Actively Recruiting
Comparison of LLETZ Versus LEEP for the Treatment of Cervical Dysplasia
Led by Ruhr University of Bochum · Updated on 2025-01-30
206
Participants Needed
1
Research Sites
229 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Comparison of LLETZ Versus LEEP for the Treatment of Cervical Dysplasia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed High Grade Squamous Intraepithelial Lesion (HSIL)
- Colposcopically visible lesion
- No previous treatment for the disease
You will not qualify if you...
- Pregnancy at or after inclusion in the study (pregnancy after conization and before 6-month control does not exclude)
- Use of immunosuppressive drugs, including glucocorticoids
- Known HIV positive status
- Malignant disease requiring treatment
- Unsatisfactory colposcopy
AI-Screening
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Trial Site Locations
Total: 1 location
1
Dept. OBGYN Ruhr University Bochum
Herne, Germany, 44625
Actively Recruiting
Research Team
C
Clemens B Temfper, MD, MBA
CONTACT
G
Günther A Rezniczek, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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