Single Dose Versus Split Dose Polyethylene Glycol-based Colonic Lavage for Colonoscopy

NCT01610856 | Completed

• 2 other identifiers: 21972Ethics ID 21972
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

Proper bowel cleansing prior is an essential requirement for the conduct of colonoscopy. However, due to the nature of cleansing process, the ideal bowel cleansing preparation remains elusive. The objective of this study is to compare the efficacy, safety and tolerability of oral polyethylene glycol lavage given either as a single dose or split dose. The study will be a randomized controlled single blind two group study. The primary study outcomes will be the previously validated Ottawa bowel preparation score.

Conditions

Colonoscopy Preparation

Keywords

bowel preparation; bowel purgative; bowel cleansing; colonoscopy

Outcome Measures

Primary Outcomes (1)

• The Ottawa Bowel Preparation Score

  A validated scale. Each of the right, mid and rectosigmoid colon is rated on a 5-point scale (0-4). In addition, a complete 3-point rating for overall colonic fluid is assessed resulting in an overall score range of 0 to 14. An excellent preparation with little fluid would score 0 to 1; a good preparation, 2 to 4; while scores higher than 4 would indicate progressively worsening bowel preparations. A completely unprepared colon would score 11 to 14, depending on the amount of colonic fluid.

  Measured at time of Colonoscopy

Study Arms (2)

PEG - 4 L

EXPERIMENTAL

4 Litres PEG bowel preparation given the day prior to colonoscopy with a clear fluid diet

Drug: Polyethylene Glycol

Split Dose PEG

ACTIVE COMPARATOR

4 Litres of Colyte given as two split doses of 2L each either the day before colonoscopy 8 hours apart in the case of an AM colonoscopy or in the case of an afternoon colonoscopy given 5PM the day before and 6:00AM the day of the colonoscopy

Drug: polyethylene glycol

Interventions

polyethylene glycol DRUG

4 Litres of polyethylene glycol bowel preparation solution

Also known as: co-lyte, Go-lyte, PEG

PEG - 4 L

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• patients with acute coronary syndrome,
• congestive heart failure,
• unstable angina,
• known or suspected renal failure,
• ascites,
• megacolon,
• known or suspected bowel obstruction, or
• other comorbidities that may prevent colonoscopy will be excluded. Patients will also be excluded if they previously had partial or subtotal colectomy or if the colonoscopy is warranted for the evaluation of diarrhea.

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Forzani & MacPhail Colon Cancer Screening Centre

Calgary, Alberta, T2N 4Z6, Canada

Location

Related Publications (1)

• Mohamed R, Hilsden RJ, Dube C, Rostom A. Split-Dose Polyethylene Glycol Is Superior to Single Dose for Colonoscopy Preparation: Results of a Randomized Controlled Trial. Can J Gastroenterol Hepatol. 2016;2016:3181459. doi: 10.1155/2016/3181459. Epub 2016 Apr 13.

  PMID: 27446836 DERIVED

MeSH Terms

Interventions

Polyethylene Glycols

Intervention Hierarchy (Ancestors)

Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Alaa Rostom, MD MSc FRCPC

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD MSc FRCPC

Study Record Dates

• First Submitted: May 30, 2012
• First Posted: June 4, 2012
• Study Start: March 1, 2010
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: June 4, 2012

Record last verified: 2012-05

Locations

CA (1)