Clinical trial NCT01454388: A Trial Comparing Breakfast Versus no Breakfast Prior to Colonoscopy
Official title: A Randomized Controlled Trial Comparing Breakfast Versus no Breakfast
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Clinically Indicated Colonoscopy
Lead sponsor: Queen's University
Sponsor class: OTHER
Collaborators: name: Hotel Dieu Hospital
First posted: 2011-10-19
Enrollment: 496
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief 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

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 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

Primary outcomes:
measure: bowel cleansing efficacy
timeFrame: 2 days
Secondary outcomes:
measure: Hunger
timeFrame: day of colonoscopy (day 1)
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Hotel Dieu Hospital
state: Ontario
Study officials:
affiliation: Queen's University
name: Lawrence Hookey, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.