About this trial
Type of study: Randomized controlled study
Investigated Procedure: Artificial Intelligence Software for Polyp Detection in Colonoscopy training
Trial participants: Endoscopy trainees during their training with at least one year of training ahead and no previous structured exposure to CADe
Objectives:
Primary: Adenoma Miss Rate (AMR) in the end of the first year of training for each group and after the crossover.
Secondary: Further endoscopists-related parameters will be recorded and compared between the two arms: PDR, ADR, aADR, PMR, withdrawal time, CIR, AEs
The investigators will be asked, when possible, to follow-up the patients until they have their next colonoscopy or a diagnosis of CRC to assess for interval cancer.
Eligibility criteria
Qualifiers
Trial participants: Endoscopy trainees at any time of their training, with at least one year of training ahead without previous structured exposure to CADe during their training.
Provision of signed and dated informed consent form understand the risks and benefits of the study
Aged ≥18 years old
Able to read and write in the provided language.
Disqualifiers
Trial participants: Endoscopy trainees after their basic training, during the last year of training or with systematic exposure to CADe.
Patients with a known contraindication for biopsy, bowel obstruction or perforation,
Pregnant or lactating females
Known polyposis syndromes, or who had a history of inflammatory bowel disease (IBD), CRC, or colorectal surgery.
Trial design
Treatments tested in this trial
- Artificial Intelligence in colonoscopy
- Conventional colonoscopy training