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NCT02205125 Clinical Trial

Cold Polypectomy Site Study

Colonic Polyps Clinical Trial

Official title:
Prospective Characterization of the Mucosal Defect After Cold Snare Polypectomy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02205125
Other study ID # HREC2013/8/6.6(3797)
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 2013
Est. completion date December 2013

Study information
Verified date March 2021
Source Western Sydney Local Health District
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 88
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - Patients undergoing colonoscopy with at least one polyp identified where polypectomy is planned. Exclusion Criteria: - Age < 18 years - Patients where polypectomy is not planned to be undertaken (patients scheduled for diagnostic colonoscopy only).

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Australia Westmead Hospital Endoscopy Unit Sydney New South Wales

Sponsors (1)
Lead Sponsor Collaborator
Professor Michael Bourke

Country where clinical trial is conducted

Australia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Frequency and constituents of stalk projections in cold snare polypectomy sites Biopsy of post cold snare polypectomy stalk to determine constituents of stalk. This was reviewed 14 days following the procedure. 14 days
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