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Radiofrequency Ablation vs Doppler-guided Haemorrhoidal Artery Ligation in the Treatment of Haemorrhoidal Disease
Sponsor: Centre Hospitalier Departemental Vendee
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
Official title: Radiofrequency Haemorrhoidal Thermoablation Versus Doppler-guided Haemorrhoidal Artery Ligation With Mucopexy in the Treatment of Haemorrhoidal Disease: a Multicenter Randomized Non-inferiority Trial
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
168
Start Date
2024-02-21
Completion Date
2030-09-15
Last Updated
2026-03-13
Healthy Volunteers
No
Interventions
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.
Locations (18)
Centre Hospitalier Universitaire
Amiens, France
Centre Hospitalier Universitaire
Angers, France
Maison de Santé Bagatelle
Bordeaux, 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