The Bowel CLEAnsing: A National Initiative

NCT02547571 | Completed Phase 4

• 1 other identifier: V2015-001
• Study Type: interventional
• Target: 3,476
• Locations: 1 country
• Sites: 10

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.

Conditions

Subjets Requiring a Colonoscopy

Keywords

Outpatient

Outcome Measures

Primary Outcomes (1)

• Bowel cleansing according to the Boston Scale

  Day of colonoscopy

Secondary Outcomes (12)

• 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

Study Arms (12)

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

ACTIVE COMPARATOR

Drug: High volume PEG split-dose; Other: Clear liquid diet; Other: Early colonoscopy (stratified)

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

ACTIVE COMPARATOR

Drug: High volume PEG split-dose; Other: Low residue diet; Other: Early colonoscopy (stratified)

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

ACTIVE COMPARATOR

Drug: Low volume PEG split-dose; Other: Clear liquid diet; Other: Early colonoscopy (stratified)

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

ACTIVE COMPARATOR

Drug: Low volume PEG split-dose; Other: Low residue diet; Other: Early colonoscopy (stratified)

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

ACTIVE COMPARATOR

Drug: High volume PEG non split, day before; Other: Clear liquid diet; Other: Early colonoscopy (stratified)

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

ACTIVE COMPARATOR

Drug: High volume PEG non split, day before; Other: Low residue diet; Other: Early colonoscopy (stratified)

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

ACTIVE COMPARATOR

Drug: High volume PEG split-dose; Other: Clear liquid diet; Other: Later colonoscopy (stratified)

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

ACTIVE COMPARATOR

Drug: High volume PEG split-dose; Other: Low residue diet; Other: Later colonoscopy (stratified)

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

ACTIVE COMPARATOR

Drug: Low volume PEG split-dose; Other: Clear liquid diet; Other: Later colonoscopy (stratified)

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

ACTIVE COMPARATOR

Drug: Low volume PEG split-dose; Other: Low residue diet; Other: Later colonoscopy (stratified)

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

ACTIVE COMPARATOR

Drug: Low volume PEG non split, same day; Other: Clear liquid diet; Other: Later colonoscopy (stratified)

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

ACTIVE COMPARATOR

Drug: Low volume PEG non split, same day; Other: Low residue diet; Other: Later colonoscopy (stratified)

Interventions

High volume PEG split-dose DRUG

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.

Also known as: Colyte® or PegLyte®

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

Low volume PEG split-dose DRUG

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.

Also known as: Bi-PegLyte®

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

High volume PEG non split, day before DRUG

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.

Also known as: Colyte® or PegLyte®

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

Low volume PEG non split, same day DRUG

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.

Also known as: Bi-PegLyte®

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

Clear liquid diet OTHER

1) Early colonoscopy; 2) High-dose, day before; 3)Clear liquid; 1) Early colonoscopy; 2) High-dose, split-dose; 3)Clear liquid; 1) Early colonoscopy; 2) Low volume split-dose; 3)Clear liquid; 1) Later colonoscopy; 2) High-dose, split-dose; 3)Clear liquid; 1) Later colonoscopy; 2) Low volume day before; 3)Clear liquid; 1) Later colonoscopy; 2) Low volume split-dose; 3)Clear liquid

Low residue diet OTHER

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

Early colonoscopy (stratified) OTHER

"Early" appointments: 7:30 AM to 10h30 AM

1) Early colonoscopy; 2) High-dose, day before; 3)Clear liquid; 1) Early colonoscopy; 2) High-dose, day before; 3)Low residue; 1) Early colonoscopy; 2) High-dose, split-dose; 3)Clear liquid; 1) Early colonoscopy; 2) High-dose, split-dose; 3)Low residue; 1) Early colonoscopy; 2) Low volume split-dose; 3)Clear liquid; 1) Early colonoscopy; 2) Low volume split-dose; 3)Low residue

Later colonoscopy (stratified) OTHER

"Later" appointments: 10:30 AM to 4:30 PM.

1) Later colonoscopy; 2) High-dose, split-dose; 3)Clear liquid; 1) Later colonoscopy; 2) High-dose, split-dose; 3)Low residue; 1) Later colonoscopy; 2) Low volume day before; 3)Clear liquid; 1) Later colonoscopy; 2) Low volume day before; 3)Low residue; 1) Later colonoscopy; 2) Low volume split-dose; 3)Clear liquid; 1) Later colonoscopy; 2) Low volume split-dose; 3)Low residue

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Outpatients
• years or older
• Able to comprehend the trial
• Have an indication for full colonoscopy

You may not qualify if:

• Subjects are excluded from enrollment into the study if any of the following are present:
• Subject refusal
• Previous bowel preparation in the last 14 days
• Pregnancy or breastfeeding
• Reduced mobility
• 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

Sponsors & Collaborators

• Alan Barkun: lead
• Pendopharm: collaborator

Study Sites (10)

Forzani & MacPhail Colon Cancer Screening Centre

Calgary, Alberta, T2N 4Z6, Canada

Location

University of Alberta Hospital

Edmonton, Alberta, T6G 2X8, Canada

Location

St. Paul's Hospital

Vancouver, British Columbia, V6Z 2K5, Canada

Location

Health Sciences center and St. Boniface Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

QEII HSC

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Western University

London, Ontario, N6A 5W9, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, K1H 1A2, Canada

Location

CHUM

Montreal, Quebec, H2W 2J3, Canada

Location

McGill University Health Centre

Montreal, Quebec, H3G 1A4, Canada

Location

Hôpital St-Sacrement, CHU de Québec-Université Laval

Québec, G1S 4L8, Canada

Location

Related Publications (46)

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• Barkun AN, Martel M, Epstein IL, Halle P, Hilsden RJ, James PD, Rostom A, Sey M, Singh H, Sultanian R, Telford JJ, von Renteln D. The Bowel CLEANsing National Initiative: High-Volume Split-Dose Vs Low-Volume Split-Dose Polyethylene Glycol Preparations: A Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2022 Jun;20(6):e1469-e1477. doi: 10.1016/j.cgh.2021.09.005. Epub 2021 Sep 9.

  PMID: 34509641 DERIVED

MeSH Terms

Interventions

Golytely

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Gatroenterologist

Study Record Dates

• First Submitted: September 1, 2015
• First Posted: September 11, 2015
• Study Start: March 1, 2016
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: September 13, 2018

Record last verified: 2018-09

Locations

CA (10)