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Validation/Dissemination Of A Temporal Bone Dissection Simulator

NCT ID: NCT00887185

Last Updated: 2011-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2011-08-31

Brief Summary

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Designed to test the efficacy of a computer based virtual simulation for teaching ear surgery.

Detailed Description

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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.

Conditions

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Computer Simulation Education

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Simulator training for temporal bone surgery

Intervention Type OTHER

Subjects in experimental arm are asked to spend 2 weeks practicing temporal bone surgical procedures using a computer simulation.

2 Simulator training

Subjects perform temporal bone surgical dissection training on a simulator.

Group Type EXPERIMENTAL

Simulator training for temporal bone surgery

Intervention Type OTHER

Subjects in experimental arm are asked to spend 2 weeks practicing temporal bone surgical procedures using a computer simulation.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Simulator training Surgical training

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role collaborator

Gregory Wiet

OTHER

Sponsor Role lead

Responsible Party

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Gregory Wiet

Clinical Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Gregory J Wiet, MD

Role: PRINCIPAL_INVESTIGATOR

The Ohio State University, Nationwide Children's Hospital

Locations

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The Ohio State University

Columbus, Ohio, United States

Site Status

Countries

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United States

References

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Wiet GJ, Schmalbrock P, Powell K, Stredney D. Use of ultra-high-resolution data for temporal bone dissection simulation. Otolaryngol Head Neck Surg. 2005 Dec;133(6):911-5. doi: 10.1016/j.otohns.2005.05.655.

Reference Type BACKGROUND
PMID: 16360513 (View on PubMed)

Stredney D, Wiet GJ, Bryan J, Sessanna D, Murakami J, Schmalbrock P, Powell K, Welling B. Temporal bone dissection simulation--an update. Stud Health Technol Inform. 2002;85:507-13.

Reference Type BACKGROUND
PMID: 15458142 (View on PubMed)

Wiet GJ, Stredney D, Sessanna D, Bryan JA, Welling DB, Schmalbrock P. Virtual temporal bone dissection: an interactive surgical simulator. Otolaryngol Head Neck Surg. 2002 Jul;127(1):79-83. doi: 10.1067/mhn.2002.126588.

Reference Type BACKGROUND
PMID: 12161735 (View on PubMed)

Fernandez SA, Wiet GJ, Butler NN, Welling B, Jarjoura D. Reliability of surgical skills scores in otolaryngology residents: analysis using generalizability theory. Eval Health Prof. 2008 Dec;31(4):419-36. doi: 10.1177/0163278708324444. Epub 2008 Oct 7.

Reference Type RESULT
PMID: 18842619 (View on PubMed)

Butler NN, Wiet GJ. Reliability of the Welling scale (WS1) for rating temporal bone dissection performance. Laryngoscope. 2007 Oct;117(10):1803-8. doi: 10.1097/MLG.0b013e31811edd7a.

Reference Type RESULT
PMID: 17721407 (View on PubMed)

Other Identifiers

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5R01DC006458-05

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NIH Grant 5R01DC006458-05

Identifier Type: -

Identifier Source: secondary_id

2006H0194

Identifier Type: -

Identifier Source: org_study_id