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RecruitingNAINTERVENTIONAL

Comparison of LLETZ Versus LEEP for the Treatment of Cervical Dysplasia

This study looks at two standard ways to treat abnormal cells in the cervix, called LLETZ and LEEP. These abnormal cells, known as cervical dysplasia, can sometimes turn into cervical cancer if not treated. Both LLETZ and LEEP involve removing a piece of the cervix where the abnormal cells are. The main goal is to find out which method is more effective at completely removing all the problem cells without leaving any behind. We also want to see if one method causes fewer side effects, particularly for women who are thinking about future pregnancies. This research is important to help doctors decide the best way to treat cervical changes, making sure the treatment is as safe and effective as possible.

At a glance

Status
Recruiting
Phase
NA
Sponsor
Ruhr University of Bochum
Enrolment target
206
Start
07 Jun 2021
Estimated completion
01 Nov 2025

What is this study about?

When you have a smear test, sometimes it shows up abnormal cells on your cervix. These abnormal cells are called cervical dysplasia, and if they're left untreated, they could eventually turn into cervical cancer. Luckily, doctors can remove these abnormal cells with a simple procedure, and this usually stops cancer from developing.

There are a few ways doctors can remove these cells, but this study specifically looks at two common ones: LLETZ and LEEP. Both procedures use a thin, heated wire loop to carefully remove the problematic area from your cervix. The main difference is that LLETZ usually removes a slightly larger area, including a part of the cervix called the transformation zone, where abnormal cells often start. LEEP, on the other hand, aims to remove only the abnormal cells that are visible, trying to keep as much healthy tissue as possible.

Doctors want to make sure they remove all the abnormal cells to prevent them from growing back or turning into cancer. This is called 'oncologic safety'. At the same time, they want to avoid removing too much healthy tissue, as this could lead to complications later on, especially for women who plan to have children. This study will compare LLETZ and LEEP to see which method is better at removing all the abnormal cells safely and effectively, while also considering how much healthy tissue is removed. This will help doctors make the best choices for women's health.

Key takeaways

  • Compares two treatments (LLETZ and LEEP) for abnormal cervical cells.
  • Aims to find the safest and most effective treatment.
  • Focuses on completely removing abnormal cells.
  • Considers potential impact on future pregnancies.
  • Information gathered will improve future patient care.

Who may be eligible?

To join this study, you need to be a woman aged 18 or older with abnormal cells on your cervix. A specialist doctor must have confirmed that these cells are of a higher grade, and they must be visible during a special examination called a colposcopy. You also shouldn't have had any treatment for these specific abnormal cells before. You also shouldn't have started taking any medicines that suppress your immune system.

There are also some reasons why you wouldn't be able to join. For example, if you are currently pregnant or become pregnant before the study's first follow-up appointment (though getting pregnant after this appointment is okay). If you are taking medicines that weaken your immune system, or if you have HIV, or another serious illness that requires medical treatment, you wouldn't be able to participate. Also, if the colposcopy examination isn't clear enough, you might not be eligible.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Have you been told you have high-grade abnormal cells on your cervix?
  3. Are these abnormal cells visible to the doctor during examination?
  4. Have you not had any prior treatment for these specific abnormal cells?
  5. Are you not currently pregnant?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be assigned to either the LLETZ or LEEP procedure. Both procedures are common ways to remove abnormal cells from your cervix. After the procedure, you'll have follow-up appointments to check how you're healing and to make sure all the abnormal cells have been removed. This will likely involve another colposcopy and potentially further smear tests to monitor your progress over time. The study will track your health for about six months after the procedure to see the results. Your doctor will discuss the exact number of appointments and what each involves.

Potential risks and benefits

Taking part in this study could potentially benefit you by ensuring your abnormal cervical cells are treated effectively, which helps prevent cervical cancer. Researchers will carefully compare the effectiveness of two common procedures, contributing to better healthcare for women in the future. As with any medical procedure, there are some risks, such as bleeding, infection, and potential effects on future pregnancies, which your doctor will explain in detail. You are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

  • Dept. OBGYN Ruhr University Bochum
    Verified postcode
    Herne, Germany· Recruiting

Common questions

What is cervical dysplasia?

Cervical dysplasia means you have abnormal cells on your cervix that, if left untreated, could turn into cervical cancer.

What are LLETZ and LEEP?

These are two common, safe procedures where doctors use a heated wire loop to remove the abnormal cells from your cervix.

Why is this study important?

This study helps doctors understand which procedure, LLETZ or LEEP, is best at removing abnormal cells completely while causing the fewest side effects.

Will I know which treatment I receive?

Yes, you will be told whether you will have the LLETZ or LEEP procedure as part of the study.

Can I still have children after these procedures?

Both procedures are generally safe for future pregnancies, but this study aims to see if one might have fewer risks related to pregnancy.

How to find out more

Clemens B Temfper, MD, MBA

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Comparison of LLETZ Versus LEEP for the Treatment of Cervica…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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