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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
Sponsor:
Information provided by (Responsible Party):
MJCamargo, Oswaldo Cruz Foundation

Brief Summary:
The purpose of this trial is to evaluate if Straight Wire Excision of the Transformation Zone (SWETZ) is superior to (Large Loop Excision of the Transformation Zone) LLETZ cone in reducing the incomplete excision of disease.

Condition or disease Intervention/treatment Phase
Cervical Intraepithelial Neoplasia Procedure: SWETZ Procedure: LLETZ cone Phase 3

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 164 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SWETZ
Straight wire excision of transformation zone is an electrosurgical conization method, which uses a straight wire electrode.
Procedure: SWETZ
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.




Primary Outcome Measures :
  1. 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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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients were eligible if the colposcopist decided that a cone biopsy was indicated.
  • Common indications for a cone biopsy included:

    • High-grade Squamous Intraepithelial Lesion in a type 3 transformation zone,
    • suspicion of micro-invasive or invasive carcinoma and
    • suspicion of glandular disease.

Exclusion Criteria:

  • Patients were excluded if pregnancy, coagulation disorders and cervicitis were present or if they refused to participate in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01929993


Locations
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Brazil
Fernandes Figueira Institute - Oswaldo Cruz Foundation
Rio de Janeiro, RJ, Brazil, 22250-020
Sponsors and Collaborators
Oswaldo Cruz Foundation
Investigators
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Study Director: Maria J Camargo, PHD Oswaldo Cruz Foundation

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: MJCamargo, PHD, Oswaldo Cruz Foundation
ClinicalTrials.gov Identifier: NCT01929993     History of Changes
Other Study ID Numbers: 522/12
First Posted: August 28, 2013    Key Record Dates
Results First Posted: June 9, 2015
Last Update Posted: July 23, 2015
Last Verified: June 2015
Keywords provided by MJCamargo, Oswaldo Cruz Foundation:
Conization
Cervical Intraepithelial Neoplasia
Cervix Dysplasia
Therapy
Electrosurgery
Additional relevant MeSH terms:
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Cervical Intraepithelial Neoplasia
Neoplasms
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type