Comparing 4L Golytely to 2L Golytely With 15mg Bisacodyl Regimens for Inpatient Colonic Preparation
2L Golytely and Oral Bisacodyl 15 mg Versus 4L Golytely Regimen for Inpatient Colonoscopy Bowel Preparation: A Randomized, Non-Inferiority Open Trial
1 other identifier
interventional
N/A
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Nov 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 12, 2011
CompletedFirst Posted
Study publicly available on registry
October 17, 2011
CompletedStudy Start
First participant enrolled
November 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedSeptember 19, 2013
September 1, 2013
6 months
October 12, 2011
September 17, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Difference in Boston Bowel Preparation Scale & Ottawa Bowel Preparation Scale between the two groups
These are established rating scales to evaluate the quality of bowel prep. The ratings will be compared between the two groups.
30min
Secondary Outcomes (2)
Difference in the number of participants who develop distress symptoms from bowel prep (and the type) between the two groups
20hours
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.
20hours
Study Arms (2)
2L Golytely/15mg bisacodyl
EXPERIMENTALSubjects will be asked to take 2L Golytely + 15mg bisacodyl for bowel prep the day before colonoscopy.
Standard bowel prep
ACTIVE COMPARATORSubject will receive standard bowel prep (4L Golytely) prior to colonoscopy.
Interventions
Subjects will be asked to take 4L of Golytely the day prior to procedure.
Subjects will be asked to take 2L Golytely and 15mg bisacodyl the day prior to procedure.
Eligibility Criteria
You may qualify if:
- Inpatients undergoing colonoscopy
- Age 19 or over
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6, Canada
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert A. Enns, Dr.
University of British Columbia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 12, 2011
First Posted
October 17, 2011
Study Start
November 1, 2011
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
September 19, 2013
Record last verified: 2013-09