Evaluation of Information on Bowel Preparation for Morning Colonoscopy

Harminder Singh

Status: Completed

Conditions: Patient Compliance; Colonoscopy

Treatments: Other: Mandatory Split bowel preparation

Study type: Observational

Funder types: Other

Identifiers

NCT03650725

H2018:202

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

1,000 participants in 2 patient groups

Mandatory Split bowel preparation

Description:

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.

Treatment:

Other: Mandatory Split bowel preparation

Optional Split bowel preparation

Description:

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.