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Laparoscopic Training With Laser Guidance Trial (LVG)

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Rigshospitalet

Status

Completed

Conditions

Depth Perception

Treatments

Device: Laser Visual Guidance
Device: 2 D vision

Study type

Interventional

Funder types

Other

Identifiers

NCT02407483
2014-6022

Details and patient eligibility

About

"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.

Full 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).

Enrollment

32 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

32 participants in 2 patient groups

Laser Visual Guidance group
Experimental group
Description:
Will be tested using simulated laparoscopic tasks with the use of laser visual guidance
Treatment:
Device: Laser Visual Guidance
Normal 2D vision group
Active Comparator group
Description:
Will be tested using simulated laparoscopic tasks without the use of laser visual guidance
Treatment:
Device: 2 D vision

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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