Laparoscopic Training With Laser Guidance Trial (LVG)

October 1, 2018 updated by: Stine Maya Dreier Sørensen, Rigshospitalet, Denmark

Laparoscopic Simulator Training With or Without Laser Visual Guidance -A Randomized Trial

"Laparoscopic simulation training with or without laser visual guidance -A randomised study" which investigates if the use of laser visual guidance can help the novices to learn the laparoscopic skills.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background: The loss of depth perception due to working in a three-dimensional space based on two-dimensional images is one of the challenging aspects of laparoscopy compared to conventional open surgery.

Objectives: To examine the effect of laser visual guidance on laparoscopic performance and cognitive load in a simulated setting for novices.

Methods: Randomised Clinical Trial- Laser visual guidance vs. normal 2 D vision.

Outcomes:

Primary outcome: Motor skills performance parameters-movement-time:

Cumulative instrument movement-time for both the right and left instrument for the test session,

Secondary outcome: 2) The overall composite score.

Exploratory outcomes: 3) The NASA Task Load index (NASA-TLX).

Study Type

Interventional

Enrollment (Actual)

32

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

  • Denmark
    • Cooenhagen Ø
      • Copenhagen, Cooenhagen Ø, Denmark, 2100
        • Centre for Clinical Education

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Surgical novices / medical students enrolled at The Faculty of Health Science, University of Copenhagen.
  • Participants are required to provide informed consent before inclusion.

Exclusion Criteria:

  • Participation in prior studies involving laparoscopic training.
  • Experience with laparoscopy surgery (having performed minimum one laparoscopic procedure as primary surgeon, including supervised procedures).
  • No informed consent.
  • Does not speak Danish on a conversational level.

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

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Laser Visual Guidance group
Will be tested using simulated laparoscopic tasks with the use of laser visual guidance
Device: Laser Visual Guidance
Laparoscopic simulator training, tested with laser visual guidance
Active Comparator: Normal 2D vision group
Will be tested using simulated laparoscopic tasks without the use of laser visual guidance
Device: 2 D vision
Laparoscopic simulator training, tested without laser visual guidance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motor skills performance parameters (Cumulative Instrument movement-time)
Time Frame: 3 hours
Cumulative Instrument movement-time
3 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The composite performance score (errors)
Time Frame: 3 hours
points
3 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The NASA Task Load index (NASA-TLX).
Time Frame: 3 hours
Work load index
3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Lars Konge, MD, PhD, Center for Clinical Education, Rigshospitalet,

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

March 1, 2015

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

March 19, 2015

First Submitted That Met QC Criteria

April 2, 2015

First Posted (Estimate)

April 3, 2015

Study Record Updates

Last Update Posted (Actual)

October 2, 2018

Last Update Submitted That Met QC Criteria

October 1, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2014-6022

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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