A Trial of Two Electrosurgical Conizations: Histopathological Analysis of Excision Margins
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|ClinicalTrials.gov Identifier: NCT01929993|
Recruitment Status : Completed
First Posted : August 28, 2013
Results First Posted : June 9, 2015
Last Update Posted : July 23, 2015
|Condition or disease||Intervention/treatment||Phase|
|Cervical Intraepithelial Neoplasia||Procedure: SWETZ Procedure: LLETZ cone||Phase 3|
Cone biopsy is a surgical procedure which objectives the excision of endocervical pre-invasive disease located at transformation zone or glandular epithelium. Although cone biopsy is considered adequate for the treatment of endocervical dysplastic epithelium , using electrosurgery as opposed to the cold knife technique of cone biopsy has been criticized because of the perceived potential for incomplete excision of disease, thermal damage and surgical specimen fragmentation, which might increase the risk of missing early invasive cancer. Also, incomplete excision margin of disease exposes women to an increased risk of residual post-treatment disease.
The standard procedure, Large Loop Excision of the Transformation Zone (LLETZ-cone), is performed with a large loop electrode of 20-25 mm depth.
The experimental intervention is Straight Wire Excision of the Transformation Zone (SWETZ), a method of excision using a 1cm straight disposal of 0.20 wire to remove the endocervical transformation zone or glandular disease.
Both procedures were previously studied in another clinical trial(NCT00995020), but the histological analysis were inconclusive for many outcomes. SWETZ were superior to LLETZ cone to acquire complete excision of disease, with no statistical significance, probably due to the small sample size.
This study objectives a better histological analyses of the surgical specimens related to incomplete excision, thermal damage and fragmentation.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||164 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Large Loop Excision of Transformation Zone Cone Versus Straight Wire Excision of Transformation Zone : Histopathological Analysis of Excision Margins|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||February 2012|
Straight wire excision of transformation zone is an electrosurgical conization method, which uses a straight wire electrode.
Straight wire excision of transformation zone is an electrosurgical conization method, which uses a straight wire electrode as a knife to remove the dysplastic epithelium of the cervix.
Other Name: NETZ - Needle excision of transformation zone
Active Comparator: LLETZ cone
LLETZ cone is a electrosurgical conization method, which is performed with a large loop electrode of 20 mm depth.
Procedure: LLETZ cone
LLETZ cone is a electrosurgical conization method, which is performed with a large loop electrode of 20 mm depth. The loop is applied to the cervix outside the lateral margin of the transformation zone and brought slowly to the controlateral transformation zone margin.
Other Name: LEEP - Loop electrosurgical excision procedure.
- The Prevalence of Incomplete Excision of Dysplasia at the Endocervical Excision Margin as Recognized Histologically. [ Time Frame: one month after the procedure ]Incomplete excision was considered when high-grade intraepithelial (CIN2-3) or microinvasive neoplasia was present in the endocervical limit of the excised specimen.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01929993
|Fernandes Figueira Institute - Oswaldo Cruz Foundation|
|Rio de Janeiro, RJ, Brazil, 22250-020|
|Study Director:||Maria J Camargo, PHD||Oswaldo Cruz Foundation|