Robotic Surgery Simulation Training Clinical Trial
Official title:
Randomized Controlled Evaluation of Robotic Cardiac Surgery Training Modalities
| NCT number | NCT02357056 |
| Other study ID # | 106343 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | April 2015 |
| Est. completion date | July 2015 |
| Verified date | November 2018 |
| Source | Lawson Health Research Institute |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 40 |
| Est. completion date | July 2015 |
| Est. primary completion date | June 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Canadian Surgical Technologies & Advanced Robotics (CSTAR) | London | Ontario |
| Lead Sponsor | Collaborator |
|---|---|
| Lawson Health Research Institute |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time to Complete Mitral Valve Annuloplasty | 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. | 3 months | |
| Primary | Time To Complete 10cm dissection of the Internal Thoracic Artery | 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 months | |
| Primary | Global Evaluative Assessment of Robotic Skills (GEARS) Score | A validated objective scoring tool will be used to evaluate overall robotic surgical skill for each task. | 3 Months | |
| Secondary | Duration of Training | Total duration of time spent on the robot in order to reach proficiency marks set by expert surgeons will be recorded and compared. | 3 Months |