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RECRUITINGINTERVENTIONAL

Comparison of LLETZ Versus LEEP for the Treatment of Cervical Dysplasia

Comparison of Two Surgical Approaches in the Treatment of Cervical Dysplasia: Complete Removal of the Transformation Zone (LLETZ) Versus Isolated Resection of the Colposcopically Visible Lesion (LEEP)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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).

Who May Be Eligible (Plain English)

Who May Qualify: - diagnosed by tissue sample (biopsy-confirmed) High Grade Squamous Intraepithelial Lesion (HSIL) - Colposcopically visible lesion - No therapy of the disease so far Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

PROCEDURE

LLETZ

LLETZ is one of several possible surgical interventions for treating cervical dysplasia. The transformation zone of the cervix is completely removed

PROCEDURE

LEEP

LEEP is one of several possible surgical interventions for treating cervical dysplasia. Only the dysplastic lesion is removed without removing the whole transformation zone.

Locations (1)

Dept. OBGYN Ruhr University Bochum
Herne, Germany