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Comparison of LLETZ Versus LEEP for the Treatment of Cervical Dysplasia

StatusRecruiting
PhaseNot applicable
Started
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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.

Record History

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  1. Primary completion date: Sep 2024 to Jun 2025
    • Study completion date: Mar 2025 to Nov 2025
    v8
  2. Primary completion date: Jul 2023 to Sep 2024
    • Study completion date: Jan 2024 to Mar 2025
    v7
  3. Primary completion date: Dec 2022 to Jul 2023
    • Study completion date: Aug 2023 to Jan 2024
    v6
  4. 2 versions Re-verified since Jun 2, 2022, no change to tracked fieldsv4-v5
  5. Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Study sites: 0 to 1
    • Primary completion date: Oct 2022 to Dec 2022
    • Study completion date: Jun 2023 to Aug 2023
    • Start date changed from estimate of Apr 2021 to Jun 7, 2021
  6. Primary endpoint revisedv2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT04772937
Lead Sponsor Ruhr University of Bochum
Conditions
(from sponsor)		 Cervical Dysplasia
Related terms Uterine Cervical Dysplasia, Uterine Cervical Neoplasms
Enrollment 206 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov