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Comparison of Prophylactic Clip and Detachable Snare

Primary Purpose

Colonic Polyp

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Prophylactic clip
Detachable snare
Sponsored by
The Catholic University of Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colonic Polyp

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with pedunculated colorectal polyps, the heads of which were larger than 10mm and the stalk of which were large than 5 mm in diameter, were included.

Exclusion Criteria:

  • bleeding tendency
  • poor preparation
  • sessile polyp

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Prophylactic clip

    Detachable snare

    Arm Description

    Prophylactic clip

    Detachable snare

    Outcomes

    Primary Outcome Measures

    Postpolypectomy bleeding

    Secondary Outcome Measures

    Full Information

    First Posted
    July 29, 2011
    Last Updated
    August 18, 2013
    Sponsor
    The Catholic University of Korea
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01406379
    Brief Title
    Comparison of Prophylactic Clip and Detachable Snare
    Official Title
    Comparison of Clip and Detachable Snare in Preventing Postpolypectomy Bleeding for Pedunculated Colonic Polyps: a Prospective, Randomized Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2010 (undefined)
    Primary Completion Date
    January 2013 (Actual)
    Study Completion Date
    February 2013 (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
    Although endoscopic colonic polypectomy has been an established procedure for two decades, the risk of bleeding is still higher after resecting of pedunculated polyps, because of the presence of a large artery in the stalk. Several preventive methods such as detachable snare and adrenaline injection have been proposed in the management of postpolypectomy bleeding in large colonic polyps. For prophylactic clip, there was no prospective randomized study assessing the efficacy in the prevention of postpolypectomy bleeding for the large pedunculated polyps. So we designed a prospective, randomized study to compares the efficacy of application of prophylactic clip and detachable snare in the prevention of postpolypectomy bleeding in large polyps. Application of prophylactic clip will be as effective and safe method as detachable snare in the prevention of postpolypectomy bleeding for the large pedunculated colonic polyps.

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Prophylactic clip
    Arm Type
    Experimental
    Arm Description
    Prophylactic clip
    Arm Title
    Detachable snare
    Arm Type
    Active Comparator
    Arm Description
    Detachable snare
    Intervention Type
    Procedure
    Intervention Name(s)
    Prophylactic clip
    Intervention Description
    Before conventional snare polypectomy, hemoclips were applied on the base of stalk in the prophylactic clip group
    Intervention Type
    Procedure
    Intervention Name(s)
    Detachable snare
    Intervention Description
    In the detachable snare group, detachable snare was positioned at the base of stalk and followed by conventional snare polypectomy
    Primary Outcome Measure Information:
    Title
    Postpolypectomy bleeding
    Time Frame
    Immediate (bleeding occurring immediately after polypectomy and lasting for 30 s or more) and delayed bleeding complications were assessed. Delayed bleeding was subdivide into early (<24 h) and late (>24 h-30 days).

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with pedunculated colorectal polyps, the heads of which were larger than 10mm and the stalk of which were large than 5 mm in diameter, were included. Exclusion Criteria: bleeding tendency poor preparation sessile polyp

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    24830400
    Citation
    Ji JS, Lee SW, Kim TH, Cho YS, Kim HK, Lee KM, Kim SW, Choi H. Comparison of prophylactic clip and endoloop application for the prevention of postpolypectomy bleeding in pedunculated colonic polyps: a prospective, randomized, multicenter study. Endoscopy. 2014 Jul;46(7):598-604. doi: 10.1055/s-0034-1365515. Epub 2014 May 15. Erratum In: Endoscopy. 2014 Dec;46(12):1123. Endoscopy. 2014 Sep;46(9):817.
    Results Reference
    derived

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    Comparison of Prophylactic Clip and Detachable Snare

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