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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00460980
Other study ID # AAAB9401
Secondary ID
Status Withdrawn
Phase N/A
First received April 13, 2007
Last updated April 2, 2015
Start date May 2006
Est. completion date April 2008

Study information

Verified date April 2015
Source Columbia University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

This study proposes evaluation of an educational tool, a laparoscopic virtual reality simulator. The purpose of this study is to determine whether training on the LapSim Simulator transfers to improved laparoscopic cholecystectomy operative performance in an animal model.


Description:

This is study protocol involves the training and evaluation of general surgery interns on a laparoscopic simulator (LapSim®, Surgical Science Ltd, Göteborg, Sweden, version 3.0.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date April 2008
Est. primary completion date April 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Surgical interns (PGY 1) are eligible

- Twenty-five (25) participants will comprise this group

Exclusion Criteria:

- Prior clinical experience with laparoscopic surgery as the assistant surgeon.

- Prior simulation training (mechanical, PC-based or otherwise).

Study Design

Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor)


Related Conditions & MeSH terms


Intervention

Behavioral:
Virtual reality laparoscopic simulator training
The aim of this project is to determine whether a structured approach to teaching laparoscopic skills to beginning surgeons with a virtual reality trainer will improve skills prior to actual operative experience. We aim to show that with the virtual reality trainer, operative skills will be improved and that overall operative time will be decreased.

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 Score on Global Outcomes Assessment of Laparoscopic Skills 5 weeks, 10 weeks No
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