Risk of Post-polypectomy Bleeding With Prophylactic Hemoclipping

NCT ID: NCT01647581

Last Updated: 2019-10-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11182 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-01

Study Completion Date

2018-11-01

Brief Summary

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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

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Conditions

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Post-polypectomy Bleeding Polypectomy Elective Colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Clip

A clip is been placed at the polypectomy site.

Group Type EXPERIMENTAL

Hemoclip Placement

Intervention Type DEVICE

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

No Clip

A hemoclip is not placed at the site of the polypectomy.

Group Type PLACEBO_COMPARATOR

NO hemoclip placement

Intervention Type DEVICE

No hemoclip placement (placebo / sham)

Interventions

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Hemoclip Placement

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

Intervention Type DEVICE

NO hemoclip placement

No hemoclip placement (placebo / sham)

Intervention Type DEVICE

Other Intervention Names

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Clip No Clip

Eligibility Criteria

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Inclusion Criteria

* Patients presenting for elective colonoscopy

Exclusion Criteria

* Patients in which polypectomy can not be performed safely
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Linda A Feagins

Role: PRINCIPAL_INVESTIGATOR

VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Locations

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VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Dallas, Texas, United States

Site Status

South Texas Health Care System, San Antonio, TX

San Antonio, Texas, United States

Site Status

Central Texas Veterans Health Care System, Temple, TX

Temple, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 31158369 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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DVAMC-11-026

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CLNB-005-13F

Identifier Type: -

Identifier Source: org_study_id

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