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

Stereoscopic Vision Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02361463
• Other study ID #: 2015-001
• Status: Completed
• Phase: N/A
• Start date: February 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

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.

Recruitment information / eligibility

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

Eligibility

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.

Related Conditions & MeSH terms

• Stereoscopic Vision

Intervention

Device:
• 3D vision
Laparoscopic simulator training to proficiency under 3D conditions
• 2D vision
Laparoscopic simulator training to proficiency under 2D conditions

Locations

Country	Name	City	State
Denmark	Centre for Clinical Education	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (7)

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. — View 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Wilhelm D, Reiser S, Kohn N, Witte M, Leiner U, Mühlbach 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Workload: NASA TLX questionnaire after the first and fifth attempt on procedural module,		1 year
Other	Visual and physical discomfort questionnaire after each training session (adverse effect: eye strain, headache, dizziness, nausea, tired and sore neck/back),		1 year
Primary	Time (minutes) to reach the predefined proficiency level for the basic skills and the salpingectomy procedure		1 year
Secondary	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