Materials: Selection, Representativeness, and Grouping
The study is a randomized controlled clinical trial conducted at Västra Götaland region.
Patients are randomized to receive either AI or conventional endoscopy, and each endoscopy
unit has access to at least one AI device. Informed consent is obtained from patients before
the examination.
Before the examination, patients are asked if they want to participate in the study. If the
patient wishes to participate, informed consent is obtained. The endoscopist then draws a
slip from an envelope, determining whether conventional colonoscopy or AI will be used.
During conventional colonoscopy, the patient is examined according to routine practice. After
the examination, a questionnaire is filled out, recording various findings from the
examination. During AI examinations, the AI system is activated only during instrument
withdrawal. The system identifies polyps and alerts the endoscopist. Additionally, two of the
AI systems (GI-Genius, CADEYE) have the ability to characterize the detected polyps and
provide an interpretation of whether the changes are benign or malignant. After the
examination, a similar questionnaire is completed as in conventional colonoscopy.
Method: Data Collection
Basic data will be recorded, including the reason for the examination, other illnesses,
medications, demographic data such as gender, age, family history of cancer, and the time of
the examination (morning or afternoon). During the examination, the following will be
recorded: the number of polyps, macroscopic classification of polyps, AI system's
characterization of the polyps, bowel cleansing quality, laxative method, medication during
the examination, complications occurring during or after the examination. Withdrawal time is
recorded, as well as the number of false-positive polyps and supplementation with
histological data of polyps after review by the pathologist.
Three different AI systems will be used at the various hospital sites, namely EndoAid
(Olympus), CADEYE (Fujinon), and GI-Genius (Medtronic). All units will randomize each
examination to either AI or non-AI.