The Bowel CLEAnsing: A National Initiative

Subjets Requiring a Colonoscopy Clinical Trial

— B-CLEAN  

Official title:

The Bowel CLEAnsing: A National Initiative

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02547571
• Other study ID #: V2015-001
• Status: Completed
• Phase: Phase 4
• Start date: March 2016
• Est. completion date: September 2018

Study information

• Verified date: September 2018
• Source: McGill University Health Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3476
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Subjets Requiring a Colonoscopy

Intervention

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.
• 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.
• 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.
• 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:
• Clear liquid diet

• Low residue diet

• Early colonoscopy (stratified)
"Early" appointments: 7:30 AM to 10h30 AM
• Later colonoscopy (stratified)
"Later" appointments: 10:30 AM to 4:30 PM.

Locations

Country	Name	City	State
Canada	Forzani & MacPhail Colon Cancer Screening Centre	Calgary	Alberta
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	QEII HSC	Halifax	Nova Scotia
Canada	Western University	London	Ontario
Canada	CHUM	Montreal	Quebec
Canada	McGill University Health Centre	Montreal	Quebec
Canada	The Ottawa Hospital	Ottawa	Ontario
Canada	Hôpital St-Sacrement, CHU de Québec-Université Laval	Québec
Canada	St. Paul's Hospital	Vancouver	British Columbia
Canada	Health Sciences center and St. Boniface Hospital	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
Alan Barkun	Pendopharm

Country where clinical trial is conducted

Canada, 

References & Publications (45)

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Johnson DA, Barkun AN, Cohen LB, Dominitz JA, Kaltenbach T, Martel M, Robertson DJ, Boland CR, Giardello FM, Lieberman DA, Levin TR, Rex DK; US Multi-Society Task Force on Colorectal Cancer. Optimizing adequacy of bowel cleansing for colonoscopy: recommen — View Citation

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Marmo R, Rotondano G, Riccio G, Marone A, Bianco MA, Stroppa I, Caruso A, Pandolfo N, Sansone S, Gregorio E, D'Alvano G, Procaccio N, Capo P, Marmo C, Cipolletta L. Effective bowel cleansing before colonoscopy: a randomized study of split-dosage versus no — View Citation

Martel M, Barkun AN, Menard C, Restellini S, Kherad O, Vanasse A. Split-Dose Preparations Are Superior to Day-Before Bowel Cleansing Regimens: A Meta-analysis. Gastroenterology. 2015 Jul;149(1):79-88. doi: 10.1053/j.gastro.2015.04.004. Epub 2015 Apr 8. — View Citation

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* Note: There are 45 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bowel cleansing according to the Boston Scale		Day of colonoscopy
Secondary	Subject willingness to repeat the preparation (survey)		Day of colonoscopy
Secondary	Withdrawal time and total procedural time		Day of colonoscopy
Secondary	Cecal or ileal intubation rate for colonoscopies		Day of colonoscopy
Secondary	Polyp detection and polypectomy rate		Day of colonoscopy
Secondary	Right colon polyp detection rate		Day of colonoscopy
Secondary	Specific lesional rates identified according to pathology		up to 30 days
Secondary	% of preparation taken by the subject		Day of colonoscopy
Secondary	Subject travel time to endoscopy unit (hrs)		Day of colonoscopy
Secondary	Incontinence		Day of colonoscopy
Secondary	Fecal Immunochemical Test value		Day of colonoscopy
Secondary	Montreal score compared to BBPS		Day of colonoscopy
Secondary	Ottawa Bowel Preparation Scores compared to BBPS		Day of colonoscopy