The Bowel CLEAnsing: A National Initiative

NCT ID: NCT02547571

Last Updated: 2018-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

3476 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2018-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Subjets Requiring a Colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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1) Early colonoscopy; 2) High-dose, split-dose; 3)Clear liquid

Group Type ACTIVE_COMPARATOR

High volume PEG split-dose

Intervention Type DRUG

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.

Clear liquid diet

Intervention Type OTHER

Early colonoscopy (stratified)

Intervention Type OTHER

"Early" appointments: 7:30 AM to 10h30 AM

1) Early colonoscopy; 2) High-dose, split-dose; 3)Low residue

Group Type ACTIVE_COMPARATOR

High volume PEG split-dose

Intervention Type DRUG

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 residue diet

Intervention Type OTHER

Early colonoscopy (stratified)

Intervention Type OTHER

"Early" appointments: 7:30 AM to 10h30 AM

1) Early colonoscopy; 2) Low volume split-dose; 3)Clear liquid

Group Type ACTIVE_COMPARATOR

Low volume PEG split-dose

Intervention Type DRUG

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.

Clear liquid diet

Intervention Type OTHER

Early colonoscopy (stratified)

Intervention Type OTHER

"Early" appointments: 7:30 AM to 10h30 AM

1) Early colonoscopy; 2) Low volume split-dose; 3)Low residue

Group Type ACTIVE_COMPARATOR

Low volume PEG split-dose

Intervention Type DRUG

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.

Low residue diet

Intervention Type OTHER

Early colonoscopy (stratified)

Intervention Type OTHER

"Early" appointments: 7:30 AM to 10h30 AM

1) Early colonoscopy; 2) High-dose, day before; 3)Clear liquid

Group Type ACTIVE_COMPARATOR

High volume PEG non split, day before

Intervention Type DRUG

Colyte® or PegLyte® will be provided to the subject who will be asked to drink 4L of preparation starting at 6:00 PM the day before the procedure, at a rate of 240 mL every 10 minutes until completed.

Clear liquid diet

Intervention Type OTHER

Early colonoscopy (stratified)

Intervention Type OTHER

"Early" appointments: 7:30 AM to 10h30 AM

1) Early colonoscopy; 2) High-dose, day before; 3)Low residue

Group Type ACTIVE_COMPARATOR

High volume PEG non split, day before

Intervention Type DRUG

Colyte® or PegLyte® will be provided to the subject who will be asked to drink 4L of preparation starting at 6:00 PM the day before the procedure, at a rate of 240 mL every 10 minutes until completed.

Low residue diet

Intervention Type OTHER

Early colonoscopy (stratified)

Intervention Type OTHER

"Early" appointments: 7:30 AM to 10h30 AM

1) Later colonoscopy; 2) High-dose, split-dose; 3)Clear liquid

Group Type ACTIVE_COMPARATOR

High volume PEG split-dose

Intervention Type DRUG

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.

Clear liquid diet

Intervention Type OTHER

Later colonoscopy (stratified)

Intervention Type OTHER

"Later" appointments: 10:30 AM to 4:30 PM.

1) Later colonoscopy; 2) High-dose, split-dose; 3)Low residue

Group Type ACTIVE_COMPARATOR

High volume PEG split-dose

Intervention Type DRUG

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 residue diet

Intervention Type OTHER

Later colonoscopy (stratified)

Intervention Type OTHER

"Later" appointments: 10:30 AM to 4:30 PM.

1) Later colonoscopy; 2) Low volume split-dose; 3)Clear liquid

Group Type ACTIVE_COMPARATOR

Low volume PEG split-dose

Intervention Type DRUG

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.

Clear liquid diet

Intervention Type OTHER

Later colonoscopy (stratified)

Intervention Type OTHER

"Later" appointments: 10:30 AM to 4:30 PM.

1) Later colonoscopy; 2) Low volume split-dose; 3)Low residue

Group Type ACTIVE_COMPARATOR

Low volume PEG split-dose

Intervention Type DRUG

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.

Low residue diet

Intervention Type OTHER

Later colonoscopy (stratified)

Intervention Type OTHER

"Later" appointments: 10:30 AM to 4:30 PM.

