Clinical trial NCT00887185: Validation/Dissemination Of A Temporal Bone Dissection Simulator
Official title: Validation/Dissemination Of A Temporal Bone Dissection Simulator
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Computer Simulation
Education
Keywords: Surgical Simulation
Surgical skills training
Temporal bone surgery
Computer simulation
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2009-04-23
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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

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.

Eligibility 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.

Primary outcomes:
measure: Performance on temporal bone dissection.
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: The Ohio State University, Nationwide Children's Hospital
name: Gregory J Wiet, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.