Radiofrequency Ablation vs Doppler-guided Haemorrhoidal Artery Ligation in the Treatment of Haemorrhoidal Disease
NCT ID: NCT06170736
Last Updated: 2025-08-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
168 participants
INTERVENTIONAL
2024-02-21
2028-09-15
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Doppler-Guided Haemorrhoidal Artery Ligation
Patients will be treated by DGHAL 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.
Radiofrequency Ablation
Patients will be treated by radiofrequency ablation.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Centre Hospitalier Departemental Vendee
OTHER
Responsible Party
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Principal Investigators
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Marc-Henri JEAN, Dr
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Departemental Vendée
Locations
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Centre Hospitalier Universitaire
Amiens, , France
Centre Hospitalier Universitaire
Angers, , France
Maison de Santé Bagatelle
Bordeaux, , France
Centre Hospitalier Privé
Brest, , France
Centre Hospitalier Départemental de Vendée
La Roche-sur-Yon, , France
Hôpital de la Louvière
Lille, , 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
Countries
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Central Contacts
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Facility Contacts
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Centre H Universitaire
Role: primary
Centre H Universitaire
Role: primary
Centre H Universitaire
Role: primary
Other Identifiers
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CHD22_0066
Identifier Type: -
Identifier Source: org_study_id
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