Effect of Cap-Fitted Colonoscopy on Miss Rates at Colonoscopy
Patient will undergo tandem colonoscopy on the same day using propofol sedation. Patients
will undergo one colonoscopy without the cap and a second colonoscopy with the cap on. We
will endeavor to keep the total examination time equal between the groups and approximately
six minutes. The order in which patients receive the two colonoscopies (i.e. cap or without
cap first) will be randomized. Any polyps detected during the first colonoscopy will be
removed during that procedure. During the withdrawal phase, the time for examination will
be measured with a stopwatch, and the stopwatch will be stopped at any time a polyp is
located and restarted when the polyp has been removed and retrieved. The stopwatch will
also be stopped for suctioning fluid or washing debris from the colon surface. Any polyp
detected and removed during the first colonoscopy will be counted as the detection for that
procedure. During the second colonoscopy, all polyps will also be removed when detected.
Any polyp identified and removed during the second procedure will be counted as a miss for
the first procedure. All polyps will be sent separately for pathologic evaluation. The
time required to remove and retrieve polyps with and without the cap on will be measured
using a stopwatch as a secondary end point. The primary end point will be the miss rate for
colonoscopy with the cap and colonoscopy without the cap.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Screening
The number of polyps found during the first colonoscopy will be compared to the number of polyps found during the second colonoscopy to determine the miss rate.
after the second colonoscopy is completed
Douglas K Rex, MD
Indiana University School of Medicine
United States: Institutional Review Board
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