search
Back to results

Adenoma Detection by Polypectomy During Both Insertion and Withdrawal

Primary Purpose

Adenoma of Large Intestine

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Both insertion and withdrawal
Only withdrawal
Sponsored by
The Catholic University of Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Adenoma of Large Intestine

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient undergoing screening or surveillance colonoscopy

Exclusion Criteria:

  • Previous colorectal resection, Polyposis syndrome, Inflammatory bowel disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Both insertion and withdrawal

    Only withdrawal

    Arm Description

    Outcomes

    Primary Outcome Measures

    Adenoma detection rate

    Secondary Outcome Measures

    Number of adenoma per patient

    Full Information

    First Posted
    August 16, 2013
    Last Updated
    February 9, 2019
    Sponsor
    The Catholic University of Korea
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01925833
    Brief Title
    Adenoma Detection by Polypectomy During Both Insertion and Withdrawal
    Official Title
    Comparison of Adenoma Detection by Polypectomy During Both Insertion and Withdrawal Versus Only Withdrawal of Colonoscopy: a Randomized, Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2013 (Actual)
    Primary Completion Date
    July 2016 (Actual)
    Study Completion Date
    December 2016 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Standard method of colonoscopy is to insert the colonoscope rapidly to reach the cecum, with careful inspection and polypectomy during the withdrawal phase. However, small polyps (e.g. <1cm) seen during insertion phase are difficult to find during withdrawal phase. Also, colon is in different conformation during insertion and withdrawal phases. We think careful inspection and polypectomy during both insertion and withdrawal can improve adenoma detection rate.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Adenoma of Large Intestine

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    1142 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Both insertion and withdrawal
    Arm Type
    Experimental
    Arm Title
    Only withdrawal
    Arm Type
    Active Comparator
    Intervention Type
    Procedure
    Intervention Name(s)
    Both insertion and withdrawal
    Intervention Description
    inspection and polypectomy during both insertion and withdrawal of colonoscopy
    Intervention Type
    Procedure
    Intervention Name(s)
    Only withdrawal
    Intervention Description
    inspection and polypectomy during only withdrawal of colonoscopy
    Primary Outcome Measure Information:
    Title
    Adenoma detection rate
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    Number of adenoma per patient
    Time Frame
    4 weeks
    Other Pre-specified Outcome Measures:
    Title
    Polyp miss rate
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patient undergoing screening or surveillance colonoscopy Exclusion Criteria: Previous colorectal resection, Polyposis syndrome, Inflammatory bowel disease

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    31953727
    Citation
    Gweon TG, Lee SW, Ji JS, Lee JR, Kim JS, Kim BW, Choi H. Comparison of adenoma detection by colonoscopy between polypectomy performed during both insertion and withdrawal versus during withdrawal only: a multicenter, randomized, controlled trial. Surg Endosc. 2020 Dec;34(12):5461-5468. doi: 10.1007/s00464-019-07342-4. Epub 2020 Jan 17.
    Results Reference
    derived

    Learn more about this trial

    Adenoma Detection by Polypectomy During Both Insertion and Withdrawal

    We'll reach out to this number within 24 hrs