Robotic Cardiac Surgery Wet Lab Simulation Study

NCT ID: NCT05043064

Last Updated: 2025-02-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2022-02-28

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.

Detailed Description

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Conditions

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Robotic Cardiac Surgery Simulation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors
All tasks will be recorded and evaluated blinded using the modified Global Evaluative Assessment of Robotic Skills (mGEARS) score by two not participating raters

Study Groups

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Experienced robotic cardiac surgeons

Group Type ACTIVE_COMPARATOR

Wet lab tasks

Intervention Type PROCEDURE

Robotic-assisted internal thoracic artery harvesting, mitral annulus sutures placement and atrial closure in porcine model

Cardiac surgeons with limited robotic experience

Group Type ACTIVE_COMPARATOR

Wet lab tasks

Intervention Type PROCEDURE

Robotic-assisted internal thoracic artery harvesting, mitral annulus sutures placement and atrial closure in porcine model

Non-cardiac surgeons with limited robotic experience

Group Type ACTIVE_COMPARATOR

Wet lab tasks

Intervention Type PROCEDURE

Robotic-assisted internal thoracic artery harvesting, mitral annulus sutures placement and atrial closure in porcine model

Interventions

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Wet lab tasks

Robotic-assisted internal thoracic artery harvesting, mitral annulus sutures placement and atrial closure in porcine model

Intervention Type PROCEDURE

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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Aalborg University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Gennady Atroshchenko

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gennady V Atroshchenko, MD

Role: PRINCIPAL_INVESTIGATOR

Aalborg University Hospital

Locations

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Aalborg University Hospital

Aalborg, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 40652436 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38204726 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2020-000992-55

Identifier Type: -

Identifier Source: org_study_id

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