Robotic Cardiac Surgery Simulation
Conditions
Keywords
Robotic Cardiac Surgery, Wet Lab Simulation
Brief summary
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.
Interventions
PROCEDUREWet lab tasks
Robotic-assisted internal thoracic artery harvesting, mitral annulus sutures placement and atrial closure in porcine model
Sponsors
Aalborg University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
All tasks will be recorded and evaluated blinded using the modified Global Evaluative Assessment of Robotic Skills (mGEARS) score by two not participating raters
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time-based Score | 6 months | The time-based score (TBS) was calculated as follows: TBS = maximal total training time per task - actual completion time - errors. Units of measure - seconds. Minimum score 0, Maximum score 1222. TBS was calculated in seconds, where 0 was the lowest score and a higher number indicated a faster time to perform the task. The score range |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modified Global Evaluative Assessment of Robotic Skills (mGEARS) | 6 months | In modified Global Evaluative Assessment of Robotic Skills (mGEARS) the tasks were not rated on autonomy domain as autonomy could not be evaluated from recordings. The mGEARS score was used to evaluate the overall robotic proficiency by 5 domains: depth perception, bimanual dexterity, efficiency, force sensitivity, and robotic control. The score ranged from 5 to 25, where 5 and 25 indicated the least and most proficient performance, respectively. |
Countries
Denmark
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Experienced Robotic Cardiac Surgeons Wet lab tasks: Robotic-assisted internal thoracic artery harvesting, mitral annulus sutures placement and atrial closure in porcine model | 4 |
| Cardiac Surgeons With Limited Robotic Experience Wet lab tasks: Robotic-assisted internal thoracic artery harvesting, mitral annulus sutures placement and atrial closure in porcine model | 7 |
| Non-cardiac Surgeons With Limited Robotic Experience Wet lab tasks: Robotic-assisted internal thoracic artery harvesting, mitral annulus sutures placement and atrial closure in porcine model | 8 |
| Total | 19 |
Baseline characteristics
| Characteristic | Experienced Robotic Cardiac Surgeons | Cardiac Surgeons With Limited Robotic Experience | Non-cardiac Surgeons With Limited Robotic Experience | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 6 Participants | 7 Participants | 17 Participants |
| Age, Continuous | 44 years | 55 years | 42 years | 45 years |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Sex: Female, Male Female | 0 Participants | 2 Participants | 3 Participants | 5 Participants |
| Sex: Female, Male Male | 4 Participants | 5 Participants | 5 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 7 | 0 / 8 |
| other Total, other adverse events | 0 / 4 | 0 / 7 | 0 / 8 |
| serious Total, serious adverse events | 0 / 4 | 0 / 7 | 0 / 8 |
Outcome results
Primary
Time-based Score
The time-based score (TBS) was calculated as follows: TBS = maximal total training time per task - actual completion time - errors. Units of measure - seconds. Minimum score 0, Maximum score 1222. TBS was calculated in seconds, where 0 was the lowest score and a higher number indicated a faster time to perform the task. The score range
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experienced Robotic Cardiac Surgeons | Time-based Score | 553 score on a scale | Standard Deviation 47 |
| Cardiac Surgeons With Limited Robotic Experience | Time-based Score | 127 score on a scale | Standard Deviation 171 |
| Non-cardiac Surgeons With Limited Robotic Experience | Time-based Score | 143 score on a scale | Standard Deviation 181 |
Secondary
Modified Global Evaluative Assessment of Robotic Skills (mGEARS)
In modified Global Evaluative Assessment of Robotic Skills (mGEARS) the tasks were not rated on autonomy domain as autonomy could not be evaluated from recordings. The mGEARS score was used to evaluate the overall robotic proficiency by 5 domains: depth perception, bimanual dexterity, efficiency, force sensitivity, and robotic control. The score ranged from 5 to 25, where 5 and 25 indicated the least and most proficient performance, respectively.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experienced Robotic Cardiac Surgeons | Modified Global Evaluative Assessment of Robotic Skills (mGEARS) | 20 score on a scale | Standard Deviation 5 |
| Cardiac Surgeons With Limited Robotic Experience | Modified Global Evaluative Assessment of Robotic Skills (mGEARS) | 13 score on a scale | Standard Deviation 2 |
| Non-cardiac Surgeons With Limited Robotic Experience | Modified Global Evaluative Assessment of Robotic Skills (mGEARS) | 11 score on a scale | Standard Deviation 3 |