NCT00887185

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2006

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

April 21, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 23, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

September 27, 2011

Status Verified

September 1, 2011

Enrollment Period

4.8 years

First QC Date

April 21, 2009

Last Update Submit

September 26, 2011

Conditions

Computer SimulationEducation

Keywords

Surgical SimulationSurgical skills trainingTemporal bone surgeryComputer simulation

Outcome Measures

Primary Outcomes (1)

  • Performance on temporal bone dissection.

    2 weeks

Study Arms (2)

1 - Traditional training

ACTIVE COMPARATOR

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

2 Simulator training

EXPERIMENTAL

Subjects perform temporal bone surgical dissection training on a simulator.

Other: Simulator training for temporal bone surgery

Interventions

Simulator training for temporal bone surgeryOTHER

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

Also known as: Simulator training, Surgical training
1 - Traditional training2 Simulator training

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Not enrolled in ENT training program or interest in ENT training.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (5)

  • 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.

    PMID: 16360513BACKGROUND

  • 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.

    PMID: 15458142BACKGROUND

  • 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.

    PMID: 12161735BACKGROUND

  • 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.

    PMID: 18842619RESULT

  • 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.

    PMID: 17721407RESULT

Study Officials

  • Gregory J Wiet, MD

    The Ohio State University, Nationwide Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

April 21, 2009

First Posted

April 23, 2009

Study Start

October 1, 2006

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

September 27, 2011

Record last verified: 2011-09

Locations

US(1)