Completed

NCT Number: NCT01454388

A Trial Comparing Breakfast Versus no Breakfast Prior to Colonoscopy

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

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Key information

Conditions

Clinically Indicated Colonoscopy

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hotel Dieu Hospital

Kingston, Ontario, K7L 5G2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Breakfast

Other

Primary outcomes

bowel cleansing efficacy

Time frame: 2 days

Quality of bowel cleansing as measured by Ottawa Bowel Scale

Secondary outcomes

Hunger

Time frame: day of colonoscopy (day 1)

Using a tolerance scale and VAS hunger will be assessed

Sponsors and collaborators

Lead sponsor

Queen's University

Other

Collaborators

Hotel Dieu Hospital

Registry information

Official study title

A Randomized Controlled Trial Comparing Breakfast Versus no Breakfast

Important dates

Study start: 2010
Primary completion: 2012
First posted: Oct 19, 2011
Registry last updated: Dec 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.