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Age: 18Years +
FEMALE
ID04772937

Comparing Two Surgical Methods for Cervical Dysplasia Full Removal of the Transformation Zone LLETZ Versus Targeted Removal of the Visible Lesion LEEP

Led by Ruhr University of Bochum · Updated on 2025-01-30

206

Participants Needed

1

Research Sites

21 weeks

Total Duration

AI-Summary

What this Trial Is About

Cervical dysplasia is a precancerous condition that can lead to cervical cancer. Researchers are comparing two common surgical treatments, LLETZ and LEEP, to determine which method is safer in completely removing the abnormal tissue, known as oncological safety. This study aims to optimize surgical care by directly comparing the effectiveness of these procedures in women diagnosed with high-grade squamous intraepithelial lesions confirmed by biopsy. The study involves two surgical approaches LLETZ removes the entire transformation zone of the cervix including the lesion, while LEEP targets only the visible dysplastic lesion without removing the whole transformation zone. Participants will be randomly assigned to receive either LLETZ or LEEP surgery. After surgery, tissue samples are examined for completeness of lesion removal. Follow-up includes a test of cure with Pap smear and HPV testing 6 to 8 months after surgery to evaluate treatment success and detect any abnormalities. Participants undergo initial surgery followed by histological analysis of the removed tissue within days. At 6 to 8 months post-surgery, follow-up exams assess Pap smear results, HPV status, and colposcopic findings. If tests are normal, participants return to routine screening if abnormalities are found, further follow-up or treatment is planned. Patient pain, blood loss during surgery, and complication rates are also monitored. The study lasts until the 6-8 month follow-up, with additional monitoring as clinically needed.

CONDITIONS

Brief Title

Comparison of LLETZ Versus LEEP for the Treatment of Cervical Dysplasia

Research Team

C

Clemens B Temfper, MD, MBA

G

Günther A Rezniczek, PhD

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