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. All
materials and costs associated with the examination are recorded.
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.
