RecruitingNot ApplicableNCT04772937

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)

Sponsor

Ruhr University of Bochum

Enrollment

206 participants

Start Date

Jun 7, 2021

Study Type

INTERVENTIONAL

Conditions

Cervical Dysplasia

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria3

Histologically confirmed High Grade Squamous Intraepithelial Lesion (HSIL)
Colposcopically visible lesion
No therapy of the disease so far

Exclusion Criteria5

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

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Interventions

PROCEDURELLETZ

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

PROCEDURELEEP

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