Comparison of Clenpiq vs Golytely Bowel Preparation
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/4/2019 |
| Start Date: | July 11, 2018 |
| End Date: | January 2021 |
| Contact: | Hennie Hasson, RN |
| Email: | hassonh@ccf.org |
| Phone: | 216-444-6975 |
Randomized Comparison of the Impact of Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Versus Polyethylene Glycol Bowel Preparation on Inpatient Colonoscopy Quality Parameters
This is a prospective randomized study which will be done at main campus Cleveland Clinic.
The investigators will be comparing the colon cleansing by the Boston Bowel Preparation Scale
in participants undergoing colonoscopy as an inpatient at our hospital. Participants will be
randomized to the the standard of care (4 Liter polyethylene glycol based preparation) or a
low volume bowel preparation (sodium picosulfate, a stimulant laxative, magnesium oxide and
anhydrous citric acid (SP/MC)). Both agents will either be administered as full dose the
evening before or as split-dose on the evening before and on the day of the procedure.
The investigators will be comparing the colon cleansing by the Boston Bowel Preparation Scale
in participants undergoing colonoscopy as an inpatient at our hospital. Participants will be
randomized to the the standard of care (4 Liter polyethylene glycol based preparation) or a
low volume bowel preparation (sodium picosulfate, a stimulant laxative, magnesium oxide and
anhydrous citric acid (SP/MC)). Both agents will either be administered as full dose the
evening before or as split-dose on the evening before and on the day of the procedure.
The purpose of our study is to determine if a 4L bowel cleansing agent is more effective than
a low volume bowel preparation, and if the time of dosing (single dose night before vs split
dose) of the bowel preparation results in better bowel cleansing in participants undergoing
colonoscopy. Eligible participants undergoing colonoscopy with conscious sedation will be
randomly assigned to one of two bowel preparations and one of two dosing schemas of bowel
preparation. Participants not eligible for conscious sedation and are undergoing colonoscopy
with general anesthesia will be randomized only to the single dose arms of the study.
Participants will complete a questionnaire while drinking the bowel preparation to determine
timing and tolerability of the bowel preparation.
a low volume bowel preparation, and if the time of dosing (single dose night before vs split
dose) of the bowel preparation results in better bowel cleansing in participants undergoing
colonoscopy. Eligible participants undergoing colonoscopy with conscious sedation will be
randomly assigned to one of two bowel preparations and one of two dosing schemas of bowel
preparation. Participants not eligible for conscious sedation and are undergoing colonoscopy
with general anesthesia will be randomized only to the single dose arms of the study.
Participants will complete a questionnaire while drinking the bowel preparation to determine
timing and tolerability of the bowel preparation.
Inclusion Criteria:
- Patients who need a colonoscopy while in the hospital (Cleveland Clinic main campus) will
be eligible to participate.
Exclusion Criteria:
- Creatinine clearance less than 30 ml/min
- History of heart failure with current shortness of breath at rest causing limited
physical activity, arrhythmia, unstable angina or acute myocardial infarction
- Small bowel obstruction, ileus or bowel perforation
- Dementia or cognitive dysfunction to an extent that they cannot perform the study
related documentation or consent to participate in the study.
- Gastroparesis
- Toxic megacolon or undergoing colonoscopy for decompression
- Taking oral tetracyclines, fluoroquinolones, antibiotics, iron, digoxin,
chlorpromazine and penicillamine within 2 hours before or 6 hours after administration
of Clenpiq or stimulant laxatives within 24 hours
- History of prior colorectal surgery
- Allergy to any of the ingredients in Clenpiq or golytely
- if the procedure is planned in the intensive care unit (ICU)
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