The Bowel CLEAnsing: A National Initiative

Study Overview
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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.

Official Title
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The Bowel CLEAnsing: A National Initiative

Conditions
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Subjets Requiring a Colonoscopy

Intervention / Treatment
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* 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)


Participation Criteria
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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: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1) Early colonoscopy; 2) High-dose, split-dose; 3)Clear liquid<br> | Drug: High volume PEG split-dose<br>* 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.<br>* Other names: Colyte® or PegLyte®;Other: Clear liquid diet<br> <br> Other: Early colonoscopy (stratified)<br>* Early appointments: 7:30 AM to 10h30 AM<br>|
| Active Comparator: 1) Early colonoscopy; 2) High-dose, split-dose; 3)Low residue<br> | Drug: High volume PEG split-dose<br>* 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.<br>* Other names: Colyte® or PegLyte®;Other: Low residue diet<br> <br> Other: Early colonoscopy (stratified)<br>* Early appointments: 7:30 AM to 10h30 AM<br>|
| Active Comparator: 1) Early colonoscopy; 2) Low volume split-dose; 3)Clear liquid<br> | Drug: Low volume PEG split-dose<br>* 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.<br>* Other names: Bi-PegLyte®;Other: Clear liquid diet<br> <br> Other: Early colonoscopy (stratified)<br>* Early appointments: 7:30 AM to 10h30 AM<br>|
| Active Comparator: 1) Early colonoscopy; 2) Low volume split-dose; 3)Low residue<br> | Drug: Low volume PEG split-dose<br>* 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.<br>* Other names: Bi-PegLyte®;Other: Low residue diet<br> <br> Other: Early colonoscopy (stratified)<br>* Early appointments: 7:30 AM to 10h30 AM<br>|
| Active Comparator: 1) Early colonoscopy; 2) High-dose, day before; 3)Clear liquid<br> | Drug: High volume PEG non split, day before<br>* 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.<br>* Other names: Colyte® or PegLyte®;Other: Clear liquid diet<br> <br> Other: Early colonoscopy (stratified)<br>* Early appointments: 7:30 AM to 10h30 AM<br>|
| Active Comparator: 1) Early colonoscopy; 2) High-dose, day before; 3)Low residue<br> | Drug: High volume PEG non split, day before<br>* 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.<br>* Other names: Colyte® or PegLyte®;Other: Low residue diet<br> <br> Other: Early colonoscopy (stratified)<br>* Early appointments: 7:30 AM to 10h30 AM<br>|
| Active Comparator: 1) Later colonoscopy; 2) High-dose, split-dose; 3)Clear liquid<br> | Drug: High volume PEG split-dose<br>* 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.<br>* Other names: Colyte® or PegLyte®;Other: Clear liquid diet<br> <br> Other: Later colonoscopy (stratified)<br>* Later appointments: 10:30 AM to 4:30 PM.<br>|
| Active Comparator: 1) Later colonoscopy; 2) High-dose, split-dose; 3)Low residue<br> | Drug: High volume PEG split-dose<br>* 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.<br>* Other names: Colyte® or PegLyte®;Other: Low residue diet<br> <br> Other: Later colonoscopy (stratified)<br>* Later appointments: 10:30 AM to 4:30 PM.<br>|
| Active Comparator: 1) Later colonoscopy; 2) Low volume split-dose; 3)Clear liquid<br> | Drug: Low volume PEG split-dose<br>* 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.<br>* Other names: Bi-PegLyte®;Other: Clear liquid diet<br> <br> Other: Later colonoscopy (stratified)<br>* Later appointments: 10:30 AM to 4:30 PM.<br>|
| Active Comparator: 1) Later colonoscopy; 2) Low volume split-dose; 3)Low residue<br> | Drug: Low volume PEG split-dose<br>* 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.<br>* Other names: Bi-PegLyte®;Other: Low residue diet<br> <br> Other: Later colonoscopy (stratified)<br>* Later appointments: 10:30 AM to 4:30 PM.<br>|
| Active Comparator: 1) Later colonoscopy; 2) Low volume day before; 3)Clear liquid<br> | Drug: Low volume PEG non split, same day<br>* 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.<br>* Other names: Bi-PegLyte®;Other: Clear liquid diet<br> <br> Other: Later colonoscopy (stratified)<br>* Later appointments: 10:30 AM to 4:30 PM.<br>|
| Active Comparator: 1) Later colonoscopy; 2) Low volume day before; 3)Low residue<br> | Drug: Low volume PEG non split, same day<br>* 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.<br>* Other names: Bi-PegLyte®;Other: Low residue diet<br> <br> Other: Later colonoscopy (stratified)<br>* Later appointments: 10:30 AM to 4:30 PM.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bowel cleansing according to the Boston Scale |  | Day of colonoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Outpatient