Radiofrequency Ablation vs Doppler-guided Haemorrhoidal Artery Ligation in the Treatment of Haemorrhoidal Disease (RADIOLIGA)

March 12, 2026 updated by: Centre Hospitalier Departemental Vendee

Radiofrequency Haemorrhoidal Thermoablation Versus Doppler-guided Haemorrhoidal Artery Ligation With Mucopexy in the Treatment of Haemorrhoidal Disease: a Multicenter Randomized Non-inferiority Trial

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

168

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Amiens, France
        • Recruiting
        • Centre Hospitalier Universitaire
        • Contact:
          • Centre H Universitaire
        • Principal Investigator:
          • Charles SABBAGH
      • Angers, France
        • Recruiting
        • Centre Hospitalier Universitaire
        • Principal Investigator:
          • Aurélien VENARA
      • Bordeaux, France, 33000
        • Recruiting
        • Maison de Santé Bagatelle
        • Principal Investigator:
          • Dominique BOUCHARD, Dr
      • Brest, France
        • Recruiting
        • Centre Hospitalier Prive
        • Principal Investigator:
          • Clément COUETTE
      • La Roche-sur-Yon, France
        • Recruiting
        • Centre Hospitalier Départemental de Vendée
        • Principal Investigator:
          • Marc-Henri JEAN, Dr
      • Lille, France
        • Recruiting
        • Hôpital de la Louvière
        • Principal Investigator:
          • Antoine LAMBLIN
      • Limoges, France
        • Recruiting
        • CHU Limoges
        • Principal Investigator:
          • Pierre-Alexandre FERRERO
      • Lyon, France
        • Recruiting
        • Clinique de la Sauvegarde
        • Principal Investigator:
          • Benjamin DARNIS
      • Nantes, France
        • Recruiting
        • Clinique Jules Verne
        • Principal Investigator:
          • Farouk DRISSI
      • Nantes, France
        • Recruiting
        • Centre Hospitalier Universitaire
        • Contact:
          • Centre H Universitaire
        • Principal Investigator:
          • Emilie DUCHALAIS-DASSONEVILLE
      • Paris, France
        • Recruiting
        • Institut Mutualiste Montsouris
        • Principal Investigator:
          • Marie-Lise THIERRY
      • Paris, France
        • Recruiting
        • Hopital Saint Joseph
        • Principal Investigator:
          • Amine ALAM
      • Poissy, France
        • Recruiting
        • Centre Hospitalier Interrégional
        • Principal Investigator:
          • Béatrice VINSON-BONNET
      • Rennes, France
        • Recruiting
        • Centre Hospitalier Universitaire
        • Contact:
          • Centre H Universitaire
        • Principal Investigator:
          • Amandine LANDEMAINE
      • Saint-Herblain, France
        • Not yet recruiting
        • Cabinet de Proctologie
        • Principal Investigator:
          • Damien SOUDAN
      • Saint-Mandé, France
        • Recruiting
        • Hopital D'Instruction Des Armees
        • Principal Investigator:
          • Anne-Cécile EZANNO
      • Saint-Nazaire, France
        • Recruiting
        • Clinique de l'Estuaire
        • Principal Investigator:
          • Yann REDON
      • Écully, France
        • Recruiting
        • Clinique du Val d'Ouest
        • Principal Investigator:
          • Philippe GUILLEM, PH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Major patient,
  • With symptomatic Grade II or III haemorrhoidal disease,
  • Requiring surgical management,
  • Patient able to understand the protocol and having given written informed consent to participate in the study,
  • Patient affiliated to the social security system or entitled to it.

Exclusion Criteria:

  • Hemostasis disorders
  • Active external haemorrhoidal disease (thrombosis)
  • History of surgical procedure for treatment of haemorrhoids (instrumental treatment is not a contra-indication)
  • Associated proctological pathology (anal fissure, chronic suppuration, external rectal prolapse)
  • History of colorectal cancer
  • History of inflammatory bowel disease
  • History of rectal resection
  • Patient participating in another interventional clinical research protocol involving a drug or clinical investigation of a medical device
  • Patient who is pregnant, breastfeeding or able to procreate without effective contraception* at the time of inclusion
  • Patient under guardianship, curators or deprived of liberty.

  • Patient under court protection.

    • oral contraceptive (pill), monthly vaginal ring, weekly transdermal patch, subcutaneous implant, intrauterine devices (IUD), or sterilisation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Doppler-Guided Haemorrhoidal Artery Ligation
Patients will be treated by DGHAL procedure.
Procedure: Doppler-Guided Haemorrhoidal Artery Ligation
The principle consists of locating the signal emitted by the haemorrhoidal arteries using a Doppler probe. Once identified, the arteries are ligated in order to remove the arterial vascularization of the haemorrhoidal bundles. The treatment of the prolapse is reinforced by a folding of the mucosa of the lower rectum, called mucopexy.
Experimental: Radiofrequency Ablation
Patients will be treated by radiofrequency ablation.
Procedure: Radiofrequency ablation
The principle consists of inserting a metal probe under the mucosa of the anus, in contact with the haemorrhoidal bundles to be treated. A source of radiofrequency is then delivered through this probe in contact with the haemorrhoidal veins which will be sclerosed. The procedure is repeated for each haemorrhoidal bundle to be treated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Failure rate at one year post-operatively
Time Frame: one year post-operatively
The evaluation of failure rate will be based on the calculation of the HDSS score grouping the different symptoms (pain, discomfort, bleeding, soiling and prolapse). Failure rate will be defined by a score greater than or equal to the preoperative score or by a reoperation (surgical or instrumental) for relapse of the symptoms.
one year post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Departemental Vendee

Investigators

  • Principal Investigator: Marc-Henri JEAN, Dr, Centre Hospitalier Departemental Vendee

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2024

Primary Completion (Estimated)

February 15, 2028

Study Completion (Estimated)

September 15, 2030

Study Registration Dates

First Submitted

December 6, 2023

First Submitted That Met QC Criteria

December 6, 2023

First Posted (Actual)

December 14, 2023

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 12, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHD22_0066

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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