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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 : Recruiting
First Posted : September 21, 2011
Last Update Posted : July 13, 2016
Sponsor:
Information provided by (Responsible Party):
Kyung-Jo Kim, Asan Medical Center

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
Polyp of Large Intestine Procedure: prophylactic clip application

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 384 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 2011
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
U.S. FDA Resources

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).



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.



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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
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

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


Contacts
Contact: Kyung-Jo Kim, M.D. 02-3010-3196 capsulendos@gmail.com
Contact: Sang Hyoung Park, M.D. 02-3010-5768 umdalpin@hanmail.net

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

Publications:
Responsible Party: Kyung-Jo Kim, Clinical Associate Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01437631     History of Changes
Other Study ID Numbers: 2011-0653
First Posted: September 21, 2011    Key Record Dates
Last Update Posted: July 13, 2016
Last Verified: July 2016

Keywords provided by Kyung-Jo Kim, Asan Medical Center:
colon polyp
endoscopic polypectomy
postpolypectomy bleeding
prophylactic clip application

Additional relevant MeSH terms:
Hemorrhage
Polyps
Pathologic Processes
Pathological Conditions, Anatomical