Comparing two surgical methods for treating cervical dysplasia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to compare the oncological safety of two surgical procedures, LLETZ and LEEP, for the treatment of cervical dysplasia. LLETZ involves the complete resection of the dysplastic lesion along with the transformation zone, while LEEP targets only the visibly affected area. The primary focus is to determine which method has a lower rate of incomplete resection, known as 'non-in-sano rate'. By evaluating these two approaches, the study seeks to optimize surgical therapy for cervical dysplasia and improve patient outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histologically confirmed High Grade Squamous Intraepithelial Lesion (HSIL)
* Colposcopically visible lesion
* No therapy of the disease so far

Exclusion Criteria:

* 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.
* Taking immunosuppressive drugs (incl. glucocorticoids)
* Known HIV positivity
* Malignant disease requiring treatment
* Unsatisfactory colposcopy

Where it's running

• Dept. OBGYN Ruhr University Bochum
  Herne, Germany Recruiting

Study contacts

• Principal investigator: Clemens B Tempfer, MD, MBA — Ruhr-Universität Bochum / Marien Hospital Herne
• Study coordinator: Clemens B Temfper, MD, MBA
• Email: clemens.tempfer@rub.de
• Phone: +492323499

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.