Colonoscopy Clinical Trial
Official title:
Explore the Relationship Between the Percentage of Colonoscopy Withdrawal Overspeed and the Adenoma Detection Rate: a Prospective, Multicenter, Observational Study
NCT number | NCT05444166 |
Other study ID # | EA-22-020 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | July 29, 2022 |
Est. completion date | November 29, 2023 |
In this study, the investigators used the optical flow method to measure the colonoscopy withdrawal speed, and doctors were selected from multiple hospitals to collect prospective colonoscopy screening videos, and the percentage of colonoscopy withdrawal overspeed was calculated to explore the relationship between it based on optical flow method and the adenoma detection rate.
Status | Recruiting |
Enrollment | 550 |
Est. completion date | November 29, 2023 |
Est. primary completion date | October 29, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Male or female =18 years old; 2. Able to read, understand and sign an informed consent; 3. The investigator believes that the subjects can understand the process of the clinical study, are willing and able to complete all study procedures and follow-up visits, and cooperate with the study procedures; 4. Patients requiring screening colonoscopy. Exclusion Criteria: 1. Have drug or alcohol abuse or mental disorder in the last 5 years; 2. Pregnant or lactating women; 3. Patients with known multiple polyp syndrome; 4. patients with known inflammatory bowel disease; 5. known intestinal stenosis or space-occupying tumor; 6. known colon obstruction or perforation; 7. patients with a history of colorectal surgery; 8. Patients with a previous history of allergy to pre-used spasmolysis; 9. Unable to perform biopsy and polyp removal due to coagulation disorders or oral anticoagulants; 10. High-risk diseases or other special conditions that the investigator considers the subject unsuitable for participation in the clinical trial. |
Country | Name | City | State |
---|---|---|---|
China | Renmin Hospital | Hubei | Wuhan, Hubei |
Lead Sponsor | Collaborator |
---|---|
Renmin Hospital of Wuhan University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The adenoma detection rate (ADR) | ADR was calculated by dividing the total number of patients being detected adenomas by the number of colonoscopies. | A month | |
Primary | The percentage of colonoscopy withdrawal overspeed | The percentage of colonoscopy withdrawal overspeed was calculated by dividing the time of colonoscopy withdrawal overspeed by the total time of colonoscopy withdrawal. | A month | |
Secondary | The polyp detection rate (PDR) | PDR was calculated by dividing the total number of patients being detected polyps by the number of colonoscopies. | A month | |
Secondary | The mean number of polyps per patient (MNP) | MNP was calculated by dividing the total number of polyps by the number of colonoscopies. | A month | |
Secondary | The mean number of adenomas per patient (MAP) | MAP was calculated by dividing the total number of adenomas by the number of colonoscopies. | A month | |
Secondary | colonoscopy withdrawal time | The time is taken to finish the examination from the beginning of the ileocecal region. | A month | |
Secondary | colonoscopy forward time | The time is taken to go from the rectum to the ileocecal region. | A month |
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