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Clinical Trials/NCT05043064
NCT05043064CompletedNot Applicable

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

Aalborg University Hospital1 site in 1 country19 target enrollmentStarted: September 1, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
19
Locations
1
Primary Endpoint
Time-based Score

Study Overview

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.

Study Design

Study Type
Interventional
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 Criteria

Sex
All
Accepts 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

Arms & Interventions

Non-cardiac surgeons with limited robotic experience

Active Comparator

Intervention: Wet lab tasks (Procedure)

Experienced robotic cardiac surgeons

Active Comparator

Intervention: Wet lab tasks (Procedure)

Cardiac surgeons with limited robotic experience

Active Comparator

Intervention: Wet lab tasks (Procedure)

Outcomes

Primary Outcomes

Time-based Score

Time Frame: 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 Outcomes

  • Modified Global Evaluative Assessment of Robotic Skills (mGEARS)(6 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Gennady Atroshchenko

Principal Investigator

Aalborg University Hospital

Study Sites (1)

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