RecruitingNot ApplicableNCT04772937

Comparison of LLETZ Versus LEEP for the Treatment of Cervical Dysplasia

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)

Sponsor

Ruhr University of Bochum

Enrollment

206 participants

Start Date

Jun 7, 2021

Study Type

INTERVENTIONAL

Conditions

Cervical Dysplasia

Summary

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).

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two very similar procedures — LLETZ and LEEP — for treating high-grade cervical cell changes (called HSIL, or high-grade squamous intraepithelial lesion). Both procedures remove abnormal cells from the cervix using an electrical wire loop, and the study aims to find out if one method is better than the other. **You may be eligible if...** - You have been diagnosed with high-grade cervical cell changes (HSIL) confirmed by biopsy - The abnormal area is visible during colposcopy (a cervical exam with magnification) - You have not yet received any treatment for this condition **You may NOT be eligible if...** - You are currently pregnant - You are taking immune-suppressing medications (including steroids) - You have a known HIV infection - You have a cancer that requires active treatment - The colposcopy exam was incomplete or unsatisfactory Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDURELLETZ

LLETZ is one of several possible surgical interventions for treating cervical dysplasia. The transformation zone of the cervix is completely removed

PROCEDURELEEP

LEEP is one of several possible surgical interventions for treating cervical dysplasia. Only the dysplastic lesion is removed without removing the whole transformation zone.