Clinical trial NCT02547571: The Bowel CLEAnsing: A National Initiative
Official title: The Bowel CLEAnsing: A National Initiative
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Subjets Requiring a Colonoscopy
Keywords: Outpatient
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: Pendopharm
First posted: 2015-09-11
Enrollment: 3476
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Bowel cleansing according to the Boston Scale
timeFrame: Day of colonoscopy
Secondary outcomes:
measure: Subject willingness to repeat the preparation (survey)
timeFrame: Day of colonoscopy
measure: Withdrawal time and total procedural time
timeFrame: Day of colonoscopy
measure: Cecal or ileal intubation rate for colonoscopies
timeFrame: Day of colonoscopy
measure: Polyp detection and polypectomy rate
timeFrame: Day of colonoscopy
measure: Right colon polyp detection rate
timeFrame: Day of colonoscopy
measure: Specific lesional rates identified according to pathology
timeFrame: up to 30 days
measure: % of preparation taken by the subject
timeFrame: Day of colonoscopy
measure: Subject travel time to endoscopy unit (hrs)
timeFrame: Day of colonoscopy
measure: Incontinence
timeFrame: Day of colonoscopy
measure: Fecal Immunochemical Test value
timeFrame: Day of colonoscopy
measure: Montreal score compared to BBPS
timeFrame: Day of colonoscopy
measure: Ottawa Bowel Preparation Scores compared to BBPS
timeFrame: Day of colonoscopy
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Forzani & MacPhail Colon Cancer Screening Centre
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
city: Winnipeg
country: Canada
facility: Health Sciences center and St. Boniface Hospital
state: Manitoba
city: Halifax
country: Canada
facility: QEII HSC
state: Nova Scotia
city: London
country: Canada
facility: Western University
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Montreal
country: Canada
facility: CHUM
state: Quebec
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
city: Québec
country: Canada
facility: Hôpital St-Sacrement, CHU de Québec-Université Laval
Study officials:
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