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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SWETZ | Experimental | Straight wire excision of transformation zone is an electrosurgical conization method, which uses a straight wire electrode. |
|
| LLETZ cone | Active Comparator | LLETZ cone is a electrosurgical conization method, which is performed with a large loop electrode of 20 mm depth. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SWETZ | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | one month after the procedure |
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Inclusion Criteria:
Patients were eligible if the colposcopist decided that a cone biopsy was indicated.
Common indications for a cone biopsy included:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria J Camargo, PHD | Oswaldo Cruz Foundation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fernandes Figueira Institute - Oswaldo Cruz Foundation | Rio de Janeiro | Rio de Janeiro | 22250-020 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25783647 | Derived | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Straight Wire Excision of Transformation Zone (SWETZ) | Straight wire excision of transformation zone is an electrosurgical conization method, which uses a straight wire electrode to remove the dysplastic epithelium of the cervix. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Large Loop Excision of the Transformation Zone (LLETZ-cone) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Any compromised margin. | Posted | Number | participants | one month after the procedure |
|
Adverse events were observed during or through the first week after the procedures.
Participants at risk: the ones originally included and who received one of the procedures, no matter who had been excluded from the primary outcome analysis.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SWETZ | Straight wire excision of transformation zone is an electrosurgical conization method, which uses a straight wire electrode. 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hysterectomy | Injury, poisoning and procedural complications | Non-systematic Assessment | Hysterectomy due to vascular injury |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Needed general anesthesia | Injury, poisoning and procedural complications | Non-systematic Assessment | Needed general anesthesia due to some discomfort during the procedure. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Fábio Russomano | Fundação Oswaldo Cruz | 55 21 25541815 | fabiorussomano@gmail.com |
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| ID | Term |
|---|---|
| D002578 | Uterine Cervical Dysplasia |
| D000084462 | Hyperthermia |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
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|
| LLETZ cone | Procedure | 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. |
|
|
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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Number | participants |
|
LLETZ cone is a electrosurgical conization method, which is performed with a large loop electrode of 20 mm depth. 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. |
|
|
| 1 |
| 81 |
| 1 |
| 81 |
| EG001 | LLETZ Cone | LLETZ cone is a electrosurgical conization method, which is performed with a large loop electrode of 20 mm depth. 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. | 1 | 78 | 1 | 78 |
|
| vaginal injury | Injury, poisoning and procedural complications | Non-systematic Assessment | Accidental opening of the vaginal mucosa up to near the muscle layer of the bladder. |
|
|
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| D005831 |
| Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018882 | Heat Stress Disorders |
| D014947 | Wounds and Injuries |