A Trial Comparing Breakfast Versus no Breakfast Prior to Colonoscopy

Clinically Indicated Colonoscopy Clinical Trial

Official title:

A Randomized Controlled Trial Comparing Breakfast Versus no Breakfast

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01454388
• Other study ID #: breakfast colonoscopy study
• Status: Completed
• Phase: Phase 4
• First received: October 12, 2011
• Last updated: December 16, 2015
• Start date: January 2010

Study information

• Verified date: December 2015
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 496
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Clinically Indicated Colonoscopy

Intervention

Other:
• breakfast

Locations

Country	Name	City	State
Canada	Hotel Dieu Hospital	Kingston	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Queen's University	Hotel Dieu Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bowel cleansing efficacy	Quality of bowel cleansing as measured by Ottawa Bowel Scale	2 days	No
Secondary	Hunger	Using a tolerance scale and VAS hunger will be assessed	day of colonoscopy (day 1)	No