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Diathermy Cone Biopsy: A Study of Two Techniques.

2014-07-23 21:12:28 | BioPortfolio

Summary

The purpose of this trial is to determine whether SWETZ (Straight Wire Excision of Transformation Zone) is a superior alternative to LLETZ cone biopsy in the management of pre-invasive endocervical disease.

SWETZ is a new cone biopsy procedure performed with a straight wire electrode and it will be compared to LLETZ cone, which is performed with a large loop electrode.

Description

The treatment of precancerous lesions hinges on the destruction, or more commonly, the excision of the cervical transformation zone (TZ). When the TZ contains squamous precancer and is completely ectocervical and therefore full visible, excision or destruction is an effective and relatively straightforward therapeutic entity. However in a small proportion of women a cone biopsy is necessary. A cone biopsy often requires the excision of 20-30 mms of endocervical canal.

Interventions.

1. The standard procedure, LLETZ - cone ( also called LEEP), is performed with a large loop electrode of 20-25 mm depth. The activated loop is applied to the cervix outside the lateral margin of TZ and brought slowly to the controlateral TZ margin with the objective to acquire 20-25 mm up the canal.

2. The experimental intervention is SWETZ, a method of excision using a 1cm straight disposal of 0.20 wire to remove the endocervical transformation zone or glandular disease. The activated wire is used as a knife, fashioning a cone with desired dimensions.

This technique may be able to excise the endocervical TZ with a lower rate of morbidity and incomplete excision rate than LLETZ cone biopsy.

The hypothesis to be tested in this trial is that SWETZ is superior to LLETZ cone biopsy in the management of endocervical pre-invasive disease.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Conditions

Uterine Cervical Dysplasia

Intervention

Straight Wire Excision of Transformation Zone, Large Loop Excision of Transformation Zone (cone biopsy)

Location

Instituto Fernandes Figueira - Oswaldo Cruz Foundation
Rio de Janeiro
Brazil
22250-020

Status

Recruiting

Source

Oswaldo Cruz Foundation

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:12:28-0400

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