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

NCT ID: NCT02530099

Last Updated: 2016-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Laparoscopic Simulation Training

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Blinding Strategy

NONE

Study Groups

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Control group

Receive no training.

Group Type NO_INTERVENTION

No interventions assigned to this group

CN-group

Receive basic camera navigation training.

Group Type EXPERIMENTAL

CN-group

Intervention Type PROCEDURE

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

Procedure-group

Receive training on a laparoscopic procedure.

Group Type EXPERIMENTAL

Procedure-group

Intervention Type PROCEDURE

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

Interventions

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CN-group

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

Intervention Type PROCEDURE

Procedure-group

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

* 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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Cecilia Nilsson

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type DERIVED
PMID: 27770252 (View on PubMed)

Other Identifiers

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CN-Trial

Identifier Type: -

Identifier Source: org_study_id

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