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Completed

NCT Number: NCT03650725

Evaluation of Information on Bowel Preparation for Morning Colonoscopy

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.

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Key information

Conditions

Colonoscopy Behavior Health Behavior Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Health Sciences Center

Winnipeg, Manitoba, R3E 3P4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mandatory Split bowel preparation

Other

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.

Other names: Instructions for Bowel preparation before colonoscopy

Primary outcomes

  1. Quality of bowel cleanliness as measured by Boston Bowel Preparation Scale Score (0-2) in all segments

    Time frame: 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 outcomes

  1. 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.

    Time frame: 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.

  2. Amount of laxative intake

    Time frame: 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.

  3. Proportion with split dose laxative intake

    Time frame: 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.

  4. Endoscopic Outcome 1: Cecal intubation (colonoscopy completion)

    Time frame: At the scheduled colonoscopy procedure, expected average within 3 months

    Compare cecal intubation rate between the groups.

  5. Endoscopic Outcome 2: Withdrawal time during colonoscopy performance

    Time frame: At the scheduled colonoscopy procedure, expected average within 3 months

    Compare withdrawal time between the groups.

  6. Endoscopic Outcome 3: total time for performance of colonoscopy

    Time frame: At the scheduled colonoscopy procedure, expected average within 3 months

    Compare total procedure time between the groups.

  7. Endoscopic Outcome 4: polyps during colonoscopy

    Time frame: At the scheduled colonoscopy procedure, expected average within 3 months

    Compare polyp detection (adenoma, sessile serrated polyps) detection rates between the groups.

  8. Patient experience data outcome 1: use of split dose bowel preparation

    Time frame: Before scheduled colonoscopy procedure, expected average within 3 months

    We will determine the proportion reporting: use of split dose and day before bowel preparation

  9. Patient experience data outcome 2: complete intake of all of the prescribed laxative

    Time frame: Before scheduled colonoscopy procedure, expected average within 3 months

    We will determine the proportion reporting consumption of all of the laxative

  10. Patient experience data outcome 3: incontinence episodes while preparing for colonoscopy

    Time frame: 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

  11. Patient experience data outcome 4: Sleep in night before colonoscopy

    Time frame: Before scheduled colonoscopy procedure, expected average within 3 months

    We will determine and compare the total duration of sleep

  12. Patient experience data outcome 5: willingness to repeat colonoscopy using same laxative preparation

    Time frame: 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

  13. Patient experience data outcome 6: pre-colonoscopy anxiety (Likert scale 1-5)

    Time frame: 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.

  14. Patient experience data outcome 7: difficulty with bowel preparation (Likert scale 1-10)

    Time frame: 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)

Other outcomes

  1. Quality of bowel cleanliness as measured by total Ottawa Bowel Preparation Scale Score (0-14)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Harminder Singh

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2023
First posted
Aug 29, 2018
Registry last updated
Jan 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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