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

Study Overview
=================
Brief 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.

Official Title
-----------------
Simulation-based Training of Operating Assistants: Procedure- Versus Camera Navigation Training - a Randomized Controlled Trial Examining Clinical Transfer

Conditions
-----------------
Laparoscopic Simulation Training

Intervention / Treatment
-----------------
* Procedure: CN-group
* Procedure: Procedure-group


Participation Criteria
=================
Eligibility Criteria
-----------------
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.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Receive no training. | |
| Experimental: CN-group<br>Receive basic camera navigation training. | Procedure: CN-group<br>* Time limited simulation based training on camera navigation tasks on a virtual reality-simulator.<br>|
| Experimental: Procedure-group<br>Receive training on a laparoscopic procedure. | Procedure: Procedure-group<br>* Time limited simulation based training on laparoscopic procedure on a virtual reality-simulator.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgeons' rating on camera navigation performance during a procedure in the operating room. |  | up to 1-3 weeks post training | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 2 months |