NCT Number: NCT02547571
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Forzani & MacPhail Colon Cancer Screening Centre, Calgary, Alberta, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects are excluded from enrollment into the study if any of the following are present:
General exclusion criteria:
Medical/Endoscopic exclusion criteria:
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: Colyte® or PegLyte®
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: Bi-PegLyte®
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: Colyte® or PegLyte®
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: Bi-PegLyte®
"Early" appointments: 7:30 AM to 10h30 AM
"Later" appointments: 10:30 AM to 4:30 PM.
Time frame: Day of colonoscopy
Time frame: Day of colonoscopy
Time frame: Day of colonoscopy
Time frame: Day of colonoscopy
Time frame: Day of colonoscopy
Time frame: Day of colonoscopy
Time frame: up to 30 days
Time frame: Day of colonoscopy
Time frame: Day of colonoscopy
Time frame: Day of colonoscopy
Time frame: Day of colonoscopy
Time frame: Day of colonoscopy
Time frame: Day of colonoscopy
Alan Barkun
Other
Acronym: B-CLEAN
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
