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Trial details imported from

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Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
Tolerability, Efficacy and Mucosal Inflammation Associated With Orally Administered Colon Cleansing for Colonoscopy
Scientific title
A Prospective Audit of Tolerability, Mucosal Cleansing Efficacy and Mucosal Abnormalities Associated With Standard Orally Administered Colon Cleansing Preparations for Colonoscopy
Secondary ID [1] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colonoscopy 0 0
Condition category
Condition code

Study type
Description of intervention(s) / exposure
Treatment: Drugs - Colonlytely
Treatment: Drugs - Picolax/Picoprep
Treatment: Drugs - Fleet

Active Comparator: 1 - PEG (Colonlytely) - 4 litres

Active Comparator: 2 - Picosulphate (Picolax/Picoprep) - 2 sachets

Active Comparator: 3 - Sodium Phosphate (Fleet) - 2 bottles

Treatment: Drugs: Colonlytely
Bowel preparation

Treatment: Drugs: Picolax/Picoprep
Bowel preparation

Treatment: Drugs: Fleet
Bowel preparation

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Primary outcome [1] 0 0
To assess which bowel preparation provides the best colon cleansing using a validated score and is best tolerated by patients.
Timepoint [1] 0 0
At time of colonoscopy
Secondary outcome [1] 0 0
To assess the incidence of mucosal inflammation/ulceration induced by each colon cleansing agent.
Timepoint [1] 0 0
At time of colonscopy

Key inclusion criteria
- All patients who are referred to undergo ambulatory colonoscopy at Kaleeya Hospital
would be entered into the study
Minimum age
18 Years
Maximum age
75 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
- Prior history of inflammatory bowel disease or suspected inflammatory bowel disease,
or patients on current non steroidal antiinflammatory medication (excluding low dose
aspirin). These patients may have mucosal inflammation/ulceration which would prevent
analysis of mucosal abnormalities due to the colon cleansing agent and so would not be

- Patients with heart failure (NYHA >2) or renal failure (GFR<30) (since fluid shifts
associated with sodium phosphate bowel preparation have been reported).

- All patients over the age of 75 due to potential dehydration and hyperphosphatemia
from the bowel preparations.

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people assessing the outcomes
Intervention assignment
Other design features
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Department of Gastroenterology, Fremantle Hospital - Fremantle
Recruitment postcode(s) [1] 0 0
6160 - Fremantle

Funding & Sponsors
Primary sponsor type
Fremantle Hospital and Health Service

Ethics approval
Ethics application status

Brief summary
Colonoscopy is the gold standard investigation for assessing the lining of the colon. Colon
cleansing preparations are required to be taken prior to colonoscopy to provide effective
visualisation and identification of any abnormalities and different types of colon cleansing
preparations exist.

Some colon cleansing preparations have been shown to cause visible changes in the lining of
the bowel which may cause confusion and incorrect diagnoses to be made.

This audit aims to assess the ability of different colon cleansing preparations to clear the
colon of faeces. The tolerability of each will also be assessed, as will any changes in the
lining of the bowel to assess if one type of colon preparation is more likely to cause
visible changes than another.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Ian C Lawrance, MD PhD
Address 0 0
Department of Gastroenterology, Fremantle Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications