Outcomes in Simulated Endoscopy Training

Part of paid clinical trials in Oklahoma City, Oklahoma.

Sponsor
University of Oklahoma
Study ID
NCT03495141
Status
Recruiting

Conditions

  • Impact of Supervision on Endoscopy Simulation Curriculum

Eligibility Criteria

Sex
ALL
Age
22 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • Supervision/Coaching — BEHAVIORAL
    Supervision involves coaching the trainee on insertion and withdrawal technique in a standard colonoscopy in a novice trainee

Study Details

Eligible participants are those who are members of the general surgery residency pediatric gastroenterology fellowship, and adult gastroenterology fellowship. Through a randomized-controlled trial, participants will fill out a baseline set of demographic information including year of training, approximate number of colonoscopies to date, specialty, age, sex and handedness. Participation in this activity is completely voluntary. Trainees will be randomized to one of two groups. Either first participating in an unassisted colonoscopy module twice and then taking a questionnaire and then transitioning to a supervised/coached colonoscopy module session twice and taking a questionnaire, versus the reverse, in which the participant first partakes in a supervised/coached colonoscopy module session twice and then transitions to performing a colonoscopy module twice, unassisted. Objective measures will be assessed by the module software and supervising faculty. Specifically, using individuals' survey responses to see if early supervision improves survey scores. Survey questions focus on student learning, completing module objectives and faculty performance in simulation. The survey will also ask subjects to self-rate their scores and comfort level with endoscopy skills. Survey responses will not be linked to an individuals' performance in their program training and endoscopy coaches will not be made aware of the survey responses.

Key Dates

First listed
Apr 11, 2018
Start date
Mar 6, 2018
Status verified
Jul 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: Supervised
    Participants first take part in supervised/coached colonoscopy module session twice (case one and case two) and then transition to performing an unassisted colonoscopy module twice (case three and case four).
  • Active Comparator: Unsupervised
    Participants will either first partake in an unsupervised colonoscopy module twice (case one and case two) and then transition to a supervised/coached colonoscopy module session twice (case three and case four).

Primary Outcome Measure

Percentage of mucosa inspected [ Time Frame: through study completion, an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of OklahomaOklahoma CityOklahoma73104
Samantha Harbert
405-271-2045

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