Actively Recruiting
Radiofrequency Ablation vs Doppler-guided Haemorrhoidal Artery Ligation in the Treatment of Haemorrhoidal Disease
Led by Centre Hospitalier Departemental Vendee · Updated on 2026-03-13
168
Participants Needed
18
Research Sites
342 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Surgical treatment of grade II/III internal haemorrhoidal disease is indicated in the case of medical and/or instrumental treatment failure. Minimal invasive alternatives to haemorrhoidectomy have been introduced in the last decades to treat grade II/III haemorrhoids. Doppler-Guided haemorrhoidal artery ligation (DGHAL) represents a good therapeutic option in this condition with good short and mid-term outcomes but postoperative recurrence rates up to 35% at 5 years. Recently, a technique of radiofrequency ablation (RFA) has been introduced with promising outcomes. A recent systematic review reported a significant improvement of preoperative symptoms and a recurrence rate \< 5%. To date, there is no study comparing DGHAL to RFA in the treatment of grade II/III haemorrhoids. The aim of this study is to demonstrate the non-inferiority in terms of failure rate of haemorrhoidal radiofrequency ablation compared to Doppler-guided haemorrhoidal artery ligation, associated with mucopexy, in the treatment of grade II and III haemorrhoidal disease
CONDITIONS
Official Title
Radiofrequency Ablation vs Doppler-guided Haemorrhoidal Artery Ligation in the Treatment of Haemorrhoidal Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients aged 18 to 80 years
- Symptomatic Grade II or III haemorrhoidal disease
- Haemorrhoidal disease requiring surgical treatment
- Able to understand the study and provide written informed consent
- Affiliated with or entitled to social security coverage
You will not qualify if you...
- Bleeding or clotting disorders
- Active external haemorrhoidal disease with thrombosis
- Previous surgical treatment for haemorrhoids (instrumental treatment allowed)
- Other proctological conditions such as anal fissure, chronic suppuration, or external rectal prolapse
- History of colorectal cancer
- History of inflammatory bowel disease
- History of rectal resection surgery
- Participation in another interventional clinical trial involving drugs or devices
- Pregnant, breastfeeding, or able to conceive without effective contraception at enrollment
- Under legal guardianship, curatorship, court protection, or deprived of liberty
AI-Screening
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Trial Site Locations
Total: 18 locations
1
Centre Hospitalier Universitaire
Amiens, France
Actively Recruiting
2
Centre Hospitalier Universitaire
Angers, France
Actively Recruiting
3
Maison de Santé Bagatelle
Bordeaux, France, 33000
Actively Recruiting
4
Centre Hospitalier Privé
Brest, France
Actively Recruiting
5
Clinique du val d'Ouest
Écully, France
Actively Recruiting
6
Centre Hospitalier Départemental de Vendée
La Roche-sur-Yon, France
Actively Recruiting
7
Hôpital de la Louvière
Lille, France
Actively Recruiting
8
CHU Limoges
Limoges, France
Actively Recruiting
9
Clinique de la Sauvegarde
Lyon, France
Actively Recruiting
10
Centre Hospitalier Universitaire
Nantes, France
Actively Recruiting
11
Clinique Jules Verne
Nantes, France
Actively Recruiting
12
Hôpital Saint Joseph
Paris, France
Actively Recruiting
13
Institut Mutualiste Montsouris
Paris, France
Actively Recruiting
14
Centre Hospitalier Interrégional
Poissy, France
Actively Recruiting
15
Centre Hospitalier Universitaire
Rennes, France
Actively Recruiting
16
Cabinet de Proctologie
Saint-Herblain, France
Not Yet Recruiting
17
hôpital d'Instruction des Armées
Saint-Mandé, France
Actively Recruiting
18
Clinique de l'Estuaire
Saint-Nazaire, France
Actively Recruiting
Research Team
A
Agnès DORION
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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