The Bowel CLEAnsing: A National Initiative

Alan Barkun3,476 enrolled

Overview

The purpose of this study is to compare diet, type of bowel preparation and time of colonoscopy to determine if one method is better than the other and, if they are the same, identify the one which is the most convenient for the patients.

The objective of the current proposed trial is thus to compare the cleanliness achieved with PEG high-volume (2L+2L) split-dose versus PEG (1L+1L)+Bisacodyl low-volume split-dose, or PEG high volume (4L) non-split day before versus PEG low volume (2L) non-split same day preparation, according to time of endoscopy (early or later), as well as assess the role of diet (low residue or clear liquid diet) according to these different Canadian outpatient preparation regimens.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

3,476

Conditions

Subjets Requiring a Colonoscopy

Interventions

High volume PEG split-doseDRUG

Colyte® or PegLyte® will be provided to the subject who will be asked to drink 2L of the preparation starting at 7:00 PM the day before the procedure at a rate of 240 mL every 10 minutes until completed. The second dose of 2L of preparation will be taken the morning of the colonoscopy starting 4-5 hours prior to the planned procedural time at a rate of 240 mL every 10 minutes until completed.

Low volume PEG split-doseDRUG

Bi-PegLyte® will be provided to the subject who will be asked to ingest 3 tabs of Bisacodyl 5 mg (total 15 mg) at 2:00 PM the day before the procedure. After the first bowel movement, or if there is no bowel movement within 6 hours of taking the Bisacodyl tablets, the subject will be asked to drink 1L of the solution at a rate of 240 mL every 10 minutes until the solution is completed. The second dose of 1L of preparation will be taken the morning of the colonoscopy starting 4-5 hours prior to the procedure at a rate of 240 mL every 10 minutes. Use of antacids will not be permitted within one hour of taking bisacodyl.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Outpatients * 18 years or older * Able to comprehend the trial * Have an indication for full colonoscopy Exclusion Criteria: Subjects are excluded from enrollment into the study if any of the following are present: General exclusion criteria: * Subject refusal * Previous bowel preparation in the last 14 days * Pregnancy or breastfeeding * Reduced mobility Medical/Endoscopic exclusion criteria: * Suspected or diagnosed with bowel obstruction * Any colonic surgery * Toxic megacolon * Ileus * Ischemic colitis * Decompensated heart failure * Severe acute renal failure * Severe liver disease * Severe electrolyte imbalance

Locations (10)

Forzani & MacPhail Colon Cancer Screening Centre

Calgary, Alberta, Canada

University of Alberta Hospital

Edmonton, Alberta, Canada

St. Paul's Hospital

Vancouver, British Columbia, Canada