Assessment of large colon diminutive polyps via real time colonoscopy visualisation compared with standard practice.

Not Applicable

• Conditions: Diminutive (<5mm) colonic polyps; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12612001023842
• Lead Sponsor: Sujievvan Chandran

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-09-24
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 146

Inclusion Criteria

Adults aged >18.
Complete colonoscopy
Use of high definition Olympus colonoscopes with narrow band imaging.
Satisfactory or good bowel preparation.
>1 polyp which are < 5mm in size.
Operators: Consultant gastroenterologists

Exclusion Criteria

Patients with underlying inflammatory bowel disease, primary sclerosing cholangitis or previous colon cancer.
Poor bowel preparation at the time of colonoscopy.
Incomplete colonoscopy
Polyp specimen not retrieved for analysis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome to assess the accuracy of optical endoscopic diagnosis of diminutive colonic polyps.<br><br>The endoscopist will be asked to make an endoscopic diagnosis of the diminutive colonic polyp at the time of the procedure and record this down in addition to suggesting a surveillance interval based on NHMRC guidelines based on the endoscopic assessment. Endoscopic analysis will be performed with standard white light examination in addition to narrow band imaging (NBI) which is an optical image enhancement technology incorporated into Olympus colonoscopies used in our department. NBI enhances the visibility of vessels and other structures on mucosal surface which aides optical diagnosis of colonic pathology. The polyps will then be sent to pathology as per standard practice. At the end of the study period the endoscopists optical assessment will be compared with the histological diagnosis.[At baseline]

Secondary Outcome Measures

Name	Time	Method
If optical assessment is comparable, to then review whether a cut and discard method would be a safe and cost effective strategy.<br>Cut and dischard method refers to the resection and discarding the polyp tissue rather than sending the polyp tissue for histological assessment.<br><br>Safety would be dictated by the rate of dysplasia/malignancy identified in diminutive polyps therefore assessing whether a cut and discard approach to polyps this size would be clinically appropriate.<br><br>A cost benefit analysis would be performed at the end of the study if optical diagnosis has been shown to be comparable. The cost of tissue transportation, histological assessment and subsequent cost of hospital follow up would all be included.[At baseline]