Biopsy Incisional With Trepan in Periocular Lesions

NCT ID: NCT00865813

Last Updated: 2009-03-19

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2009-12-31

Brief Summary

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The purpose of this study was to identify accuracy rates of 2mm punch biopsy technique in diagnosing periocular malignancy.

Detailed Description

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In each case, the histology obtained at biopsy was compared with that identified at the time of tumor excision.

Conditions

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Tumor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Punch Biopsy

Group Type EXPERIMENTAL

Punch Biopsy

Intervention Type PROCEDURE

1. Instillation of anesthetic eye drops.
2. Asepsis
3. Placement of surgical cloths and drapes
4. Infiltration of the involved region with anesthetic solution plus adrenalin in1:200.00 dilution.
5. Trephination of the most typical area of the lesion with a punch (2mm in diameter) of stainless steel by applying gentle pressure and twisting the trephine until its introduction into the suspicious lesions
6. Removal of the excised tissue with the aid of an insulin needle or conjuntival forceps, the base then bein cut with an number 11 surgical blade

Interventions

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Punch Biopsy

1. Instillation of anesthetic eye drops.
2. Asepsis
3. Placement of surgical cloths and drapes
4. Infiltration of the involved region with anesthetic solution plus adrenalin in1:200.00 dilution.
5. Trephination of the most typical area of the lesion with a punch (2mm in diameter) of stainless steel by applying gentle pressure and twisting the trephine until its introduction into the suspicious lesions
6. Removal of the excised tissue with the aid of an insulin needle or conjuntival forceps, the base then bein cut with an number 11 surgical blade

Intervention Type PROCEDURE

Other Intervention Names

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Punch 2 mm Biopsy

Eligibility Criteria

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Inclusion Criteria

* All lesions were initially examined at the slitlamp, after which lesions with malignant characteristics such as texture, size or color alterations asociated with ulceration, prominent borders or elevated contours, irregular borders, telangiectasias or loss of eyelashes were included.

Exclusion Criteria

* Lesions with not malignant characteristics
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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University of Sao Paulo

Principal Investigators

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Rachel C Carneiro

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo - Hospital das Clinicas

Other Identifiers

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1143/07

Identifier Type: -

Identifier Source: org_study_id

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