Evaluation of Information on Bowel Preparation for Morning Colonoscopy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Information Provided to Patients Provided About Bowel Preparation for Morning Colonoscopy

Conditions
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Colonoscopy, Patient Compliance

Intervention / Treatment
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* Other: Mandatory Split bowel preparation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mandatory Split bowel preparation<br>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. | Other: Mandatory Split bowel preparation<br>* 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.<br>* Other names: Instructions for Bowel preparation before colonoscopy;|
| Optional Split bowel preparation<br>Patients will be advised on split-dose bowel preparation (as per option 1), but will also receive instructions on day before bowel preparation. The instructions will indicate that split-dose bowel preparation is the optimal preparation for cleansing the bowel and for visualizing polyps, but they may choose day before bowel preparation if the split dose preparation is too difficult for them. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At the scheduled colonoscopy procedure performed with the instructions provided, expected average within 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | At the scheduled colonoscopy procedure, expected average within 3 months | 
| Endoscopic Outcome 2: Withdrawal time during colonoscopy performance | Compare withdrawal time between the groups. | 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. | 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. | 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 | 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 | 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 | 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 | 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 | 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. | 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) | Assessed immediately before scheduled colonoscopy procedure, expected average within 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colonoscopy, bowel preparation