None listed
Conditions
Interventions
Procedure/Surgery : This randomized controlled trial compares different colonoscopy approaches based on the use of a transparent distal cap and an artificial intelligence (AI)–assisted real-time compu
AI alerts are used to assist lesion recognition during withdrawal inspection. (2) AI-only group: no distal cap is used, and the same AI CADe system is activated from the start of the procedure and ope
AI alerts are used during withdrawal inspection. (3) Standard HD group (control): neither a distal cap nor the AI CADe system is used
standard HD white-light colonoscopy is performed. In all groups, mucosal inspection is conducted during withdrawal after cecal intubation
a minimum withdrawal time of 6 minutes is recommended and documented. Bowel cleansing quality is assessed using the Boston Bowel Preparation Scale (BBPS). The only between-group differences are (i) di
all other procedural elements, lesion management, and histopathologic assessment are
Sponsors
Yonsei University, Wonju Severance Christian Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Adult patients aged 40 years or older and younger than 80 years. 2.Patients scheduled to undergo colonoscopy for screening, post-polypectomy surveillance, or diagnostic work-up. 3.Patients who are able to understand the purpose, procedures, and potential risks of the study and provide voluntary written informed consent. 4.Patients who are mentally alert and capable of communication and following instructions. 5.Patients who are deemed by the investigator to be able to safely undergo colonoscopy with the use of a transparent distal cap and an AI-assisted system at the participating institution.
Exclusion criteria
Exclusion criteria: 1.Patients referred from other institutions for polypectomy after a diagnosis of colorectal adenoma, dysplasia, or carcinoma. 2.Patients with a history of colorectal cancer (CRC) or prior colorectal resection. 3.Patients with a diagnosis of inflammatory bowel disease (IBD). 4.Patients with familial adenomatous polyposis (FAP), Peutz–Jeghers syndrome, or other hereditary polyposis syndromes. 5.Patients with a high bleeding risk who are receiving anticoagulant therapy that cannot be safely discontinued, making polypectomy unsafe. 6.Patients for whom colonoscopy is considered high risk due to severe cardiopulmonary disease or other serious comorbid conditions. 7.Pregnant women. 8.Patients who are unable to understand the study or provide informed consent due to conditions such as cognitive impairment. 9.Patients who are deemed inappropriate for participation in the study at the investigator’s discretion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adenoma Detection Rate (ADR), defined as the proportion of participants in whom at least one histologically confirmed adenoma is detected during colonoscopy. | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of participants in whom at least one colorectal polyp is detected during colonoscopy.;The proportion of participants with at least one histologically confirmed sessile serrated lesion detected during colonoscopy.;The proportion of participants with at least one advanced adenoma, defined as adenoma =10 mm, with high-grade dysplasia, or with villous components.;The mean number of adenomas detected per colonoscopy.;Detection rates of lesions categorized by size (1–4 mm, 5–9 mm, =10 mm).;Detection rates according to anatomical location (right colon, transverse colon, left colon, rectum).;Associations between lesion detection rates and factors such as withdrawal time (=6 minutes), endoscopist experience, age, sex, and indication for colonoscopy. | — |
Countries
Korea, Republic of
Contacts
Public ContactSu Young Kim
Yonsei University, Wonju Severance Christian Hospital
Outcome results
None listed