A Trial Comparing Breakfast Versus no Breakfast Prior to Colonoscopy

A Randomized Controlled Trial Comparing Breakfast Versus no Breakfast

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

Study Overview

• Status: Completed
• Conditions: Clinically Indicated Colonoscopy
• Intervention / Treatment: Other: 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.

• Study Type: Interventional
• Enrollment (Actual): 496
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Kingston, Ontario, Canada, K7L 5G2
      • Hotel Dieu Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
bowel cleansing efficacy	Quality of bowel cleansing as measured by Ottawa Bowel Scale	2 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hunger	Using a tolerance scale and VAS hunger will be assessed	day of colonoscopy (day 1)

Collaborators and Investigators

• Sponsor: Queen's University
• Collaborators: Hotel Dieu Hospital

Publications and helpful links

General Publications

• Flemming JA, Green J, Melicharkova A, Vanner S, Hookey L. Low-residue breakfast during the preparation for colonoscopy using a polyethylene glycol electrolyte solution: a randomised non-inferiority trial. BMJ Open Gastroenterol. 2015 May 28;2(1):e000029. doi: 10.1136/bmjgast-2015-000029. eCollection 2015.

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: October 12, 2011
• First Submitted That Met QC Criteria: October 18, 2011
• First Posted (Estimate): October 19, 2011

Study Record Updates

• Last Update Posted (Estimate): December 17, 2015
• Last Update Submitted That Met QC Criteria: December 16, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: breakfast colonoscopy study