Comparison of LLETZ Versus LEEP for the Treatment of Cervical Dysplasia

Recruiting now · Not applicable

Conditions studied: Cervical Dysplasia

In brief

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).

Key facts

Study ID

NCT04772937

Run by

Ruhr University of Bochum

People needed

206

Starts

2021-06-07

Expected to finish

2025-11-01

Last updated by the study team

2025-01-30

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Dept. OBGYN Ruhr University Bochum — Herne, Germany (enrolling)

Full record on ClinicalTrials.gov

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