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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00750763




Registration number
NCT00750763
Ethics application status
Date submitted
10/09/2008
Date registered
11/09/2008
Date last updated
25/08/2009

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
FHHS
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

Intervention/exposure
Study type
Interventional
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

Outcomes
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

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
Yes
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 studied.
* 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
Diagnosis
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
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2008
Sample size
Target
Accrual to date
Final
676
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Department of Gastroenterology, Fremantle Hospital - Fremantle
Recruitment postcode(s) [1] 0 0
6160 - Fremantle

Funding & Sponsors
Primary sponsor type
Other
Name
Fremantle Hospital and Health Service
Address
Country

Ethics approval
Ethics application status

Summary
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
https://clinicaltrials.gov/study/NCT00750763
Trial related presentations / publications
Lawrance IC, Willert RP, Murray K. A validated bowel-preparation tolerability questionnaire and assessment of three commonly used bowel-cleansing agents. Dig Dis Sci. 2013 Apr;58(4):926-35. doi: 10.1007/s10620-012-2449-0. Epub 2012 Oct 25.
Lawrance IC, Willert RP, Murray K. Bowel cleansing for colonoscopy: prospective randomized assessment of efficacy and of induced mucosal abnormality with three preparation agents. Endoscopy. 2011 May;43(5):412-8. doi: 10.1055/s-0030-1256193. Epub 2011 May 4.
Public notes

Contacts
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00750763