A Trial Comparing Breakfast Versus no Breakfast Prior to Colonoscopy

NCT ID: NCT01454388

Last Updated: 2015-12-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 496 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31

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.

Conditions

Clinically Indicated Colonoscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

PEG plus breakfast

patients are allowed to have a low residue breakfast the day prior to colonoscopy

Group Type: ACTIVE_COMPARATOR

breakfast

Intervention Type: OTHER

PEG without breakfast

Group Type: NO_INTERVENTION

No interventions assigned to this group

picosalax plus breakfast

patients are allowed to have a low residue breakfast the day prior to colonoscopy

Group Type: ACTIVE_COMPARATOR

breakfast

Intervention Type: OTHER

picosalax without breakfast

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

breakfast

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hotel Dieu Hospital

OTHER

Sponsor Role: collaborator

Queen's University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Lawrence Hookey

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lawrence Hookey, MD

Role: PRINCIPAL_INVESTIGATOR

Queen's University

Locations

Hotel Dieu Hospital

Kingston, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 26462280 (View on PubMed)

Other Identifiers

breakfast colonoscopy study

Identifier Type: -

Identifier Source: org_study_id