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

April 2, 2015 updated by: Columbia University
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.

Study Overview

Status

Withdrawn

Conditions

Detailed 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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New York
      • New York, New York, United States, 10032
        • Columbia University College of Physicians and Surgeons

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Virtual reality laparoscopic simulator

Virtual reality laparoscopic simulator training:

Residents will participate in a structured approach to teaching laparoscopic skills to beginning surgeons with a virtual reality trainer will improve skills prior to actual operative experience.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Score on Global Outcomes Assessment of Laparoscopic Skills
Time Frame: 5 weeks, 10 weeks
5 weeks, 10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

April 13, 2007

First Submitted That Met QC Criteria

April 13, 2007

First Posted (Estimate)

April 17, 2007

Study Record Updates

Last Update Posted (Estimate)

April 6, 2015

Last Update Submitted That Met QC Criteria

April 2, 2015

Last Verified

April 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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