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Stereoscopic VisionNCT02361463

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

A study testing 3D vision and 2D vision in people with Stereoscopic Vision, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Stereoscopic Vision
What is being tested?
3D vision and 2D vision
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteDenmark
Study dates
Feb 2015to Aug 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Centre for Clinical Education

    Copenhagen, 2100

Other trials in Denmark

About this study

Official title: 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.

Being tested
3D vision, 2D vision
Keywords
Laparoscopy;, Training;, Three-Dimensional

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3D visionDevice

    Laparoscopic simulator training to proficiency under 3D conditions

  • 2D visionDevice

    Laparoscopic simulator training to proficiency under 2D conditions

Study groups in NCT02361463
Study groupRoleWhat they receive
3D groupExperimentalWill practice under 3D vision conditions on a laparoscopic virtual reality simulator
Receives: Device: 3D vision
2D groupActive comparatorWill practice under 2D vision conditions on a laparoscopic virtual reality simulator
Receives: Device: 2D vision

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 1 year

Secondary outcomes (1)

  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

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2015 (estimated)
  2. Study startFeb 2015
  3. Primary completionJun 2015
  4. Study completionAug 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02361463
Sponsor's protocol ID
2015-001
Status last verified
Oct 2018
First submitted
3 Feb 2015
Last updated
2 Oct 2018
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 24059674

  • 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.

    PubMed 17992561

  • 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.

    PubMed 25131843

  • 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.

    PubMed 25002241

  • 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.

    PubMed 24651895

  • 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.

    PubMed 24094658

  • 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.

    PubMed 24016365

  • 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.

    PubMed 28302275

Questions about this trial

What is this clinical trial studying?

A study testing 3D vision and 2D vision in people with Stereoscopic Vision, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time (minutes) to reach the predefined proficiency level for the basic skills and the salpingectomy procedure (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02361463, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2018.

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