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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00435630
Other study ID # AAAA7372
Secondary ID
Status Completed
Phase N/A
First received February 14, 2007
Last updated November 19, 2012
Start date July 2004
Est. completion date August 2008

Study information

Verified date November 2012
Source Columbia University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the learning curve for each of seven tasks in a virtual reality laparoscopic simulator by medical students.


Description:

Developing objective methodology for assessing technical skill is paramount to superior surgical training. Alternatives to the traditional apprenticeship model of surgical training are necessary in today's emphasis on cost containment and professional competency.

Metrics are widely employed in virtual environments and provide a yardstick for performance measurement. The current method of defining metrics for medical simulation remains more an art than a science. Many studies have demonstrated that trainees who practice laparoscopic skills in a simulated environment will improve their mastery of those skills when tested in that same environment. Fewer studies have been able to document the learning curve for mastery of tasks in a virtual reality simulator. This study will investigate the learning curve for tasks in a virtual reality laparoscopic simulator.


Recruitment information / eligibility

Status Completed
Enrollment 29
Est. completion date August 2008
Est. primary completion date January 2005
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Medical students, years 1 through 4 are eligible.

- No prior clinical experience with laparoscopic surgery as the assistant surgeon.

- No prior simulation training (mechanical, PC-based or otherwise).

Exclusion Criteria:

- Persons who are not medical students.

- Medical students with prior clinical experience with laparoscopic surgery as the assistant surgeon.

- Medical students with prior simulation training (mechanical, PC-based or otherwise).

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Other:
LapSim training
complete curriculum training on LapSim surgical simulator

Locations

Country Name City State
United States Columbia University College of Physicians and Surgeons New York New York

Sponsors (1)

Lead Sponsor Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Establish learning curve for each of seven tasks on the simulator. For each of the module seven modules, the computer automatically measures set parameters. Each measured parameter that is recorded in the simulator will be used in data analysis. 6 months No
Secondary Establish test-retest reliability for each of seven tasks on the simulator. 6 months No
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