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

February 24, 2020 updated by: Kyung-Jo Kim, Asan Medical Center

Does a Prophylactic Clip Application Decrease IPPB(Immediate Postpolypectomy Bleeding) and DPPB(Delayed Postpolypectomy Bleeding) After Colonoscopic Removal for a Large Pedunculated Polyps (>1cm)?

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

137

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the occurrence of immediate post-polypectomy bleeding
Time Frame: 1 day
At 1 day after endoscopic polypectomy, CBC will be done.
1 day
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.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Investigators

  • Principal Investigator: Kyung-Jo Kim, M.D., Asan Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

April 30, 2015

Study Completion (Actual)

April 30, 2015

Study Registration Dates

First Submitted

September 19, 2011

First Submitted That Met QC Criteria

September 20, 2011

First Posted (Estimate)

September 21, 2011

Study Record Updates

Last Update Posted (Actual)

February 26, 2020

Last Update Submitted That Met QC Criteria

February 24, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-0653

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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