Efficacy Study of Diathermy Cone Biopsy for the Treatment of Cervical Intraepithelial Lesion
A Study of Two Cone Biopsy Techniques For Women With Cervical Pre-Invasive Disease. LLETZ Cone and SWETZ.
The purpose of this trial is to determine whether SWETZ (Straight Wire Excision of Transformation Zone) is a superior alternative to LLETZ cone (Large Loop Excision of Transformation Zone 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.
Study Overview
Status
Conditions
Detailed Description
The treatment of precancerous lesions hinges on the destruction, or more commonly, the excision of the cervical transformation zone . When the transformation zone 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.
- The standard procedure, LLETZ - cone (Large Loop Excision of Transformation Zone cone biopsy), is performed with a large loop electrode of 20-25 mm depth. The activated loop was applied to the cervix outside the lateral margin of transformation zone and brought slowly to the controlateral margin with the objective to acquire 20-25 mm up the canal.
- The experimental intervention is SWETZ (Straight Wire Excision of Transformation Zone), 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 was used as a knife, fashioning a cone with desired dimensions.
This technique may be able to excise the endocervical transformation zone 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 in the management of endocervical pre-invasive disease.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Rio de Janeiro, Brazil, 22250-020
- Instituto Fernandes Figueira - Oswaldo Cruz Foundation
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Rio de Janeiro, Brazil
- Instituto Fernandes Figueira
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Incompletely visible transformation zone in women with High grade Squamous Intraepithelial Lesion (HSIL)
- Suspicion of microinvasive carcinoma or occult invasive carcinoma
- Suspicion of glandular disease
Exclusion Criteria:
- Pregnancy
- Coagulation disorders
- Cervicitis were present
- Refusal to participate in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: SWETZ
The intervention administered in this arm is the straight wire excision of the transformation zone, a electrosurgical method to perform a cone biopsy using a 1 cm straight wire of 0.20 mm wire.
The activated wire is used in much the same way as a cold knife or laser beam fashioning the surgical specimen to achieve two centimeters cm at cervical canal..
|
Straight wire excision of transformation zone is a electrosurgical conization method,which uses a straight wire electrode as a knife to remove the dysplastic epithelium of the cervix.
Other Names:
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Active Comparator: LLETZ cone
The intervention administered in this arm is the large loop excision of transformation zone as a cone biopsy, performed using a large loop electrode of 2 cm depth, applied to the cervix to achieving two centimeters at cervical canal .
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LLETZ cone is a electrosurgical conization method, which is performed with a large loop electrode of 20-25 mm depth.
The loop is applied to the cervix outside the lateral margin of TZ and brought slowly to the controlateral TZ margin.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Endocervical Margin Not Free of Disease.
Time Frame: 3 months after the surgery is performed.
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Primary outcome is the number of participants with incomplete excision of dysplasia at the endocervical excision margin as recognized histologically.
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3 months after the surgery is performed.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Time Spent to Perform the Procedure
Time Frame: Time spent from randomization to complete the procedure
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Time was recorded from insertion until removal of the vaginal speculum.
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Time spent from randomization to complete the procedure
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: WALTER PRENDIVILLE, PhD, British Society of Colposcopy
- Study Director: WALTER PRENDIVILLE, PhD, International Federation of Cervical Pathology and Colposcopy
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 522/99
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