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

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

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

MedlinePlus related topics: Colonoscopy

Drug Information available for: Picosulfate sodium Sodium phosphate, dibasic 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

Show Detailed Description

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

No publications provided

Responsible Party:	Department of Gastroenterology, Fremantle Hospital ( A/Prof Ian C Lawrance )
Study ID Numbers:	FHHS
Study First Received:	September 10, 2008
Last Updated:	September 11, 2008
ClinicalTrials.gov Identifier:	NCT00750763 History of Changes
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
Laxatives
Sodium phosphate
Digestive System Diseases
Mucositis
Gastrointestinal Diseases

Cathartics
Picosulfate sodium
Stomatognathic Diseases
Gastroenteritis
Congenital Abnormalities
Inflammation

Additional relevant MeSH terms:

Mouth Diseases
Sodium phosphate
Digestive System Diseases
Mucositis
Gastrointestinal Diseases
Therapeutic Uses

Gastrointestinal Agents
Cathartics
Stomatognathic Diseases
Gastroenteritis
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009