Explore the Relationship Between the Percentage of Colonoscopy Withdrawal Overspeed and the ADR

Sponsor
Renmin Hospital of Wuhan University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05444166
Collaborator
(none)
550
1
3.9
139.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Study showed that adequate withdrawal time is an important prerequisite for full mucosal inspection. In a large population-based analysis, a 1-min increase in withdrawal time led to a 3.6% increase in the ADR. Protocols or expert consensus recommend a standard withdrawal time of 6 min or longer. However, Findings of studies showed that a number of colonoscopies had a withdrawal time less than 6 min, which greatly reduces the ADR.

    Investigator's preliminary experiments have shown that deep learning can monitor the colonoscopy withdrawal time in real-time and improve the adenoma detection rate. Based on the above rich foundation of preliminary work and the massive demand for improving the colonoscopy withdrawal assessment system.

    The investigators improved EndoAngel to use optical flow method to monitor the colonoscopy withdrawal speed. The performance of the EndoAngel system was verified in colonoscopy videos. The investigators then aimed to evaluate whether the EndoAngel system could improve polyp detection rate after restricting the colonoscopy withdrawal speed.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    550 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Explore the Relationship Between the Percentage of Colonoscopy Withdrawal Overspeed and the Adenoma Detection Rate: a Prospective, Multicenter, Observational Study
    Anticipated Study Start Date :
    Jul 4, 2022
    Anticipated Primary Completion Date :
    Oct 1, 2022
    Anticipated Study Completion Date :
    Nov 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. The adenoma detection rate (ADR) [A month]

      ADR was calculated by dividing the total number of patients being detected adenomas by the number of colonoscopies.

    2. The percentage of colonoscopy withdrawal overspeed [A month]

      The percentage of colonoscopy withdrawal overspeed was calculated by dividing the time of colonoscopy withdrawal overspeed by the total time of colonoscopy withdrawal.

    Secondary Outcome Measures

    1. The polyp detection rate (PDR) [A month]

      PDR was calculated by dividing the total number of patients being detected polyps by the number of colonoscopies.

    2. The mean number of polyps per patient (MNP) [A month]

      MNP was calculated by dividing the total number of polyps by the number of colonoscopies.

    3. The mean number of adenomas per patient (MAP) [A month]

      MAP was calculated by dividing the total number of adenomas by the number of colonoscopies.

    4. colonoscopy withdrawal time [A month]

      The time is taken to finish the examination from the beginning of the ileocecal region.

    5. colonoscopy forward time [A month]

      The time is taken to go from the rectum to the ileocecal region.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Renmin Hospital Hubei Wuhan, Hubei China 430000

    Sponsors and Collaborators

    • Renmin Hospital of Wuhan University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Renmin Hospital of Wuhan University
    ClinicalTrials.gov Identifier:
    NCT05444166
    Other Study ID Numbers:
    • EA-22-020
    First Posted:
    Jul 5, 2022
    Last Update Posted:
    Jul 7, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 7, 2022