Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT04772937

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

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed High Grade Squamous Intraepithelial Lesion (HSIL)
  • Colposcopically visible lesion
  • No previous treatment for the disease
Not Eligible

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

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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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