Outcomes in Simulated Endoscopy Training

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-50
SponsorUniversity of Oklahoma

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Unwilling to consent.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Supervision/Coaching

    Behavioral

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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: SupervisedActive comparator 1 intervention
Group B: UnsupervisedActive comparator 1 intervention

Trial outcomes

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

Time frame
through study completion, an average of 1 year

Secondary outcomes

1

Time to reach cecum

Time to reach cecum after time of colonoscope insertion

Time frame
through study completion, an average of 1 year
2

Participant satisfaction score

Participants will be asked to self-report satisfaction with supervised and unsupervised endoscopic simulator experiences

Time frame
through study completion, an average of 1 year

Other outcomes

Sponsors and contacts

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