Randomized Controlled Evaluation of Robotic Cardiac Surgery Training Modalities

NCT ID: NCT02357056

Last Updated: 2018-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2015-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Wet Lab

Intervention Type: OTHER

ITA dissection and Annuloplasty Sutures in porcine model.

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.

Group Type: ACTIVE_COMPARATOR

Dry Lab

Intervention Type: OTHER

Camera and clutching, peg transferring, intracorporeal knot tying

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.

Group Type: ACTIVE_COMPARATOR

Virtual Reality

Intervention Type: OTHER

daVinci Surgical Skills simulation

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Wet Lab

ITA dissection and Annuloplasty Sutures in porcine model.

Intervention Type: OTHER

Dry Lab

Camera and clutching, peg transferring, intracorporeal knot tying

Intervention Type: OTHER

Virtual Reality

daVinci Surgical Skills simulation

Intervention Type: OTHER

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bob Kiaii, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiac Surgery

Locations

Canadian Surgical Technologies & Advanced Robotics (CSTAR)

London, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 26680752 (View on PubMed)

Other Identifiers

106343

Identifier Type: -

Identifier Source: org_study_id