Colonoscopy Clinical Trial
Official title:
Efficacy of a Low Volume PEG Purgative (MoviPrep®) Administered Entirely in the Morning Compared to Split Dose (PM/AM) Administration
This study will evaluate whether morning-only dosing of MoviPrep® (2L) for afternoon colonoscopy is as effective as a standard dosing regimen of half of the volume of MoviPrep® (1L) solution the evening prior, and half (1L) the morning of, colonoscopy. MoviPrep® is a low volume (2 liters) polyethylene glycol (PEG)-based purgative that is approved for evening-only or split (evening and morning) dosing to cleanse the colon prior to colonoscopy. Patients undergoing afternoon colonoscopies often have inferior colon cleansing. There is evidence that morning-only purgative administration of large volume PEG (4L) is safe and effective. This study will assess whether administration of a low volume PEG regimen will maintain efficacy and improve tolerance by changing a 2-day preparation procedure into a regimen that is completed in 1 day.
primary objectives
• To compare the efficacy of morning dose only MoviPrep® ("AM Dosing") where one-half of the
prep is given 7 hours before colonoscopy and the second half is given 4 hours before
colonoscopy, versus split dose (PM/AM) MoviPrep® ("PM/AM Dosing") where one-half of the prep
is given at 6pm the night prior to colonoscopy and the second half is given 4 hours before
colonoscopy.
Efficacy will be assessed based on cleansing of the entire colon, with successful cleansing
defined as a score of excellent or good and unsuccessful cleansing defined as a score of
fair or poor.
Secondary objectives
- To assess the tolerability of AM Dosing MoviPrep® versus PM/AM Dosing MoviPrep® based
on percentage of prep completed, sleep quality/quantity, future prep choice (same prep
or alternative prep described), and incidence and severity (using 11-point Likert
scale) of any adverse events (i.e. nausea, vomiting, abdominal pain, bloating,
light-headedness).
- To evaluate the safety of each dosing administration based on vitals with orthostatic
measures (BP, pulse) on day of colonoscopy.
- To evaluate the effect of colon prep on work and productivity as measured by the degree
of interference with work/productivity the day prior to colonoscopy.
- To assess difference between two dosing arms with respect to analysis of right colon
cleansing, and overall adenoma detection in terms of number, size, location, histology,
and morphology.
- To determine the effect of purgative dosing on procedure efficiency by measuring (a)
total procedure time, (b) time from anus to cecum, and (c) withdrawal time (excluding
time taken for interventions).
- To evaluate the effect of purgative dosing regimen on amount of flushing required
during the procedure (0 = none, 1 = <50 ml, 2 = 50-100 ml, 3 = >100 ml).
- To validate a new grading scale for colon cleansing using the de-identified recordings
of colonoscopies performed during this study.
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