Cap Assisted Colonoscopy Enhances Quality Based Competency in Colonoscopy Among Trainees
Condition: Endoscopy, Gastrointestinal
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Distal Attachment Cap
Intervention type(s): Device
Intervention description(s): Colonoscopies are performed under the supervision of board certified attending gastroenterologists experienced in colonoscopy. Attending physicians will provide assistance at their discretion or at the request of the trainee. All close examinations for polyps will be carried out on withdrawal of the colonoscope.
Other intervention name(s): US Endoscopy Distal Attachment Cap
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Colonoscopy; Training Techniques; Endoscopy, Gastrointestinal