- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02357056
Randomized Controlled Evaluation of Robotic Cardiac Surgery Training Modalities
November 2, 2018 updated by: Lawson Health Research Institute
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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London, Ontario, Canada, N6A 5A5
- Canadian Surgical Technologies & Advanced Robotics (CSTAR)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Wet Lab
Subjects in the wet lab group will perform dissections of the internal thoracic artery and placement of annuloplasty stitches in the mitral valve in pig models until time proficiency is reached based on the performance of our expert robotic surgeons.
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ITA dissection and Annuloplasty Sutures in porcine model.
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Active Comparator: Dry Lab
Subjects in the dry lab group will perform exercises form the fundamentals of laparoscopic surgery (FLS) program adapted for the daVinci robot.
These exercises included, camera and clutching, peg transfer and intracorporeal knot tying.
Participants will repeat these tasks until time proficiency is reached based on the performance of our expert robotic surgeons.
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Camera and clutching, peg transferring, intracorporeal knot tying
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Active Comparator: Virtual Reality
Subjects in the virtual reality group will perform exercises from a 9 task curriculum, on the daVinci Skills Simulator.
These exercises included, camera and clutching, energy switching, peg board, energy dissection, matchboard, ringwalk, suture sponge, and vertical defect suturing.
Participants will repeat these tasks all metrics are passed and an overall score is reached based on the performance of our expert robotic surgeons.
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daVinci Surgical Skills simulation
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No Intervention: Control
The control group will receive no training after they complete the initial assessment and undergo randomization.
They will be invited back after several weeks to complete the final assessment to control for any improvement in performance from the initial assessment alone and normal progression through surgical training outside of this project.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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3 months
|
Time To Complete 10cm dissection of the Internal Thoracic Artery
Time Frame: 3 months
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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.
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3 months
|
Global Evaluative Assessment of Robotic Skills (GEARS) Score
Time Frame: 3 Months
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A validated objective scoring tool will be used to evaluate overall robotic surgical skill for each task.
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3 Months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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3 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Bob Kiaii, MD, Department of Cardiac Surgery
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2015
Primary Completion (Actual)
June 1, 2015
Study Completion (Actual)
July 1, 2015
Study Registration Dates
First Submitted
January 29, 2015
First Submitted That Met QC Criteria
February 2, 2015
First Posted (Estimate)
February 6, 2015
Study Record Updates
Last Update Posted (Actual)
November 6, 2018
Last Update Submitted That Met QC Criteria
November 2, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- 106343
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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