Endoscopy, Gastrointestinal Clinical Trial
Official title:
Cap Assisted Colonoscopy Enhances Quality Based Competency in Colonoscopy Among Trainees
The purpose of this study is to identify if performing diagnostic colonoscopy with a small plastic cap attached to the camera will improve performance of colonoscopies by physician trainees.
Training novice endoscopists to perform effective diagnostic colonoscopy is a central
objective of Gastroenterology fellowship. Though there is no universal definition of
competency, it is traditionally assessed with a combination of objective measures such as
volume of procedures and subjective factors such as formal evaluations. As quality measures
such as cecal intubation time, cecal intubation rate, and adenoma detection rate gain in
importance in clinical practice, they should be increasingly incorporated as objectives into
more formalized and objective training methodologies.
Indeed, though 140 colonoscopies have been suggested as a rough volume threshold needed for
trainees to gain competence, evidence suggests that the number may actually be much higher
when taking various objective quality measures into account.
Recent attention has turned to various measures to improve trainee performance such as
computer simulation and magnetic endoscopy imaging. Along these lines, simple, effective, and
economical measures are needed to improve trainee performance.
Cap assisted colonoscopy (CAC) is performed with the aid of a transparent inert cap attached
to the distal end of the colonoscope. CAC allows close examination of mucosa proximal to
flexures and haustral folds and prevents "red out" when closely approximated against mucosa,
aiding in luminal orientation and examination. CAC has been shown to improve cecal intubation
time, polyp detection rate, and adenoma detection rate in the hands of experienced
practitioners. A handful of studies have also indicated that these benefits also extend to
trainees, while another prospective study showed no improvement in cecal intubation rate.
The investigators hypothesize that cap assisted colonoscopy will result in significantly
improved cecal intubation rate and time, as well as adenoma detection rate, among trainees
when compared with standard non cap assisted colonoscopy in a large academic Gastroenterology
training program in the United States.
The study is a prospective randomized trial of colonoscopies performed at Harris Health
System Ben Taub Hospital by all novice endoscopy trainees from July 2015 until enrollment is
complete. Novice endoscopy trainees are defined as endoscopists with less than 10
colonoscopies performed by July 2015. All colonoscopies included will be performed by the
novice endoscopist under direct supervision of a board certified attending
gastroenterologist.
Each colonoscopy fulfilling the inclusion criteria will be randomized with equal probability
to a cap assisted colonoscopy (CAC) group or a control standard colonoscopy (SC) group.
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