Colonoscopy TRaining With or Without Artificial INtelligence Among Endoscopy Residents
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Artificial Intelligence in colonoscopy, Conventional colonoscopy training.
- Who it may be relevant to
- Registry conditions: Colonoscopy Training. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Greece
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Colonoscopy Training With or Without Artificial Intelligence Among Endoscopy Residents: a Randomized Controlled Study
Overview
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 test Artificial Intelligence in colonoscopy
Training in colonoscopy with or without CADe - Diagnostic test Conventional colonoscopy training
The trainees will be trained with the conventional colonoscopy for the study period
Primary outcome measures
- Adenoma Miss Rate (AMR) at the end of the first year of training for each group and after the crossover. [Time frame: 3 months]
Secondary outcome measures (4)
- Polyp Miss Rate (PMR) [Time frame: 3 months]
- Adenoma Detection Rate (ADR) [Time frame: 3 months]
- Polyp Detection Rate (PDR) [Time frame: 3 months]
- Adverse events rate [Time frame: 3 months]
Eligibility criteria
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.
- 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.
- 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:
- 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.
- Any patient whose cecum is not reached and who were highly suspected of having polyposis syndromes, IBD, intestinal tuberculosis, or CRC.
- Incomplete bowel preparation (segmental Boston Bowel Preparation Score <2, or total <6)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Other
Study locations
Greece · 1 center
- General University Hospital of Larissa — Larissa
Identifiers
NCT: NCT07420309 · 31637-23/07/2025