Colorectal Cancer
Conditions
Keywords
Suprep, Simethicone, Colorectal cancer screening, Routine colonoscopy, sodium sulfate/potassium sulfate/magnesium sulfate, Bowel cleansing, Mass 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.
Interventions
DRUGSimethicone
Patients will be randomized to receive either simethicone or placebo in addition to oral sodium sulfate/potassium sulfate/magnesium sulfate solution (Suprep), and will be blinded to whether they are in the simethicone arm or the placebo arm of the trial. Simethicone and placebo will be prepared as identically-appearing liquid solution (2.4 mL) with the assistance of a pharmacist. The simethicone or placebo solution will then be assigned to patients according to the randomization scheme and samples will be labeled with patient information prior to distribution. Only the pharmacist will participate in the labeling process and know which patients receive simethicone or placebo; administering staff, nurses, physicians, and patients will be blinded to this.
DRUGPlacebo
Patients will be randomized to receive either simethicone or placebo in addition to oral sodium sulfate/potassium sulfate/magnesium sulfate solution (Suprep), and will be blinded to whether they are in the simethicone arm or the placebo arm of the trial. Simethicone and placebo will be prepared as identically-appearing liquid solution (2.4 mL) with the assistance of a pharmacist. The simethicone or placebo solution will then be assigned to patients according to the randomization scheme and samples will be labeled with patient information prior to distribution. Only the pharmacist will participate in the labeling process and know which patients receive simethicone or placebo; administering staff, nurses, physicians, and patients will be blinded to this.
DRUGsodium sulfate/potassium sulfate/magnesium sulfate solution
Both arms will receive sodium sulfate/potassium sulfate/magnesium sulfate solution for bowel preparation
Sponsors
MercyOne Des Moines Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall bowel cleansing | During procedure | To be assessed during removal of the colonoscope during the procedure and blinded endoscopist will score using a written questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with adverse effects | Day prior to and day of colonoscopy | A written patient questionnaire will be used to assess patient acceptability and tolerability by recording any adverse effects experienced, including nausea, vomiting, headache, insomnia, bloating, abdominal pain, abdominal discomfort, abdominal cramps or any others. |
| Number of patients completing the bowel preparation | Day prior to and day of colonoscopy | A written patient questionnaire will be used to assess compliance by asking if the total prescribed volume of solution was ingested and by recording number of evacuations. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Presence of bubbles | During procedure | To be assessed during removal of the colonoscope during the procedure and blinded endoscopist will score using a written questionnaire |
| Degree of haziness | During procedure | To be assessed during removal of the colonoscope during the procedure and blinded endoscopist will score using a written questionnaire |
Countries
United States
Outcome results
None listed