The Bowel CLEAnsing: A National Initiative (B-CLEAN)

Alan Barkun

Status and phase: Completed; Phase 4

Conditions: Subjets Requiring a Colonoscopy

Treatments: Drug: Low volume PEG non split, same day; Drug: Low volume PEG split-dose; Drug: High volume PEG non split, day before; Drug: High volume PEG split-dose; Other: Later colonoscopy (stratified); Other: Low residue diet; Other: Early colonoscopy (stratified); Other: Clear liquid diet

Study type: Interventional

Funder types: Other

Identifiers

NCT02547571

V2015-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,476 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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3,476 participants in 12 patient groups

1) Early colonoscopy; 2) High-dose, split-dose; 3)Clear liquid

Active Comparator group

Treatment:

Drug: High volume PEG split-dose

Other: Early colonoscopy (stratified)

Other: Clear liquid diet

1) Early colonoscopy; 2) High-dose, split-dose; 3)Low residue

Active Comparator group

Treatment:

Other: Low residue diet

Drug: High volume PEG split-dose

Other: Early colonoscopy (stratified)

1) Early colonoscopy; 2) Low volume split-dose; 3)Clear liquid

Active Comparator group

Treatment:

Drug: Low volume PEG split-dose

Other: Early colonoscopy (stratified)

Other: Clear liquid diet

1) Early colonoscopy; 2) Low volume split-dose; 3)Low residue

Active Comparator group

Treatment:

Other: Low residue diet

Drug: Low volume PEG split-dose

Other: Early colonoscopy (stratified)

1) Early colonoscopy; 2) High-dose, day before; 3)Clear liquid

Active Comparator group

Treatment:

Drug: High volume PEG non split, day before

Other: Early colonoscopy (stratified)

Other: Clear liquid diet

1) Early colonoscopy; 2) High-dose, day before; 3)Low residue

Active Comparator group

Treatment:

Other: Low residue diet

Drug: High volume PEG non split, day before

Other: Early colonoscopy (stratified)

1) Later colonoscopy; 2) High-dose, split-dose; 3)Clear liquid

Active Comparator group

Treatment:

Other: Later colonoscopy (stratified)

Drug: High volume PEG split-dose

Other: Clear liquid diet

1) Later colonoscopy; 2) High-dose, split-dose; 3)Low residue

Active Comparator group

Treatment:

Other: Later colonoscopy (stratified)

Other: Low residue diet

Drug: High volume PEG split-dose

1) Later colonoscopy; 2) Low volume split-dose; 3)Clear liquid

Active Comparator group

Treatment:

Other: Later colonoscopy (stratified)

Drug: Low volume PEG split-dose

Other: Clear liquid diet

1) Later colonoscopy; 2) Low volume split-dose; 3)Low residue

Active Comparator group

Treatment:

Other: Later colonoscopy (stratified)

Other: Low residue diet

Drug: Low volume PEG split-dose

1) Later colonoscopy; 2) Low volume day before; 3)Clear liquid

Active Comparator group

Treatment:

Other: Later colonoscopy (stratified)

Other: Clear liquid diet

Drug: Low volume PEG non split, same day

1) Later colonoscopy; 2) Low volume day before; 3)Low residue

Active Comparator group

Treatment:

Other: Later colonoscopy (stratified)

Other: Low residue diet

Drug: Low volume PEG non split, same day