Surgery for cervical intraepithelial neoplasia.
Pierre P L Martin-Hirsch, Evangelos Paraskevaidis, Andrew Bryant...
https://pubmed.ncbi.nlm.nih.gov/24302546Actively Recruiting
Led by Ruhr University of Bochum · Updated on 2025-01-30
206
Participants Needed
1
Research Sites
21 weeks
Total Duration
Cervical dysplasia is a precancerous condition that can lead to cervical cancer. Researchers are comparing two common surgical treatments, LLETZ and LEEP, to determine which method is safer in completely removing the abnormal tissue, known as oncological safety. This study aims to optimize surgical care by directly comparing the effectiveness of these procedures in women diagnosed with high-grade squamous intraepithelial lesions confirmed by biopsy. The study involves two surgical approaches: LLETZ removes the entire transformation zone of the cervix including the lesion, while LEEP targets only the visible dysplastic lesion without removing the whole transformation zone. Participants will be randomly assigned to receive either LLETZ or LEEP surgery. After surgery, tissue samples are examined for completeness of lesion removal. Follow-up includes a "test of cure" with Pap smear and HPV testing 6 to 8 months after surgery to evaluate treatment success and detect any abnormalities. Participants undergo initial surgery followed by histological analysis of the removed tissue within days. At 6 to 8 months post-surgery, follow-up exams assess Pap smear results, HPV status, and colposcopic findings. If tests are normal, participants return to routine screening; if abnormalities are found, further follow-up or treatment is planned. Patient pain, blood loss during surgery, and complication rates are also monitored. The study lasts until the 6-8 month follow-up, with additional monitoring as clinically needed.
CONDITIONS
Comparison of LLETZ Versus LEEP for the Treatment of Cervical Dysplasia
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo surgical treatment by either LLETZ or LEEP to remove cervical dysplastic lesions.
1 surgical visit (in-person)
Duration - Up to 3 weeks
Participants are monitored for complications and recovery within 3 weeks after the surgery, including assessment of pain and blood loss.
Approximately 1 to 2 visits (in-person)
Duration - 6 to 8 months
Participants return for a 6-8 month follow-up including PAP smear, HPV test, and colposcopic examination to evaluate treatment success and cervical health.
1 follow-up visit (in-person)
Total: 1 location
1
Dept. OBGYN Ruhr University Bochum
Herne, Germany, 44625
Actively Recruiting
C
Clemens B Temfper, MD, MBA
G
Günther A Rezniczek, PhD
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Have more questions? Get in touch with our team for quick support
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Pierre P L Martin-Hirsch, Evangelos Paraskevaidis, Andrew Bryant...
https://pubmed.ncbi.nlm.nih.gov/24302546K L Chua, A Hjerpe
https://pubmed.ncbi.nlm.nih.gov/9234930