Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT06170736

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

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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