Comparing two surgical methods for treating 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)
This study is testing which of two surgical methods for treating cervical dysplasia is safer and more effective in removing abnormal cells.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 206 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Ruhr University of Bochum Academic / other |
| Locations | 1 site (Herne) |
| Trial ID | NCT04772937 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are women with histologically confirmed High Grade Squamous Intraepithelial Lesion (HSIL) and a colposcopically visible lesion.
Not a fit: Patients who are pregnant, taking immunosuppressive drugs, or have other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical techniques that enhance the safety and effectiveness of cervical dysplasia treatment.
How similar studies have performed: While there is limited direct comparison data between LLETZ and LEEP, previous studies on cervical dysplasia treatments have shown varying degrees of success with different surgical methods.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Herne
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.