Back to resultsEffect of Prophylactic Clip Application for the Prevention of Postpolypectomy Bleeding in Pedunculated Colonic Polyps
Primary Purpose
Bleeding
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Prophylactic clip
No prophylactic management
Sponsored by
About this trial
This is an interventional treatment trial for Bleeding
Eligibility Criteria
Inclusion Criteria:
- Patients with pedunculated colorectal polyps, the heads of which were larger than 10mm and the stalk of which were large than 5 mm in diameter, were included.
Exclusion Criteria:
- bleeding tendency, poor preparation, sessile polyp
Sites / Locations
- Incheon St. Mary's Hospital, The Catholic University of Korea
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Prophylactic clip
No prophylactic management
Arm Description
Before conventional snare polypectomy, hemoclips will be applied on the base of stalk.
Conventional snare polypectomy will be performed without any preventive management.
Outcomes
Primary Outcome Measures
Postpolypectomy bleeding
Immediate and delayed postpolypectomy bleeding
Secondary Outcome Measures
Full Information
NCT ID
NCT02156193
First Posted
June 3, 2014
Last Updated
January 23, 2020
Sponsor
The Catholic University of Korea
1. Study Identification
Unique Protocol Identification Number
NCT02156193
Brief Title
Effect of Prophylactic Clip Application for the Prevention of Postpolypectomy Bleeding in Pedunculated Colonic Polyps
Official Title
Effect of Prophylactic Clip Application for the Prevention of Postpolypectomy Bleeding in Large Pedunculated Colonic Polyps: a Randomized, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
June 2014 (Actual)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
May 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Catholic University of Korea
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Although endoscopic colonic polypectomy has been an established procedure for two decades, the risk of bleeding is still higher after resecting of pedunculated polyps, because of the presence of a large artery in the stalk. Preventive methods such as endoloop and epinephrine injection have been proposed in the management of postpolypectomy bleeding in large colonic polyps. For prophylactic clip, there was no randomized controlled study assessing the efficacy in the prevention of postpolypectomy bleeding for the large pedunculated polyps. So the investigators designed a randomized controlled trial to confirm the efficacy of application of prophylactic clip in the prevention of postpolypectomy bleeding in large polyps.
Detailed Description
Patients who had pedunculated colorectal polyps with heads larger than 10 mm and stalks larger than 5 mm in diameter were included. In clip group, hemoclips were applied to the base of the stalk, followed by conventional snare polypectomy. In conventional group, conventional snare polypectomy was done without any preventive management. Immediate and delayed bleeding complications were assessed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bleeding
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
238 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prophylactic clip
Arm Type
Experimental
Arm Description
Before conventional snare polypectomy, hemoclips will be applied on the base of stalk.
Arm Title
No prophylactic management
Arm Type
Active Comparator
Arm Description
Conventional snare polypectomy will be performed without any preventive management.
Intervention Type
Procedure
Intervention Name(s)
Prophylactic clip
Intervention Description
Prophylactic clipping
Intervention Type
Procedure
Intervention Name(s)
No prophylactic management
Intervention Description
No prophylaxis
Primary Outcome Measure Information:
Title
Postpolypectomy bleeding
Description
Immediate and delayed postpolypectomy bleeding
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with pedunculated colorectal polyps, the heads of which were larger than 10mm and the stalk of which were large than 5 mm in diameter, were included.
Exclusion Criteria:
bleeding tendency, poor preparation, sessile polyp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeong-Seon Ji, Dr
Organizational Affiliation
Incheon St. Mary's Hospital, The Catholic University of Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Incheon St. Mary's Hospital, The Catholic University of Korea
City
Incheon
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
33417897
Citation
Gweon TG, Lee KM, Lee SW, Kim DB, Ji JS, Lee JM, Chung WC, Paik CN, Choi H. Effect of prophylactic clip application for the prevention of postpolypectomy bleeding of large pedunculated colonic polyps: a randomized controlled trial. Gastrointest Endosc. 2021 Jul;94(1):148-154. doi: 10.1016/j.gie.2020.12.040. Epub 2021 Jan 5.
Results Reference
derived
Learn more about this trial
Effect of Prophylactic Clip Application for the Prevention of Postpolypectomy Bleeding in Pedunculated Colonic Polyps
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