Trial registered on ANZCTR


Trial ID
ACTRN12612000481875
Ethics application status
Approved
Date submitted
26/04/2012
Date registered
2/05/2012
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.
Scientific title
A low residue diet versus clear fluids prior to colonoscopy. The impact on bowel preparation quality and tolerability.
Secondary ID [1] 280393 0
Nil
Universal Trial Number (UTN)
Trial acronym

Health condition
Health condition(s) or problem(s) studied:
Colonoscopy bowel preparation 286373 0
Condition category
Condition code
Oral and Gastrointestinal 286615 286615 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 284755 0
Other interventions
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
Control group
Active

Outcomes
Primary outcome [1] 287028 0
Successful bowel preparation (cleanliness) as defined by an overall grading of A or B on the Harefield Bowel Cleansing Scale
Timepoint [1] 287028 0
At the time of colonoscopy
Secondary outcome [1] 297235 0
Bowel preparation (cleanliness) by colonic segment as defined by the Harefield Bowel Cleansing Scale
Timepoint [1] 297235 0
At the time of colonoscopy
Secondary outcome [2] 297236 0
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.
Timepoint [2] 297236 0
Questionnaire administered on the day of colonoscopy, prior to the procedure

Food diary completed over the 24 hours prior to the colonoscopy
Secondary outcome [3] 297237 0
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
Timepoint [3] 297237 0
As assessed by the questionnaire administered on the day of colonoscopy, prior to the procedure
Secondary outcome [4] 297238 0
Polyp detection rate/adenoma detection ratio
Timepoint [4] 297238 0
At the time of colonoscopy
Secondary outcome [5] 297239 0
Caecal intubation rate
Timepoint [5] 297239 0
At the time of colonoscopy
Secondary outcome [6] 297240 0
Time to complete colonoscopy
Timepoint [6] 297240 0
At the time of colonoscopy
Secondary outcome [7] 297241 0
Bowel preparation (cleanliness) as defined by the Harefield Bowel Cleansing Scale for Morning versus Afternoon procedures
Timepoint [7] 297241 0
At the time of colonoscopy

Eligibility
Key inclusion criteria
participants who are undergoing outpatient colonoscopy for clinically accepted indications
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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).

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
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
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation in permuted blocks
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy

Recruitment
Anticipated date of first participant enrolment
30/07/2012
Actual date of first participant enrolment
Anticipated date last participant enrolled
Actual date last participant enrolled
Anticipated date of last data collection
Actual date of last data collection
Target sample size
250
Actual sample size
Recruitment status
Recruiting
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285162 0
Commercial sector/Industry
Name [1] 285162 0
Norgine Pharmaceuticals
Address [1] 285162 0
3/14 Rodborough Road
Frenchs Forest
NSW 2086
Country [1] 285162 0
Australia
Primary sponsor type
Individual
Name
Dr Gregor Brown
Address
Head of Endoscopy
Department of Gastroenterology
The Alfred Hospital
Level 4
55 Commercial Road
Prahran
VIC 3181
Country
Australia
Secondary sponsor category [1] 284029 0
Individual
Name [1] 284029 0
Dr Joshua Butt
Address [1] 284029 0
Endoscopy Fellow
The Department of Gastroenterology
The Alfred Hospital
Level 4
55 Commercial Road
Prahran
VIC 3181
Country [1] 284029 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287175 0
Alfred Health Human Ethics Committee
Ethics committee address [1] 287175 0
The Office of Research and Ethics Governance
Ground Floor, Linlay Pavillion
The Alfred Hospital
55 Commercial Rd,
Prahran
VIC 3181
Ethics committee country [1] 287175 0
Australia
Date submitted for ethics approval [1] 287175 0
23/02/2012
Approval date [1] 287175 0
30/04/2012
Ethics approval number [1] 287175 0
45-12

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34112 0
Address 34112 0
Country 34112 0
Phone 34112 0
Fax 34112 0
Email 34112 0
Contact person for public queries
Name 17359 0
Dr Joshua Butt
Address 17359 0
Endoscopy Fellow
Department of Gastroenterology
The Alfred Hospital
55 Commercial Rd
Prahran
VIC 3181
Country 17359 0
Australia
Phone 17359 0
+61 3 92762000
Fax 17359 0
Email 17359 0
j.butt@alfred.org.au
Contact person for scientific queries
Name 8287 0
Dr Gregor Brown
Address 8287 0
Head of Endoscopy
Department of Gastroenterology
The Alfred Hospital
55 Commercial Rd
Prahran
VIC 3181
Country 8287 0
Australia
Phone 8287 0
+61 3 90763375
Fax 8287 0
Email 8287 0
g.brown@alfred.org.au