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Assessing Endoloop-assisted Polypectomy in Patients With Antiplatelet Therapy

NCT ID: NCT01800656

Last Updated: 2013-02-28

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

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2010-12-31

Brief Summary

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The aims of this study were to examine: 1) safety and feasibility of antiplatelet therapy interruption 7 days prior to polypectomy in patients with long-term antiplatelet therapy; 2) safety and feasibility of endoloop assisted snare polypectomy in patients with long-term antiplatelet therapy; 3) safety and feasibility of so called "ligate and let go" approach in patients with long-term antiplatelet therapy.

Detailed Description

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Conditions

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Colorectal 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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Ligate and let go

Subjects are submitted to endoloop-assisted "ligate and let go" colorectal polypectomy.

Group Type EXPERIMENTAL

Endoloop-assisted "ligate and let go" colorectal polypectomy

Intervention Type PROCEDURE

The technique implies placement of endoloop snare on the base of large pedunculated colorectal polyps without consecutive snare polypectomy.

Snare polypectomy

Subjects are submitted to endoloop-assisted snare colorectal polypectomy

Group Type ACTIVE_COMPARATOR

Endoloop-assisted snare colorectal polypectomy

Intervention Type PROCEDURE

The technique implies placement of endoloop snare on the base of large pedunculated colorectal polyps with consecutive snare polypectomy.

Interventions

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Endoloop-assisted "ligate and let go" colorectal polypectomy

The technique implies placement of endoloop snare on the base of large pedunculated colorectal polyps without consecutive snare polypectomy.

Intervention Type PROCEDURE

Endoloop-assisted snare colorectal polypectomy

The technique implies placement of endoloop snare on the base of large pedunculated colorectal polyps with consecutive snare polypectomy.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* pedunculated colorectal polyps
* larger than 2cm in diameter
* long-term antiplatelet therapy

Exclusion Criteria

* presence of intraepithelial
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr Milutin Bulajic

OTHER

Sponsor Role lead

Responsible Party

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Dr Milutin Bulajic

Principal investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Milutin Bulajic, Dr

Role: PRINCIPAL_INVESTIGATOR

Hospital Danilo I Cetinje

Other Identifiers

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ENDL-001

Identifier Type: -

Identifier Source: org_study_id