Clive, Iowa 50325


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT02523911


Primary Contact:

Principal Investigator
Tercio Lopes, MD
Iowa Digestive Disease Center

Tercio Lopes, MD
Email: Limongister@gmail.com


Backup Contact:

N/A


Location Contact:

Clive, Iowa 50325
United States

Laura L Ulmer, DO
Phone: 515-473-1762
Email: lulmer@mercydesmoines.org

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 20, 2017

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