Impact of Computer-aided Detection System on the Proximal Adenoma Miss Rate
NCT ID: NCT07308743
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
686 participants
INTERVENTIONAL
2025-12-31
2027-07-31
Brief Summary
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Detailed Description
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2. Study population 1) Inclusion criteria:
1. Patients age 40-75 years old, regardless of gender
2. Patients presenting for physical examination, colorectal cancer screening or diagnosis
3. Patients voluntarily signs an informed consent form 2) Exclusion criteria:
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1. Unable to cooperate ot tolerate colonoscopy
2. History of inflammatory bowel disease
3. History of colorectal cancer
4. Previous colorectal surgery
5. History of recurrent constipation
6. Taking anticoagulant and antiplatelet drugs berfore procedure
7. High risk conditions such as severe cardiovascular and cerebrovascular diseases, severe anemia, or uncorrected infections
8. Pregnant or lactating women Researchers concluded that patient was not suitable to participate in this trial.
3\) Post-randomization exclusion criteria:
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1. Cecum could not be intubated for various reasons
2. Boston Bowel Preparation Scale (BBPS) score of the proximal colon is \<2
3. 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.
4. 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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Computer-aided detection-assisted colonoscopy
Tandem colonoscopy of proximal colon assisted with computer-aided detection system followed by conventional white-light colonoscopy
Computer-aided detection-assisted colonoscopy
Computer-aided detection-assisted colonoscopy for detection of colonic polyp
Conventional white-light colonoscopy
Tandem conventional white-light colonoscopy of proximal colon followed by usual computer-aided detection-assisted colonoscopy
Conventional white-light colonoscopy
Conventional white-light colonoscopy
Interventions
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Computer-aided detection-assisted colonoscopy
Computer-aided detection-assisted colonoscopy for detection of colonic polyp
Conventional white-light colonoscopy
Conventional white-light colonoscopy
Eligibility Criteria
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Inclusion Criteria
2. Patients presenting for physical examination, colorectal cancer screening or diagnosis
3. Patients voluntarily signs an informed consent form
Exclusion Criteria
2. History of inflammatory bowel disease
3. History of colorectal cancer
4. Previous colorectal surgery
5. History of recurrent constipation
6. Taking anticoagulant and antiplatelet drugs berfore procedure
7. High risk conditions such as severe cardiovascular and cerebrovascular diseases, severe anemia, or uncorrected infections
8. Pregnant or lactating women Researchers concluded that patient was not suitable to participate in this trial.
40 Years
75 Years
ALL
Yes
Sponsors
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The Fifth Affiliated Hospital of Zunyi Medical College
OTHER
Longgang District People's Hospital of Shenzhen
OTHER
Yangjiang People's Hospital
OTHER
Jiangmen Central Hospital
OTHER
Dongguan Shuixiang Central Hospital
UNKNOWN
Pingshan District People's Hospital of shenzhen
UNKNOWN
Huizhou Third People's Hospital
UNKNOWN
Nanfang Hospital, Southern Medical University
OTHER
Responsible Party
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Locations
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Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Zelong Han, MD, PhD
Role: primary
Bitao Lin, MD
Role: backup
Other Identifiers
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NFEC-2025-679
Identifier Type: -
Identifier Source: org_study_id