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)

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Histologically confirmed High Grade Squamous Intraepithelial Lesion (HSIL)

• Colposcopically visible lesion

• No therapy of the disease so far

Locations
Other Locations
Germany
Dept. OBGYN Ruhr University Bochum
RECRUITING
Herne
Contact Information
Primary
Clemens B Temfper, MD, MBA
clemens.tempfer@rub.de
+492323499
Backup
Günther A Rezniczek, PhD
guenther.rezniczek@rub.de
+492323499
Time Frame
Start Date: 2021-06-07
Estimated Completion Date: 2025-11
Participants
Target number of participants: 206
Treatments
Other: LLETZ group
LLETZ (large loop excision of the transformation zone) is one of several possible surgical interventions for treating cervical dysplasia.
Other: LEEP group
LEEP (loop electrosurgical excision procedure) is one of several possible surgical interventions for treating cervical dysplasia.
Related Therapeutic Areas
Sponsors
Leads: Ruhr University of Bochum

This content was sourced from clinicaltrials.gov