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

This study has been completed.
Sponsor:
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
  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
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, see Learn About Clinical Studies.

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 July 22, 2014