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A Trial of Two Electrosurgical Conizations: Histopathological Analysis of Excision Margins

Primary Purpose

Cervical Intraepithelial Neoplasia

Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
SWETZ
LLETZ cone
Sponsored by
Oswaldo Cruz Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Intraepithelial Neoplasia focused on measuring Conization, Cervical Intraepithelial Neoplasia, Cervix Dysplasia, Therapy, Electrosurgery

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Fernandes Figueira Institute - Oswaldo Cruz Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SWETZ

LLETZ cone

Arm Description

Straight wire excision of transformation zone is an electrosurgical conization method, which uses a straight wire electrode.

LLETZ cone is a electrosurgical conization method, which is performed with a large loop electrode of 20 mm depth.

Outcomes

Primary Outcome Measures

The Prevalence of Incomplete Excision of Dysplasia at the Endocervical Excision Margin as Recognized Histologically.
Incomplete excision was considered when high-grade intraepithelial (CIN2-3) or microinvasive neoplasia was present in the endocervical limit of the excised specimen.

Secondary Outcome Measures

Full Information

First Posted
June 10, 2012
Last Updated
June 30, 2015
Sponsor
Oswaldo Cruz Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01929993
Brief Title
A Trial of Two Electrosurgical Conizations: Histopathological Analysis of Excision Margins
Official Title
Large Loop Excision of Transformation Zone Cone Versus Straight Wire Excision of Transformation Zone : Histopathological Analysis of Excision Margins
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oswaldo Cruz Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Intraepithelial Neoplasia
Keywords
Conization, Cervical Intraepithelial Neoplasia, Cervix Dysplasia, Therapy, Electrosurgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
164 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SWETZ
Arm Type
Experimental
Arm Description
Straight wire excision of transformation zone is an electrosurgical conization method, which uses a straight wire electrode.
Arm Title
LLETZ cone
Arm Type
Active Comparator
Arm Description
LLETZ cone is a electrosurgical conization method, which is performed with a large loop electrode of 20 mm depth.
Intervention Type
Procedure
Intervention Name(s)
SWETZ
Other Intervention Name(s)
NETZ - Needle excision of transformation zone
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
LLETZ cone
Other Intervention Name(s)
LEEP - Loop electrosurgical excision procedure.
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Prevalence of Incomplete Excision of Dysplasia at the Endocervical Excision Margin as Recognized Histologically.
Description
Incomplete excision was considered when high-grade intraepithelial (CIN2-3) or microinvasive neoplasia was present in the endocervical limit of the excised specimen.
Time Frame
one month after the procedure

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria J Camargo, PHD
Organizational Affiliation
Oswaldo Cruz Foundation
Official's Role
Study Director
Facility Information:
Facility Name
Fernandes Figueira Institute - Oswaldo Cruz Foundation
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
22250-020
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
25783647
Citation
Russomano F, Tristao MA, Cortes R, de Camargo MJ. A comparison between type 3 excision of the transformation zone by straight wire excision of the transformation zone (SWETZ) and large loop excision of the transformation zone (LLETZ): a randomized study. BMC Womens Health. 2015;15:12. doi: 10.1186/s12905-015-0174-5. Epub 2015 Feb 18.
Results Reference
derived

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A Trial of Two Electrosurgical Conizations: Histopathological Analysis of Excision Margins

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