Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
ID04772937

Comparison of Two Surgical Approaches in the Treatment of Cervical Dysplasia: Complete Removal of the Transformation Zone (LLETZ) Versus Targeted Resection of the Visible Lesion (LEEP)

Led by Ruhr University of Bochum · Updated on 2025-01-30

206

Participants Needed

1

Research Sites

21 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Brief Title

Comparison of LLETZ Versus LEEP for the Treatment of Cervical Dysplasia

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed High Grade Squamous Intraepithelial Lesion (HSIL)
  • Colposcopically visible lesion
  • No prior treatment for cervical dysplasia
  • Female participants aged 18 years or older
Not Eligible

You will not qualify if you...

  • Pregnancy at or after study inclusion (pregnancy after conization and before 6-month control is allowed)
  • Use of immunosuppressive drugs, including glucocorticoids
  • Known HIV infection
  • Presence of malignant disease requiring treatment
  • Unsatisfactory colposcopy results preventing proper evaluation or treatment planning
  • Male participants or females under 18 years old are excluded by default due to study design and eligibility criteria restrictions if applicable (not explicitly stated but implied by gender and age criteria).

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery

Duration - 1 day

Participants undergo surgical treatment by either LLETZ or LEEP to remove cervical dysplastic lesions.

1 surgical visit (in-person)

Post-operative Follow-up

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)

Follow-up

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)

Trial Site Locations

Total: 1 location

1

Dept. OBGYN Ruhr University Bochum

Herne, Germany, 44625

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Research Team

C

Clemens B Temfper, MD, MBA

G

Günther A Rezniczek, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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