Clinical trial NCT02523911: 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 type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Colorectal Cancer
Keywords: Suprep
Simethicone
Colorectal cancer screening
Routine colonoscopy
sodium sulfate/potassium sulfate/magnesium sulfate
Bowel cleansing
Mass screening
Lead sponsor: MercyOne Des Moines Medical Center
Sponsor class: OTHER
First posted: 2015-08-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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 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

Primary outcomes:
measure: Overall bowel cleansing
timeFrame: During procedure
Secondary outcomes:
measure: Number of patients with adverse effects
timeFrame: Day prior to and day of colonoscopy
measure: Number of patients completing the bowel preparation
timeFrame: Day prior to and day of colonoscopy
Other outcomes:
measure: Presence of bubbles
timeFrame: During procedure
measure: Degree of haziness
timeFrame: During procedure
Locations:
city: Jacksonville
country: United States
facility: UF Health Jacksonville
state: Florida
city: Clive
country: United States
facility: Iowa Endoscopy Center
state: Iowa
Study officials:
affiliation: Iowa Digestive Disease Center
name: Tercio Lopes, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida Health Systems, Jacksonville
name: Silvio de Melo, MD
role: PRINCIPAL_INVESTIGATOR
References:
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