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Tolerability, Efficacy and Mucosal Inflammation Associated With Orally Administered Colon Cleansing for Colonoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00750763
Recruitment Status : Completed
First Posted : September 11, 2008
Last Update Posted : August 25, 2009
Information provided by:
Fremantle Hospital and Health Service

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.

Condition or disease Intervention/treatment Phase
Colonoscopy Drug: Colonlytely Drug: Picolax/Picoprep Drug: Fleet Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 676 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: A Prospective Audit of Tolerability, Mucosal Cleansing Efficacy and Mucosal Abnormalities Associated With Standard Orally Administered Colon Cleansing Preparations for Colonoscopy
Study Start Date : January 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arm Intervention/treatment
Active Comparator: 1
PEG (Colonlytely) - 4 litres
Drug: Colonlytely
Bowel preparation
Other Name: Polyethylene glycol

Active Comparator: 2
Picosulphate (Picolax/Picoprep) - 2 sachets
Drug: Picolax/Picoprep
Bowel preparation
Other Name: Picosulphate

Active Comparator: 3
Sodium Phosphate (Fleet) - 2 bottles
Drug: Fleet
Bowel preparation
Other Name: Sodium Phosphate

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. To assess the incidence of mucosal inflammation/ulceration induced by each colon cleansing agent. [ Time Frame: At time of colonscopy ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00750763

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Australia, Western Australia
Department of Gastroenterology, Fremantle Hospital
Fremantle, Western Australia, Australia, 6160
Sponsors and Collaborators
Fremantle Hospital and Health Service
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Principal Investigator: Ian C Lawrance, MD PhD Department of Gastroenterology, Fremantle Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: A/Prof Ian C Lawrance, Department of Gastroenterology, Fremantle Hospital Identifier: NCT00750763    
Other Study ID Numbers: FHHS
First Posted: September 11, 2008    Key Record Dates
Last Update Posted: August 25, 2009
Last Verified: August 2009
Keywords provided by Fremantle Hospital and Health Service:
Mucosal inflammation
Additional relevant MeSH terms:
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Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Picosulfate sodium
Gastrointestinal Agents