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Serrated Polyp Detection Rate Between Carbon Dioxide and Air Insufflation

Primary Purpose

Serrated Polyp

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Carbon dioxide insufflation colonoscopy
Air insufflation colonoscopy
Sponsored by
The Catholic University of Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Serrated Polyp

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:Patients 45-75-years-old who underwent a colonoscopy -

Exclusion Criteria:polyposis syndrome, Inflammatory bowel disease, previous colorectal operation

-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Carbon dioxide insufflation colonoscopy

    Air insufflation colonoscopy

    Arm Description

    Carbon dioxide insufflation colonoscopy

    Room air insufflation colonoscopy

    Outcomes

    Primary Outcome Measures

    Serrated polyp detection rate

    Secondary Outcome Measures

    Full Information

    First Posted
    August 6, 2018
    Last Updated
    August 6, 2018
    Sponsor
    The Catholic University of Korea
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03623906
    Brief Title
    Serrated Polyp Detection Rate Between Carbon Dioxide and Air Insufflation
    Official Title
    Comparison of Serrated Polyp Detection Rate Between Carbon Dioxide and Air Insufflation During Colonoscopy: a Randomized Controlled Multicenter Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 1, 2018 (Anticipated)
    Primary Completion Date
    August 31, 2020 (Anticipated)
    Study Completion Date
    December 31, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The Catholic University of Korea

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Sessile serrated adenomas are characterized by their flat shape and the presence of a yellow mucus cap overlying the lesion. These morphological features may account for their diagnostic difficulty during colonoscopy. Missed proximal sessile serrated adenomas are regarded as an important cause for interval cancers in the right colon and emphasize the importance of developing quality measures intended to enhance their detection. There is only one single-center retrospective cohort study on the impact of carbon dioxide insufflation on the detection of serrated polyps during colonoscopy. The investigators designed a randomized, controlled trial to compare the effect of carbon dioxide insufflation vs. room air insufflation on serrated polyp detection rate.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Serrated Polyp

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    1280 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Carbon dioxide insufflation colonoscopy
    Arm Type
    Experimental
    Arm Description
    Carbon dioxide insufflation colonoscopy
    Arm Title
    Air insufflation colonoscopy
    Arm Type
    Active Comparator
    Arm Description
    Room air insufflation colonoscopy
    Intervention Type
    Procedure
    Intervention Name(s)
    Carbon dioxide insufflation colonoscopy
    Intervention Description
    Carbon dioxide insufflation colonoscopy
    Intervention Type
    Procedure
    Intervention Name(s)
    Air insufflation colonoscopy
    Intervention Description
    Room air insufflation colonoscopy
    Primary Outcome Measure Information:
    Title
    Serrated polyp detection rate
    Time Frame
    7 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    45 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria:Patients 45-75-years-old who underwent a colonoscopy - Exclusion Criteria:polyposis syndrome, Inflammatory bowel disease, previous colorectal operation -

    12. IPD Sharing Statement

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    Serrated Polyp Detection Rate Between Carbon Dioxide and Air Insufflation

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