Role of Computer-Aided Detection Colonoscopy in Polyp Detection Rate (CADEC)

Gian Eugenio Tontini

Status

Completed

Conditions

Colorectal Polyps

Treatments

Device: Colonoscopy with CADe system

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT07171333

OSMAMI-15/09/2022-0042892-U

Details and patient eligibility

About

High-definition (HD) colonoscopy is the gold standard for early diagnosis and treatment of lower gastrointestinal neoplasms, with the adenoma detection rate (ADR) serving as a key quality indicator due to its inverse correlation with colorectal cancer incidence. ADR is influenced by operator expertise, fatigue, and human error, which may be mitigated by advanced imaging technologies such as computer-aided detection (CADe). CADe systems provide real-time visual and auditory alerts for suspected polyps and have been shown to increase ADR, though their effectiveness under different operator conditions (high- vs. low-volume, fatigue-related performance, impact on polyp detection rate [PDR] and withdrawal time) remains unclear. This multicenter, prospective, national, open-label randomized trial (6 Italian centers) will compare HD-Iscan colonoscopy with and without CADe assistance (1:1 allocation), with primary endpoint ADR and secondary endpoints including PDR, withdrawal time, and performance stratified by operator fatigue. Eligible patients (aged 40-80, undergoing screening, surveillance, or diagnostic colonoscopy) will be recruited consecutively, with exclusions for prior colonic resection, recent diverticulitis, inflammatory bowel disease, familial polyposis, inadequate bowel preparation, complete colonoscopy within 5 years, inability to consent, or unsafe ongoing antithrombotic therapy. Colonoscopies will follow ESGE guidelines with standard split-dose PEG preparation; all polyps will be resected and documented. Operator allocation to high- (≥200 colonoscopies/year) or low-volume (<200/year) groups will follow routine clinical scheduling, with stratified analyses performed. The trial involves no investigational drugs or additional invasive procedures, and no adverse events are anticipated beyond those inherent to colonoscopy.

Enrollment

421 patients

Sex

All

Ages

40 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Age 40-80 years, any sex
Indication for screening, surveillance, or diagnostic colonoscopy (e.g., anemia, abdominal symptoms)
Written informed consent

Exclusion criteria

Previous (even partial) colon resection or colonic stenosis
Acute diverticulitis within 4 weeks
Inflammatory bowel disease, familial adenomatous polyposis, or microscopic colitis
Complete colonoscopy within 5 years
Inadequate suspension of antithrombotic/antiplatelet therapy (per ESGE guidelines)
Inability to provide consent
Inadequate bowel preparation (Boston Bowel Preparation Scale <2 in any segment)