Trial Outcomes & Findings for Robotic Cardiac Surgery Wet Lab Simulation Study (NCT NCT05043064)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

19 participants

Primary outcome timeframe

6 months

Results posted on

2025-02-26

Participant Flow

Participant milestones

Participant milestones
Measure	Experienced Robotic Cardiac Surgeons Wet lab tasks: Robotic-assisted internal thoracic artery harvesting, mitral annulus sutures placement and atrial closure in porcine model	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	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
Overall Study STARTED	4	7	8
Overall Study COMPLETED	4	7	8
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experienced Robotic Cardiac Surgeons n=4 Participants Wet lab tasks: Robotic-assisted internal thoracic artery harvesting, mitral annulus sutures placement and atrial closure in porcine model	Cardiac Surgeons With Limited Robotic Experience n=7 Participants Wet lab tasks: Robotic-assisted internal thoracic artery harvesting, mitral annulus sutures placement and atrial closure in porcine model	Non-cardiac Surgeons With Limited Robotic Experience n=8 Participants Wet lab tasks: Robotic-assisted internal thoracic artery harvesting, mitral annulus sutures placement and atrial closure in porcine model	Total n=19 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=4 Participants	0 Participants n=7 Participants	0 Participants n=8 Participants	0 Participants n=19 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=4 Participants	6 Participants n=7 Participants	7 Participants n=8 Participants	17 Participants n=19 Participants
Age, Categorical >=65 years	0 Participants n=4 Participants	1 Participants n=7 Participants	1 Participants n=8 Participants	2 Participants n=19 Participants
Age, Continuous	44 years n=4 Participants	55 years n=7 Participants	42 years n=8 Participants	45 years n=19 Participants
Sex: Female, Male Female	0 Participants n=4 Participants	2 Participants n=7 Participants	3 Participants n=8 Participants	5 Participants n=19 Participants
Sex: Female, Male Male	4 Participants n=4 Participants	5 Participants n=7 Participants	5 Participants n=8 Participants	14 Participants n=19 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Experienced Robotic Cardiac Surgeons n=4 Participants Wet lab tasks: Robotic-assisted internal thoracic artery harvesting, mitral annulus sutures placement and atrial closure in porcine model	Cardiac Surgeons With Limited Robotic Experience n=7 Participants Wet lab tasks: Robotic-assisted internal thoracic artery harvesting, mitral annulus sutures placement and atrial closure in porcine model	Non-cardiac Surgeons With Limited Robotic Experience n=8 Participants Wet lab tasks: Robotic-assisted internal thoracic artery harvesting, mitral annulus sutures placement and atrial closure in porcine model
Time-based Score	553 score on a scale Standard Deviation 47	127 score on a scale Standard Deviation 171	143 score on a scale Standard Deviation 181

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Experienced Robotic Cardiac Surgeons n=4 Participants Wet lab tasks: Robotic-assisted internal thoracic artery harvesting, mitral annulus sutures placement and atrial closure in porcine model	Cardiac Surgeons With Limited Robotic Experience n=7 Participants Wet lab tasks: Robotic-assisted internal thoracic artery harvesting, mitral annulus sutures placement and atrial closure in porcine model	Non-cardiac Surgeons With Limited Robotic Experience n=8 Participants Wet lab tasks: Robotic-assisted internal thoracic artery harvesting, mitral annulus sutures placement and atrial closure in porcine model
Modified Global Evaluative Assessment of Robotic Skills (mGEARS)	20 score on a scale Standard Deviation 5	13 score on a scale Standard Deviation 2	11 score on a scale Standard Deviation 3

Adverse Events

Experienced Robotic Cardiac Surgeons

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cardiac Surgeons With Limited Robotic Experience

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non-cardiac Surgeons With Limited Robotic Experience

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Gennady V Atroshchenko

Aalborg University Hospital

Phone: 97 66 46 49

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place