Tolerability, Efficacy and Mucosal Inflammation Associated With Orally Administered Colon Cleansing for Colonoscopy - Full Text View

Purpose

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.

Condition	Intervention	Phase
Colonoscopy	Drug: Colonlytely Drug: Picolax/Picoprep Drug: Fleet	Phase IV

ChemIDplus related topics:

Sodium phosphate, dibasic Picosulfate sodium Pramocaine Pramoxine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	A Prospective Audit of Tolerability, Mucosal Cleansing Efficacy and Mucosal Abnormalities Associated With Standard Orally Administered Colon Cleansing Preparations for Colonoscopy

Further study details as provided by Fremantle Hospital and Health Service:

Primary Outcome Measures:

To assess which bowel preparation provides the best colon cleansing using a validated score and is best tolerated by patients. [ Time Frame: At time of colonoscopy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess the incidence of mucosal inflammation/ulceration induced by each colon cleansing agent. [ Time Frame: At time of colonscopy ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	800
Study Start Date:	January 2008
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator PEG (Colonlytely) - 4 litres	Drug: Colonlytely Bowel preparation
2: Active Comparator Picosulphate (Picolax/Picoprep) - 2 sachets	Drug: Picolax/Picoprep Bowel preparation
3: Active Comparator Sodium Phosphate (Fleet) - 2 bottles	Drug: Fleet Bowel preparation

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Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

All patients who are referred to undergo ambulatory colonoscopy at Kaleeya Hospital would be entered into the study

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00750763

Contacts


Contact: Ian C Lawrance, MD Phd	618 9431 3333	Ian.Lawrance@uwa.edu.au

Locations


Australia, Western Australia
	Department of Gastroenterology, Fremantle Hospital	Recruiting
	Fremantle, Western Australia, Australia, 6160
	Contact: Ian C Lawrance, MD PhD 618 9431 3333 ian.lawrance@uwa.edu.au
	Contact: Jillian Philpott 618 9431 3333 Jillian.Philpott@health.wa.gov.au
	Principal Investigator: Ian C Lawrance, MD PhD
	Sub-Investigator: Robert Willert, MBChB PhD
	Sub-Investigator: Andre Chong, MD
	Sub-Investigator: Callum Pearce, MB MD
	Sub-Investigator: Koya Ayonrinde, MD

Sponsors and Collaborators

Fremantle Hospital and Health Service

Investigators


Principal Investigator:	Ian C Lawrance, MD PhD	Department of Gastroenterology, Fremantle Hospital

More Information

Responsible Party:	Department of Gastroenterology, Fremantle Hospital ( A/Prof Ian C Lawrance )
Study ID Numbers:	FHHS
First Received:	September 10, 2008
Last Updated:	September 11, 2008
ClinicalTrials.gov Identifier:	NCT00750763
Health Authority:	Australia: Human Research Ethics Committee

Keywords provided by Fremantle Hospital and Health Service:

Mucosal inflammation

Fleet

Picoprep

Colonlytely

Colonoscopy

tolerability

efficacy

Study placed in the following topic categories:

Mouth Diseases

Sodium phosphate

Digestive System Diseases

Mucositis

Gastrointestinal Diseases

Picosulfate sodium

Stomatognathic Diseases

Gastroenteritis

Congenital Abnormalities

Inflammation

Additional relevant MeSH terms:

Therapeutic Uses

Gastrointestinal Agents

Cathartics

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 06, 2008

Sponsored by:	Fremantle Hospital and Health Service
Information provided by:	Fremantle Hospital and Health Service
ClinicalTrials.gov Identifier:	NCT00750763