Background: In randomized controlled trials, split-dose bowel preparation for colonoscopy has been shown to provide better bowel cleansing than day before bowel preparation. However, people who volunteer to be in clinical trials may be more adherent to a challenging bowel preparation regimen than people in the general community undergoing colonoscopy. This may be especially true for colonoscopies scheduled for the morning, when the later dose of the split-dose bowel preparation would be administered in the early morning hours. Hence the results of the available trials may not be applicable to patients undergoing morning colonoscopy in routine medical practices. Aims: To compare the effectiveness of mandatory split-dose bowel preparation to optional split-dose bowel preparation protocols for morning colonoscopies in a non-inferiority pragmatic trial. Anticipated results and significance: The study will produce a better understanding of the most effective approach to bowel preparation for early morning colonoscopies and suggest specific recommendations for colonoscopy practice.
Patient will be randomized by the central booking office. Patient experience survey will be administered prior to colonoscopy. Chart review will be done to obtain data from the medical records and endoscopy reports. Please see outcomes and planned analysis.
Study Type
OBSERVATIONAL
Enrollment
1,000
Intervention describes the standard of care patient split bowel preparation instructions as mandatory, instead of giving patient instructions with option of choice between split or day before bowel prep.
Health Sciences Center
Winnipeg, Manitoba, Canada
Quality of bowel cleanliness as measured by Boston Bowel Preparation Scale Score (0-2) in all segments
Proportion with adequate cleansing as measured by Boston Bowel Preparation Scale Score ≥2 in all segments. Boston Bowel Preparation Scale Score is reported as score of 0 to 3 in 3 segments of the colon. The score is then summed for a total score of 0 to 9. Higher Boston score, better quality of bowel cleanliness.
Time frame: At the scheduled colonoscopy procedure performed with the instructions provided, expected average within 3 months
Composite with any of the following: cancellations in the day before colonoscopy; no shows for colonoscopy appointment; phone calls for questions on the bowel preparation and/or rescheduling because of the bowel preparation.
Determine the proportion with any of the following: cancellations in the day before colonoscopy; no shows for colonoscopy appointment (composite and separate analysis for these 2 outcomes); phone calls for questions on the bowel preparation and/or rescheduling because of the bowel preparation (indicator of staff workload generated).. This is a composite measure of number of individuals in each of the listed categories. Each will also be reported separately.
Time frame: Anytime before the scheduled colonoscopy procedure performed with the instructions provided, expected average within 3 months
Amount of laxative intake
Amount of laxative intake before colonoscopy will be compared in the two groups.
Time frame: In the 24 hours before the scheduled colonoscopy,expected average within 3 months
Proportion with split dose laxative intake
Split dose refers to taking half the dose of the laxative day before colonoscopy and half on the day of the colonoscopy.
Time frame: In the 24 hours before the scheduled colonoscopy,expected average within 3 months
Endoscopic Outcome 1: Cecal intubation (colonoscopy completion)
Compare cecal intubation rate between the groups.
Time frame: At the scheduled colonoscopy procedure, expected average within 3 months
Endoscopic Outcome 2: Withdrawal time during colonoscopy performance
Compare withdrawal time between the groups.
Time frame: At the scheduled colonoscopy procedure, expected average within 3 months
Endoscopic Outcome 3: total time for performance of colonoscopy
Compare total procedure time between the groups.
Time frame: At the scheduled colonoscopy procedure, expected average within 3 months
Endoscopic Outcome 4: polyps during colonoscopy
Compare polyp detection (adenoma, sessile serrated polyps) detection rates between the groups.
Time frame: At the scheduled colonoscopy procedure, expected average within 3 months
Patient experience data outcome 1: use of split dose bowel preparation
We will determine the proportion reporting: use of split dose and day before bowel preparation
Time frame: Before scheduled colonoscopy procedure, expected average within 3 months
Patient experience data outcome 2: complete intake of all of the prescribed laxative
We will determine the proportion reporting consumption of all of the laxative
Time frame: Before scheduled colonoscopy procedure, expected average within 3 months
Patient experience data outcome 3: incontinence episodes while preparing for colonoscopy
We will determine the proportion reporting incontinence episodes during bowel preparation and during travel to the colonoscopy appointment
Time frame: Before scheduled colonoscopy procedure, expected average within 3 months
Patient experience data outcome 4: Sleep in night before colonoscopy
We will determine and compare the total duration of sleep
Time frame: Before scheduled colonoscopy procedure, expected average within 3 months
Patient experience data outcome 5: willingness to repeat colonoscopy using same laxative preparation
We will determine the proportion reporting patient willingness to repeat colonoscopy using same preparation
Time frame: Assessed immediately before scheduled colonoscopy procedure, expected average within 3 months
Patient experience data outcome 6: pre-colonoscopy anxiety (Likert scale 1-5)
We will determine and compare the pre-colonoscopy anxiety rating, assessed on 5 point Likert scale (1-5). Higher values represent higher anxiety.
Time frame: Assessed immediately before scheduled colonoscopy procedure, expected average within 3 months
Patient experience data outcome 7: difficulty with bowel preparation (Likert scale 1-10)
We will determine and compare difficulty with bowel preparation rating, as reported by patients on a ten point Likert scale (1-10). Higher values represent less difficulty (i.e. more tolerance)
Time frame: Assessed immediately before scheduled colonoscopy procedure, expected average within 3 months
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