Back to resultsRisk of Post-polypectomy Bleeding With Prophylactic Hemoclipping
Primary Purpose
Post-polypectomy Bleeding, Polypectomy, Elective Colonoscopy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hemoclip Placement
NO hemoclip placement
Sponsored by
About this trial
This is an interventional prevention trial for Post-polypectomy Bleeding focused on measuring hemoclip, colonoscopy, post-polypectomy bleed
Eligibility Criteria
Inclusion Criteria:
- Patients presenting for elective colonoscopy
Exclusion Criteria:
- Patients in which polypectomy can not be performed safely
Sites / Locations
- VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
- South Texas Health Care System, San Antonio, TX
- Central Texas Veterans Health Care System, Temple, TX
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Clip
No Clip
Arm Description
A clip is been placed at the polypectomy site.
A hemoclip is not placed at the site of the polypectomy.
Outcomes
Primary Outcome Measures
Number of Patients With Delayed Post Polypectomy Bleeding
rectal bleeding with associated Hb 2g drop, hemodynamic instability, or need for repeat colonoscopy or angiography or surgery
Secondary Outcome Measures
Full Information
NCT ID
NCT01647581
First Posted
July 19, 2012
Last Updated
September 24, 2019
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT01647581
Brief Title
Risk of Post-polypectomy Bleeding With Prophylactic Hemoclipping
Official Title
Risk of Post-Polypectomy Bleeding With Prophylactic Hemoclipping
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
September 1, 2011 (Actual)
Primary Completion Date
November 1, 2018 (Actual)
Study Completion Date
November 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A randomized trial aimed at determining whether or not hemoclips are effective in preventing post-polypectomy bleeds on polyps that are 10mm in size or greater.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-polypectomy Bleeding, Polypectomy, Elective Colonoscopy
Keywords
hemoclip, colonoscopy, post-polypectomy bleed
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
11182 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Clip
Arm Type
Experimental
Arm Description
A clip is been placed at the polypectomy site.
Arm Title
No Clip
Arm Type
Placebo Comparator
Arm Description
A hemoclip is not placed at the site of the polypectomy.
Intervention Type
Device
Intervention Name(s)
Hemoclip Placement
Other Intervention Name(s)
Clip
Intervention Description
Placement of hemoclip at polypectomy site for polyps at least 1cm in size
Intervention Type
Device
Intervention Name(s)
NO hemoclip placement
Other Intervention Name(s)
No Clip
Intervention Description
No hemoclip placement (placebo / sham)
Primary Outcome Measure Information:
Title
Number of Patients With Delayed Post Polypectomy Bleeding
Description
rectal bleeding with associated Hb 2g drop, hemodynamic instability, or need for repeat colonoscopy or angiography or surgery
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients presenting for elective colonoscopy
Exclusion Criteria:
Patients in which polypectomy can not be performed safely
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda A Feagins
Organizational Affiliation
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
Facility Name
South Texas Health Care System, San Antonio, TX
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Central Texas Veterans Health Care System, Temple, TX
City
Temple
State/Province
Texas
ZIP/Postal Code
76504
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31158369
Citation
Feagins LA, Smith AD, Kim D, Halai A, Duttala S, Chebaa B, Lunsford T, Vizuete J, Mara M, Mascarenhas R, Meghani R, Kundrotas L, Dunbar KB, Cipher DJ, Harford WV, Spechler SJ. Efficacy of Prophylactic Hemoclips in Prevention of Delayed Post-Polypectomy Bleeding in Patients With Large Colonic Polyps. Gastroenterology. 2019 Oct;157(4):967-976.e1. doi: 10.1053/j.gastro.2019.05.003. Epub 2019 May 31.
Results Reference
derived
Learn more about this trial
Risk of Post-polypectomy Bleeding With Prophylactic Hemoclipping
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