Colorectal carcinoma, colorectal polyps, colorectal adenomas
Conditions
Sponsors
Radboudumc
Eligibility
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - = 18 years; - Referred and scheduled for either diagnostic, screening (non-iFOBT based) or surveillance colonoscopy.
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Known colorectal tumor or polyp on referral; - Referral for a therapeutic procedure (i.e. endoscopic mucosal resection, intervention for lower gastro-intestinal bleeding, etc.); - Inadequately corrected anticoagulation disorders or anticoagulation medication use; - American Society of Anesthesiologists (ASA) score = 3; - Known or suspected inflammatory bowel disease; - Inability to provide informed consent. Patients that have inadequate bowel preparation, as measured by the Boston Bowel Preparation Score (BBPS): adequate bowel cleansing is considered when the total BBPS is = 6 points along with a score = 2 in each segment of the colon, will be included in the analysis. As the performance of the system in an inadequately prepared colon will also be an important outcome in this feasibility trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Polyp detection rate (PDR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean number of polyps; Mean number of adenomas; Adenoma detection rate (ADR); Polyp location, shape and size; Withdrawal time of the colonoscope (minutes); Procedure time (minutes); Boston Bowel Preparation Scale; (Serious) adverse events; Endoscopists' evaluation of missed polyps, user friendliness and frequency of false positives. | — |
Contacts
Public ContactElsa Soons
Radboudumc
Outcome results
None listed