LVG: Laparoscopic Training With Laser Guidance Trial

Sponsor

Rigshospitalet, Denmark (Other)

Overall Status

Completed

CT.gov ID

NCT02407483

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

6.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Depth Perception	Device: Laser Visual Guidance Device: 2 D vision	N/A

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:

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).

Study Design

Study Type:

Interventional

Actual Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Study Start Date :

Mar 1, 2015

Actual Primary Completion Date :

Jul 1, 2015

Actual Study Completion Date :

Aug 1, 2015

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Laser Visual Guidance group

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

Device: Laser Visual Guidance

Laparoscopic simulator training, tested with laser visual guidance

Active Comparator: Normal 2D vision group

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

Device: 2 D vision

Laparoscopic simulator training, tested without laser visual guidance

Outcome Measures

Primary Outcome Measures

Motor skills performance parameters (Cumulative Instrument movement-time) [3 hours]
Cumulative Instrument movement-time

Secondary Outcome Measures

The composite performance score (errors) [3 hours]
points

Other Outcome Measures

The NASA Task Load index (NASA-TLX). [3 hours]
Work load index

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre for Clinical Education	Copenhagen	Cooenhagen Ø	Denmark	2100

Sponsors and Collaborators

Rigshospitalet, Denmark

Investigators

Principal Investigator: Lars Konge, MD, PhD, Center for Clinical Education, Rigshospitalet,

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Stine Maya Dreier Sørensen, Medical Student, Rigshospitalet, Denmark

ClinicalTrials.gov Identifier:

NCT02407483

Other Study ID Numbers:

2014-6022

First Posted:

Apr 3, 2015

Last Update Posted:

Oct 2, 2018

Last Verified:

Oct 1, 2018

Keywords provided by Stine Maya Dreier Sørensen, Medical Student, Rigshospitalet, Denmark

Laparoscopy

Training Programs

Study Results

No Results Posted as of Oct 2, 2018