Colorectal Neoplasms
Conditions
Brief summary
Narrow band imaging or electronic chromoendoscopy might provide similar adenoma detection capabilities while limiting time spent when compared to conventional chromoendoscopy method.
Interventions
DEVICENarrow band imaging
Blue light is used during withdrawal phase instead of the regular white light to highlight surface changes
OTHERChromoendoscopy
Indigo carmine will be sprayed during withdrawal phase of colonoscopy
High definition equipment will be used to perform colonoscopy
Sponsors
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Subject)
Masking description
Randomization cards will be sealed and opened after the subject is deemed eligible for the study by the PI. This will be done in an area away from the subject but due to the nature of the study, PI can't be blinded.
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Age ≥ 40 years 2. Referral for screening, surveillance or diagnostic colonoscopy
Exclusion criteria
1. Inflammatory bowel disease 2. History of colorectal cancer or colon resection 3. Indication of positive FIT or cologuard 4. Any colorectal cancer syndromes (FAP, HNPCC, SPS) 5. Patient with poor bowel preparation identified during insertion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adenomas per colonoscopy | during the procedure | total number of adenomas divided by total number of procedures |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adenoma detection rate | during the procedure | total number of patients with adenomas divided by total number of procedures |
| Sessile serrated polyps per colonoscopy | during the procedure | total number of sessile serrated polyps divided by total number of procedures |
| Sessile serrated polyp detection rate | during the procedure | total number of patients with sessile serrated polyps divided by total number of procedures |
| Withdrawal time | during the procedure | Time from cecal intubation to end of the procedure |
| Inspection time | during the procedure | Time during withdrawal minus time for interventions including washing, suctioning and polypectomy or biopsies |
Countries
United States
Outcome results
None listed