The Bowel CLEAnsing: A National Initiative

Phase 4

Completed

• Conditions: Subjets Requiring a Colonoscopy
• Interventions: Drug: Low volume PEG split-dose; Drug: High volume PEG split-dose; Drug: Low volume PEG non split, same day; Drug: High volume PEG non split, day before; Other: Clear liquid diet; Other: Low residue diet; Other: Later colonoscopy (stratified); Other: Early colonoscopy (stratified)

• Registration Number: NCT02547571
• Lead Sponsor: Alan Barkun

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.

Study Timeline

• Study First Submitted: 2015-09-01
• Study First Submitted QC: 2015-09-09
• Study First Posted: 2015-09-11
• Study Start: 2016-03
• Status Verified: 2018-09
• Primary Completion: 2018-09
• Study Completion: 2018-09
• Last Update Submitted: 2018-09-12
• Last Update Posted: 2018-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3476

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1) Later colonoscopy; 2) High-dose, split-dose; 3)Clear liquid	Later colonoscopy (stratified)	-
1) Early colonoscopy; 2) Low volume split-dose; 3)Clear liquid	Low volume PEG split-dose	-
1) Early colonoscopy; 2) Low volume split-dose; 3)Clear liquid	Early colonoscopy (stratified)	-
1) Later colonoscopy; 2) High-dose, split-dose; 3)Clear liquid	High volume PEG split-dose	-
1) Later colonoscopy; 2) High-dose, split-dose; 3)Clear liquid	Clear liquid diet	-
1) Later colonoscopy; 2) High-dose, split-dose; 3)Low residue	Low residue diet	-
1) Early colonoscopy; 2) High-dose, split-dose; 3)Clear liquid	Clear liquid diet	-
1) Early colonoscopy; 2) High-dose, split-dose; 3)Low residue	High volume PEG split-dose	-
1) Early colonoscopy; 2) Low volume split-dose; 3)Low residue	Low residue diet	-
1) Later colonoscopy; 2) Low volume split-dose; 3)Clear liquid	Clear liquid diet	-
1) Later colonoscopy; 2) Low volume day before; 3)Clear liquid	Low volume PEG non split, same day	-
1) Early colonoscopy; 2) High-dose, split-dose; 3)Clear liquid	High volume PEG split-dose	-
1) Early colonoscopy; 2) High-dose, split-dose; 3)Low residue	Low residue diet	-
1) Early colonoscopy; 2) Low volume split-dose; 3)Low residue	Low volume PEG split-dose	-
1) Early colonoscopy; 2) High-dose, day before; 3)Clear liquid	Early colonoscopy (stratified)	-
1) Early colonoscopy; 2) Low volume split-dose; 3)Low residue	Early colonoscopy (stratified)	-
1) Early colonoscopy; 2) High-dose, day before; 3)Low residue	High volume PEG non split, day before	-
1) Early colonoscopy; 2) High-dose, day before; 3)Low residue	Early colonoscopy (stratified)	-
1) Later colonoscopy; 2) Low volume split-dose; 3)Low residue	Later colonoscopy (stratified)	-
1) Later colonoscopy; 2) Low volume day before; 3)Low residue	Low residue diet	-
1) Early colonoscopy; 2) High-dose, split-dose; 3)Clear liquid	Early colonoscopy (stratified)	-
1) Early colonoscopy; 2) High-dose, split-dose; 3)Low residue	Early colonoscopy (stratified)	-
1) Early colonoscopy; 2) Low volume split-dose; 3)Clear liquid	Clear liquid diet	-
1) Early colonoscopy; 2) High-dose, day before; 3)Clear liquid	High volume PEG non split, day before	-
1) Early colonoscopy; 2) High-dose, day before; 3)Clear liquid	Clear liquid diet	-
1) Early colonoscopy; 2) High-dose, day before; 3)Low residue	Low residue diet	-
1) Later colonoscopy; 2) High-dose, split-dose; 3)Low residue	Later colonoscopy (stratified)	-
1) Later colonoscopy; 2) Low volume split-dose; 3)Low residue	Low residue diet	-
1) Later colonoscopy; 2) Low volume day before; 3)Clear liquid	Clear liquid diet	-
1) Later colonoscopy; 2) Low volume day before; 3)Clear liquid	Later colonoscopy (stratified)	-
1) Later colonoscopy; 2) Low volume day before; 3)Low residue	Low volume PEG non split, same day	-
1) Later colonoscopy; 2) High-dose, split-dose; 3)Low residue	High volume PEG split-dose	-
1) Later colonoscopy; 2) Low volume split-dose; 3)Clear liquid	Later colonoscopy (stratified)	-
1) Later colonoscopy; 2) Low volume day before; 3)Low residue	Later colonoscopy (stratified)	-
1) Later colonoscopy; 2) Low volume split-dose; 3)Clear liquid	Low volume PEG split-dose	-
1) Later colonoscopy; 2) Low volume split-dose; 3)Low residue	Low volume PEG split-dose	-

Primary Outcome Measures

Name	Time	Method
Bowel cleansing according to the Boston Scale	Day of colonoscopy

Secondary Outcome Measures

Name	Time	Method
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
Montreal score compared to BBPS	Day of colonoscopy
Ottawa Bowel Preparation Scores compared to BBPS	Day of colonoscopy
Fecal Immunochemical Test value	Day of colonoscopy

Trial Locations

Locations (10)

University of Alberta Hospital; 🇨🇦 Edmonton, Alberta, Canada

St. Paul's Hospital; 🇨🇦 Vancouver, British Columbia, Canada

CHUM; 🇨🇦 Montreal, Quebec, Canada

McGill University Health Centre; 🇨🇦 Montreal, Quebec, Canada

Western University; 🇨🇦 London, Ontario, Canada

The Ottawa Hospital; 🇨🇦 Ottawa, Ontario, Canada

Health Sciences center and St. Boniface Hospital; 🇨🇦 Winnipeg, Manitoba, Canada

Forzani & MacPhail Colon Cancer Screening Centre; 🇨🇦 Calgary, Alberta, Canada

Hôpital St-Sacrement, CHU de Québec-Université Laval; 🇨🇦 Québec, Canada

QEII HSC; 🇨🇦 Halifax, Nova Scotia, Canada