Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12608000310369
Ethics application status
Approved
Date submitted
23/06/2008
Date registered
30/06/2008
Date last updated
3/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of dye spraying with magnification colonoscopy for detecting colorectal polyp.
Scientific title
Evaluation of dye spraying with magnification colonoscopy for detecting flat adenomas in the colorectum
Secondary ID [1] 602 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patints receiving colonoscopy for standard indication. 3297 0
Condition category
Condition code
Oral and Gastrointestinal 3459 3459 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
During colonoscopy, 0.2% indigo carmine solution was applied down the side-channel of the instrument using a 20mL syringe containing 5mL indigo carmine and a cushion of air. A minimum volume of 20ml of indigo carmine was applied diffusely to the entire right colon (defined as proximal to the splenic flexure), and in a targeted fashion to the left colon, on any suspicious areas of the colonic mucosa. Recruitment ceased when 200 patients had been recruited into each arm.
Intervention code [1] 3035 0
Diagnosis / Prognosis
Comparator / control treatment
Standard colonocopy. Recruitment ceased when 200 patients had been recruited into each arm.
Control group
Active

Outcomes
Primary outcome [1] 4357 0
All polyps detected at colonoscopy were resected using standard colonoscopic techniques, and colorectal polyp numbers per patient were assessed.
Timepoint [1] 4357 0
After recruitment is stopped, colorectal polyps which were verified on histology were assessed.
Secondary outcome [1] 7343 0
prevalence of colorectal polyp (the percentage of patients with at least one polyp)
Timepoint [1] 7343 0
After recruitment is stopped, colorectal polyps which were verified on histology were assessed.

Eligibility
Key inclusion criteria
Consecutive unselected patients presenting for colonoscopy. Colonoscopy was performed for standard clinical indications.
Minimum age
19 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Known polyposis syndromes, hereditary non-polyposis colorectal cancer, inflammatory bowel disease and patients referred for polypectomy from other institutions. Additional exclusion criteria included: poor bowel preparation, incomplete colonoscopy, anticoagulant therapy and patient refusal.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/02/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3504 0
Hospital
Name [1] 3504 0
Royal Brisbane and Women's Hospital
Country [1] 3504 0
Australia
Primary sponsor type
Individual
Name
Mark N Appleyard
Address
Department of Gastroenterology
Royal Brisbane and Women's Hospital
Butterfield Street, Herston, QLD 4029
Country
Australia
Secondary sponsor category [1] 3147 0
Individual
Name [1] 3147 0
Kazutomo Togashi
Address [1] 3147 0
Division of Endoscopy
Jichi Medical University
3311-1 Yakushiji
Shimotsuke, Tochigi 329-0498 Japan
Country [1] 3147 0
Japan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5542 0
Human Research Ethics Committees, Royal Brisbane and Women's Hospital
Ethics committee address [1] 5542 0
Office of the Human Research Ethics Committees
Royal Brisbane and Women's Hospital
Butterfield Street, Herston, QLD 4029
Ethics committee country [1] 5542 0
Australia
Date submitted for ethics approval [1] 5542 0
30/12/2002
Approval date [1] 5542 0
03/02/2003
Ethics approval number [1] 5542 0
2003/02

Summary
Brief summary
The aim was to study whether indigo carmine dye spray colonoscopy increases a detection rate of colorectal polyp including flat adenoma in an Australian population.
Trial website
Trial related presentations / publications
Digestive Disease Week in USA, 2004
Public notes

Contacts
Principal investigator
Name 28691 0
Address 28691 0
Country 28691 0
Phone 28691 0
Fax 28691 0
Email 28691 0
Contact person for public queries
Name 11848 0
Mark N Appleyard
Address 11848 0
Department of Gastroenterology
Royal Brisbane and Women's Hospital
Butterfield, Herston, QLD 4029
Country 11848 0
Australia
Phone 11848 0
07-3636-2656
Fax 11848 0
Email 11848 0
Mark_Appleyard@health.qld.gov.au
Contact person for scientific queries
Name 2776 0
Kazutomo Togashi
Address 2776 0
Division of Endoscopy
Jichi Medical University
3311-1 Yakushiji
Shimotsuke, Tochigi 329-0498 Japan
Country 2776 0
Japan
Phone 2776 0
81+285587371
Fax 2776 0
Email 2776 0
ktogashi@jichi.ac.jp

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.