Trial from ANZCTR


Trial ID ACTRN12612000481875
Trial Status: Registered
Date Submitted: 26/04/2012
Date Registered: 2/05/2012
Prospectively registered

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Public title A low residue diet versus clear fluids prior to colonoscopy. The impact on bowel preparation quality and tolerability.
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format 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 0
Nil
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UTN
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Trial acronym
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Health condition(s) or problem(s) studied:
Colonoscopy bowel preparation 286373 0
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Condition category: Condition code:
Oral and Gastrointestinal Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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286615 286615 0 0

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Descriptions 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:
Other interventions 284755 0
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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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Primary Outcome: Successful bowel preparation (cleanliness) as defined by an overall grading of A or B on the Harefield Bowel Cleansing Scale 287028 0
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Timepoint: At the time of colonoscopy 287028 0
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Secondary Outcome: Bowel preparation (cleanliness) by colonic segment as defined by the Harefield Bowel Cleansing Scale 297235 0
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Timepoint: At the time of colonoscopy 297235 0
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Secondary Outcome: 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. 297236 0
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Timepoint: 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: 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 297237 0
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Timepoint: As assessed by the questionnaire administered on the day of colonoscopy, prior to the procedure 297237 0
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Secondary Outcome: Polyp detection rate/adenoma detection ratio 297238 0
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Timepoint: At the time of colonoscopy 297238 0
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Secondary Outcome: Caecal intubation rate 297239 0
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Timepoint: At the time of colonoscopy 297239 0
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Secondary Outcome: Time to complete colonoscopy 297240 0
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Timepoint: At the time of colonoscopy 297240 0
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Secondary Outcome: Bowel preparation (cleanliness) as defined by the Harefield Bowel Cleansing Scale for Morning versus Afternoon procedures 297241 0
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Timepoint: At the time of colonoscopy 297241 0
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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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Gender Both males and females
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Healthy volunteers? 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 type Interventional
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Purpose of the study Diagnosis
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Allocation to intervention Randomised controlled trial
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Describe the 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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Describe the 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 (choose all that apply)


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Assignment Parallel
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Other design features
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Type of endpoint(s) Efficacy
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Statistical Methods/Analysis
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Phase Not Applicable
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Anticipated date of first participant enrolment 30/07/2012
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Date of first participant enrolment
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Anticipated date last participant recruited/enrolled
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Actual date last participant recruited/enrolled
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Target sample size 250
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Recruitment status Recruiting
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Recruitment in Australia

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Recruitment outside Australia

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Funding Source: Commercial sector/Industry 285162 0
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Name: Norgine Pharmaceuticals 285162 0
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Address: 3/14 Rodborough Road
Frenchs Forest
NSW 2086
285162 0
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Country: Australia 285162 0
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Primary Sponsor 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: Individual 284029 0
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Name: Dr Joshua Butt 284029 0
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Address: Endoscopy Fellow
The Department of Gastroenterology
The Alfred Hospital
Level 4
55 Commercial Road
Prahran
VIC 3181
284029 0
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Country: Australia 284029 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: Alfred Health Human Ethics Committee 287175 0
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Address: The Office of Research and Ethics Governance
Ground Floor, Linlay Pavillion
The Alfred Hospital
55 Commercial Rd,
Prahran
VIC 3181
287175 0
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Country: Australia 287175 0
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Approval Date: 30/04/2012 287175 0
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Submitted Date: 23/02/2012 287175 0
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HREC: 45-12 287175 0
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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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Public Notes
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Principal Investigator
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Contact person for public queries
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Name: Dr Joshua Butt
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Address: Endoscopy Fellow Department of Gastroenterology The Alfred Hospital 55 Commercial Rd Prahran VIC 3181
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Country: Australia
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Tel: +61 3 92762000
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Email: j.butt@alfred.org.au
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Contact person for scientific queries
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Name: Dr Gregor Brown
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Address: Head of Endoscopy Department of Gastroenterology The Alfred Hospital 55 Commercial Rd Prahran VIC 3181
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Country: Australia
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Tel: +61 3 90763375
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Email: g.brown@alfred.org.au
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