Evaluation of Information on Bowel Preparation for Morning Colonoscopy
- Conditions
- Patient ComplianceColonoscopy
- Interventions
- Other: Mandatory Split bowel preparation
- Registration Number
- NCT03650725
- Lead Sponsor
- Harminder Singh
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1000
- Must be 18 years of age or older
- Must have colonoscopy appointment with any 4 of the participating GI doctors at Health Sciences Centre-Winnipeg
- Must use 4 liter type of bowel preparation
- Has colonoscopy appointment with non-participating GI doctor and/or a non-participating endoscopy hospital/clinic
- Patient and/or referral doctor requested a non-4 liter bowel preparation
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Mandatory Split bowel preparation Mandatory Split bowel preparation Patients will be advised to take 4 liters of polyethylene glycol (PEG), split into two 2 liter doses. The first 2 liters are to be taken starting at 1800 hours the day before the colonoscopy, and the second dose is to be taken starting 4-5 hours prior to the scheduled time for the colonoscopy. Each dose will be taken within a 2-hour time span.
- Primary Outcome Measures
Name Time Method Quality of bowel cleanliness as measured by Boston Bowel Preparation Scale Score (0-2) in all segments At the scheduled colonoscopy procedure performed with the instructions provided, expected average within 3 months 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.
- Secondary Outcome Measures
Name Time Method 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. Anytime before the scheduled colonoscopy procedure performed with the instructions provided, expected average within 3 months 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.
Endoscopic Outcome 4: polyps during colonoscopy At the scheduled colonoscopy procedure, expected average within 3 months Compare polyp detection (adenoma, sessile serrated polyps) detection rates between the groups.
Patient experience data outcome 1: use of split dose bowel preparation Before scheduled colonoscopy procedure, expected average within 3 months We will determine the proportion reporting: use of split dose and day before bowel preparation
Patient experience data outcome 2: complete intake of all of the prescribed laxative Before scheduled colonoscopy procedure, expected average within 3 months We will determine the proportion reporting consumption of all of the laxative
Patient experience data outcome 5: willingness to repeat colonoscopy using same laxative preparation Assessed immediately before scheduled colonoscopy procedure, expected average within 3 months We will determine the proportion reporting patient willingness to repeat colonoscopy using same preparation
Patient experience data outcome 6: pre-colonoscopy anxiety (Likert scale 1-5) Assessed immediately before scheduled colonoscopy procedure, expected average within 3 months We will determine and compare the pre-colonoscopy anxiety rating, assessed on 5 point Likert scale (1-5). Higher values represent higher anxiety.
Amount of laxative intake In the 24 hours before the scheduled colonoscopy,expected average within 3 months Amount of laxative intake before colonoscopy will be compared in the two groups.
Proportion with split dose laxative intake In the 24 hours before the scheduled colonoscopy,expected average within 3 months Split dose refers to taking half the dose of the laxative day before colonoscopy and half on the day of the colonoscopy.
Endoscopic Outcome 1: Cecal intubation (colonoscopy completion) At the scheduled colonoscopy procedure, expected average within 3 months Compare cecal intubation rate between the groups.
Patient experience data outcome 4: Sleep in night before colonoscopy Before scheduled colonoscopy procedure, expected average within 3 months We will determine and compare the total duration of sleep
Endoscopic Outcome 2: Withdrawal time during colonoscopy performance At the scheduled colonoscopy procedure, expected average within 3 months Compare withdrawal time between the groups.
Endoscopic Outcome 3: total time for performance of colonoscopy At the scheduled colonoscopy procedure, expected average within 3 months Compare total procedure time between the groups.
Patient experience data outcome 3: incontinence episodes while preparing for colonoscopy Before scheduled colonoscopy procedure, expected average within 3 months We will determine the proportion reporting incontinence episodes during bowel preparation and during travel to the colonoscopy appointment
Patient experience data outcome 7: difficulty with bowel preparation (Likert scale 1-10) Assessed immediately before scheduled colonoscopy procedure, expected average within 3 months 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)
Trial Locations
- Locations (1)
Health Sciences Center
🇨🇦Winnipeg, Manitoba, Canada