- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00460980
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Withdrawn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
Intervention / Treatment
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.
Sponsor
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
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAB9401
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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