Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000918224
Ethics application status
Approved
Date submitted
16/04/2008
Date registered
26/10/2009
Date last updated
26/10/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessing cold biopsy forceps polypectomy for the resection of diminutive polyps
Scientific title
Assessing the efficacy of resection using cold biopsy forceps polypectomy in patients with diminutive polyps
Universal Trial Number (UTN)
Trial acronym
POLYP-01
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colonic Polyps 3065 0
Condition category
Condition code
Oral and Gastrointestinal 3219 3219 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
Patients with colonic polyps under 5mm will undergo forceps polypectomy without electrocautery until what there is no visible polyp tissue. The first sample(s) will be stored and labelled as 1a. The polypectomy site will then be resected using endoscopic mucosal resection. This sample will be stored and labelled 1b. The two samples will be collected during the same procedure. The polypectomy procedures are expected to take less than 15 minutes. Comparison of sample 1a and 1b will allow us to assess efficacy of resection with forceps polypectomy.

The study duration/intervention will be 12 months.
Intervention code [1] 2808 0
Treatment: Other
Comparator / control treatment
All patients will receive the same treatment, there will not be a compator group as such. The techniques will be compared in each patient, not different patient groups.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 4102 0
Rate of Complete Resection of polyps less than 5mm with cold biopsy forceps. This is assessed by comparing the histology of sample 1a and sample 1b. Where residual polyp tissue is found in 1b by definition this is incomplete resection. The rate of resection will be calculated by dividing the total number of polyps completely resected by the total number of polyps.
Timepoint [1] 4102 0
Conclusion of Colonoscopy
Secondary outcome [1] 6905 0
Predictors of complete resection of diminutive polyps using cold biopsy forceps polypectomy. The predictors assessed for are polyp size and histology (i.e. adenoma versus hyperplastic). The resection rates in the various grousp will be compared statistically.
Timepoint [1] 6905 0
Conclusion of Colonoscopy

Eligibility
Key inclusion criteria
Patients with colonic polyps less than 5mm
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients under 18years of age, patients treated with Clopidogrel or Warfarin with an International Normalised Ratio > 2, patients with a cardiac pacemaker or defibrillator.

Study design
Purpose of the study
Treatment
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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3312 0
Hospital
Name [1] 3312 0
St Vincent's Hospital Melbourne
Country [1] 3312 0
Australia
Funding source category [2] 243912 0
Hospital
Name [2] 243912 0
St Vincent's Hospital Melbourne, Department of Gastroenterology
Country [2] 243912 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital Melbourne
Address
35 Fitzroy St, Fitzroy, VIC 3065
Country
Australia
Secondary sponsor category [1] 251257 0
None
Name [1] 251257 0
Address [1] 251257 0
Country [1] 251257 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5297 0
St Vincent's Hospital Human Research and Ethcis Committee (HREC)
Ethics committee address [1] 5297 0
Ethics committee country [1] 5297 0
Australia
Date submitted for ethics approval [1] 5297 0
Approval date [1] 5297 0
Ethics approval number [1] 5297 0
1/08/0031

Summary
Brief summary
The study is designed to assess the effectiveness of removing polyps in the colon using a common technique, the biopsy forceps.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28537 0
Address 28537 0
Country 28537 0
Phone 28537 0
Fax 28537 0
Email 28537 0
Contact person for public queries
Name 11694 0
Dr Marios Efthymiou
Address 11694 0
35 Fitzroy St, Fitzroy, VIC 3065
Country 11694 0
Australia
Phone 11694 0
+61392882299
Fax 11694 0
+61386781032
Email 11694 0
[email protected]
Contact person for scientific queries
Name 2622 0
Dr Marios Efthymiou
Address 2622 0
35 Fitzroy St, Fitzroy, VIC 3065
Country 2622 0
Australia
Phone 2622 0
+61392882299
Fax 2622 0
+61386781032
Email 2622 0
[email protected]

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.