Randomized Controlled Evaluation of Robotic Cardiac Surgery Training Modalities

NCT02357056 | Completed

• 1 other identifier: 106343
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Robotic Surgery Simulation Training

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• Duration of Training

  3 Months

Study Arms (4)

Wet Lab

ACTIVE COMPARATOR

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

Dry Lab

ACTIVE COMPARATOR

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

Virtual Reality

ACTIVE COMPARATOR

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

Control

NO INTERVENTION

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.

Interventions

Wet Lab OTHER

ITA dissection and Annuloplasty Sutures in porcine model.

Wet Lab

Dry Lab OTHER

Camera and clutching, peg transferring, intracorporeal knot tying

Dry Lab

Virtual Reality OTHER

daVinci Surgical Skills simulation

Virtual Reality

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Canadian Surgical Technologies & Advanced Robotics (CSTAR)

London, Ontario, N6A 5A5, Canada

Location

Related Publications (1)

• Valdis M, Chu MW, Schlachta CM, Kiaii B. Validation of a Novel Virtual Reality Training Curriculum for Robotic Cardiac Surgery: A Randomized Trial. Innovations (Phila). 2015 Nov-Dec;10(6):383-8. doi: 10.1097/IMI.0000000000000222.

  PMID: 26680752 DERIVED

Study Officials

• Bob Kiaii, MD

  Department of Cardiac Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2015
• First Posted: February 6, 2015
• Study Start: April 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: July 1, 2015
• Last Updated: November 6, 2018

Record last verified: 2018-11

Locations

CA (1)