome Measures :
  1. Performance on temporal bone dissection. [ Time Frame: 2 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Enrolled in residency for ear, nose and throat training or medical student interested in ear, nose and throat training.

Exclusion Criteria:

  • Not enrolled in ENT training program or interest in ENT training.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00887185


Locations
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Gregory Wiet
National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
Principal Investigator: Gregory J Wiet, MD The Ohio State University, Nationwide Children's Hospital
More Information