Randomized Controlled Evaluation of Robotic Cardiac Surgery Training Modalities

Sponsor
Lawson Health Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT02357056
Collaborator
(none)
40
1
4
3
13.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Wet Lab
  • Other: Dry Lab
  • Other: Virtual Reality
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Randomized Controlled Evaluation of Robotic Cardiac Surgery Training Modalities
Study Start Date :
Apr 1, 2015
Actual Primary Completion Date :
Jun 1, 2015
Actual Study Completion Date :
Jul 1, 2015

Arms and Interventions

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.

Other: Wet Lab
ITA dissection and Annuloplasty Sutures in porcine model.

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.

Other: Dry Lab
Camera and clutching, peg transferring, intracorporeal knot tying

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.

Other: Virtual Reality
daVinci Surgical Skills simulation

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.

Outcome Measures

Primary Outcome Measures

  1. Time to Complete Mitral Valve Annuloplasty [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 [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 [3 Months]

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

Secondary Outcome Measures

  1. Duration of Training [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Canadian Surgical Technologies & Advanced Robotics (CSTAR) London Ontario Canada N6A 5A5

Sponsors and Collaborators

  • Lawson Health Research Institute

Investigators

  • Principal Investigator: Bob Kiaii, MD, Department of Cardiac Surgery

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT02357056
Other Study ID Numbers:
  • 106343
First Posted:
Feb 6, 2015
Last Update Posted:
Nov 6, 2018
Last Verified:
Nov 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Nov 6, 2018