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

MercyOne Des Moines Medical Center

Status: Withdrawn

Conditions: Colorectal Cancer

Treatments: Drug: Simethicone; Drug: sodium sulfate/potassium sulfate/magnesium sulfate solution; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02523911

MMC2015-31

Details and patient eligibility

About

The purpose of this study is to investigate Suprep bowel preparation, with and without the anti-gas medication simethicone, in terms of efficacy and patient tolerability in the preparation of patients undergoing routine colonoscopy for colorectal cancer screening.

Full description

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.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups, including a placebo group

Simethicone Group

Active Comparator group

Description:

Early in the evening prior to colonoscopy, patients will be instructed to consume one 6 ounce bottle of oral sodium sulfate/potassium sulfate/magnesium sulfate (Suprep) solution (containing sodium sulfate 17.5 grams, potassium sulfate 3.13 grams, and magnesium sulfate 1.6 grams) diluted with 16 ounces of water over one hour. Over the next hour, the patient will be instructed to drink an additional 32 ounces of water. On the day of colonoscopy, the same procedure will be repeated. Patients will take 2.4 mL simethicone in a half glass of water immediately after consuming each dose of the Suprep. All of the bowel preparation solution and required water should be consumed at least 2 hours prior to colonoscopy.

Treatment:

Drug: sodium sulfate/potassium sulfate/magnesium sulfate solution

Drug: Simethicone

Placebo Group

Placebo Comparator group

Description:

Early in the evening prior to colonoscopy, patients will be instructed to consume one 6 ounce bottle of oral sodium sulfate/potassium sulfate/magnesium sulfate (Suprep) solution (containing sodium sulfate 17.5 grams, potassium sulfate 3.13 grams, and magnesium sulfate 1.6 grams) diluted with 16 ounces of water over one hour. Over the next hour, the patient will be instructed to drink an additional 32 ounces of water. On the day of colonoscopy, the same procedure will be repeated. Patients will take 2.4 mL of placebo (identical in appearance to simethicone) in a half glass of water immediately after consuming each dose of the Suprep. All of the bowel preparation solution and required water should be consumed at least 2 hours prior to colonoscopy.

Treatment:

Drug: Placebo

Drug: sodium sulfate/potassium sulfate/magnesium sulfate solution