Status:
COMPLETED
Tolerability, Efficacy and Mucosal Inflammation Associated With Orally Administered Colon Cleansing for Colonoscopy
Lead Sponsor:
Fremantle Hospital and Health Service
Conditions:
Colonoscopy
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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 ...
Detailed Description
There are several published trials of different colon cleansing agents for colonoscopy (which is the investigation of choice for visualisation of the colonic mucosa) which compare different regimens. ...
Eligibility Criteria
Inclusion
- All patients who are referred to undergo ambulatory colonoscopy at Kaleeya Hospital would be entered into the study
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
676 Patients enrolled
Trial Details
Trial ID
NCT00750763
Start Date
January 1 2008
End Date
December 1 2008
Last Update
August 25 2009
Active Locations (1)
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1
Department of Gastroenterology, Fremantle Hospital
Fremantle, Western Australia, Australia, 6160