Adenoma Colon, Colonic Adenoma
Conditions
Keywords
ADR, CADe, Endo-AID
Brief summary
The goal of this clinical trial is to evaluate the diagnostic yield of CADe in a consecutive population undergoing colonoscopy. The main question it aims to answer is the Adenoma Detection Rate (ADR). Participants undergoing colonoscopy will be randomized in a 1:1 ratio to either receive Computer-Aided Detection (CADe) colonoscopy or a conventional colonoscopy (CC). Researchers will compare the CADe group and the CC-group to see if CAD-e can increase the ADR significantly.
Interventions
DEVICEENDO-Aid by Olympus
Colonoscopy assisted by ENDO-AID device
Sponsors
Fondazione Poliambulanza Istituto Ospedaliero
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years or ≤85 * Patients undergoing screening, follow-up, or diagnostic colonoscopy
Exclusion criteria
* Suspected or known inflammatory bowel disease * Colonic resection * Taking anticoagulants or antiaggregants that contraindicate the performance of therapy * Patients with incomplete colonoscopy * Patients with inadequate preparation using the Boston Colonic Preparation Scale (BBPS). A cleaning quality of less than 2 points in any of the 3 colonic sections will be considered inadequate. * Inability to provide informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adenoma detection rate (ADR) | 1 years | ADR defined as the proportion of patients with at least 1 adenoma detected. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Polyp detection rate (PDR) | 1 years | PDR defined as the proportion of patients with at least 1 polyp detected. |
| Polyp per colonoscopy (PPC) | 1 years | PPC defined as total number of polyps resected divided by the total number of colonoscopies. |
| Adenoma per colonoscopy (APC) | 1 years | APC defined as total number of histologically confirmed adenomas resected divided by the total number of colonoscopies. |
| Sessile serrated lesion detection rate (SSLDR) | 1 years | SSLDR percentage of patients who have 1 or more histologically confirmed sessile serrated lesion resected divided by the total number of colonoscopies. |
| Advanced adenoma detection rate (AADR) | 1 years | AADR Adenomas are classified as advanced with a size \>= 10mm and/or a (tubulo)villous histology and/or high-grade dysplasia (HGD) |
Countries
Italy
Outcome results
None listed