Ongoing, recruitingPhase III and phase IV (Integrated)Interventional

Evaluation of the value of perianal infiltration during thermodestruction of hemorrhoidal disease by Radiofrequency (RAFAELO® procedure)

This research is looking into a treatment called RAFAELO® for people with piles (haemorrhoids). The main goal is to find out if giving a pain-numbing medicine called ropivacaine around the affected area during the RAFAELO® procedure helps reduce pain significantly in the first six hours after the operation. Researchers want to compare patients who receive this pain relief with those who don't, to see if adding ropivacaine makes a real difference to their comfort. This study is in the later stages of testing (Phase III and IV), meaning the treatment has already undergone some earlier safety checks. If successful, this could lead to an improved experience for patients undergoing this procedure.

At a glance

Status

Ongoing, recruiting

Phase

Phase III and phase IV (Integrated)

Sponsor

Centre Hospitalier Departemental Vendee

Enrolment target

134

Start

29 May 2024

hemorrhoidal disease

What is this study about?

This study is investigating a treatment for piles, also known as haemorrhoids. Piles are swollen blood vessels located inside or around your bottom, which can cause discomfort, itching, and sometimes bleeding. The specific treatment being looked at here is called the RAFAELO® procedure, which uses radiofrequency energy to treat the piles.

The main question this study wants to answer is whether injecting a pain-numbing medicine, called ropivacaine, into the area around the piles during the RAFAELO® procedure helps reduce pain afterwards. The researchers are particularly interested in how much pain patients experience in the first six hours following the procedure, as this is when the pain-numbing effect of ropivacaine is expected to be most active.

By comparing patients who receive this pain medicine with those who don't, the study aims to determine if this extra step makes the RAFAELO® procedure more comfortable and effective for relieving pain. This research is important because finding ways to manage pain better after procedures can greatly improve a patient's recovery and overall experience.

Key takeaways

This study is for people with piles (haemorrhoids).
It's looking at improving pain control during a treatment called RAFAELO®.
It investigates if a numbing medicine (ropivacaine) helps reduce pain in the first 6 hours after the procedure.
You must be 18 or older to potentially take part.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To be considered for this study, you need to be an adult, aged 18 years or older. There is no upper age limit, meaning older adults can also take part if they meet other criteria.

Both men and women are welcome to participate in this research. The study needs a diverse group of people to understand how the treatment works across different individuals.

Beyond age and gender, specific medical details about your piles will be checked by the study doctor to make sure you're a good fit. This helps ensure the study is safe for you and that the results will be meaningful for others with similar conditions.

Quick self-check

Are you 18 years old or older?
Do you have piles (haemorrhoids)?
Are you a man or a woman?
Are you willing to consider having the RAFAELO® procedure?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you would first have a screening visit to check if you are suitable. If you qualify, you would then undergo the RAFAELO® procedure for your piles. During this procedure, you would either receive the pain-numbing medicine ropivacaine or not, depending on which group you are assigned to. This decision is made randomly, like flipping a coin.

After the procedure, the main assessment will be about your pain levels over the first six hours. You would likely be asked to rate your pain using a simple scale. There will be follow-up appointments to monitor your recovery and make sure you are doing well. The full duration of your participation would be explained to you by the study team.

Potential risks and benefits

Taking part in this study might offer a potential benefit of better pain control after your RAFAELO® procedure if you receive the pain-numbing medicine. However, there's no guarantee that you will personally benefit. As with any medical procedure, there are potential risks, such as side effects from the pain medicine or complications from the procedure itself, which the study team will explain fully. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (1)

—
France

Common questions

What are piles?

Piles, also known as haemorrhoids, are swollen blood vessels inside or around your bottom that can cause itching, pain, and sometimes bleeding.

What is the RAFAELO® procedure?

The RAFAELO® procedure uses radiofrequency energy to treat piles. It's a way to shrink or remove them.

What is ropivacaine?

Ropivacaine is a medicine used to numb an area of your body to help reduce pain, similar to local anaesthetic.

Will I know if I receive the pain-numbing medicine?

In this type of study, often neither you nor the doctors know who receives the active medicine and who doesn't, to reduce bias. This is chosen randomly.

What does a 'Phase III and IV' study mean?

It means the treatment has already been tested for safety in earlier studies and is now being compared to existing treatments or further evaluated for long-term safety and effectiveness in a larger group of people.