Clinical trial NCT02361463: 2D Versus 3D Laparoscopic Training on a Virtual Reality Simulator
Official title: 2D Versus 3D Laparoscopic Training on a Virtual Reality Simulator - A Randomised Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stereoscopic Vision
Keywords: Laparoscopy;
Training;
Three-Dimensional
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2015-02-11
Enrollment: 32
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Time (minutes) to reach the predefined proficiency level for the basic skills and the salpingectomy procedure
timeFrame: 1 year
Secondary outcomes:
measure: 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
timeFrame: 1 year
Other outcomes:
measure: Workload: NASA TLX questionnaire after the first and fifth attempt on procedural module,
timeFrame: 1 year
measure: Visual and physical discomfort questionnaire after each training session (adverse effect: eye strain, headache, dizziness, nausea, tired and sore neck/back),
timeFrame: 1 year
Locations:
city: Copenhagen
country: Denmark
facility: Centre for Clinical Education
Study officials:
affiliation: Centre for Clinical Education
name: Stine Maya Dreier Sørensen, B.M.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Cicione A, Autorino R, Breda A, De Sio M, Damiano R, Fusco F, Greco F, Carvalho-Dias E, Mota P, Nogueira C, Pinho P, Mirone V, Correia-Pinto J, Rassweiler J, Lima E. Three-dimensional vs standard laparoscopy: comparative assessment using a validated program for laparoscopic urologic skills. Urology. 2013 Dec;82(6):1444-50. doi: 10.1016/j.urology.2013.07.047. Epub 2013 Oct 2.
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citation: Sorensen SMD, Konge L, Bjerrum F. 3D vision accelerates laparoscopic proficiency and skills are transferable to 2D conditions: A randomized trial. Am J Surg. 2017 Jul;214(1):63-68. doi: 10.1016/j.amjsurg.2017.03.001. Epub 2017 Mar 9.