Laparoscopic Training With Laser Guidance Trial

Study Overview
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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.

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).

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

Conditions
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Depth Perception

Intervention / Treatment
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* Device: Laser Visual Guidance
* Device: 2 D vision


Participation Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopy, Training Programs