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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.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SWETZ | Experimental | 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.. |
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| LLETZ cone | Active Comparator | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Straight Wire Excision of Transformation Zone | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Endocervical Margin Not Free of Disease. | Primary outcome is the number of participants with incomplete excision of dysplasia at the endocervical excision margin as recognized histologically. | 3 months after the surgery is performed. |
| Measure | Description | Time Frame |
|---|---|---|
| Time Spent to Perform the Procedure | Time was recorded from insertion until removal of the vaginal speculum. | Time spent from randomization to complete the procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| WALTER PRENDIVILLE, PhD | British Society of Colposcopy | Study Director |
| WALTER PRENDIVILLE, PhD | International Federation of Cervical Pathology and Colposcopy | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Fernandes Figueira - Oswaldo Cruz Foundation | Rio de Janeiro | Rio de Janeiro | 22250-020 | Brazil | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25516462 | Derived | Camargo MJ, Russomano FB, Tristao MA, Huf G, Prendiville W. Large loop versus straight-wire excision of the transformation zone for treatment of cervical intraepithelial neoplasia: a randomised controlled trial of electrosurgical techniques. BJOG. 2015 Mar;122(4):552-7. doi: 10.1111/1471-0528.13200. Epub 2014 Dec 17. |
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127 women were eligible for both arms: 5 refused to participate, 19 did not meet inclusion criteria.
Between November 1999 and December 2004, patients were assessed for eligibility, the great majority in Rio de Janeiro.
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| ID | Title | Description |
|---|---|---|
| FG000 | SWETZ - Straight Wire Excision of the Transformation Zone | The experimental intervention was SWETZ (straight wire excision of the transformation zone), which uses a 1cm straight wire electrode to perform a cone. The activated electrode is applied for shaping a cone with the ambition of removing 20-25 mm length of endocervical epithelium. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Large Loop Excision of Transformation Zone (cone biopsy) | Procedure | 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. |
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| Instituto Fernandes Figueira |
| Rio de Janeiro |
| Rio de Janeiro |
| Brazil |
| FG001 |
| LLETZ Cone: Large Loop Excision of Transformation Zone - Cone |
The standard procedure, LLETZ - cone (large loop excision of tranformation zone used as cone biopsy), was performed with a large loop electrode of 20-25 mm depth. The activated loop is applied to the cervix outside the lateral margin of TZ (transformation zone) and brought slowly to just outside the controlateral transformation zone margin with the ambition of removing 20-25 mm length of endocervical epithelium. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | SWETZ - Straight Wire Excision of the Transformation Zone | The experimental intervention was SWETZ, which uses a 1cm straight wire electrode to perform a cone. The activated electrode is applied for shaping a cone with the ambition of removing 20-25 mm length of endocervical epithelium. |
| BG001 | LLETZ Cone - Loop Excision of TZ Cone Biopsy | The standard procedure, LLETZ - cone, was performed with a large loop electrode of 20-25 mm depth. The activated loop is applied to the cervix outside the lateral margin of TZ and brought slowly to just outside the controlateral TZ margin with the ambition of removing 20-25 mm length of endocervical epithelium. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Endocervical Margin Not Free of Disease. | Primary outcome is the number of participants with incomplete excision of dysplasia at the endocervical excision margin as recognized histologically. | All data were analysed bu intention to treat. | Posted | Number | participants | 3 months after the surgery is performed. |
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| Secondary | Time Spent to Perform the Procedure | Time was recorded from insertion until removal of the vaginal speculum. | Posted | Mean | Standard Deviation | minuts | Time spent from randomization to complete the procedure |
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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 the Transformation Zone | The experimental intervention was SWETZ, which uses a 1cm straight wire electrode to perform a cone. The activated electrode is applied for shaping a cone with the ambition of removing 20-25 mm length of endocervical epithelium. | 0 | 51 | 0 | 51 | ||
| EG001 | LLETZ Cone - Loop Excision of TZ Cone Biopsy | The standard procedure, LLETZ - cone, was performed with a large loop electrode of 20-25 mm depth. The activated loop is applied to the cervix outside the lateral margin of TZ and brought slowly to just outside the controlateral TZ margin with the ambition of removing 20-25 mm length of endocervical epithelium. | 0 | 52 | 0 | 52 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Investigator: MJCamargo [Camargo Maria José] Official Title: PHD | Affiliation: Oswaldo Cruz Foundation | 00552199777009 | mariaj.camargo@hotmail.com |
| ID | Term |
|---|---|
| D002578 | Uterine Cervical Dysplasia |
| D000084462 | Hyperthermia |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| 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 |
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| ID | Term |
|---|---|
| D019092 | Conization |
| ID | Term |
|---|---|
| D001706 | Biopsy |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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| Male |
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| Male |
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| Ireland |
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