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Clinical Trials/NCT02407483
NCT02407483CompletedNot Applicable

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

Rigshospitalet, Denmark2 sites in 1 country32 target enrollmentStarted: March 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
32
Locations
2
Primary Endpoint
Motor skills performance parameters (Cumulative Instrument movement-time)

Study Overview

Brief Summary

"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.

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:

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

Laser Visual Guidance group

Experimental

Will be tested using simulated laparoscopic tasks with the use of laser visual guidance

Intervention: Laser Visual Guidance (Device)

Normal 2D vision group

Active Comparator

Will be tested using simulated laparoscopic tasks without the use of laser visual guidance

Intervention: 2 D vision (Device)

Outcomes

Primary Outcomes

Motor skills performance parameters (Cumulative Instrument movement-time)

Time Frame: 3 hours

Cumulative Instrument movement-time

Secondary Outcomes

  • The composite performance score (errors)(3 hours)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Stine Maya Dreier Sørensen

Medical Student

Rigshospitalet, Denmark

Study Sites (2)

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