Comparison of LLETZ Versus LEEP for the Treatment of Cervical Dysplasia
NCT04772937
Summary
Cervical dysplasia is the precursor of cervical cancer. LEEP and LLETZ are standard surgical procedures to treat cervical dysplasia. There is no direct head-to-head comparison between LEEP and LLETZ in the literature regarding oncologic safety, for which complete resection of the dysplastic lesion (so-called 'in-sano resection') is the most appropriate postoperative surrogate parameter. Further clinical studies are therefore useful to optimize surgical therapy for cervical dysplasia. The primary objective of the present study is to compare LLETZ (resection of the dysplastic lesion including the transformation zone) with targeted resection of the colposcopically conspicuous lesion only (LEEP) and to compare it with regard to oncological safety (defined as non-in-sano rate).
Eligibility
Inclusion Criteria: * Histologically confirmed High Grade Squamous Intraepithelial Lesion (HSIL) * Colposcopically visible lesion * No therapy of the disease so far Exclusion Criteria: * Pregnancy of the patient at/after inclusion in the study; pregnancy after conization and before the control after 6 months is possible and does not lead to exclusion from the study. * Taking immunosuppressive drugs (incl. glucocorticoids) * Known HIV positivity * Malignant disease requiring treatment * Unsatisfactory colposcopy
Conditions2
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NCT04772937