B-CLEAN: The Bowel CLEAnsing: A National Initiative
Study Details
Study Description
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 |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| 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 Names:
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 Names:
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 Names:
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 Names:
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 Names:
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 Names:
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 Names:
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 Names:
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 Names:
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 Names:
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 Names:
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 Names:
Other: Low residue diet
Other: Later colonoscopy (stratified)
"Later" appointments: 10:30 AM to 4:30 PM.
|
Outcome Measures
Primary Outcome Measures
- Bowel cleansing according to the Boston Scale [Day of colonoscopy]
Secondary Outcome Measures
- Subject willingness to repeat the preparation (survey) [Day of colonoscopy]
- Withdrawal time and total procedural time [Day of colonoscopy]
- Cecal or ileal intubation rate for colonoscopies [Day of colonoscopy]
- Polyp detection and polypectomy rate [Day of colonoscopy]
- Right colon polyp detection rate [Day of colonoscopy]
- Specific lesional rates identified according to pathology [up to 30 days]
- % of preparation taken by the subject [Day of colonoscopy]
- Subject travel time to endoscopy unit (hrs) [Day of colonoscopy]
- Incontinence [Day of colonoscopy]
- Fecal Immunochemical Test value [Day of colonoscopy]
- Montreal score compared to BBPS [Day of colonoscopy]
- Ottawa Bowel Preparation Scores compared to BBPS [Day of colonoscopy]
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Forzani & MacPhail Colon Cancer Screening Centre | Calgary | Alberta | Canada | T2N 4Z6 |
| 2 | University of Alberta Hospital | Edmonton | Alberta | Canada | T6G 2X8 |
| 3 | St. Paul's Hospital | Vancouver | British Columbia | Canada | V6Z 2K5 |
| 4 | Health Sciences center and St. Boniface Hospital | Winnipeg | Manitoba | Canada | R2H 2A6 |
| 5 | QEII HSC | Halifax | Nova Scotia | Canada | B3H 2Y9 |
| 6 | Western University | London | Ontario | Canada | N6A 5W9 |
| 7 | The Ottawa Hospital | Ottawa | Ontario | Canada | K1H 1A2 |
| 8 | CHUM | Montreal | Quebec | Canada | H2W 2J3 |
| 9 | McGill University Health Centre | Montreal | Quebec | Canada | H3G 1A4 |
| 10 | Hôpital St-Sacrement, CHU de Québec-Université Laval | Québec | Canada | G1S 4L8 |
Sponsors and Collaborators
- Alan Barkun
- Pendopharm
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- V2015-001