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Spots Global Cancer Trial Database for Efficacy and Tolerability of Suprep With and Without Simethicone for Routine Colonoscopy for Colorectal Cancer Screening

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Trial Identification

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

Official Title: Sodium Sulfate/Potassium Sulfate/Magnesium Sulfate Bowel Preparation With and Without Simethicone for Routine Colonoscopy: A Double-blinded Randomized Controlled Trial

Study ID: NCT02523911

Study Description

Brief Summary: 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.

Detailed 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: Yes

Locations

UF Health Jacksonville, Jacksonville, Florida, United States

Iowa Endoscopy Center, Clive, Iowa, United States

Contact Details

Name: Tercio Lopes, MD

Affiliation: Iowa Digestive Disease Center

Role: PRINCIPAL_INVESTIGATOR

Name: Silvio de Melo, MD

Affiliation: University of Florida Health Systems, Jacksonville

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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