Optical diagnosis versus laser measurement of polyps* size during colonoscopy and implications for surveillance

Conditions: Polyps
precursors of colorectal cancer
10017987

Registration Number: NL-OMON51774

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 60

Inclusion Criteria

• Adult patients (>18 years)
• Scheduled for screening, surveillance, or diagnostic colonoscopy
• Polyps of all forms <= 25mm as assessed by the endoscopist

Exclusion Criteria

• Therapeutic colonoscopy
• Inflammatory bowel disease (IBD)
• American Society of Anesthesiologists score of >3
• Inadequate bowel preparation (Boston bowel preparation scale score [BBPS] <2
per segment);
• No polyps identified during colonoscopy or only small (<5mm) hyperplastic
rectal polyps
• Inadequately corrected anticoagulation disorder or anticoagulation medication
use
• Inability to provide informed consent

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint of this study is establishing Cohens* Kappa coefficient in<br /><br>determining the size of polyps for the following categories: <5mm, 5-9mm,<br /><br>>=10mm, for the interobserver agreement between AccuMeasure and biopsy forceps<br /><br>assisted measurement. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary objectives are to assess:<br /><br>• Reproducibility of AM using successive measurements of the same polyp;<br /><br>• Precision estimate of AM as compared to optical- and biopsy forceps assisted<br /><br>assessment;<br /><br>• Size differences for optical-, biopsy forceps-, and AM assessment as compared<br /><br>to pathology size measurement;<br /><br>• Subgroups based on polyp morphology (i.e., sessile or adenomatous lesions);<br /><br>• Time needed to measure polyp size and learning curve;<br /><br>• Endoscopist advised surveillance interval based on optical assessment during<br /><br>colonoscopy, on measurement with an open biopsy forceps, and on measurement<br /><br>with AccuMeasure.<br /><br>• Safety, in terms of (severe) adverse events up to 30 days post-procedure</p><br>