Tolerability, Efficacy and Mucosal Inflammation Associated With Orally Administered Colon Cleansing for Colonoscopy
This study has been completed.
Sponsor:
Fremantle Hospital and Health Service
Information provided by:
Fremantle Hospital and Health Service
ClinicalTrials.gov Identifier:
NCT00750763
First received: September 10, 2008
Last updated: August 24, 2009
Last verified: August 2009
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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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study 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 ] [ 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 ]
| 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 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
Locations
| Australia, Western Australia | |
| Department of Gastroenterology, Fremantle Hospital | |
| Fremantle, Western Australia, Australia, 6160 | |
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 by Fremantle Hospital and Health Service
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | A/Prof Ian C Lawrance, Department of Gastroenterology, Fremantle Hospital |
| ClinicalTrials.gov Identifier: | NCT00750763 History of Changes |
| Other Study ID Numbers: | FHHS |
| Study First Received: | September 10, 2008 |
| Last Updated: | August 24, 2009 |
| Health Authority: | Australia: Human Research Ethics Committee |
Keywords provided by Fremantle Hospital and Health Service:
|
Mucosal inflammation Fleet Picoprep Colonlytely |
Colonoscopy tolerability efficacy |
Additional relevant MeSH terms:
|
Inflammation Mucositis Pathologic Processes Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Mouth Diseases |
Stomatognathic Diseases Picosulfate sodium Sodium phosphate Cathartics Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013