1) Later colonoscopy; 2) Low volume day before; 3)Clear liquid

Group Type ACTIVE_COMPARATOR

Low volume PEG non split, same day

Intervention Type DRUG

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 and will drink 2L of preparation the morning of the colonoscopy starting 4 hours prior to the procedure at a rate of 240 mL every 10 minutes, until completed. Use of antacids will not be permitted within one hour of taking Bisacodyl.

Clear liquid diet

Intervention Type OTHER

Later colonoscopy (stratified)

Intervention Type OTHER

"Later" appointments: 10:30 AM to 4:30 PM.

1) Later colonoscopy; 2) Low volume day before; 3)Low residue

Group Type ACTIVE_COMPARATOR

Low volume PEG non split, same day

Intervention Type DRUG

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 and will drink 2L of preparation the morning of the colonoscopy starting 4 hours prior to the procedure at a rate of 240 mL every 10 minutes, until completed. Use of antacids will not be permitted within one hour of taking Bisacodyl.

Low residue diet

Intervention Type OTHER

Later colonoscopy (stratified)

Intervention Type OTHER

"Later" appointments: 10:30 AM to 4:30 PM.

Interventions

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High volume PEG split-dose

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.

Intervention Type DRUG

Low volume PEG split-dose

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.

Intervention Type DRUG

High volume PEG non split, day before

Colyte® or PegLyte® will be provided to the subject who will be asked to drink 4L of preparation starting at 6:00 PM the day before the procedure, at a rate of 240 mL every 10 minutes until completed.

Intervention Type DRUG

Low volume PEG non split, same day

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 and will drink 2L of preparation the morning of the colonoscopy starting 4 hours prior to the procedure at a rate of 240 mL every 10 minutes, until completed. Use of antacids will not be permitted within one hour of taking Bisacodyl.

Intervention Type DRUG

Clear liquid diet

Intervention Type OTHER

Low residue diet

Intervention Type OTHER

Early colonoscopy (stratified)

"Early" appointments: 7:30 AM to 10h30 AM

Intervention Type OTHER

Later colonoscopy (stratified)

"Later" appointments: 10:30 AM to 4:30 PM.

Intervention Type OTHER

Other Intervention Names

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Colyte® or PegLyte® Bi-PegLyte® Colyte® or PegLyte® Bi-PegLyte®

Eligibility Criteria

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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:


* Subject refusal
* Previous bowel preparation in the last 14 days
* Pregnancy or breastfeeding
* Reduced mobility


* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pendopharm

INDUSTRY

Sponsor Role collaborator

Alan Barkun

OTHER

Sponsor Role lead

Responsible Party

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Alan Barkun

Gatroenterologist

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Forzani & MacPhail Colon Cancer Screening Centre

Calgary, Alberta, Canada

Site Status

University of Alberta Hospital

Edmonton, Alberta, Canada

Site Status

St. Paul's Hospital

Vancouver, British Columbia, Canada

Site Status

Health Sciences center and St. Boniface Hospital

Winnipeg, Manitoba, Canada

Site Status

QEII HSC

Halifax, Nova Scotia, Canada

Site Status

Western University

London, Ontario, Canada

Site Status

The Ottawa Hospital

Ottawa, Ontario, Canada

Site Status

CHUM

Montreal, Quebec, Canada

Site Status

McGill University Health Centre

Montreal, Quebec, Canada

Site Status

Hôpital St-Sacrement, CHU de Québec-Université Laval

Québec, , Canada

Site Status

Countries

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Canada

References

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Barkun AN, Martel M, Epstein IL, Halle P, Hilsden RJ, James PD, Rostom A, Sey M, Singh H, Sultanian R, Telford JJ, von Renteln D. The Bowel CLEANsing National Initiative: High-Volume Split-Dose Vs Low-Volume Split-Dose Polyethylene Glycol Preparations: A Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2022 Jun;20(6):e1469-e1477. doi: 10.1016/j.cgh.2021.09.005. Epub 2021 Sep 9.

Reference Type DERIVED
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Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

V2015-001

Identifier Type: -

Identifier Source: org_study_id

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