Laparoscopic Training With Laser Guidance Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2015-08-31

Brief Summary

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"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.

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Detailed Description

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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).

Conditions

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Depth Perception

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Laser Visual Guidance group

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

Group Type EXPERIMENTAL

Laser Visual Guidance

Intervention Type DEVICE

Laparoscopic simulator training, tested with laser visual guidance

Normal 2D vision group

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

Group Type ACTIVE_COMPARATOR

2 D vision

Intervention Type DEVICE

Laparoscopic simulator training, tested without laser visual guidance

Interventions

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Laser Visual Guidance

Laparoscopic simulator training, tested with laser visual guidance

Intervention Type DEVICE

2 D vision

Laparoscopic simulator training, tested without laser visual guidance

Intervention Type DEVICE

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes