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Trial registered on ANZCTR
Registration number
ACTRN12612000481875
Ethics application status
Approved
Date submitted
26/04/2012
Date registered
2/05/2012
Date last updated
30/07/2012
Type of registration
Prospectively registered
Titles & IDs
Public title
A low residue diet versus clear fluids prior to colonoscopy. The impact on bowel preparation quality and tolerability.
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Scientific title
A low residue diet versus clear fluids prior to colonoscopy. The impact on bowel preparation quality and tolerability.
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Secondary ID [1]
280393
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Colonoscopy bowel preparation
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Condition category
Condition code
Oral and Gastrointestinal
286615
286615
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Low residue diet on the day prior to colonoscopy
This commences at breakfast on the day prior to colonoscopy
A low residue diet is one that contains few indigestible components. Foods allowed include such thing as cheese, white bread, pasta and vanilla ice cream among others
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Intervention code [1]
284755
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Other interventions
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Comparator / control treatment
Clear fluid diet on the day prior to colonoscopy
This commences on the day prior to colonoscopy after 7am (A light breakfast is allowed before 7 am).
Clear fluids allowed include such fluids as water, lemonade, apple juice and clear soup broth
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Control group
Active
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Outcomes
Primary outcome [1]
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Successful bowel preparation (cleanliness) as defined by an overall grading of A or B on the Harefield Bowel Cleansing Scale
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Assessment method [1]
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Timepoint [1]
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At the time of colonoscopy
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Secondary outcome [1]
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Bowel preparation (cleanliness) by colonic segment as defined by the Harefield Bowel Cleansing Scale
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Assessment method [1]
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Timepoint [1]
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At the time of colonoscopy
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Secondary outcome [2]
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Tolerance, acceptance and compliance with the dietary regimen and bowel preparation regimen as assessed by a questionairre and food diary. The questionnaire contains questions about compliance with the bowel preparation regimen, medication use and some co-morbid conditions. It also contains questions with visual analogue scale responses in order to assess tolerance to the bowel preparation regimen. It has not previously been validated.
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Assessment method [2]
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Timepoint [2]
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Questionnaire administered on the day of colonoscopy, prior to the procedure
Food diary completed over the 24 hours prior to the colonoscopy
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Secondary outcome [3]
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Factors other than dietary allocation that affect bowel preparation quality such as a history of constipation, laxative use, opioid use, body mass index, diagnosis of diabetes mellitus
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Assessment method [3]
297237
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Timepoint [3]
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As assessed by the questionnaire administered on the day of colonoscopy, prior to the procedure
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Secondary outcome [4]
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Polyp detection rate/adenoma detection ratio
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Assessment method [4]
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Timepoint [4]
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At the time of colonoscopy
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Secondary outcome [5]
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Caecal intubation rate
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Assessment method [5]
297239
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Timepoint [5]
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At the time of colonoscopy
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Secondary outcome [6]
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Time to complete colonoscopy
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Assessment method [6]
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Timepoint [6]
297240
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At the time of colonoscopy
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Secondary outcome [7]
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Bowel preparation (cleanliness) as defined by the Harefield Bowel Cleansing Scale for Morning versus Afternoon procedures
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Assessment method [7]
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Timepoint [7]
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At the time of colonoscopy
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Eligibility
Key inclusion criteria
participants who are undergoing outpatient colonoscopy for clinically accepted indications
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Conditions generally considered as exclusions to colonoscopy in normal clinical practice. They are suspected bowel perforation, gastric outlet obstruction, toxic megacolon, severe colitis, and pregnancy or lactation.
Significant renal failure (eGFR<30) or significant heart failure (New York Heart Association Class III or IV).
History of phenylketonuria (PKU) or Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency and any person with a known hypersensitivity to a constituent of Movicol (Registered Trademark).
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Persons who require an outpatient colonoscopy will be invited to participate. Participants will be randomly allocated to one of the dietary regimens on a 1:1 basis. This will be done via the opening of a sealed opaque envelope at the time that the colonoscopy is booked to an endosocopy list
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation in permuted blocks
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
30/07/2012
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
250
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Norgine Pharmaceuticals
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Address [1]
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3/14 Rodborough Road
Frenchs Forest
NSW 2086
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Country [1]
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Australia
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Primary sponsor type
Individual
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Name
Dr Gregor Brown
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Address
Head of Endoscopy
Department of Gastroenterology
The Alfred Hospital
Level 4
55 Commercial Road
Prahran
VIC 3181
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Country
Australia
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Secondary sponsor category [1]
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Individual
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Name [1]
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Dr Joshua Butt
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Address [1]
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Endoscopy Fellow
The Department of Gastroenterology
The Alfred Hospital
Level 4
55 Commercial Road
Prahran
VIC 3181
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Country [1]
284029
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Alfred Health Human Ethics Committee
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Ethics committee address [1]
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The Office of Research and Ethics Governance
Ground Floor, Linlay Pavillion
The Alfred Hospital
55 Commercial Rd,
Prahran
VIC 3181
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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23/02/2012
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Approval date [1]
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30/04/2012
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Ethics approval number [1]
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45-12
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Summary
Brief summary
For a successful colonoscopy, good views of the bowel lining are essential. Ideally, a bowel cleansing preparation should be effective at cleaning out the bowel but should also be well tolerated with minimal abdominal discomfort, nausea or other adverse symptoms.
Historically, oral intake on the day prior to colonoscopy has been limited to clear fluids alone - without food. Rather than a restriction to clear fluids, a low-residue diet may also result in good quality bowel preparation.
This research project is aiming to determine whether there is any difference in the bowel cleansing quality or how well it is tolerated (such as the degree of hunger, nausea, interference with daily activities) between a standard dietary restriction to clear fluids and a low-residue diet (one that contains few indigestible components) on the day prior to colonoscopy.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Dr Joshua Butt
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Address
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Endoscopy Fellow
Department of Gastroenterology
The Alfred Hospital
55 Commercial Rd
Prahran
VIC 3181
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Country
17359
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Australia
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Phone
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+61 3 92762000
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Fax
17359
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Gregor Brown
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Address
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Head of Endoscopy
Department of Gastroenterology
The Alfred Hospital
55 Commercial Rd
Prahran
VIC 3181
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Country
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Australia
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Phone
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+61 3 90763375
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Fax
8287
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Email
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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