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WithdrawnNCT00460980Updated Apr 6, 2015

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

An interventional study of Virtual reality laparoscopic simulator training in Gallstones, sponsored by Columbia University. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-04-06.

Sponsored by Columbia University · Not applicable and Interventional

Why this study was withdrawn
Principal investigator left institution.
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Gallstones

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Keywords

  • resident training
  • laparoscopic skills
  • surgical skills assessment
03

In context

Gallstones

346 studies on the registry are indexed under Gallstones; 46 are open to participants now.

Browse Gallstones studies →

Lead sponsor

Columbia University is the lead sponsor of 1,103 studies on the registry; 193 are open to participants now.

Of its 172 completed or terminated interventional studies of FDA-regulated products, 142 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Surgical interns (PGY 1) are eligible
  • Twenty-five (25) participants will comprise this group

Exclusion criteria

Exclusion Criteria:

  • Prior clinical experience with laparoscopic surgery as the assistant surgeon.
  • Prior simulation training (mechanical, PC-based or otherwise).
05

Study design

Phase
Not applicable
Allocation
Not applicable
Intervention model
Single group
Masking
Single (Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • 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.

    Behavioral: Virtual reality laparoscopic simulator training

Interventions

  • BehavioralVirtual 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.

06

What researchers measure

Primary outcomes

  1. Score on Global Outcomes Assessment of Laparoscopic Skills

    Time frame: 5 weeks, 10 weeks

07

Study locations

1 site
  • Columbia University College of Physicians and Surgeons
    New York, New York 10032, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00460980
Lead sponsor
Columbia University
Responsible party
Sponsor
First posted
Apr 17, 2007
Start date
May 2006
Primary completion
Apr 2008
Completion
Apr 2008
Last update
Apr 6, 2015

Study contacts

Dennis L Fowler, MD
principal investigator · Columbia University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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