Back to resultsEFficacy of Prophylactic Clip Application in Decrease of Immediate Postpolypectomy Bleeding and Delayed Postpolypectomy Bleeding After Colonoscopic Removal for a Large Pedunculated Polyps
Primary Purpose
Polyp of Large Intestine
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
prophylactic clip application
Sponsored by
About this trial
This is an interventional prevention trial for Polyp of Large Intestine focused on measuring colon polyp, endoscopic polypectomy, postpolypectomy bleeding, prophylactic clip application
Eligibility 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
Sites / Locations
- Asan Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
endoclip
no endoclip
Arm Description
The group of patients who undergo prophylactic clip application after colonoscopic polypectomy of a large pedunculated polyp(>1cm).
The group of patients who do not undergo prophylactic clip application after colonoscopic polypectomy of a large pedunculated polyp(>1cm).
Outcomes
Primary Outcome Measures
the occurrence of immediate post-polypectomy bleeding
At 1 day after endoscopic polypectomy, CBC will be done.
the occurrence of delayed post-polypectomy bleeding
At 2 weeks after endoscopic polypectomy, history of hematochezia will be taken at outpatient clinic.
Secondary Outcome Measures
Full Information
NCT ID
NCT01437631
First Posted
September 19, 2011
Last Updated
February 24, 2020
Sponsor
Asan Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01437631
Brief Title
EFficacy of Prophylactic Clip Application in Decrease of Immediate Postpolypectomy Bleeding and Delayed Postpolypectomy Bleeding After Colonoscopic Removal for a Large Pedunculated Polyps
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 Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2011 (undefined)
Primary Completion Date
April 30, 2015 (Actual)
Study Completion Date
April 30, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polyp of Large Intestine
Keywords
colon polyp, endoscopic polypectomy, postpolypectomy bleeding, prophylactic clip application
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
137 (Actual)
8. Arms, Groups, and Interventions
Arm Title
endoclip
Arm Type
Experimental
Arm Description
The group of patients who undergo prophylactic clip application after colonoscopic polypectomy of a large pedunculated polyp(>1cm).
Arm Title
no endoclip
Arm Type
No Intervention
Arm Description
The group of patients who do not undergo prophylactic clip application after colonoscopic polypectomy of a large pedunculated polyp(>1cm).
Intervention Type
Procedure
Intervention Name(s)
prophylactic clip application
Intervention Description
prophylactic clip application after colonoscopic polypectomy
Primary Outcome Measure Information:
Title
the occurrence of immediate post-polypectomy bleeding
Description
At 1 day after endoscopic polypectomy, CBC will be done.
Time Frame
1 day
Title
the occurrence of delayed post-polypectomy bleeding
Description
At 2 weeks after endoscopic polypectomy, history of hematochezia will be taken at outpatient clinic.
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyung-Jo Kim, M.D.
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
12709699
Citation
Shioji K, Suzuki Y, Kobayashi M, Nakamura A, Azumaya M, Takeuchi M, Baba Y, Honma T, Narisawa R. Prophylactic clip application does not decrease delayed bleeding after colonoscopic polypectomy. Gastrointest Endosc. 2003 May;57(6):691-4. doi: 10.1067/mge.2003.193.
Results Reference
background
PubMed Identifier
32164613
Citation
Soh JS, Seo M, Kim KJ. Prophylactic clip application for large pedunculated polyps before snare polypectomy may decrease immediate postpolypectomy bleeding. BMC Gastroenterol. 2020 Mar 12;20(1):68. doi: 10.1186/s12876-020-01210-5.
Results Reference
derived
Learn more about this trial
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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