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EFficacy of Prophylactic Clip Application in Decrease of Immediate Postpolypectomy Bleeding and Delayed Postpolypectomy Bleeding After Colonoscopic Removal for a Large Pedunculated Polyps

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ClinicalTrials.gov Identifier: NCT01437631
Recruitment Status : Completed
First Posted : September 21, 2011
Last Update Posted : February 26, 2020
Sponsor:
Information provided by (Responsible Party):
Kyung-Jo Kim, Asan Medical Center

Study Description
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Brief Summary:
The aim of this study is to evaluate the efficacy of prophylactic clip application after colonoscopic removal for a large pedunculated polyp (> 1cm) in preventing immediate postpolypectomy bleeding (IPPB) and delayed postpolypectomy bleeding (DPPB).

Condition or disease Intervention/treatment Phase
Polyp of Large Intestine Procedure: prophylactic clip application Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 137 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Does a Prophylactic Clip Application Decrease IPPB(Immediate Postpolypectomy Bleeding) and DPPB(Delayed Postpolypectomy Bleeding) After Colonoscopic Removal for a Large Pedunculated Polyps (>1cm)?
Study Start Date : September 1, 2011
Actual Primary Completion Date : April 30, 2015
Actual Study Completion Date : April 30, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arms and Interventions
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Arm Intervention/treatment
Experimental: endoclip
The group of patients who undergo prophylactic clip application after colonoscopic polypectomy of a large pedunculated polyp(>1cm).
 Procedure: prophylactic clip application
prophylactic clip application after colonoscopic polypectomy
No Intervention: no endoclip
The group of patients who do not undergo prophylactic clip application after colonoscopic polypectomy of a large pedunculated polyp(>1cm).


Outcome Measures
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Primary Outcome Measures :
  1. the occurrence of immediate post-polypectomy bleeding [ Time Frame: 1 day ]
    At 1 day after endoscopic polypectomy, CBC will be done.

  2. the occurrence of delayed post-polypectomy bleeding [ Time Frame: 2 weeks ]
    At 2 weeks after endoscopic polypectomy, history of hematochezia will be taken at outpatient clinic.


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who have a large pedunculated polyp(>1cm) in the colon

Exclusion Criteria:

  • Age under 20 years
  • Subjects who are taking anticoagulants
  • Subjects who have an abnormal coagulogram (platelet count, international normalized ratio, or activated partial thromboplastin time)
  • Subjects who have inflammatory bowel diseases
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01437631


Locations
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Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Asan Medical Center
Investigators
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Principal Investigator: Kyung-Jo Kim, M.D. Asan Medical Center
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Kyung-Jo Kim, Clinical Associate Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01437631    
Other Study ID Numbers: 2011-0653
First Posted: September 21, 2011    Key Record Dates
Last Update Posted: February 26, 2020
Last Verified: February 2020
Keywords provided by Kyung-Jo Kim, Asan Medical Center:
colon polyp
endoscopic polypectomy
postpolypectomy bleeding
prophylactic clip application
Additional relevant MeSH terms:
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Hemorrhage
Polyps
Pathologic Processes
Pathological Conditions, Anatomical