Risk of Post-polypectomy Bleeding With Prophylactic Hemoclipping

VA Office of Research and Development11,182 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

11,182

Conditions

Post-polypectomy Bleeding Polypectomy Elective Colonoscopy

Interventions

Hemoclip PlacementDEVICE

Placement of hemoclip at polypectomy site for polyps at least 1cm in size

NO hemoclip placementDEVICE

No hemoclip placement (placebo / sham)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients presenting for elective colonoscopy Exclusion Criteria: * Patients in which polypectomy can not be performed safely

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

Outcomes

Primary Outcomes

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

Time frame: 30 days

Data from ClinicalTrials.gov

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