Skip to main content
OpenTrials
Completed

NCT Number: NCT02407483

Laparoscopic Training With Laser Guidance 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Depth Perception

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Clinical Education

Copenhagen, Cooenhagen Ø, 2100, Denmark

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Laser Visual Guidance

Device

Laparoscopic simulator training, tested with laser visual guidance

2 D vision

Device

Laparoscopic simulator training, tested without laser visual guidance

Primary outcomes

  1. Motor skills performance parameters (Cumulative Instrument movement-time)

    Time frame: 3 hours

    Cumulative Instrument movement-time

Secondary outcomes

  1. The composite performance score (errors)

    Time frame: 3 hours

    points

Other outcomes

  1. The NASA Task Load index (NASA-TLX).

    Time frame: 3 hours

    Work load index

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

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

Acronym: LVG

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Apr 3, 2015
Registry last updated
Oct 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.