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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02205125




Registration number
NCT02205125
Ethics application status
Date submitted
26/07/2014
Date registered
31/07/2014
Date last updated
23/03/2021

Titles & IDs
Public title
Cold Polypectomy Site Study
Scientific title
Prospective Characterization of the Mucosal Defect After Cold Snare Polypectomy
Secondary ID [1] 0 0
HREC2013/8/6.6(3797)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colonic Polyps 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Frequency and constituents of stalk projections in cold snare polypectomy sites
Timepoint [1] 0 0
14 days

Eligibility
Key inclusion criteria
- Patients undergoing colonoscopy with at least one polyp identified where polypectomy
is planned.
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Age < 18 years

- Patients where polypectomy is not planned to be undertaken (patients scheduled for
diagnostic colonoscopy only).

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2013
Sample size
Target
Accrual to date
Final
88
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Westmead Hospital Endoscopy Unit - Sydney
Recruitment postcode(s) [1] 0 0
2145 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
Professor Michael Bourke
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Removal of polyps at colonoscopy reduces colon cancer. Snare polypectomy is the conventional
method for removal however the snared area after removal can occasionally appear uneven
raising the possibility that complete removal has not occurred. The significance of this
irregularity has not be studied. This study aims to separately sample the irregular area and
determine the constituents while recording how frequently this occurs during routine
colonoscopy and polypectomy. We hypothesize that the irregular areas are submucosal tissue
and do not represent polyp tissue left behind.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02205125
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael Bourke, MBBS, FRACP
Address 0 0
WSLHD
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02205125