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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experienced robotic cardiac surgeons | Active Comparator |
| |
| Cardiac surgeons with limited robotic experience | Active Comparator |
| |
| Non-cardiac surgeons with limited robotic experience | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wet lab tasks | Procedure | Robotic-assisted internal thoracic artery harvesting, mitral annulus sutures placement and atrial closure in porcine model |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gennady V Atroshchenko, MD | Aalborg University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg University Hospital | Aalborg | 9000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40652436 | Derived | Atroshchenko GV, Korup LR, Hashemi N, Ostergaard LR, Tolsgaard MG, Rasmussen S. Artificial intelligence-based action recognition and skill assessment in robotic cardiac surgery simulation: a feasibility study. J Robot Surg. 2025 Jul 13;19(1):384. doi: 10.1007/s11701-025-02563-3. | |
| 38204726 | Derived | Atroshchenko GV, Navarra E, Valdis M, Sandoval E, Hashemi N, Cerny S, Pereda D, Palmen M, Bjerrum F, Bruun NH, Tolsgaard MG. Simulation-based assessment of robotic cardiac surgery skills: An international multicenter, cross-specialty trial. JTCVS Open. 2023 Nov 2;16:619-627. doi: 10.1016/j.xjon.2023.10.029. eCollection 2023 Dec. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Experienced Robotic Cardiac Surgeons | Wet lab tasks: Robotic-assisted internal thoracic artery harvesting, mitral annulus sutures placement and atrial closure in porcine model |
| FG001 | 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 |
| FG002 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Experienced Robotic Cardiac Surgeons | Wet lab tasks: Robotic-assisted internal thoracic artery harvesting, mitral annulus sutures placement and atrial closure in porcine model |
| BG001 | Cardiac Surgeons With Limited Robotic Experience |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experienced Robotic Cardiac Surgeons | Wet lab tasks: Robotic-assisted internal thoracic artery harvesting, mitral annulus sutures placement and atrial closure in porcine model |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Gennady V Atroshchenko | Aalborg University Hospital | 97 66 46 49 | 45 | g.atroshchenko@rn.dk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 11, 2021 | Aug 9, 2024 | Prot_SAP_000.pdf |
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All tasks will be recorded and evaluated blinded using the modified Global Evaluative Assessment of Robotic Skills (mGEARS) score by two not participating raters
| 6 months |
Wet lab tasks: Robotic-assisted internal thoracic artery harvesting, mitral annulus sutures placement and atrial closure in porcine model
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG002 | 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 |
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | 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 | 0 | 7 | 0 | 7 | 0 | 7 |
| EG002 | 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 | 0 | 8 | 0 | 8 | 0 | 8 |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|