Clinical trial NCT03650725: Evaluation of Information on Bowel Preparation for Morning Colonoscopy
Official title: Evaluation of Information Provided to Patients Provided About Bowel Preparation for Morning Colonoscopy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colonoscopy
Patient Compliance
Keywords: Colonoscopy
bowel preparation
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2018-08-29
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Description of Population: We will enroll all persons who are scheduled to undergo colonoscopy by one of the four participating gastroenterologists at an outpatient hospital-based endoscopy centre in Winnipeg, Canada, in this trial. These four gastroenterologists have been in practice for 10 years or greater, and all perform over 400 colonoscopies annually. Patients are referred to these gastroenterologists by a centralized referral program, which is responsible for scheduling the procedure and for distributing the bowel preparation instructions- This program is randomly assigning to mandatory and optional split preparation as part of routine care; stratified randomization by early vs. later morning.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of bowel cleanliness as measured by Boston Bowel Preparation Scale Score (0-2) in all segments
timeFrame: At the scheduled colonoscopy procedure performed with the instructions provided, expected average within 3 months
Secondary outcomes:
measure: 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.
timeFrame: Anytime before the scheduled colonoscopy procedure performed with the instructions provided, expected average within 3 months
measure: Amount of laxative intake
timeFrame: In the 24 hours before the scheduled colonoscopy,expected average within 3 months
measure: Proportion with split dose laxative intake
timeFrame: In the 24 hours before the scheduled colonoscopy,expected average within 3 months
measure: Endoscopic Outcome 1: Cecal intubation (colonoscopy completion)
timeFrame: At the scheduled colonoscopy procedure, expected average within 3 months
measure: Endoscopic Outcome 2: Withdrawal time during colonoscopy performance
timeFrame: At the scheduled colonoscopy procedure, expected average within 3 months
measure: Endoscopic Outcome 3: total time for performance of colonoscopy
timeFrame: At the scheduled colonoscopy procedure, expected average within 3 months
measure: Endoscopic Outcome 4: polyps during colonoscopy
timeFrame: At the scheduled colonoscopy procedure, expected average within 3 months
measure: Patient experience data outcome 1: use of split dose bowel preparation
timeFrame: Before scheduled colonoscopy procedure, expected average within 3 months
measure: Patient experience data outcome 2: complete intake of all of the prescribed laxative
timeFrame: Before scheduled colonoscopy procedure, expected average within 3 months
measure: Patient experience data outcome 3: incontinence episodes while preparing for colonoscopy
timeFrame: Before scheduled colonoscopy procedure, expected average within 3 months
measure: Patient experience data outcome 4: Sleep in night before colonoscopy
timeFrame: Before scheduled colonoscopy procedure, expected average within 3 months
measure: Patient experience data outcome 5: willingness to repeat colonoscopy using same laxative preparation
timeFrame: Assessed immediately before scheduled colonoscopy procedure, expected average within 3 months
measure: Patient experience data outcome 6: pre-colonoscopy anxiety (Likert scale 1-5)
timeFrame: Assessed immediately before scheduled colonoscopy procedure, expected average within 3 months
measure: Patient experience data outcome 7: difficulty with bowel preparation (Likert scale 1-10)
timeFrame: Assessed immediately before scheduled colonoscopy procedure, expected average within 3 months
Other outcomes:
measure: Quality of bowel cleanliness as measured by total Ottawa Bowel Preparation Scale Score (0-14)
timeFrame: At the scheduled colonoscopy procedure performed with the instructions provided, expected average within 3 months
Locations:
city: Winnipeg
country: Canada
facility: Health Sciences Center
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Harminder Singh, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Singh H, Bay D, Ip S, Bernstein CN, Nugent Z, Gheorghe R, Wightman R. Pathological reassessment of hyperplastic colon polyps in a city-wide pathology practice: implications for polyp surveillance recommendations. Gastrointest Endosc. 2012 Nov;76(5):1003-8. doi: 10.1016/j.gie.2012.07.026.
citation: Pruthi D, Duerksen DR, Singh H. The practice of gastrostomy tube placement across a Canadian regional health authority. Am J Gastroenterol. 2010 Jul;105(7):1541-50. doi: 10.1038/ajg.2009.756. Epub 2010 Jan 26.
citation: Singh H, Turner D, Xue L, Targownik LE, Bernstein CN. Risk of developing colorectal cancer following a negative colonoscopy examination: evidence for a 10-year interval between colonoscopies. JAMA. 2006 May 24;295(20):2366-73. doi: 10.1001/jama.295.20.2366.