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Comparison of LLETZ Versus LEEP for the Treatment of Cervical Dysplasia

ConditionCervical Dysplasia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorRuhr University of Bochum

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed High Grade Squamous Intraepithelial Lesion (HSIL)

Colposcopically visible lesion

No therapy of the disease so far

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • LLETZ

    Procedure/Surgery

    LLETZ is one of several possible surgical interventions for treating cervical dysplasia. The transformation zone of the cervix is completely removed

  • LEEP

    Procedure/Surgery

    LEEP is one of several possible surgical interventions for treating cervical dysplasia. Only the dysplastic lesion is removed without removing the whole transformation zone.

Treatment groups

206 Participants
are divided into 2 treatment groups
Group A: LLETZ groupOther 1 intervention
Group B: LEEP groupOther 1 intervention

Trial outcomes

Primary outcomes

1

Surgical specimen margin status

Oncological safety as defined by the rate of specimens with involved margins, i.e. cervical dysplasia present at the edge of the surgical specimen.

Time frame
Pathology assessment of the cone specimen (within 2-4 days after surgery)

Secondary outcomes

1

Intraoperative and postoperative complication rate

Rate of complications such as excessive bleeding, re-operation, unplanned readmission, infection

Time frame
During and within 3 weeks after the procedure
2

Cone size

Size of the resected tissue

Time frame
During surgery
3

Patient's pain

Pain experienced by the patients (11-item Visual Analogue Scale); minimum 0 (no pain), maximum 10 (unbearable pain)

Time frame
Immediately after the surgery
4

HPV clearance

HPV high-risk positivity by PCR

Time frame
6 months post surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ruhr University of Bochum

Lead sponsor

Source ClinicalTrials.gov
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