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Comparison of Prophylactic Clip and Detachable Snare

NCT ID: NCT01406379

Last Updated: 2013-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

203 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2013-02-28

Brief Summary

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Although endoscopic colonic polypectomy has been an established procedure for two decades, the risk of bleeding is still higher after resecting of pedunculated polyps, because of the presence of a large artery in the stalk. Several preventive methods such as detachable snare and adrenaline injection have been proposed in the management of postpolypectomy bleeding in large colonic polyps. For prophylactic clip, there was no prospective randomized study assessing the efficacy in the prevention of postpolypectomy bleeding for the large pedunculated polyps. So we designed a prospective, randomized study to compares the efficacy of application of prophylactic clip and detachable snare in the prevention of postpolypectomy bleeding in large polyps. Application of prophylactic clip will be as effective and safe method as detachable snare in the prevention of postpolypectomy bleeding for the large pedunculated colonic polyps.

Detailed Description

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Conditions

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Colonic Polyp

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Prophylactic clip

Prophylactic clip

Group Type EXPERIMENTAL

Prophylactic clip

Intervention Type PROCEDURE

Before conventional snare polypectomy, hemoclips were applied on the base of stalk in the prophylactic clip group

Detachable snare

Detachable snare

Group Type ACTIVE_COMPARATOR

Detachable snare

Intervention Type PROCEDURE

In the detachable snare group, detachable snare was positioned at the base of stalk and followed by conventional snare polypectomy

Interventions

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Prophylactic clip

Before conventional snare polypectomy, hemoclips were applied on the base of stalk in the prophylactic clip group

Intervention Type PROCEDURE

Detachable snare

In the detachable snare group, detachable snare was positioned at the base of stalk and followed by conventional snare polypectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with pedunculated colorectal polyps, the heads of which were larger than 10mm and the stalk of which were large than 5 mm in diameter, were included.

Exclusion Criteria

* bleeding tendency
* poor preparation
* sessile polyp
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Catholic University of Korea

OTHER

Sponsor Role lead

Responsible Party

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Jeong-Seon Ji

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Ji JS, Lee SW, Kim TH, Cho YS, Kim HK, Lee KM, Kim SW, Choi H. Comparison of prophylactic clip and endoloop application for the prevention of postpolypectomy bleeding in pedunculated colonic polyps: a prospective, randomized, multicenter study. Endoscopy. 2014 Jul;46(7):598-604. doi: 10.1055/s-0034-1365515. Epub 2014 May 15.

Reference Type DERIVED
PMID: 24830400 (View on PubMed)

Other Identifiers

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Prophylatic clip

Identifier Type: -

Identifier Source: org_study_id