NCT04772937Recruiting
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)
Source: ClinicalTrials.gov · Last updated 30 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 206 (estimated)
- First submitted
- 22 Feb 2021
- Start date
- 7 Jun 2021
- Primary completion date
- Jun 2025
- Lead sponsor
- Ruhr University of Bochum
- Diseases
- Cervical cancer
- NCT number
- NCT04772937
What you commit to
- Study type: Interventional
- Planned participants: 206
- From 7 Jun 2021 to the primary completion date, Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Taking immunosuppressive drugs (incl. glucocorticoids)
Other illness
- Known HIV positivity
- Malignant disease requiring treatment
Other
- 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.
- Unsatisfactory colposcopy
Who the study is looking for
- Histologically confirmed High Grade Squamous Intraepithelial Lesion (HSIL)
- Colposcopically visible lesion
- No therapy of the disease so far
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dept. OBGYN Ruhr University Bochum Coordinator of this site? Confirm its status | Herne | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.