Do Motion Metrics Lead to Improved Skill Acquisition on Simulators?

April 20, 2022 updated by: Wake Forest University Health Sciences

Emphasizing the growing popularity of motion metrics are the majority of available virtual reality simulators and some newer hybrid models that offer motion tracking for performance assessment. A popular hybrid model (PROMIS) allows training with regular laparoscopic instruments in a box-trainer while automatically recording task duration and movement efficiency (pathlength and smoothness) that are immediately offered as feedback to trainees.

Despite the increasing availability of simulators that track motion, our knowledge of the impact those metrics have on trainee learning is severely limited. We do not know if it is more important to use speed, accuracy, motion efficiency or a combination thereof for performance assessment and how these metrics impact skill transfer to the OR.

Based on sound educational principles we have developed a proficiency-based laparoscopic suturing simulator curriculum. This curriculum focuses on deliberate and distributed practice, provides trainees with augmented feedback and sets expert-derived performance goals based on time and errors. We have previously demonstrated that this curriculum leads to improved operative performance of trainees compared to controls.

To measure operative performance and determine transferability, we will use a live porcine Nissen fundoplication model. Instead of placing actual patients at risk, the porcine model is preferable for this purpose as it offers objective metrics (targets are established, distances measured, knots are disrupted for slippage scoring), complete standardization, and allows multiple individuals to be tested on the same day.

We hypothesize that proficiency-based simulator training in laparoscopic suturing to expert-derived levels of speed and motion will result in better operative performance compared to participants training to levels of speed or motion alone. The study is powered to detect an at least 10% performance difference between the groups.

Specific Aims

  1. Compare whether any performance differences between the groups persist long-term
  2. Assess whether the groups demonstrate differences in safety in the operating room by comparing the inadvertent injuries in the animal OR between the groups
  3. Identify the training duration required by novices to reach proficiency in laparoscopic suturing based on speed, motion efficiency, or a combination of these metrics
  4. Identify any baseline participant characteristics that may predict individual metric-specific performance

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVE:: We hypothesized that training to expert-derived levels of speed and motion will lead to improved learning and will translate to better operating room (OR) performance of novices than training to goals of speed or motion alone. BACKGROUND:: Motion tracking has been suggested to be a more sensitive performance metric than time and errors for the assessment of surgical performance. METHODS:: An institutional review board-approved, single blinded, randomized controlled trial was conducted at our level-I American College of Surgeons accredited Education Institute. Forty-two novices trained to proficiency in laparoscopic suturing after being randomized into 3 groups: The speed group (n = 14) had to achieve expert levels of speed, the motion group (n = 15) expert levels of motion (path length and smoothness), and the speed and motion group (n = 13) both levels. To achieve proficiency, all groups also had to demonstrate error-free performance. The FLS suture module (task 5) was used for training inside the ProMIS simulator that tracks instrument motion. All groups participated in transfer and retention tests in the OR. OR performance was assessed by a blinded expert rater using Global Operative Assessment of Laparoscopic Skills, speed, accuracy, and inadvertent injuries.

Study Type

Interventional

Enrollment (Actual)

42

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

  • United States
    • North Carolina
      • Charlotte, North Carolina, United States, 28205
        • Carolinas Simulation Center

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

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • novices with no previous laparoscopic or simulation experience
  • voluntary participation

Exclusion Criteria:

  • expert in or familiarity with laparoscopy or simulation
  • physical condition that prevents the performance of laparoscopic suturing

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Speed Group
The Speed Group, (n=20) will train in laparoscopic suturing on the validated FLS suturing model until the expert level of speed (i.e. task duration < 70 seconds) has been achieved on two consecutive attempts.
Other: skills training
participants will train using different performance goals (based on different metrics)
Experimental: Motion Group
The Motion Group, (n=20) will train in laparoscopic suturing until expert levels of motion (pathlength 6700 and smoothness 560) have been achieved.
Other: skills training
participants will train using different performance goals (based on different metrics)
Experimental: Speed and Motion Group
The Speed and Motion Group (n=20) will train in laparoscopic suturing until expert levels of speed AND motion have been achieved.
Other: skills training
participants will train using different performance goals (based on different metrics)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Laparoscopic suturing performance in the animal operating room
Time Frame: end of training and retention test after 3 months
end of training and retention test after 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
inadvertent injuries in the animal OR
Time Frame: end of training test and 3 month retention test
end of training test and 3 month retention test
training duration required by novices to reach proficiency in laparoscopic suturing based on speed, motion efficiency, or a combination of these metrics
Time Frame: end of study (within one year)
end of study (within one year)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

Tulane University
Ethicon Endo-Surgery

Investigators

  • Principal Investigator: Dimitrios Stefanidis, MD, PhD, Carolinas Simulation Center

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.

General Publications

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

November 1, 2009

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

January 18, 2010

First Submitted That Met QC Criteria

January 18, 2010

First Posted (Estimate)

January 20, 2010

Study Record Updates

Last Update Posted (Actual)

April 27, 2022

Last Update Submitted That Met QC Criteria

April 20, 2022

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 11-06-20E

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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