CONE BIOPSY: LLETZ CONE vs SWETZ FOR WOMEN WITH CERVICAL PRE-INVASIVE DISEASE. A Randomised Controlled Trial.
N/A
N/A
N/A
N/A
N/A
Not Enrolling
Female
Cervical Intraepithelial Neoplasia
Female
Cervical Intraepithelial Neoplasia
Trial Information
CONE BIOPSY: LLETZ CONE vs SWETZ FOR WOMEN WITH CERVICAL PRE-INVASIVE DISEASE. A Randomised Controlled Trial.
Women with the indication to a cone biopsy were randomized to undergo to a LLETZ cone, or
SWETZ. A large loop electrode of 20-25 mm depth and a 1cm straight wire electrode were used.
The aim was to remove the endocervical epithelium dysplasia completely.
Inclusion Criteria:
- HSIL in a type 3 TZ (endocervical transformation zone)
- Suspicion of micro-invasive or invasive carcinoma
- Suspicion of glandular disease
Exclusion Criteria:
- Pregnancy
- Cervicitis
- Coagulation disorders
- Refusal to participate in the study
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Histological recognized dysplasia at the endocervical margin.
Outcome Time Frame:
Two months
Safety Issue:
No
Authority:
Brazil: Ministry of Health
Study ID:
CONEP 522/99
NCT ID:
NCT01733225
Start Date:
November 1999
Completion Date:
March 2012
Related Keywords:
- Cervical Intraepithelial Neoplasia
- Conization
- Cervical Intraepithelial Neoplasia
- Cervix Dysplasia
- Therapy
- Electrosurgery
- Neoplasms
- Cervical Intraepithelial Neoplasia
- Carcinoma in Situ
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