Radiofrequency Ablation vs Doppler-guided Haemorrhoidal Artery Ligation in the Treatment of Haemorrhoidal Disease
RADIOLIGA
Radiofrequency Haemorrhoidal Thermoablation Versus Doppler-guided Haemorrhoidal Artery Ligation With Mucopexy in the Treatment of Haemorrhoidal Disease: a Multicenter Randomized Non-inferiority Trial
1 other identifier
interventional
168
1 country
18
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2024
Longer than P75 for not_applicable
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 6, 2023
CompletedFirst Posted
Study publicly available on registry
December 14, 2023
CompletedStudy Start
First participant enrolled
February 21, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 15, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 15, 2030
March 13, 2026
March 1, 2026
4 years
December 6, 2023
March 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Failure rate at 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
Study Arms (2)
Doppler-Guided Haemorrhoidal Artery Ligation
ACTIVE COMPARATORPatients will be treated by DGHAL procedure.
Radiofrequency Ablation
EXPERIMENTALPatients will be treated by radiofrequency ablation.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Centre Hospitalier Universitaire
Amiens, France
Centre Hospitalier Universitaire
Angers, France
Maison de Santé Bagatelle
Bordeaux, 33000, France
Centre Hospitalier Privé
Brest, France
Clinique du val d'Ouest
Écully, France
Centre Hospitalier Départemental de Vendée
La Roche-sur-Yon, France
Hôpital de la Louvière
Lille, France
CHU Limoges
Limoges, France
Clinique de la Sauvegarde
Lyon, France
Centre Hospitalier Universitaire
Nantes, France
Clinique Jules Verne
Nantes, France
Hôpital Saint Joseph
Paris, France
Institut Mutualiste Montsouris
Paris, France
Centre Hospitalier Interrégional
Poissy, France
Centre Hospitalier Universitaire
Rennes, France
Cabinet de Proctologie
Saint-Herblain, France
hôpital d'Instruction des Armées
Saint-Mandé, France
Clinique de l'Estuaire
Saint-Nazaire, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marc-Henri JEAN, Dr
Centre Hospitalier Departemental Vendée
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 6, 2023
First Posted
December 14, 2023
Study Start
February 21, 2024
Primary Completion (Estimated)
February 15, 2028
Study Completion (Estimated)
September 15, 2030
Last Updated
March 13, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share