Comparison of LLETZ Versus LEEP for the Treatment of Cervical Dysplasia

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorRuhr University of Bochum

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).

Eligibility criteria

Qualifiers

Histologically confirmed High Grade Squamous Intraepithelial Lesion (HSIL)

Colposcopically visible lesion

No therapy of the disease so far

Disqualifiers

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

Trial design

Treatments tested in this trial

  • LLETZ
  • LEEP

Treatment groups

206 Participants
are divided into 2 treatment groups

Sponsors and collaborators