RecruitingNAINTERVENTIONAL

Efficacy and Safety of RAdiofrequency Versus HAL- RAR DOppler in Hemorrhoidal Pathology

This study looks at two different surgical treatments for piles (haemorrhoids) that cause symptoms like pain or bleeding. One is a newer, less invasive technique called radiofrequency (Rafaelo), which uses heat to shrink the piles. The other is a common method called arterial ligation, which involves tying off the blood vessels supplying the piles, sometimes with a 'Doppler' device to help find them. The study wants to find out which treatment works best, is safest, causes less pain, and allows people to return to their daily activities and work sooner. It's particularly for individuals whose piles are causing significant trouble and haven't responded to other treatments. The research will help doctors understand more about the radiofrequency method's effectiveness and how it compares to existing treatments.

At a glance

Status

Recruiting

Phase

Sponsor

Elsan

Enrolment target

100

Start

03 Jan 2023

Estimated completion

01 Aug 2025

Hemorrhoids

What is this study about?

This study is looking into treatments for a common problem called haemorrhoids, which many people know as 'piles'. Piles are swellings that contain blood vessels found inside or around the bottom. While everyone has these tissues, 'haemorrhoidal disease' happens when they become swollen and cause problems like pain, bleeding, or itching. If milder treatments haven't worked, surgery might be an option.

This study is comparing two different surgical approaches. One is a newer, less invasive option called radiofrequency, sometimes known as the Rafaelo technique. This method uses gentle heat to carefully shrink the piles. It's often done with light sedation or a short general anaesthetic, and aims to cause less pain and allow a quicker return to everyday life. The other treatment is a well-established surgical method called arterial ligation, which involves tying off the small blood vessels that supply the piles, often guided by a special ultrasound called a Doppler.

The main goal of this research is to see how well these two treatments work, how safe they are, and how they affect a person's quality of life, including how long people need to take off work. While the radiofrequency technique is already used in some other countries, this study will help doctors in France (where this trial is based) understand its benefits and how it stacks up against more traditional surgical options for piles. It's important to find the best ways to help people living with this uncomfortable condition.

Key takeaways

Compares two treatments for bothersome piles: radiofrequency (new) and arterial ligation (established).
Aims to find out which treatment is more effective, safer, and allows quicker recovery.
For internal piles (grade II or III) that haven't responded to other treatments.
Potential benefits include access to a newer, possibly less painful treatment.
Participation involves a surgical procedure and follow-up to assess recovery and quality of life.

Who may be eligible?

This study is looking for both men and women between 18 and 75 years old who are experiencing problems with their piles (specifically grades II or III, which means they are noticeable and sometimes protrude, but often go back in). You'd be considered if your piles are causing symptoms and haven't gotten better with simpler treatments like lifestyle changes or medications, or other minor procedures.

However, there are certain situations where you wouldn't be able to join the study. For example, if you have other ongoing gut conditions like inflammatory bowel disease, or certain blood disorders. If you're pregnant or breastfeeding, or if you're taking specific blood-thinning medications that can't be stopped, you also wouldn't be able to participate. Similarly, if you have other anal conditions like fistulas or severe fissures, or if your piles are only on the outside of your bottom, this study might not be right for you.

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.

Are you between 18 and 75 years old?
Do you have troublesome internal piles (not just external ones)?
Have your piles not improved with other non-surgical treatments?
Are you not pregnant or breastfeeding?
Do you not have other serious bowel conditions or certain blood disorders?
Are you not currently taking specific blood-thinning medicines that you cannot stop?

Answer every question to see your result.

What does participation involve?

The information provided does not fully detail the specifics of participation, such as the exact number of visits, assessments, or the total duration of follow-up. However, based on the description, if you are eligible and choose to take part, you would likely undergo one of the two surgical procedures being compared: either the radiofrequency treatment or the arterial ligation with Doppler. Both procedures are typically performed under sedation or a short general anaesthetic. You would also be asked to provide informed consent, meaning you'd fully understand the study and agree to participate. The study aims to evaluate aspects like pain levels, recovery time, improvement in quality of life, and how long you might need off work, suggesting there would be follow-up appointments or surveys to monitor these outcomes over a period after your procedure.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. For this study, a potential benefit could be access to a new, potentially less invasive treatment (radiofrequency) for your piles, which aims for a quicker recovery and less pain. You might also benefit from carefully monitored care. However, as with any surgical procedure, there are always risks, such as infection, bleeding, or complications from anaesthesia, even with minimally invasive techniques. You will be fully informed of these before deciding to participate. Remember, you can always change your mind and withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

Private hospital Guillaume de Varye
Verified postcode
Saint-Doulchard, France· Recruiting
Centre Clinical
Verified postcode
Soyaux, France· Not yet recruiting

Common questions

What are haemorrhoids (piles)?

Piles are swollen blood vessels inside or around your bottom that can cause discomfort, bleeding, or itching.

What is the Rafaelo technique?

It's a newer, less invasive treatment for piles that uses gentle heat (radiofrequency) to shrink them, aiming for less pain and quicker recovery.

Are the treatments in this study surgery?

Yes, both treatments are surgical procedures, though the radiofrequency technique is considered 'mini-invasive'.

What kind of piles is this study for?

It's for internal piles (grades II or III), which are inside your bottom and may sometimes come out but usually go back in.

Can I join if I'm pregnant?

No, pregnant or breastfeeding women cannot participate in this study.

How to find out more

Pflieger Hannah, MD

docteurhannahpflieger@gmail.com (0)2 48 68 85 63 Official trial record

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