ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00460980
Recruitment Status : Withdrawn (Principal investigator left institution.)
First Posted : April 17, 2007
Last Update Posted : April 6, 2015
Sponsor:
Information provided by (Responsible Party):
Columbia University

Brief 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.

Condition or disease Intervention/treatment Phase
Gallstones Behavioral: Virtual reality laparoscopic simulator training Not Applicable

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  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Official Title: Effect of Virtual Reality Training by Novices on Laparoscopic Cholecystectomy in a Porcine Model
Study Start Date : May 2006
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Score on Global Outcomes Assessment of Laparoscopic Skills [ Time Frame: 5 weeks, 10 weeks ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT00460980     History of Changes
Other Study ID Numbers: AAAB9401
First Posted: April 17, 2007    Key Record Dates
Last Update Posted: April 6, 2015
Last Verified: April 2015

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

Additional relevant MeSH terms:
Gallstones
Cholelithiasis
Biliary Tract Diseases
Digestive System Diseases
Cholecystolithiasis
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical