Cold Polypectomy Site Study

NCT02205125 | Completed DMC

• 1 other identifier: HREC2013/8/6.6(3797)
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Colonic Polyps

Keywords

polyp; colon; polypectomy; snare

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing colonoscopy at a tertiary endoscopy unit.

You may qualify if:

• Patients undergoing colonoscopy with at least one polyp identified where polypectomy is planned.

You may not qualify if:

• Age \< 18 years
• Patients where polypectomy is not planned to be undertaken (patients scheduled for diagnostic colonoscopy only).

Sponsors & Collaborators

• Professor Michael Bourke: lead

Study Sites (1)

Westmead Hospital Endoscopy Unit

Sydney, New South Wales, 2145, Australia

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

All polypectomy specimens were submitted for histopathological assessment as per clinical practice. The biopsy samples from the irregular areas were also submitted in the same fashion. All specimens are stored as per current clinical practice.

MeSH Terms

Conditions

Colonic Polyps; Polyps

Condition Hierarchy (Ancestors)

Intestinal Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Bourke, MBBS, FRACP

  WSLHD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Endoscopy, Westmead Hospital, Sydney, Australia

Study Record Dates

• First Submitted: July 26, 2014
• First Posted: July 31, 2014
• Study Start: August 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 23, 2021

Record last verified: 2021-03

Locations

AU (1)