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| Name | Class |
|---|---|
| The Fifth Affiliated Hospital of Zunyi Medical College | OTHER |
| Longgang District People's Hospital of Shenzhen | OTHER |
| Yangjiang People's Hospital | OTHER |
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This is a prospective, multicenter randomized controlled trial designed to determine whether the use of computer-aided detection system could reduce the miss rates of adenomas, SSLs, and polyps in the proximal colon during tandem colonoscopy.
Study Centers 1) Nanfang Hospital, Southern Medical Univerisity, Guangzhou, China 2) The Fifth Affiliated Hospital of Zunyi Medical University, Zhuhai, China 3) Longgang District People's Hospital of Shenzhen, Shenzhen, China 4) Yangjiang People's Hospital, Yangjiang, China 5) Jiangmen Central Hospital, Jiangmen, China 6) Huizhou Third People's Hospital, Huizhou, China 7) Dongguan Shuixiang Central Hospital, Dongguang, China 8) Pingshan District People's Hospital of Shenzhen, Shenzhen, China
Study population 1) Inclusion criteria:
Unable to cooperate ot tolerate colonoscopy
History of inflammatory bowel disease
History of colorectal cancer
Previous colorectal surgery
History of recurrent constipation
Taking anticoagulant and antiplatelet drugs berfore procedure
High risk conditions such as severe cardiovascular and cerebrovascular diseases, severe anemia, or uncorrected infections
Pregnant or lactating women Researchers concluded that patient was not suitable to participate in this trial.
3) Post-randomization exclusion criteria:
Study design This is a prospective , multicenter randomized controlled trial comparing the miss rates of proximal colonic lesions (including adenomas, SSLs, and polyps) by computer-aided detection-assisted colonoscopy or conventional colonoscopy. The study will be conducted in the Endoscopy Centre of the participating hospitals.
Randomization 1) Eligible patients at each center will be randomized (1:1) to computer-aided detection-assisted colonoscopy first or conventional white light colonoscopy first, followed immediately by the other procedure in tandem fashion by the same endoscopist. The proximal colon is defined as the colonic segment proximal to the hepatic flexure.
2) Randomization will be performed using computer-generated random sequences in blocks of 6, with stratification by academic level of participation center, experience of endoscopists, and indications of colonoscopy. Patients will be blinded to their group assignment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Computer-aided detection-assisted colonoscopy | Experimental | Tandem colonoscopy of proximal colon assisted with computer-aided detection system followed by conventional white-light colonoscopy |
|
| Conventional white-light colonoscopy | Active Comparator | Tandem conventional white-light colonoscopy of proximal colon followed by usual computer-aided detection-assisted colonoscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computer-aided detection-assisted colonoscopy | Device | Computer-aided detection-assisted colonoscopy for detection of colonic polyp |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proximal adenoma missed rate | The number of adenomas identified during the second right colon inspection divided by the overall number of adenomas identified during the first and second right colon inspection. | One day |
| Measure | Description | Time Frame |
|---|---|---|
| Proximal polyp missed rate | The number of polyps identified during the second right colon inspection divided by the overall number of polyps identified during the first and second right colon inspection. | One day |
| Proximal SSLs missed rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zelong Han, MD, PhD | Contact | +86 189-2506-1890 | hanzelong2025@163.com | |
| Bitao Lin, MD | Contact | +86 137-2532-1385 | linbitao1996@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanfang Hospital, Southern Medical University | Guangzhou | Guangdong | 510515 | China |
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| ID | Term |
|---|---|
| D003111 | Colonic Polyps |
| ID | Term |
|---|---|
| D007417 | Intestinal Polyps |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Jiangmen Central Hospital |
| OTHER |
| Dongguan Shuixiang Central Hospital | UNKNOWN |
| Pingshan District People's Hospital of shenzhen | UNKNOWN |
| The Third People's Hospital of Huizhou | OTHER |
Prospective randomized design
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| Conventional white-light colonoscopy | Procedure | Conventional white-light colonoscopy |
|
The number of SSLs identified during the second right colon inspection divided by the overall number of SSLs identified during the first and second right colon inspection.
| One days |
| Proximal advanced adenoma missed rate | The number of advanced adenomas identified during the second right colon inspection divided by the overall number of advanced adenomas identified during the first and second right colon inspection. | One day |