NCT00460980

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 17, 2007

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

April 6, 2015

Status Verified

April 1, 2015

Enrollment Period

1.9 years

First QC Date

April 13, 2007

Last Update Submit

April 2, 2015

Conditions

Keywords

resident traininglaparoscopic skillssurgical skills assessment

Outcome Measures

Primary Outcomes (1)

  • Score on Global Outcomes Assessment of Laparoscopic Skills

    5 weeks, 10 weeks

Study Arms (1)

Virtual reality laparoscopic simulator

OTHER

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

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.

Virtual reality laparoscopic simulator

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University College of Physicians and Surgeons

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Gallstones

Condition Hierarchy (Ancestors)

CholelithiasisBiliary Tract DiseasesDigestive System DiseasesCholecystolithiasisGallbladder DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Dennis L Fowler, MD

    Columbia University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2007

First Posted

April 17, 2007

Study Start

May 1, 2006

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

April 6, 2015

Record last verified: 2015-04

Locations