Clinical Trial

Comparison of LLETZ Versus LEEP for the Treatment of Cervical Dysplasia

Recruiting
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Record status
This record was last updated January 30, 2025 (before its estimated June 2025 completion). Its status may not reflect the trial's current state.
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).
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2021-02-25; most recent amendment 2025-01-29.
Status change: Not Yet Recruiting → Recruiting 2021-12-17
Trial Details
NCT Number NCT04772937
Lead Sponsor Ruhr University of Bochum
Conditions Cervical Dysplasia
Enrollment 206 participants
Start Date 2021-06-07
Primary Completion 2025-06 (estimated)
Study Completion 2025-11 (estimated)
Updated on ClinicalTrials.gov 2025-01-30