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.
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.
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.
Crossover
Artificial Intelligence in colonoscopy
Diagnostic testTraining in colonoscopy with or without CADe
Conventional colonoscopy training
Diagnostic testThe trainees will be trained with the conventional colonoscopy for the study period
Adenoma Miss Rate (AMR) at the end of the first year of training for each group and after the crossover.
AMR is defined as the number of adenomas detected in the by each trainee divided by the total number of adenomas detected by the respective supervising expert.
Polyp Miss Rate (PMR)
PMR is defined as the number of polyps detected in the by each trainee divided by the total number of polyps detected by the respective supervising expert.
Adenoma Detection Rate (ADR)
ADR is defined as the proportion of individuals who have at least one histologically confirmed conventional adenoma.
Polyp Detection Rate (PDR)
PDR is defined as the proportion of individuals who have at least one polyp detected during a complete screening colonoscopy and can be readily calculated based on pathology report (including adenoma, serrated sessile lesions, and inflammatory and hyperplastic polyp).
Adverse events rate
Adverse events defined by the ASGE lexicon
Click on the lead sponsor to view all of their trials.
