2D Versus 3D Laparoscopic Training on a Virtual Reality Simulator

October 1, 2018 updated by: Stine Maya Dreier Sørensen, Rigshospitalet, Denmark

2D Versus 3D Laparoscopic Training on a Virtual Reality Simulator - A Randomised Trial

Laparoscopy training programs with virtual reality simulators are widely used before new surgeons are allowed to operate on patients. Laparoscopic surgery results in shorter time to recover, less surgical trauma and thereby a shorter stay at the hospital compared with open surgery. However, it is more difficult to learn laparoscopic surgery, than open surgery, in part because surgeons have to work in a 3-dimensional space, through a 2-dimensional interface on a screen. This results in loss of depth perception and therefore a higher visual and cognitive load. This trial examines if using 3D vision instead of 2D vision on the laparoscopic virtual reality simulator reduces the time to reach proficiency, by decreasing the cognitive and visual load during practice on a Virtual Reality Simulator.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Centre for Clinical Education

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Residents working in Denmark. Participants are required to have a medical license and provide informed consent before inclusion

Exclusion Criteria:

  1. Participation in prior studies involving laparoscopic training.
  2. Experience with laparoscopy surgery (having performed minimum one laparoscopic procedure as primary surgeon, including supervised procedures).
  3. Performing more than 3 supervised laparoscopy surgeries during the intervention.
  4. Performing laparoscopy surgery between the intervention and the retention test 3-6 weeks after.
  5. No informed consent.
  6. Does not speak Danish on a conversational level.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 3D group
Will practice under 3D vision conditions on a laparoscopic virtual reality simulator
Device: 3D vision
Laparoscopic simulator training to proficiency under 3D conditions
Active Comparator: 2D group
Will practice under 2D vision conditions on a laparoscopic virtual reality simulator
Device: 2D vision
Laparoscopic simulator training to proficiency under 2D conditions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time (minutes) to reach the predefined proficiency level for the basic skills and the salpingectomy procedure
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Time (minutes) to reach the predefined proficiency level for the basic skills and salpingectomy procedure under 2D conditions after 3-6 weeks without laparoscopic training during the follow-up period
Time Frame: 1 year
1 year

Other Outcome Measures

Outcome Measure
Time Frame
Workload: NASA TLX questionnaire after the first and fifth attempt on procedural module,
Time Frame: 1 year
1 year
Visual and physical discomfort questionnaire after each training session (adverse effect: eye strain, headache, dizziness, nausea, tired and sore neck/back),
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Stine Maya Dreier Sørensen, B.M.Sc., Centre for Clinical Education

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

February 3, 2015

First Submitted That Met QC Criteria

February 6, 2015

First Posted (Estimate)

February 11, 2015

Study Record Updates

Last Update Posted (Actual)

October 2, 2018

Last Update Submitted That Met QC Criteria

October 1, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2015-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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