Subjets Requiring a Colonoscopy
Conditions
Keywords
Outpatient
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.
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.
Interventions
DRUGHigh 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.
DRUGLow 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.
DRUGHigh 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.
DRUGLow 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.
OTHERClear liquid diet
OTHERLow residue diet
OTHEREarly colonoscopy (stratified)
Early appointments: 7:30 AM to 10h30 AM
OTHERLater colonoscopy (stratified)
Later appointments: 10:30 AM to 4:30 PM.
Sponsors
Pendopharm
Alan Barkun
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bowel cleansing according to the Boston Scale | Day of colonoscopy |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Subject willingness to repeat the preparation (survey) | 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 |
| % of preparation taken by the subject | Day of colonoscopy |
Countries
Canada
Outcome results
None listed