Risk of Post-polypectomy Bleeding With Prophylactic Hemoclipping

Not Applicable

Completed

• Conditions: Elective Colonoscopy; Post-polypectomy Bleeding; Polypectomy
• Interventions: Device: NO hemoclip placement; Device: Hemoclip Placement

• Registration Number: NCT01647581
• Lead Sponsor: VA Office of Research and Development

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-09-01
• Study First Submitted: 2012-07-19
• Study First Submitted QC: 2012-07-19
• Study First Posted: 2012-07-23
• Primary Completion: 2018-11-01
• Study Completion: 2018-11-01
• Results First Submitted: 2019-08-09
• Status Verified: 2019-09
• Results First Submitted QC: 2019-09-24
• Last Update Submitted: 2019-09-24
• Results First Posted: 2019-10-15
• Last Update Posted: 2019-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11182

Inclusion Criteria

• Patients presenting for elective colonoscopy

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Exclusion Criteria

• Patients in which polypectomy can not be performed safely

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No Clip	NO hemoclip placement	A hemoclip is not placed at the site of the polypectomy.
Clip	Hemoclip Placement	A clip is been placed at the polypectomy site.

Primary Outcome Measures

Name	Time	Method
Number of Patients With Delayed Post Polypectomy Bleeding	30 days	rectal bleeding with associated Hb 2g drop, hemodynamic instability, or need for repeat colonoscopy or angiography or surgery

Trial Locations

Locations (3)

VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX; 🇺🇸 Dallas, Texas, United States

South Texas Health Care System, San Antonio, TX; 🇺🇸 San Antonio, Texas, United States

Central Texas Veterans Health Care System, Temple, TX; 🇺🇸 Temple, Texas, United States