Cold Polypectomy Site Study

March 22, 2021 updated by: Professor Michael Bourke

Prospective Characterization of the Mucosal Defect After Cold Snare Polypectomy

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

88

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2145
        • Westmead Hospital Endoscopy Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing colonoscopy at a tertiary endoscopy unit.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Professor Michael Bourke

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

July 26, 2014

First Submitted That Met QC Criteria

July 29, 2014

First Posted (Estimate)

July 31, 2014

Study Record Updates

Last Update Posted (Actual)

March 23, 2021

Last Update Submitted That Met QC Criteria

March 22, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HREC2013/8/6.6(3797)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Colonic Polyps

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Japan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe