Laparoscopic Training With Laser Guidance Trial

Depth Perception Clinical Trial

— LVG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02407483
• Other study ID #: 2014-6022
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: August 2015

Study information

• Verified date: October 2018
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: August 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Depth Perception

Intervention

Device:
• Laser Visual Guidance
Laparoscopic simulator training, tested with laser visual guidance
• 2 D vision
Laparoscopic simulator training, tested without laser visual guidance

Locations

Country	Name	City	State
Denmark	Centre for Clinical Education	Copenhagen	Cooenhagen Ø

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The NASA Task Load index (NASA-TLX).	Work load index	3 hours
Primary	Motor skills performance parameters (Cumulative Instrument movement-time)	Cumulative Instrument movement-time	3 hours
Secondary	The composite performance score (errors)	points	3 hours