Risk of Post-polypectomy Bleeding With Prophylactic Hemoclipping

September 24, 2019 updated by: VA Office of Research and Development

Risk of Post-Polypectomy Bleeding With Prophylactic Hemoclipping

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11182

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75216
        • VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
      • San Antonio, Texas, United States, 78229
        • South Texas Health Care System, San Antonio, TX
      • Temple, Texas, United States, 76504
        • Central Texas Veterans Health Care System, Temple, TX

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients presenting for elective colonoscopy

Exclusion Criteria:

  • Patients in which polypectomy can not be performed safely

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Clip
A clip is been placed at the polypectomy site.
Device: Hemoclip Placement
Placement of hemoclip at polypectomy site for polyps at least 1cm in size
Other Names:
  • Clip
Placebo Comparator: No Clip
A hemoclip is not placed at the site of the polypectomy.
Device: NO hemoclip placement
No hemoclip placement (placebo / sham)
Other Names:
  • No Clip

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Linda A Feagins, VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2011

Primary Completion (Actual)

November 1, 2018

Study Completion (Actual)

November 1, 2018

Study Registration Dates

First Submitted

July 19, 2012

First Submitted That Met QC Criteria

July 19, 2012

First Posted (Estimate)

July 23, 2012

Study Record Updates

Last Update Posted (Actual)

October 15, 2019

Last Update Submitted That Met QC Criteria

September 24, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLNB-005-13F
  • DVAMC-11-026 (Other Grant/Funding Number: MERIT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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