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RECRUITING
NCT06170736
NA

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

Sponsor: Centre Hospitalier Departemental Vendee

View on ClinicalTrials.gov

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

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.

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.

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