Cervical Intraepithelial Neoplasia Clinical Trial
Official title:
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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