Utilizing Gaze Training to Enhance Laparoscopic Skills Training

NCT03413943 | Completed

• 1 other identifier: Pro00078782_1
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Time to completion

  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 Outcomes (2)

• Number of tasks completed

  This will be collected for every repetition performed during the 6 separate training sessions within a 7-day period.

• Number of errors

  This will be collected for every repetition performed during the 6 separate training sessions within a 7-day period.

Study Arms (3)

explicit gaze training

EXPERIMENTAL

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

implicit gaze training

EXPERIMENTAL

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

sham gaze training

SHAM COMPARATOR

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

Interventions

gaze training OTHER

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.

Also known as: Argus Science

explicit gaze training; implicit gaze training; sham gaze training

Eligibility Criteria

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

You may qualify if:

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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Links

• Study Results

Study Officials

• Morgan L Cox, MD

  Duke University

  PRINCIPAL INVESTIGATOR

• Greg Appelbaum, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The gaze training subjects will be blinded to their cohort assignment, but investigators will know in order to carry out the proper training pending randomization.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: After identification of the expert gaze, subjects will be randomized into explicit or implicit gaze training techniques.

Study Record Dates

• First Submitted: January 10, 2018
• First Posted: January 29, 2018
• Study Start: January 1, 2018
• Primary Completion: March 13, 2020
• Study Completion: March 13, 2020
• Last Updated: January 12, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)