Impact of Supervision on Endoscopy Simulation Curriculum Clinical Trial
Official title:
Simbionix GI Mentor Simulated Endoscopy Training
NCT number | NCT03495141 |
Other study ID # | 8244 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 6, 2018 |
Est. completion date | December 31, 2024 |
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 22 Years to 50 Years |
Eligibility | Inclusion Criteria: - Consenting trainees of adult and pediatric gastroenterology fellowships and general surgery residencies at the University of Oklahoma Health Sciences Center. Exclusion Criteria: - Unwilling to consent. |
Country | Name | City | State |
---|---|---|---|
United States | University of Oklahoma | Oklahoma City | Oklahoma |
Lead Sponsor | Collaborator |
---|---|
University of Oklahoma |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Time to reach cecum | Time to reach cecum after time of colonoscope insertion | through study completion, an average of 1 year | |
Secondary | Participant satisfaction score | Participants will be asked to self-report satisfaction with supervised and unsupervised endoscopic simulator experiences | through study completion, an average of 1 year |