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Sponsored by: |
Fremantle Hospital and Health Service |
---|---|
Information provided by: | Fremantle Hospital and Health Service |
ClinicalTrials.gov Identifier: | NCT00750763 |
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 |
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 |
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
|
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Ian C Lawrance, MD Phd | 618 9431 3333 | Ian.Lawrance@uwa.edu.au |
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 |
Principal Investigator: | Ian C Lawrance, MD PhD | Department of Gastroenterology, Fremantle Hospital |
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 |
Mucosal inflammation Fleet Picoprep Colonlytely |
Colonoscopy tolerability efficacy |
Mouth Diseases Laxatives Sodium phosphate Digestive System Diseases Mucositis Gastrointestinal Diseases |
Cathartics Picosulfate sodium Stomatognathic Diseases Gastroenteritis Congenital Abnormalities Inflammation |
Mouth Diseases Sodium phosphate Digestive System Diseases Mucositis Gastrointestinal Diseases Therapeutic Uses |
Gastrointestinal Agents Cathartics Stomatognathic Diseases Gastroenteritis Pharmacologic Actions |