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

NCT02361463 | Completed

• 1 other identifier: 2015-001
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Stereoscopic Vision

Keywords

Laparoscopy;; Training;; Three-Dimensional

Outcome Measures

Primary Outcomes (1)

• Time (minutes) to reach the predefined proficiency level for the basic skills and the salpingectomy procedure

  1 year

Secondary Outcomes (1)

• 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

  1 year

Other Outcomes (2)

• Workload: NASA TLX questionnaire after the first and fifth attempt on procedural module,

  1 year

• Visual and physical discomfort questionnaire after each training session (adverse effect: eye strain, headache, dizziness, nausea, tired and sore neck/back),

  1 year

Study Arms (2)

3D group

EXPERIMENTAL

Will practice under 3D vision conditions on a laparoscopic virtual reality simulator

Device: 3D vision

2D group

ACTIVE COMPARATOR

Will practice under 2D vision conditions on a laparoscopic virtual reality simulator

Device: 2D vision

Interventions

3D vision DEVICE

Laparoscopic simulator training to proficiency under 3D conditions

3D group

2D vision DEVICE

Laparoscopic simulator training to proficiency under 2D conditions

2D group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Centre for Clinical Education

Copenhagen, 2100, Denmark

Location

Related Publications (8)

• Lusch A, Bucur PL, Menhadji AD, Okhunov Z, Liss MA, Perez-Lanzac A, McDougall EM, Landman J. Evaluation of the impact of three-dimensional vision on laparoscopic performance. J Endourol. 2014 Feb;28(2):261-6. doi: 10.1089/end.2013.0344. Epub 2014 Jan 10.

  PMID: 24059674 BACKGROUND

• Votanopoulos K, Brunicardi FC, Thornby J, Bellows CF. Impact of three-dimensional vision in laparoscopic training. World J Surg. 2008 Jan;32(1):110-8. doi: 10.1007/s00268-007-9253-6.

  PMID: 17992561 BACKGROUND

• Smith R, Schwab K, Day A, Rockall T, Ballard K, Bailey M, Jourdan I. Effect of passive polarizing three-dimensional displays on surgical performance for experienced laparoscopic surgeons. Br J Surg. 2014 Oct;101(11):1453-9. doi: 10.1002/bjs.9601. Epub 2014 Aug 18.

  PMID: 25131843 BACKGROUND

• Alaraimi B, El Bakbak W, Sarker S, Makkiyah S, Al-Marzouq A, Goriparthi R, Bouhelal A, Quan V, Patel B. A randomized prospective study comparing acquisition of laparoscopic skills in three-dimensional (3D) vs. two-dimensional (2D) laparoscopy. World J Surg. 2014 Nov;38(11):2746-52. doi: 10.1007/s00268-014-2674-0.

  PMID: 25002241 BACKGROUND

• Wilhelm D, Reiser S, Kohn N, Witte M, Leiner U, Muhlbach L, Ruschin D, Reiner W, Feussner H. Comparative evaluation of HD 2D/3D laparoscopic monitors and benchmarking to a theoretically ideal 3D pseudodisplay: even well-experienced laparoscopists perform better with 3D. Surg Endosc. 2014 Aug;28(8):2387-97. doi: 10.1007/s00464-014-3487-9. Epub 2014 Mar 21.

  PMID: 24651895 BACKGROUND

• 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.

  PMID: 24094658 BACKGROUND

• Mistry M, Roach VA, Wilson TD. Application of stereoscopic visualization on surgical skill acquisition in novices. J Surg Educ. 2013 Sep-Oct;70(5):563-70. doi: 10.1016/j.jsurg.2013.04.006. Epub 2013 May 20.

  PMID: 24016365 BACKGROUND

• 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.

  PMID: 28302275 DERIVED

Study Officials

• Stine Maya Dreier Sørensen, B.M.Sc.

  Centre for Clinical Education

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master student / B.M.Sc.

Study Record Dates

• First Submitted: February 3, 2015
• First Posted: February 11, 2015
• Study Start: February 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: August 1, 2015
• Last Updated: October 2, 2018

Record last verified: 2018-10

Locations

DK (1)