A Trial Comparing Breakfast Versus no Breakfast Prior to Colonoscopy

This study has been completed.
Sponsor:
Collaborator:
Gastrointestinal Diseases Research Unit
Information provided by (Responsible Party):
Lawrence Hookey, Queen's University
ClinicalTrials.gov Identifier:
NCT01454388
First received: October 12, 2011
Last updated: June 17, 2013
Last verified: June 2013
  Purpose

In addition to bowel cleansing agents, the current practice of bowel preparation for colonoscopy involves a low residue diet 48 hours prior to and a clear fluid diet the day before the procedure. This study aims to test whether patients who consume a low residue breakfast the day prior to colonoscopy have a difference in the quality of their bowel preparation. Patients requiring outpatient colonoscopies will be asked to participate. They will be randomized to either breakfast or no breakfast the day before the procedure. Colon cleanliness, patient hunger, and tolerance will be assessed.

The investigators hypothesize that there will be no difference in bowel preparation scores and will be better tolerated


Condition Intervention Phase
Clinically Indicated Colonoscopy
Other: breakfast
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: A Randomized Controlled Trial Comparing Breakfast Versus no Breakfast

Resource links provided by NLM:


Further study details as provided by Queen's University:

Primary Outcome Measures:
  • bowel cleansing efficacy [ Time Frame: 2 days ] [ Designated as safety issue: No ]
    Quality of bowel cleansing as measured by Ottawa Bowel Scale


Secondary Outcome Measures:
  • Hunger [ Time Frame: day of colonoscopy (day 1) ] [ Designated as safety issue: No ]
    Using a tolerance scale and VAS hunger will be assessed


Enrollment: 496
Study Start Date: January 2010
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PEG plus breakfast
patients are allowed to have a low residue breakfast the day prior to colonoscopy
Other: breakfast
No Intervention: PEG without breakfast
Active Comparator: picosalax plus breakfast
patients are allowed to have a low residue breakfast the day prior to colonoscopy
Other: breakfast
No Intervention: picosalax without breakfast

Detailed Description:

      Colon cleansing prior to colonoscopy is essential for an adequate examination. Research has shown that preparation prior to colonoscopy remains one of the biggest deterrents for patients considering colon screening (1).

In addition to the bowel cleansing agents another important aspect of the preparation is the diet consumed prior to the procedure. Currently 48 hours prior to colonoscopy patients are asked to consume a low residue diet. The day before the procedure they are switched to a clear fluid only diet which many patients find difficult to follow due to hunger and can lead to non-compliance with the preparation.

There have been no trials to date which have answered the question whether the consumption of breakfast alters colon cleansing with the cleansing agents currently used in Canada. Investigators found that in patients receiving sodium phosphate preparations, a full breakfast or low residue lunch had no effect on colon cleansing scores and improved hunger and energy levels (2). Several studies have looked at the result of low residue diet kits taken the day prior to the procedure and showed no difference in colon cleansing or tolerability compared to the traditional clear fluid regime (3,4).

This study aims to test whether patients who consume a low residue breakfast the day prior to colonoscopy have a difference in the quality of their colon cleansing or tolerability of the preparation compared to those who consume a clear fluid diet. The investigators hypothesize that there will be no difference in bowel preparation scores and will be better tolerated.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients for whom a GI physician has ordered a colonoscopy will be approached for inclusion in the trial

Exclusion Criteria:

  • ileus or bowel obstruction -significant constipation (<3 spontaneous bowel movements/day)- previous colorectal surgery
  • ascites
  • active inflammatory bowel disease
  • pregnancy
  • recent (<6 months) myocardial infarction or unstable angina
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01454388

Locations
Canada, Ontario
Hotel Dieu Hospital
Kingston, Ontario, Canada, K7L 5G2
Sponsors and Collaborators
Queen's University
Gastrointestinal Diseases Research Unit
Investigators
Principal Investigator: Lawrence Hookey, MD Queen's University
  More Information

No publications provided

Responsible Party: Lawrence Hookey, Principal Investigator, Queen's University
ClinicalTrials.gov Identifier: NCT01454388     History of Changes
Other Study ID Numbers: breakfast colonoscopy study
Study First Received: October 12, 2011
Last Updated: June 17, 2013
Health Authority: Canada: Health Canada

ClinicalTrials.gov processed this record on April 23, 2014