Risk of Post-polypectomy Bleeding With Prophylactic Hemoclipping
Risk of Post-Polypectomy Bleeding With Prophylactic Hemoclipping
2 other identifiers
interventional
11,182
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2011
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 19, 2012
CompletedFirst Posted
Study publicly available on registry
July 23, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2018
CompletedResults Posted
Study results publicly available
October 15, 2019
CompletedOctober 15, 2019
September 1, 2019
7.2 years
July 19, 2012
August 9, 2019
September 24, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
30 days
Study Arms (2)
Clip
EXPERIMENTALA clip is been placed at the polypectomy site.
No Clip
PLACEBO COMPARATORA hemoclip is not placed at the site of the polypectomy.
Interventions
Placement of hemoclip at polypectomy site for polyps at least 1cm in size
Eligibility Criteria
You may qualify if:
- Patients presenting for elective colonoscopy
You may not qualify if:
- Patients in which polypectomy can not be performed safely
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Dallas, Texas, 75216, United States
South Texas Health Care System, San Antonio, TX
San Antonio, Texas, 78229, United States
Central Texas Veterans Health Care System, Temple, TX
Temple, Texas, 76504, United States
Related Publications (1)
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.
PMID: 31158369DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Linda Feagins
- Organization
- VA
Study Officials
- PRINCIPAL INVESTIGATOR
Linda A Feagins
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2012
First Posted
July 23, 2012
Study Start
September 1, 2011
Primary Completion
November 1, 2018
Study Completion
November 1, 2018
Last Updated
October 15, 2019
Results First Posted
October 15, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will not share