Utilizing Gaze Training to Enhance Laparoscopic Skills Training

January 11, 2021 updated by: Duke University

Utilizing Gaze Training to Enhance Laparoscopic Technical Skills Training

The purpose of this study is to test the influences of gaze training (GT) on the acquisition of laparoscopic surgical skills. For this purpose, the investigator will compare variants of GT in the second of 2 experiments. These questions will be evaluated using the validated Fundamentals of Laparoscopic Surgery (FLS) module 1, with the overall goal of developing a surgical training curriculum that achieves expert level skill in an expedited timeframe. This research provides a novel approach to general surgery training that has the potential to reduce the amount of time and repetitions required to achieve expert laparoscopic skills.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Developing expert performance requires assessment of the thought processes underlying performance and continued refinement of skills in order to obtain automaticity and intuition. Therefore, developing expert surgical skill is a process likely to take longer than the length of residency, thereby diminishing the quality of care delivered to patients.

The proposed study will implement novel neuroscience technique of gaze training to determine if it has the capacity to accelerate technical surgical skill learning in order to achieve competency and expertise in an earlier timeframe. Studies of skill performance have demonstrated that eye movement patterns can be optimized to improve subsequent motor movements. Therefore, gaze training encourages novices to adopt the more efficient gaze patterns of experts while performing a specific task such as laparoscopic surgery. This technique has been applied in the training of surgical residents in a limited capacity making this project an innovative approach to enhance skill development.

Experiment 2: Determine if gaze training can accelerate the learning of laparoscopic skills.

In this experiment the investigators will first establish expert gaze patterns in the Fundamentals of Laparoscopic Surgery modules 1 and 5 by testing a total of 9 participants, including attending surgeons, senior residents, and novices trained to proficiency. The investigators will then compare behavioral learning curves from non-expert participants without gaze training against those trained using both explicit (by reviewing the expert gaze pattern) and implicit gaze (by using a visual mask during the training, leading the participant to follow the expert gaze) derived from the expert gaze patterns. This will be tested in 3 groups of 20 participants, who train for 40-minutes in each of 6 sessions that occur within 3 weeks.

The investigators hypothesize that both explicit and implicit gaze training will lead to faster skill acquisition, with implicit greater than explicit and measured by trials required to gain proficient module completion scores, relative to the group of participants who practice without any gaze training.

Study Type

Interventional

Enrollment (Actual)

8

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
      • Durham, North Carolina, United States, 27710
        • Duke University Medical 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age >18 years
  • Healthy male and female
  • Willing and able to provide informed consent
  • Able to follow study procedures

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: explicit gaze training
This is an arm of the second phase of the study utilizing gaze training in two different teaching techniques (explicit vs implicit).
Other: gaze training
Gaze training will consist of gaze tracking and then review of performance or the use of an implicit map to train an expert gaze pattern.
Other Names:
  • Argus Science
Experimental: implicit gaze training
This is an arm of the second phase of the study utilizing gaze training in two different teaching techniques (explicit vs implicit).
Other: gaze training
Gaze training will consist of gaze tracking and then review of performance or the use of an implicit map to train an expert gaze pattern.
Other Names:
  • Argus Science
Sham Comparator: sham gaze training
This is an arm of the second phase of the study utilizing gaze training in two different teaching techniques (explicit vs implicit).
Other: gaze training
Gaze training will consist of gaze tracking and then review of performance or the use of an implicit map to train an expert gaze pattern.
Other Names:
  • Argus Science

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to completion
Time Frame: Collected for pre- and post-tests performed prior to and after the 6 separate training sessions within 7-days.
Completion time for each repetition of FLS task 1
Collected for pre- and post-tests performed prior to and after the 6 separate training sessions within 7-days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of tasks completed
Time Frame: This will be collected for every repetition performed during the 6 separate training sessions within a 7-day period.
The number of times each FLS task 1 is completed during each training session.
This will be collected for every repetition performed during the 6 separate training sessions within a 7-day period.
Number of errors
Time Frame: This will be collected for every repetition performed during the 6 separate training sessions within a 7-day period.
The number of errors (as defined by FLS) during completion of tasks will be recorded and transitioned into a time addition.
This will be collected for every repetition performed during the 6 separate training sessions within a 7-day period.

Collaborators and Investigators

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

Sponsor

Duke University

Investigators

  • Principal Investigator: Morgan L Cox, MD, Duke University
  • Principal Investigator: Greg Appelbaum, PhD, Duke University

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.

Helpful Links

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 (Actual)

January 1, 2018

Primary Completion (Actual)

March 13, 2020

Study Completion (Actual)

March 13, 2020

Study Registration Dates

First Submitted

January 10, 2018

First Submitted That Met QC Criteria

January 26, 2018

First Posted (Actual)

January 29, 2018

Study Record Updates

Last Update Posted (Actual)

January 12, 2021

Last Update Submitted That Met QC Criteria

January 11, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • Pro00078782_1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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