Cervical Intraepithelial Neoplasia
Conditions
Keywords
Cone biopsy, Conization, Loop electrosurgical excisional procedures, Large Loop Excision of Transformation Zone, Needle Excision of Transformation Zone, Straight Wire Excision of Transformation Zone, Electrosurgery
Brief summary
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.
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. 1. 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. 2. 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.
Interventions
PROCEDUREStraight Wire Excision of Transformation Zone
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.
PROCEDURELarge Loop Excision of Transformation Zone (cone biopsy)
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.
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endocervical Margin Not Free of Disease. | 3 months after the surgery is performed. | Primary outcome is the number of participants with incomplete excision of dysplasia at the endocervical excision margin as recognized histologically. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time Spent to Perform the Procedure | Time spent from randomization to complete the procedure | Time was recorded from insertion until removal of the vaginal speculum. |
Countries
Brazil
Participant flow
Recruitment details
Between November 1999 and December 2004, patients were assessed for eligibility, the great majority in Rio de Janeiro.
Pre-assignment details
127 women were eligible for both arms: 5 refused to participate, 19 did not meet inclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 51 |
| 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. | 52 |
| Total | 103 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | margin analysis not performed | 2 | 5 |
| Overall Study | specimen fragmentation, thermal damage | 1 | 2 |
Baseline characteristics
| Characteristic | LLETZ Cone - Loop Excision of TZ Cone Biopsy | Total | SWETZ - Straight Wire Excision of the Transformation Zone |
|---|---|---|---|
| Age, Continuous | 45.6 years STANDARD_DEVIATION 11.5 | 44.6 years STANDARD_DEVIATION 10.6 | 43.7 years STANDARD_DEVIATION 9.9 |
| Region of Enrollment Brazil | 46 participants | 92 participants | 46 participants |
| Region of Enrollment Ireland | 6 participants | 11 participants | 5 participants |
| Sex: Female, Male Female | 52 Participants | 103 Participants | 51 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 51 | 0 / 52 |
| serious Total, serious adverse events | 0 / 51 | 0 / 52 |
Outcome results
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.
Time frame: 3 months after the surgery is performed.
Population: All data were analysed bu intention to treat.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SWETZ | Endocervical Margin Not Free of Disease. | 8 participants |
| LLETZ Cone | Endocervical Margin Not Free of Disease. | 10 participants |
Secondary
Time Spent to Perform the Procedure
Time was recorded from insertion until removal of the vaginal speculum.
Time frame: Time spent from randomization to complete the procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SWETZ | Time Spent to Perform the Procedure | 13.5 minuts | Standard Deviation 5.3 |
| LLETZ Cone | Time Spent to Perform the Procedure | 23.2 minuts | Standard Deviation 8.1 |