This study looks at immediate treatment of a cervix with CIN 1 versus regular six-month follow-up with colposcopy and treatment if CIN 1 progresses.
In women who present with biopsy-proven CIN 1, to compare the management approach of regular colposcopic follow-up and only treating progressive disease using the LEEP, with an approach of immediate treatment using LEEP. The primary outcome is progression to more advanced disease (i.e., CIN 2, CIN 3 or cancer).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
415
1\. loop electrosurgical excision procedure
Universidade Estadual de Campinas
Campinas, Brazil
Instituto Fernandes Figueira - Oswaldo Cruz Foundation
Rio de Janeiro, Brazil
B.C. Cancer Agency
Vancouver, British Columbia, Canada
progression to more advanced disease
Time frame: 18 months
persistent CIN 1 after 18 months
Time frame: 18 months
bleeding.
Time frame: 18 months
predict disease persistence or progression
Time frame: 18 months
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