NCT00435630

Brief Summary

The purpose of this study is to determine the learning curve for each of seven tasks in a virtual reality laparoscopic simulator by medical students.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

July 1, 2004

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 14, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 15, 2007

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

November 21, 2012

Status Verified

November 1, 2012

Enrollment Period

6 months

First QC Date

February 14, 2007

Last Update Submit

November 19, 2012

Conditions

Education

Keywords

EducationVirtual RealityLaparoscopic SurgeryLearning Curve

Outcome Measures

Primary Outcomes (1)

  • Establish learning curve for each of seven tasks on the simulator.

    For each of the module seven modules, the computer automatically measures set parameters. Each measured parameter that is recorded in the simulator will be used in data analysis.

    6 months

Secondary Outcomes (1)

  • Establish test-retest reliability for each of seven tasks on the simulator.

    6 months

Study Arms (1)

1

OTHER

Completing simulator training sessions

Other: LapSim training

Interventions

LapSim trainingOTHER

complete curriculum training on LapSim surgical simulator

1

Eligibility Criteria

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

You may qualify if:

  • Medical students, years 1 through 4 are eligible.
  • No prior clinical experience with laparoscopic surgery as the assistant surgeon.
  • No prior simulation training (mechanical, PC-based or otherwise).

You may not qualify if:

  • Persons who are not medical students.
  • Medical students with prior clinical experience with laparoscopic surgery as the assistant surgeon.
  • Medical students with 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

Study Officials

  • Dennis L Fowler, MD

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Gerald and Janet Carrus Professor of Clinical Surgical Science (In Surgery)

Study Record Dates

First Submitted

February 14, 2007

First Posted

February 15, 2007

Study Start

July 1, 2004

Primary Completion

January 1, 2005

Study Completion

August 1, 2008

Last Updated

November 21, 2012

Record last verified: 2012-11

Locations

US(1)