Colonoscopy, Patient Compliance
Conditions
Keywords
Colonoscopy, bowel preparation
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.
Interventions
OTHERMandatory Split bowel preparation
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.
Sponsors
Harminder Singh
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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 |
| 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. |
| 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 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 |
| 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. |
| 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) |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Quality of bowel cleanliness as measured by total Ottawa Bowel Preparation Scale Score (0-14) | At the scheduled colonoscopy procedure performed with the instructions provided, expected average within 3 months | Ottawa Bowel Scale score is calculated as a sum of scores in the 3 segments of colon (0-4) plus amount of fluid (0-2). All of the scores in the segments will be recorded and then summed. Comparison will be as continuous variable as dichotomous score ≤ 7. Lower the score on Ottawa scale, better the cleansing quality. |
Countries
Canada
Outcome results
None listed