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CompletedNCT02530099Updated Apr 6, 2016

Simulation-based Training of Operating Assistants: Procedure- Versus Camera Navigation Training

An interventional study of CN-group and Procedure-group in Laparoscopic Simulation Training, sponsored by Rigshospitalet, Denmark. Completed. Per ClinicalTrials.gov, last updated 2016-04-06.

Sponsored by Rigshospitalet, Denmark · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Sex
All
01

Study summary

Often the less experienced as medical students are charged with the role as camera navigator and assistant during laparoscopic surgery. Camera navigation is generally considered an easy skill, but it requires specific psychomotor and visuospatial skills. Simulation-based training can improve surgical skills, but little is known on how to optimally structure a training program to acquire camera navigation skills. The objective of this trial is to examine if simulation-based laparoscopic camera navigation skills transfer to the operating room after practicing one of two fundamentally different laparoscopic tasks on a simulator. The first group practice a procedure on a virtual reality simulator, the second group practice camera navigation on a virtual reality simulator and the third group receive no training. All participants are tested as camera navigators and assistants during a procedure in the operating room.

02

Conditions studied

  • Laparoscopic Simulation Training
03

In context

Lead sponsor

Rigshospitalet, Denmark is the lead sponsor of 1,017 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Medical students on the 4th, 5th or 6th semester, enrolled at The Faculty of Health Science, University of Copenhagen
  • Signed informed consent

Exclusion criteria

Exclusion Criteria:

  • Previous participation in trials involving simulated laparoscopic training.
  • Experience with laparoscopy surgery (having performed minimum one laparoscopic procedure as primary surgeon or as a surgical assistant).
  • No informed consent.
  • Does not speak Danish on a conversational level.
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
36 participants (actual)

Study arms

  • No intervention
    Control group

    Receive no training.

  • Experimental
    CN-group

    Receive basic camera navigation training.

    Procedure: CN-group

  • Experimental
    Procedure-group

    Receive training on a laparoscopic procedure.

    Procedure: Procedure-group

Interventions

  • ProcedureCN-group

    Time limited simulation based training on camera navigation tasks on a virtual reality-simulator.

  • ProcedureProcedure-group

    Time limited simulation based training on laparoscopic procedure on a virtual reality-simulator.

06

What researchers measure

Primary outcomes

  1. Surgeons' rating on camera navigation performance during a procedure in the operating room.

    Time frame: up to 1-3 weeks post training

Secondary outcomes

  1. Score on the intrinsic motivation inventory-scale

    An expression of motivation as a surgical assistant and camera navigation after completion of the procedure in the OR

    Time frame: 2 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Nilsson C, Sorensen JL, Konge L, Westen M, Stadeager M, Ottesen B, Bjerrum F. Simulation-based camera navigation training in laparoscopy-a randomized trial. Surg Endosc. 2017 May;31(5):2131-2139. doi: 10.1007/s00464-016-5210-5. Epub 2016 Oct 21. PubMed 27770252 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02530099
Lead sponsor
Rigshospitalet, Denmark
Responsible party
Cecilia Nilsson (MD, Rigshospitalet, Denmark) — Principal investigator
First posted
Aug 20, 2015
Start date
Sep 2015
Primary completion
Nov 2015
Completion
Dec 2015
Last update
Apr 6, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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