Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Dysplasia | Cervical Intraepithelial Neoplasia | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LEEP | Procedure | — | UNRESOLVED |
| LLETZ | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- LLETZ group
- description
- LLETZ (large loop excision of the transformation zone) is one of several possible surgical interventions for treating cervical dysplasia.
- interventionNames
- Procedure: LLETZ
- type
- OTHER
- label
- LEEP group
- description
- LEEP (loop electrosurgical excision procedure) is one of several possible surgical interventions for treating cervical dysplasia.
- interventionNames
- Procedure: LEEP
Primary outcomes (1)
- measure
- Surgical specimen margin status
- timeFrame
- Pathology assessment of the cone specimen (within 2-4 days after surgery)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDMartin-Hirsch PP, Paraskevaidis E, Bryant A, Dickinson HO. Surgery for cervical intraepithelial neoplasia. Cochrane Database Syst Rev. 2013 Dec 4;2013(12):CD001318. doi: 10.1002/14651858.CD001318.pub3. PMID 24302546
- BACKGROUNDChua KL, Hjerpe A. Human papillomavirus analysis as a prognostic marker following conization of the cervix uteri. Gynecol Oncol. 1997 Jul;66(1):108-13. doi: 10.1006/gyno.1997.4753. PMID 9234930