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This study will employ a prospective, multicenter, controlled design. It will be conducted across multiple centers, with participated centers randomly assigned to one of four groups: Group A, Group B, Group C, and Group D.
The research will primarily focus on the AI-based analysis of colonoscopic images to calculate the following metrics: caecal intubation time, red-out percentage, and the AI-based red-out avoiding score. Based on the study's implementation protocol, a decision will be made regarding whether to provide real-time feedback. Additionally, the presence of any complications will be assessed both during and after the colonoscopy procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Sham Comparator | During colonoscopy intubation, AI system is used to calculate and analyze "caecal intubation time," "red-out percentage," and the "AI-based red-out avoiding score" in real-time; however, these results are not provided as feedback to the operating colonoscopist. |
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| Group B | Experimental | During colonoscopy intubation, AI system is used to calculate and analyze "caecal intubation time," "red-out percentage," and the "AI-based red-out avoiding score" in real-time, with only the caecal intubation time being provided as feedback to the operator, while the red-out percentage and AI-based red-out avoiding score are withheld. |
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| Group C | Experimental | During colonoscopy intubation, AI system is used to calculate and analyze "caecal intubation time," "red-out percentage," and the "AI-based red-out avoiding score" in real-time, with only the red-out percentage being provided as feedback to the operator, while the caecal intubation time and AI-based red-out avoiding score are withheld. |
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| Group D | Experimental | During colonoscopy intubation, AI system is used to calculate and analyze the "caecal intubation time" "red-out percentage," and "AI-based red-out avoiding score" in real-time, with all three results provided as feedback to the operating colonoscopist. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AI system | Other | AI-system Performance Feedback in group B, group C, and group D. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Red-out percentage | The impact of real-time feedback on red-out percentage. | Stage 3 (projected to begin in 3-6 months) |
| Caecal intubation time | The impact of real-time feedback on caecal intubation time. | Stage 3 (projected to begin in 3-6 months) |
| AI-based red-out avoiding score | The impact of real-time feedback on AI-based red-out avoiding score. | Stage 3 (projected to begin in 3-6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Complications | During and after the colonoscopy, assess for any signs of complications | Stage 3 (projected to begin in 3-6 months) |
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Inclusion Criteria:
Study Participants (Patients):
Aged 18 to 70 years, any gender. Individuals scheduled to undergo diagnostic or screening colonoscopy at the investigational site.
Colonoscopists:
Expert-level colonoscopists (having performed a total of >1000 colonoscopy procedures).
Right-handed.
Exclusion Criteria:
Study Participants (Patients):
Individuals undergoing the following procedures:
cases with a history of colorectal surgery; cases with a history of chemotherapy, raditherapy; cases with a history of abdominal, and/or pelvic surgery; cases with a history of difficult colonoscopies; cases with colorectal tumours and obstructive lesions; cases with colorectal diverticula; cases with ulcerative colitis or Crohn's disease; cases with ischemic bowel disease; cases with colorectal polyposis; cases with melanosis coli; cases undergoing sigmoidoscopy; cases with poor intestional cleanliness (segment Boston bowel preparation scale (BBPS) of < 2 points, total BBPS of < 6 points); cases undergoing therapy procedures such as biopsy or CSP during the intubation phase; cases with transparent cap assisted colonoscopy; cases with water-assisted colonoscopy; cases with air insufflation level of M or L; cases failed caecal intubation within 15 min; cases with colonoscope stiffness level > 0; obese cases or underweight cases; and cases refusing participation.
Individuals who decline to provide informed consent.
Colonoscopists:
Those who have performed fewer than 300 complete colonoscopies in any calendar year within the past three years.
Those who decline to participate in the study.
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| ID | Term |
|---|---|
| D000098403 | Intelligent Systems |
| ID | Term |
|---|---|
| D001185 | Artificial Intelligence |
| D000465 | Algorithms |
| D055641 | Mathematical Concepts |
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