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

This study has been completed.
Information provided by:
Fremantle Hospital and Health Service Identifier:
First received: September 10, 2008
Last updated: August 24, 2009
Last verified: August 2009

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
Drug: Colonlytely
Drug: Picolax/Picoprep
Drug: Fleet
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:

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 ]

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

Enrollment: 676
Study Start Date: January 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00750763

Australia, Western Australia
Department of Gastroenterology, Fremantle Hospital
Fremantle, Western Australia, Australia, 6160
Sponsors and Collaborators
Fremantle Hospital and Health Service
Principal Investigator: Ian C Lawrance, MD PhD Department of Gastroenterology, Fremantle Hospital
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: A/Prof Ian C Lawrance, Department of Gastroenterology, Fremantle Hospital Identifier: NCT00750763     History of Changes
Other Study ID Numbers: FHHS
Study First Received: September 10, 2008
Last Updated: August 24, 2009

Keywords provided by Fremantle Hospital and Health Service:
Mucosal inflammation

Additional relevant MeSH terms:
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Picosulfate sodium
Gastrointestinal Agents processed this record on April 26, 2017