Outcomes in Simulated Endoscopy Training

NCT03495141 | Recruiting DMC

• 1 other identifier: 8244Exempt
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Impact of Supervision on Endoscopy Simulation Curriculum

Outcome Measures

Primary Outcomes (1)

• Percentage of mucosa inspected

  The primary outcome will be the difference in percentage of mucosa inspected between the two study groups based on the report of the simulator after each of 4 predefined cases

  through study completion, an average of 1 year

Secondary Outcomes (2)

• Time to reach cecum

  through study completion, an average of 1 year

• Participant satisfaction score

  through study completion, an average of 1 year

Study Arms (2)

Supervised

ACTIVE COMPARATOR

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).

Behavioral: Supervision/Coaching

Unsupervised

ACTIVE COMPARATOR

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).

Behavioral: Supervision/Coaching

Interventions

Supervision/Coaching BEHAVIORAL

Supervision involves coaching the trainee on insertion and withdrawal technique in a standard colonoscopy in a novice trainee

Supervised; Unsupervised

Eligibility Criteria

• Age: 22 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Consenting trainees of adult and pediatric gastroenterology fellowships and general surgery residencies at the University of Oklahoma Health Sciences Center.

You may not qualify if:

• Unwilling to consent.

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

University of Oklahoma

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

MeSH Terms

Interventions

Organization and Administration

Intervention Hierarchy (Ancestors)

Health Services Administration

Study Officials

• William Tierney, MD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Central Study Contacts

William Tierney, MD

CONTACT

405-271-5428; William-Tierney@ouhsc.edu

Molly Disbrow, MD

CONTACT

405-559-1450; molly-disbrow@ouhsc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor will not know who was randomized to supervised versus unsupervised simulator training.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2018
• First Posted: April 11, 2018
• Study Start: March 6, 2018
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)