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OpenTrials
Completed

NCT Number: NCT02357056

Randomized Controlled Evaluation of Robotic Cardiac Surgery Training Modalities

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Canadian Surgical Technologies & Advanced Robotics (CSTAR)

London, Ontario, N6A 5A5, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Wet Lab

Other

ITA dissection and Annuloplasty Sutures in porcine model.

Dry Lab

Other

Camera and clutching, peg transferring, intracorporeal knot tying

Virtual Reality

Other

daVinci Surgical Skills simulation

Primary outcomes

  1. Time to Complete Mitral Valve Annuloplasty

    Time frame: 3 months

    A 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.

  2. Time To Complete 10cm dissection of the Internal Thoracic Artery

    Time frame: 3 months

    A 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.

  3. Global Evaluative Assessment of Robotic Skills (GEARS) Score

    Time frame: 3 Months

    A validated objective scoring tool will be used to evaluate overall robotic surgical skill for each task.

Secondary outcomes

  1. Duration of Training

    Time frame: 3 Months

    Total duration of time spent on the robot in order to reach proficiency marks set by expert surgeons will be recorded and compared.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Feb 6, 2015
Registry last updated
Nov 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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