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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Asan Medical Center.
Recruitment status was  Recruiting
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Pathologic Processes
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on August 20, 2014