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

This study has been withdrawn prior to enrollment.
(Principal investigator left institution.)
Sponsor:
Information provided by (Responsible Party):
Columbia University
ClinicalTrials.gov Identifier:
NCT00460980
First received: April 13, 2007
Last updated: April 2, 2015
Last verified: April 2015
  Purpose

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.


Condition Intervention
Gallstones
Behavioral: Virtual reality laparoscopic simulator training

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Effect of Virtual Reality Training by Novices on Laparoscopic Cholecystectomy in a Porcine Model

Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Score on Global Outcomes Assessment of Laparoscopic Skills [ Time Frame: 5 weeks, 10 weeks ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: May 2006
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00460980

Locations
United States, New York
Columbia University College of Physicians and Surgeons
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Dennis L Fowler, MD Columbia University College of Physicians and Surgeons
  More Information

No publications provided

Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT00460980     History of Changes
Other Study ID Numbers: AAAB9401
Study First Received: April 13, 2007
Last Updated: April 2, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
resident training
laparoscopic skills
surgical skills assessment

ClinicalTrials.gov processed this record on April 19, 2015