Comparing two surgical methods to remove abnormal cervical cells
Compares two surgical procedures to remove abnormal cells of the cervix in adults.
Plain-language title generated from the registry record
Registry title: Comparison of LLETZ Versus LEEP for the Treatment of Cervical Dysplasia
Key facts
- Where
- Herne, GermanySee the site
Where in Germany
- Dept. OBGYN Ruhr University BochumHerne, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ruhr University of Bochum
- Trial code
- NCT04772937
- Record updated
- 30 January 2025
- Original description
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.Read full original descriptionShow less
Comparison of Two Surgical Approaches in the Treatment of Cervical Dysplasia: Complete Removal of the Transformation Zone (LLETZ) Versus Isolated Resection of the Colposcopically Visible Lesion (LEEP)
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).
Inclusion: Histologically confirmed High Grade Squamous Intraepithelial Lesion (HSIL); Colposcopically visible lesion; No therapy of the disease so far.
Exclusion: Taking immunosuppressive drugs (incl. glucocorticoids); Known HIV positivity; Malignant disease requiring treatment; 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; Unsatisfactory colposcopy.