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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
1,160
Colonoscopy assisted by ENDO-AID device
Fondazione Poliambulanza
Brescia, Bs, Italy
Policlinico Universitario Agostino Gemelli
Roma, Italy
Adenoma detection rate (ADR)
ADR defined as the proportion of patients with at least 1 adenoma detected.
Time frame: 1 years
Polyp detection rate (PDR)
PDR defined as the proportion of patients with at least 1 polyp detected.
Time frame: 1 years
Polyp per colonoscopy (PPC)
PPC defined as total number of polyps resected divided by the total number of colonoscopies.
Time frame: 1 years
Adenoma per colonoscopy (APC)
APC defined as total number of histologically confirmed adenomas resected divided by the total number of colonoscopies.
Time frame: 1 years
Sessile serrated lesion detection rate (SSLDR)
SSLDR percentage of patients who have 1 or more histologically confirmed sessile serrated lesion resected divided by the total number of colonoscopies.
Time frame: 1 years
Advanced adenoma detection rate (AADR)
AADR Adenomas are classified as advanced with a size \>= 10mm and/or a (tubulo)villous histology and/or high-grade dysplasia (HGD)
Time frame: 1 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.