Robotic Cardiac Surgery Wet Lab Simulation Study

Study Overview
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Brief Summary
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The goal of this study is to investigate validity of the wet lab robotic cardiac surgery model used for training in robotic cardiac surgery and to evaluate learning curves in trainees of different surgical specialities. The investigators hope to recruit experienced robotic cardiac surgeons (experts) and cardiac and non-cardiac surgeons with minimal robotic experience (trainees). Participants will perform three predetermined tasks common in the wet lab robotic cardiac surgery training. Participants will be evaluated at baseline for each task. From experts' performance the mastery learning level will be calculated. Trainees will perform the tasks until mastery is achieved. The investigators will then be able to evaluate validity of the wet lab model and analyze learning curves in all participants by rating their performance.

Official Title
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Validity Evidence for Simulation-based Assessment of Robotic Cardiac Surgical Skills and Examination of Learning Curves in Wet Labs

Conditions
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Robotic Cardiac Surgery Simulation

Intervention / Treatment
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* Procedure: Wet lab tasks


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Experienced robotic cardiac surgeons: robotic surgeons with total volume > 50 robotic cardiac operations and at least 20 robotic cases annually Cardiac surgeons with limited robotic experience (robotic novices): on-going or completed cardio-thoracic residency Non-cardiac surgeons with limited robotic experience (robotic novices): on-going or completed surgical specialty residency (general surgery, urology, gynaecology, ENT surgery) Exclusion Criteria: Robotic novices with > 5 hours experience of any robotic system
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Experienced robotic cardiac surgeons<br> | Procedure: Wet lab tasks<br>* Robotic-assisted internal thoracic artery harvesting, mitral annulus sutures placement and atrial closure in porcine model<br>|
| Active Comparator: Cardiac surgeons with limited robotic experience<br> | Procedure: Wet lab tasks<br>* Robotic-assisted internal thoracic artery harvesting, mitral annulus sutures placement and atrial closure in porcine model<br>|
| Active Comparator: Non-cardiac surgeons with limited robotic experience<br> | Procedure: Wet lab tasks<br>* Robotic-assisted internal thoracic artery harvesting, mitral annulus sutures placement and atrial closure in porcine model<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time-based score | Time-based scoring equation will be calculated as follows: Score = Max time - Completion time - Errors Max time is the total time that an individual will be allowed to complete the task during the base-line performance. Completion time is either; The mean time for completion of each expert's last 2 attempts which will be used to calculate the mastery learning level based on the formula above The time taken by each study participant to complete the task Errors will be divided in minor and major ones. A minor error will result in adding a 10 second penalty time to the time-based score equation. A major error will result in a score of zero, regardless of time to completion. Minor errors: moving robotic arms out of view robotic arm collision drop of the needle Major errors: avulsion of ITA or suturing model tearing/ fraying the suture gross tissue damage (specifically with the cautery) | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| modified Global Evaluative Assessment of Robotic Skills (mGEARS) | In mGEARS score the tasks will not be rated on autonomy domain as autonomy cannot be evaluated from recordings. A total score range from 5-25, where higher scores mean a better overall technical proficiency for robotic surgery. | 4 months | 
| Learning curves for each task | the training time to reach the mastery learning level for the surgeons with limited robotic experience; both total time and for each task | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Robotic Cardiac Surgery, Wet Lab Simulation