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Randomized Controlled Evaluation of Robotic Cardiac Surgery Training Modalities

Randomized Controlled Evaluation of Robotic Cardiac Surgery Training Modalities

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02357056
Enrollment
40
Registered
2015-02-06
Start date
2015-04-30
Completion date
2015-07-31
Last updated
2018-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Robotic Surgery Simulation Training

Brief summary

The purpose of this research is to objectively compare various training modalities currently available in minimally invasive and robotic surgery to determine the most effective training methods specific to robotic cardiac surgery. We hope to recruit medical trainees with minimal robotic surgery training experience, randomly assigned to one of three groups (Dry wab, da Vinci Simulator and Wet lab). Trainees will be evaluated at baseline for a standardized tasks common in robotic cardiac surgery and then divided into one of the three training modalities. Trainees will be given sufficient time to become proficient with a variety of predetermined tasks unique to each training group. The trainees will then undergo a reevaluation with the cardiac surgery specific tasks at the end of a standard training period. We will then be able to compare our three groups to show if any have benefits over the others in regards to improvement in technical ability, understanding of the robots functions, efficacy of training, speed of technical skill development, accuracy and efficiency of movement. We will rate each modality on their reproducibility, accuracy of representation, and ease of set up and perform a cost analysis for each of the training methods.

Interventions

OTHERWet Lab

ITA dissection and Annuloplasty Sutures in porcine model.

OTHERDry Lab

Camera and clutching, peg transferring, intracorporeal knot tying

OTHERVirtual Reality

daVinci Surgical Skills simulation

Sponsors

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* Residents, fellows and staff of a surgical specialty with less then 10 hours using the daVinci robot or any robotic simulator.

Exclusion criteria

* Individuals not associated with a surgical program * Individuals with \>10 hours experience driving the daVinci Robot or any robotic simulator

Design outcomes

Primary

MeasureTime frameDescription
Time to Complete Mitral Valve Annuloplasty3 monthsA total score for this task will be generated from the formula; Score = 720 - Time(s), If any damage is done to the tissues a score of zero will be assessed.
Time To Complete 10cm dissection of the Internal Thoracic Artery3 monthsA total score for this task will be generated from the formula; Score = 1320 - Time(s), If any damage is done to the tissues a score of zero will be assessed.
Global Evaluative Assessment of Robotic Skills (GEARS) Score3 MonthsA validated objective scoring tool will be used to evaluate overall robotic surgical skill for each task.

Secondary

MeasureTime frameDescription
Duration of Training3 MonthsTotal duration of time spent on the robot in order to reach proficiency marks set by expert surgeons will be recorded and compared.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026