Radiofrequency Ablation vs Doppler-guided Haemorrhoidal Artery Ligation in the Treatment of Haemorrhoidal Disease
This study is looking into the best way to treat internal piles (haemorrhoids) that are causing significant symptoms and haven't improved with other treatments. Many people choose surgery for these types of piles, and this research focuses on two less invasive surgical options. The first method is called Doppler-guided haemorrhoidal artery ligation (DGHAL). It works by tying off the blood vessels that feed the piles, causing them to shrink. While often effective, piles can sometimes return within a few years. The second method, radiofrequency ablation (RFA), uses heat to shrink the piles. Early results suggest it might lead to fewer piles returning. This study aims to directly compare RFA with DGHAL to see if RFA is just as effective in stopping piles from coming back.
At a glance
What is this study about?
If you're experiencing problems with internal piles (also known as haemorrhoids) that are classified as Grade II or III – meaning they might prolapse (come out) when you go to the toilet but then go back in by themselves or with a gentle push – and other treatments haven't worked, your doctor might suggest surgery. This study is exploring two modern, less invasive surgical options for these types of piles.
One of the techniques is called Doppler-guided haemorrhoidal artery ligation (DGHAL). This procedure uses a special ultrasound device (Doppler) to find the arteries that supply blood to the piles. Once located, these arteries are carefully tied off, which reduces the blood flow and causes the piles to shrink over time. It’s a widely used method, and most people find it helps their symptoms. However, sometimes the piles can come back after a few years.
The other technique being studied is radiofrequency ablation (RFA). This involves using gentle heat from radio waves to shrink the piles. Initial results from other studies have been promising, suggesting that RFA might be very effective and perhaps lead to fewer piles returning compared to DGHAL. Currently, no research has directly compared these two treatments side-by-side, which is why this study is so important. The main goal is to see if RFA is just as effective as DGHAL in preventing piles from coming back, giving doctors and patients more information about the best treatment choice.
Key takeaways
- This study compares two surgical treatments for internal piles.
- It aims to find out if radiofrequency ablation (RFA) is as effective as Doppler-guided haemorrhoidal artery ligation (DGHAL).
- Participation involves receiving one of these treatments and attending follow-up appointments.
- This research could help improve future treatments for piles.
- You can withdraw from the study at any time.
Who may be eligible?
To be considered for this study, you need to be an adult (age 18 to 80) who is experiencing symptoms from Grade II or III internal piles. This means your piles are causing problems and your doctor thinks you need surgery to treat them because other simpler treatments haven't worked.
You also need to be someone who can understand what the study involves and is willing to give written permission to take part. You must also be registered with the UK social security system or be entitled to receive its benefits.
There are certain reasons why you might not be able to join. For example, if you have issues with blood clotting, active external piles (like a blood clot in an outer pile), or if you’ve had surgery for piles before (basic treatments like banding are usually fine). Other reasons include having certain bowel conditions like Crohn's disease or ulcerative colitis, a history of bowel cancer, or other specific problems around your bottom like fissures or fistulas. Women who are pregnant, breastfeeding, or could become pregnant without effective contraception cannot participate. Also, if you are involved in another medical study, or if you are under special legal care or guardianship, you wouldn't be able to join this study.
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 80 years old?
- Do you have symptomatic internal piles (Grade II or III) that need surgery?
- Have you understood the study information and are willing to give written consent?
- Are you registered with or entitled to social security benefits in the UK?
- Are you not pregnant or breastfeeding, and using effective contraception if needed?
What does participation involve?
If you decide to take part in this study, you will be assigned to receive either the Doppler-guided haemorrhoidal artery ligation (DGHAL) or radiofrequency ablation (RFA) treatment for your piles. Both are surgical procedures, and you would typically have them done in a hospital setting.
After your treatment, the study team will follow up with you to check on your recovery and how well the treatment worked. This will involve scheduled visits to the clinic where doctors will assess your symptoms and the condition of your piles. You might also be asked about your comfort level and any pain you experience.
The total duration of your participation in the study, including initial assessment, treatment, and follow-up appointments, will be explained in detail by the study team. You will be given a clear schedule of when you would need to attend follow-up appointments. There will be no additional medication outside of what's typically prescribed for these procedures.
Potential risks and benefits
Locations (18)
- Centre Hospitalier UniversitaireVerified postcodeAmiens, France· Recruiting
- Centre Hospitalier UniversitaireVerified postcodeAngers, France· Recruiting
- Maison de Santé BagatelleVerified postcodeBordeaux, France· Recruiting
- Centre Hospitalier PrivéVerified postcodeBrest, France· Recruiting
- Clinique du val d'OuestVerified postcodeÉcully, France· Recruiting
- Centre Hospitalier Départemental de VendéeVerified postcodeLa Roche-sur-Yon, France· Recruiting
- Hôpital de la LouvièreVerified postcodeLille, France· Recruiting
- CHU LimogesVerified postcodeLimoges, France· Recruiting
- Clinique de la SauvegardeVerified postcodeLyon, France· Recruiting
- Centre Hospitalier UniversitaireVerified postcodeNantes, France· Recruiting
- Clinique Jules VerneVerified postcodeNantes, France· Recruiting
- Hôpital Saint JosephVerified postcodeParis, France· Recruiting
Common questions
What are Grade II/III haemorrhoids?
These are internal piles that can come out when you go to the toilet, but either go back in by themselves or can be gently pushed back inside.
What is Doppler-guided haemorrhoidal artery ligation (DGHAL)?
It's a procedure that uses a special scanner to find the blood vessels feeding the piles, then ties them off to make the piles shrink.
What is radiofrequency ablation (RFA)?
RFA uses heat from radio waves to shrink your piles and help them go away.
Will I know which treatment I'm getting?
The study aims to compare the two methods, so you might be randomly assigned to receive either DGHAL or RFA.
What happens if the treatment doesn't work?
The study will track how well each treatment works, but your doctors will discuss further options if your symptoms don't improve or if piles return.
How to find out more
Agnès DORION
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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