Comparison of LLETZ Versus LEEP for the Treatment of Cervical Dysplasia

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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.

Study 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

Primary outcome measure(s)

• Surgical specimen margin status — Pathology assessment of the cone specimen (within 2-4 days after surgery)
  Oncological safety as defined by the rate of specimens with involved margins, i.e. cervical dysplasia present at the edge of the surgical specimen.

Trial sites (1)

More Ruhr University of Bochum trials in Germany

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