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Cold Polypectomy Site Study

Sponsor
Professor Michael Bourke (Other)
Overall Status
Completed
CT.gov ID
NCT02205125
Collaborator
(none)
88
Enrollment
1
Location
4
Duration (Months)
22
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    88 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Prospective Characterization of the Mucosal Defect After Cold Snare Polypectomy
    Study Start Date :
    Aug 1, 2013
    Actual Primary Completion Date :
    Dec 1, 2013
    Actual Study Completion Date :
    Dec 1, 2013

    Outcome Measures

    Primary Outcome Measures

    1. Frequency and constituents of stalk projections in cold snare polypectomy sites [14 days]

      Biopsy of post cold snare polypectomy stalk to determine constituents of stalk. This was reviewed 14 days following the procedure.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Westmead Hospital Endoscopy Unit Sydney New South Wales Australia 2145

    Sponsors and Collaborators

    • Professor Michael Bourke

    Investigators

    • Principal Investigator: Michael Bourke, MBBS, FRACP, WSLHD

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Professor Michael Bourke, Director of Endoscopy, Westmead Hospital, Sydney, Australia, Western Sydney Local Health District
    ClinicalTrials.gov Identifier:
    NCT02205125
    Other Study ID Numbers:
    • HREC2013/8/6.6(3797)
    First Posted:
    Jul 31, 2014
    Last Update Posted:
    Mar 23, 2021
    Last Verified:
    Mar 1, 2021
    Keywords provided by Professor Michael Bourke, Director of Endoscopy, Westmead Hospital, Sydney, Australia, Western Sydney Local Health District
    polyp
    colon
    polypectomy
    snare
    Additional relevant MeSH terms:
    Colonic Polyps

    Study Results

    No Results Posted as of Mar 23, 2021