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The primary goal of this study is to estimate the effectiveness of a medical decision support system based on artificial intelligence in the endoscopic diagnosis of benign tumors.
Researchers will compare Adenoma detection rate between "artificial intelligence - assisted colonoscopy" and "conventional colonoscopy" groups to evaluate the clinical effectiveness of artificial intelligence model.
The primary outcome is adenoma detection rate per patient.
The secondary outcomes will be measured:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Artificial intelligence - assisted colonoscopy | Experimental | The decision making system based on artificial intelligence. Real - time artificial intelligence - assisted colonoscopy will be performed in this group. Detection of polyps is based on real time fixing a frame on the screen. |
|
| Conventional colonoscopy | Active Comparator | Conventional colonoscopy will be performed in this group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The system based on real - time artificial intelligence - assisted for colonoscopy | Device | Russian medical decision support system based on artificial intelligence "ArtInCol" |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adenoma detection rate | In each group, the percentage of patients with at least one histologically proven adenoma or carcinoma | during the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Polyps detection rate | In each group, the number of patients with all type of neoplasms (polyps) was detected as a percentage of the total number of patients. | during the procedure |
| Number of polyps |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dmitriy Shakhmatov | Contact | +79035651441 | mma02@yandex.ru | |
| Airat Mingazov | Contact | 89276951752 | ajr.mingazof@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Sergey Achkasov | State scientific centre of coloproctology, Moscow | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Airat Mingazov | Moscow | Russia |
|
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In each group, the number of detected all type of polyps
| during the procedure |
| Number of adenomas | In each group, the number of detected adenomas | during the procedure |
| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D003111 | Colonic Polyps |
| D004194 | Disease |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D007417 | Intestinal Polyps |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D003113 | Colonoscopy |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| 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 |
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