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The Bowel CLEAnsing: A National Initiative (B-CLEAN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02547571
Recruitment Status : Completed
First Posted : September 11, 2015
Last Update Posted : September 13, 2018
Sponsor:
Collaborator:
Pendopharm
Information provided by (Responsible Party):
Alan Barkun, McGill University Health Centre/Research Institute of the McGill University Health Centre

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Subjets Requiring a Colonoscopy Drug: High volume PEG split-dose Drug: Low volume PEG split-dose Drug: High volume PEG non split, day before Drug: Low volume PEG non split, same day Other: Clear liquid diet Other: Low residue diet Other: Early colonoscopy (stratified) Other: Later colonoscopy (stratified) Phase 4

Detailed Description:
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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3476 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: The Bowel CLEAnsing: A National Initiative
Study Start Date : March 2016
Actual Primary Completion Date : September 2018
Actual Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arm Intervention/treatment
Active Comparator: 1) Early colonoscopy; 2) High-dose, split-dose; 3)Clear liquid Drug: 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.
Other Name: Colyte® or PegLyte®

Other: Clear liquid diet
Other: Early colonoscopy (stratified)
"Early" appointments: 7:30 AM to 10h30 AM

Active Comparator: 1) Early colonoscopy; 2) High-dose, split-dose; 3)Low residue Drug: 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.
Other Name: Colyte® or PegLyte®

Other: Low residue diet
Other: Early colonoscopy (stratified)
"Early" appointments: 7:30 AM to 10h30 AM

Active Comparator: 1) Early colonoscopy; 2) Low volume split-dose; 3)Clear liquid 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.
Other Name: Bi-PegLyte®

Other: Clear liquid diet
Other: Early colonoscopy (stratified)
"Early" appointments: 7:30 AM to 10h30 AM

Active Comparator: 1) Early colonoscopy; 2) Low volume split-dose; 3)Low residue 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.
Other Name: Bi-PegLyte®

Other: Low residue diet
Other: Early colonoscopy (stratified)
"Early" appointments: 7:30 AM to 10h30 AM

Active Comparator: 1) Early colonoscopy; 2) High-dose, day before; 3)Clear liquid 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.
Other Name: Colyte® or PegLyte®

Other: Clear liquid diet
Other: Early colonoscopy (stratified)
"Early" appointments: 7:30 AM to 10h30 AM

Active Comparator: 1) Early colonoscopy; 2) High-dose, day before; 3)Low residue 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.
Other Name: Colyte® or PegLyte®

Other: Low residue diet
Other: Early colonoscopy (stratified)
"Early" appointments: 7:30 AM to 10h30 AM

Active Comparator: 1) Later colonoscopy; 2) High-dose, split-dose; 3)Clear liquid Drug: 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.
Other Name: Colyte® or PegLyte®

Other: Clear liquid diet
Other: Later colonoscopy (stratified)
"Later" appointments: 10:30 AM to 4:30 PM.

Active Comparator: 1) Later colonoscopy; 2) High-dose, split-dose; 3)Low residue Drug: 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.
Other Name: Colyte® or PegLyte®

Other: Low residue diet
Other: Later colonoscopy (stratified)
"Later" appointments: 10:30 AM to 4:30 PM.

Active Comparator: 1) Later colonoscopy; 2) Low volume split-dose; 3)Clear liquid 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.
Other Name: Bi-PegLyte®

Other: Clear liquid diet
Other: Later colonoscopy (stratified)
"Later" appointments: 10:30 AM to 4:30 PM.

Active Comparator: 1) Later colonoscopy; 2) Low volume split-dose; 3)Low residue 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.
Other Name: Bi-PegLyte®

Other: Low residue diet
Other: Later colonoscopy (stratified)
"Later" appointments: 10:30 AM to 4:30 PM.

Active Comparator: 1) Later colonoscopy; 2) Low volume day before; 3)Clear liquid 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.
Other Name: Bi-PegLyte®

Other: Clear liquid diet
Other: Later colonoscopy (stratified)
"Later" appointments: 10:30 AM to 4:30 PM.

Active Comparator: 1) Later colonoscopy; 2) Low volume day before; 3)Low residue 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.
Other Name: Bi-PegLyte®

Other: Low residue diet
Other: Later colonoscopy (stratified)
"Later" appointments: 10:30 AM to 4:30 PM.




Primary Outcome Measures :
  1. Bowel cleansing according to the Boston Scale [ Time Frame: Day of colonoscopy ]

Secondary Outcome Measures :
  1. Subject willingness to repeat the preparation (survey) [ Time Frame: Day of colonoscopy ]
  2. Withdrawal time and total procedural time [ Time Frame: Day of colonoscopy ]
  3. Cecal or ileal intubation rate for colonoscopies [ Time Frame: Day of colonoscopy ]
  4. Polyp detection and polypectomy rate [ Time Frame: Day of colonoscopy ]
  5. Right colon polyp detection rate [ Time Frame: Day of colonoscopy ]
  6. Specific lesional rates identified according to pathology [ Time Frame: up to 30 days ]
  7. % of preparation taken by the subject [ Time Frame: Day of colonoscopy ]
  8. Subject travel time to endoscopy unit (hrs) [ Time Frame: Day of colonoscopy ]
  9. Incontinence [ Time Frame: Day of colonoscopy ]
  10. Fecal Immunochemical Test value [ Time Frame: Day of colonoscopy ]
  11. Montreal score compared to BBPS [ Time Frame: Day of colonoscopy ]
  12. Ottawa Bowel Preparation Scores compared to BBPS [ Time Frame: Day of colonoscopy ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02547571


Locations
Layout table for location information
Canada, Alberta
Forzani & MacPhail Colon Cancer Screening Centre
Calgary, Alberta, Canada, T2N 4Z6
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2X8
Canada, British Columbia
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 2K5
Canada, Manitoba
Health Sciences center and St. Boniface Hospital
Winnipeg, Manitoba, Canada, R2H 2A6
Canada, Nova Scotia
QEII HSC
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
Western University
London, Ontario, Canada, N6A 5W9
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 1A2
Canada, Quebec
CHUM
Montreal, Quebec, Canada, H2W 2J3
McGill University Health Centre
Montreal, Quebec, Canada, H3G 1A4
Canada
Hôpital St-Sacrement, CHU de Québec-Université Laval
Québec, Canada, G1S 4L8
Sponsors and Collaborators
Alan Barkun
Pendopharm

Publications of Results:

Layout table for additonal information
Responsible Party: Alan Barkun, Gatroenterologist, McGill University Health Centre/Research Institute of the McGill University Health Centre
ClinicalTrials.gov Identifier: NCT02547571    
Other Study ID Numbers: V2015-001
First Posted: September 11, 2015    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Alan Barkun, McGill University Health Centre/Research Institute of the McGill University Health Centre:
Outpatient