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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

This study is currently recruiting participants.
Verified September 2011 by Asan Medical Center
Sponsor:
Information provided by (Responsible Party):
Kyung-Jo Kim, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01437631
First received: September 19, 2011
Last updated: September 20, 2011
Last verified: September 2011
History of Changes
  Purpose

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 Intervention
Polyp of Large Intestine
 Procedure: prophylactic clip application

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)?

Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • the occurrence of immediate post-polypectomy bleeding [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    At 1 day after endoscopic polypectomy, CBC will be done.

  • the occurrence of delayed post-polypectomy bleeding [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    At 2 weeks after endoscopic polypectomy, history of hematochezia will be taken at outpatient clinic.


Estimated Enrollment: 384
Study Start Date: September 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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
Study First Received: September 19, 2011
Last Updated: September 20, 2011
Health Authority: Korea: Ministry for Health, Welfare and Family Affairs

Keywords provided by Asan Medical Center:
colon polyp
endoscopic polypectomy
postpolypectomy bleeding
prophylactic clip application

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

ClinicalTrials.gov processed this record on May 22, 2013