Effect of Virtual Reality Training by Novices on Laparoscopic Cholecystectomy in a Porcine Model

Gallstones Clinical Trial

Official title:

Effect of Virtual Reality Training by Novices on Laparoscopic Cholecystectomy in a Porcine Model

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00460980
• Other study ID #: AAAB9401
• Status: Withdrawn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• Status: Withdrawn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

• Gallstones

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