The investigators wish to compare the efficacy and patient tolerability of a preparation consisting of 2L Golytely (PEG + electrolytes) plus 15mg of bisacodyl vs the standard preparation of 4L Golytely. The investigators hypothesize that 2L Golytely with 15mg bisacodyl will show similar bowel cleansing efficacy while offering better tolerability.
Full Title of Study: “2L Golytely and Oral Bisacodyl 15 mg Versus 4L Golytely Regimen for Inpatient Colonoscopy Bowel Preparation: A Randomized, Non-Inferiority Open Trial”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Single (Outcomes Assessor)
- Study Primary Completion Date: May 2012
- Drug: Standard Bowel Prep
- Subjects will be asked to take 4L of Golytely the day prior to procedure.
- Drug: 2L Golytely/bisacodyl
- Subjects will be asked to take 2L Golytely and 15mg bisacodyl the day prior to procedure.
Arms, Groups and Cohorts
- Experimental: 2L Golytely/15mg bisacodyl
- Subjects will be asked to take 2L Golytely + 15mg bisacodyl for bowel prep the day before colonoscopy.
- Active Comparator: Standard bowel prep
- Subject will receive standard bowel prep (4L Golytely) prior to colonoscopy.
Clinical Trial Outcome Measures
- Difference in Boston Bowel Preparation Scale & Ottawa Bowel Preparation Scale between the two groups
- Time Frame: 30min
- These are established rating scales to evaluate the quality of bowel prep. The ratings will be compared between the two groups.
- Difference in the number of participants who develop distress symptoms from bowel prep (and the type) between the two groups
- Time Frame: 20hours
- Number of participants who develop distress symptoms from bowel prep, and the type of distress symptoms will be compared between the two groups
- Difference in the absolute number/percentage of participants in the two groups who find the bowel prep experience easy, acceptable, difficult, very difficult, or unable to complete.
- Time Frame: 20hours
- Participants will be asked to rate their bowel prep experience (based on ease of use) on a Likert scale. The number of participants in each level will subsequently be quantified (n, %) and compared between the two groups.
Participating in This Clinical Trial
- Inpatients undergoing colonoscopy – Age 19 or over Exclusion Criteria:
- Unable to provide informed consent – Patients with constipation – Patients with suspected bowel obstruction or severe inflammatory bowel disease – Same-day colonoscopy – Intensive/critical care patient – History of colorectal resection
Gender Eligibility: All
Minimum Age: 19 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- University of British Columbia
- Provider of Information About this Clinical Study
- Overall Official(s)
- Robert A. Enns, Dr., Principal Investigator, University of British Columbia
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