Efficacy and Tolerability of Suprep With and Without Simethicone for Routine Colonoscopy for Colorectal Cancer Screening

The study will investigate sodium sulfate/potassium sulfate/magnesium sulfate (Suprep), with
and without simethicone, in terms of efficacy and patient tolerability in the preparation of
patients undergoing routine colonoscopy. Adult ambulatory outpatients who are scheduled for
elective routine colonoscopy for colorectal cancer screening will be recruited to participate
in the trial. Patients will be randomized to receive either simethicone or placebo in
addition to oral sodium sulfate/potassium sulfate/magnesium sulfate solution (Suprep) and
will receive verbal and written instruction on administration of solutions. During
colonoscopy, three areas of the colon (right colon, transverse colon, and left colon) will be
assessed during removal of the colonoscope for overall colon cleansing, presence of bubbles,
and degree of haziness; this will be scored by a blinded endoscopist. A separate written
patient questionnaire will be used to assess acceptability and tolerability of the
preparation, as well as any adverse events.

Inclusion Criteria:

- Age greater than 18 years

- Outpatients who require elective colonoscopy for colorectal cancer screening at Iowa
Endoscopy Center and at University of Florida - Jacksonville

Exclusion Criteria:

- Allergy or hypersensitivity to any constituent of the lavage solution or to
simethicone

- Presence of any contraindication to colonoscopy (i.e. uncontrolled congestive heart
failure, New York Heart Association classification III-IV, history of myocardial
infarction within 6 months, coagulopathy)

- Massive ascites

- Renal insufficiency

- Pregnancy

- History of colonic surgery

- History of anti-flatulence or laxative agent within one week

- Refusal/inability to give consent

- Patients undergoing colonoscopy for reasons other than colorectal cancer screening

- Mentally disabled

- Non-English-speaking patients