A Trial Comparing Breakfast Versus no Breakfast Prior to Colonoscopy
A Randomized Controlled Trial Comparing Breakfast Versus no Breakfast
1 other identifier
interventional
496
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 12, 2011
CompletedFirst Posted
Study publicly available on registry
October 19, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedDecember 17, 2015
December 1, 2015
2.3 years
October 12, 2011
December 16, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
bowel cleansing efficacy
Quality of bowel cleansing as measured by Ottawa Bowel Scale
2 days
Secondary Outcomes (1)
Hunger
day of colonoscopy (day 1)
Study Arms (4)
PEG plus breakfast
ACTIVE COMPARATORpatients are allowed to have a low residue breakfast the day prior to colonoscopy
PEG without breakfast
NO INTERVENTIONpicosalax plus breakfast
ACTIVE COMPARATORpatients are allowed to have a low residue breakfast the day prior to colonoscopy
picosalax without breakfast
NO INTERVENTIONInterventions
Eligibility Criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Queen's Universitylead
- Hotel Dieu Hospitalcollaborator
Study Sites (1)
Hotel Dieu Hospital
Kingston, Ontario, K7L 5G2, Canada
Related Publications (1)
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.
PMID: 26462280DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lawrence Hookey, MD
Queen's University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 12, 2011
First Posted
October 19, 2011
Study Start
January 1, 2010
Primary Completion
May 1, 2012
Last Updated
December 17, 2015
Record last verified: 2015-12