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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CADe assisted colonoscopy | Experimental | Trainees will be trained with the use of CADe |
|
| Conventional colonoscopy | Sham Comparator | Subjects will undergo training without AI for the study period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Artificial Intelligence in colonoscopy | Diagnostic Test | Training in colonoscopy with or without CADe |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
| Adenoma Detection Rate (ADR) |
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Inclusion Criteria:
Recruited patient population: Adult patients undergoing diagnostic, screening, or surveillance colonoscopy will be included.
Exclusion Criteria:
Recruited patient population:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Apostolis Papaefthymiou | Contact | 00306973853042 | appapaefthymiou@uth.gr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General University Hospital of Larissa | Recruiting | Larissa | Greece |
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| ID | Term |
|---|---|
| D001185 | Artificial Intelligence |
| D003113 | Colonoscopy |
| ID | Term |
|---|---|
| D000465 | Algorithms |
| D055641 | Mathematical Concepts |
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
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| Conventional colonoscopy training | Diagnostic Test | The trainees will be trained with the conventional colonoscopy for the study period |
|
ADR is defined as the proportion of individuals who have at least one histologically confirmed conventional adenoma.
| 3 months |
| 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). | 3 months |
| Adverse events rate | Adverse events defined by the ASGE lexicon | 3 months |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |