NCT00750763

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
676

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2008

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 11, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

August 25, 2009

Status Verified

August 1, 2009

Enrollment Period

11 months

First QC Date

September 10, 2008

Last Update Submit

August 24, 2009

Conditions

Colonoscopy

Keywords

Mucosal inflammationFleetPicoprepColonlytelyColonoscopytolerabilityefficacy

Outcome Measures

Primary Outcomes (1)

  • To assess which bowel preparation provides the best colon cleansing using a validated score and is best tolerated by patients.

    At time of colonoscopy

Secondary Outcomes (1)

  • To assess the incidence of mucosal inflammation/ulceration induced by each colon cleansing agent.

    At time of colonscopy

Study Arms (3)

1

ACTIVE COMPARATOR

PEG (Colonlytely) - 4 litres

Drug: Colonlytely

2

ACTIVE COMPARATOR

Picosulphate (Picolax/Picoprep) - 2 sachets

Drug: Picolax/Picoprep

3

ACTIVE COMPARATOR

Sodium Phosphate (Fleet) - 2 bottles

Drug: Fleet

Interventions

ColonlytelyDRUG

Bowel preparation

Also known as: Polyethylene glycol
1
Picolax/PicoprepDRUG

Bowel preparation

Also known as: Picosulphate
2
FleetDRUG

Bowel preparation

Also known as: Sodium Phosphate
3

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients who are referred to undergo ambulatory colonoscopy at Kaleeya Hospital would be entered into the study

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastroenterology, Fremantle Hospital

Fremantle, Western Australia, 6160, Australia

Location

Related Publications (2)

  • Lawrance IC, Willert RP, Murray K. A validated bowel-preparation tolerability questionnaire and assessment of three commonly used bowel-cleansing agents. Dig Dis Sci. 2013 Apr;58(4):926-35. doi: 10.1007/s10620-012-2449-0. Epub 2012 Oct 25.

    PMID: 23095990DERIVED

  • Lawrance IC, Willert RP, Murray K. Bowel cleansing for colonoscopy: prospective randomized assessment of efficacy and of induced mucosal abnormality with three preparation agents. Endoscopy. 2011 May;43(5):412-8. doi: 10.1055/s-0030-1256193. Epub 2011 May 4.

    PMID: 21547879DERIVED

MeSH Terms

Conditions

Mucositis

Interventions

Polyethylene Glycolspicosulfate sodiumsodium phosphate

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Ethylene GlycolsGlycolsAlcoholsOrganic ChemicalsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Ian C Lawrance, MD PhD

    Department of Gastroenterology, Fremantle Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 10, 2008

First Posted

September 11, 2008

Study Start

January 1, 2008

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

August 25, 2009

Record last verified: 2009-08

Locations

AU(1)