Cervical Intraepithelial Neoplasia
Conditions
Keywords
Conization, Cervical Intraepithelial Neoplasia, Cervix Dysplasia, Therapy, Electrosurgery
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.
Interventions
PROCEDURESWETZ
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.
PROCEDURELLETZ 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.
Sponsors
Oswaldo Cruz Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Prevalence of Incomplete Excision of Dysplasia at the Endocervical Excision Margin as Recognized Histologically. | 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. |
Countries
Brazil
Participant flow
Recruitment details
Women who needed type 3 excision of the Transformation Zone referred to a colposcopy clinic in Rio de Janeiro, Brazil, after cytological screening between January 2008 thru December 2011.
Participants by arm
| Arm | Count |
|---|---|
| Straight Wire Excision of Transformation Zone (SWETZ) Straight wire excision of transformation zone (SWETZ) is an electrosurgical conization method, which uses a straight wire electrode as a knife to remove the dysplastic epithelium of the cervix. | 52 |
| Large Loop Excision of the Transformation Zone (LLETZ-cone) Large loop excision of the Transformation Zone (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. | 54 |
| Total | 106 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Absent CIN, invasion present or artifact | 26 | 22 |
| Overall Study | Protocol Violation | 4 | 6 |
Baseline characteristics
| Characteristic | Straight Wire Excision of Transformation Zone (SWETZ) | Large Loop Excision of the Transformation Zone (LLETZ-cone) | Total |
|---|---|---|---|
| Age, Continuous | 44 years STANDARD_DEVIATION 13.3 | 42.3 years STANDARD_DEVIATION 10.7 | 43.1 years STANDARD_DEVIATION 12 |
| Sex/Gender, Customized Female | 52 participants | 54 participants | 106 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 81 | 1 / 78 |
| serious Total, serious adverse events | 1 / 81 | 1 / 78 |
Outcome results
Primary
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.
Time frame: one month after the procedure
Population: Any compromised margin.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SWETZ | The Prevalence of Incomplete Excision of Dysplasia at the Endocervical Excision Margin as Recognized Histologically. | 28 participants |
| LLETZ Cone | The Prevalence of Incomplete Excision of Dysplasia at the Endocervical Excision Margin as Recognized Histologically. | 39 participants |