Colonoscopy Training
Conditions
Brief summary
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.
Interventions
DIAGNOSTIC_TESTArtificial Intelligence in colonoscopy
Training in colonoscopy with or without CADe
DIAGNOSTIC_TESTConventional colonoscopy training
The trainees will be trained with the conventional colonoscopy for the study period
Sponsors
University of Thessaly
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* 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. Recruited patient population: Adult patients undergoing diagnostic, screening, or surveillance colonoscopy will be included. 1. Provision of signed and dated informed consent form understand the risks and benefits of the study 2. Aged ≥18 years old 3. Able to read and write in the provided language. 4. Participants capable to provide written informed consent and comply with the trial protocol.
Exclusion criteria
* Trial participants: Endoscopy trainees after their basic training, during the last year of training or with systematic exposure to CADe. Recruited patient population: 1. Patients with a known contraindication for biopsy, bowel obstruction or perforation, 2. Pregnant or lactating females 3. Known polyposis syndromes, or who had a history of inflammatory bowel disease (IBD), CRC, or colorectal surgery. 4. Any patient whose cecum is not reached and who were highly suspected of having polyposis syndromes, IBD, intestinal tuberculosis, or CRC. 5. Incomplete bowel preparation (segmental Boston Bowel Preparation Score \<2, or total \<6)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adenoma Miss Rate (AMR) at the end of the first year of training for each group and after the crossover. | 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Polyp Miss Rate (PMR) | 3 months | 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) | 3 months | ADR is defined as the proportion of individuals who have at least one histologically confirmed conventional adenoma. |
| Polyp Detection Rate (PDR) | 3 months | 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 | 3 months | Adverse events defined by the ASGE lexicon |
Countries
Greece
Contacts
CONTACTApostolis Papaefthymiou
Outcome results
None listed