Polyps precursors of colorectal cancer
Conditions
Interventions
Optical assessment will be performed upon identification of the polyp. Then,
measurement with AccuMeasure and biopsy forceps will be performed in a
randomized order. The endoscopist will remain blin
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Adult patients (>18 years) • Scheduled for screening, surveillance, or diagnostic colonoscopy • Polyps of all forms
Exclusion criteria
Exclusion criteria: • Therapeutic colonoscopy • Inflammatory bowel disease (IBD) • American Society of Anesthesiologists score of >3 • Inadequate bowel preparation (Boston bowel preparation scale score [BBPS]
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this study is establishing Cohens* Kappa coefficient in determining the size of polyps for the following categories: =10mm, for the interobserver agreement between AccuMeasure and biopsy forceps assisted measurement. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives are to assess: • Reproducibility of AM using successive measurements of the same polyp; • Precision estimate of AM as compared to optical- and biopsy forceps assisted assessment; • Size differences for optical-, biopsy forceps-, and AM assessment as compared to pathology size measurement; • Subgroups based on polyp morphology (i.e., sessile or adenomatous lesions); • Time needed to measure polyp size and learning curve; • Endoscopist advised surveillance interval based on optical assessment during colonoscopy, on measurement with an open biopsy forceps, and on measurement with AccuMeasure. • Safety, in terms of (severe) adverse events up to 30 days post-procedure | — |
Countries
Netherlands
Outcome results
None listed