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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
168
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.
Centre Hospitalier Universitaire
Amiens, France
RECRUITINGCentre Hospitalier Universitaire
Angers, France
RECRUITINGMaison de Santé Bagatelle
Bordeaux, France
WITHDRAWNCentre Hospitalier Privé
Brest, France
RECRUITINGCentre Hospitalier Départemental de Vendée
La Roche-sur-Yon, France
RECRUITINGHôpital de la Louvière
Lille, France
RECRUITINGClinique de la Sauvegarde
Lyon, France
RECRUITINGCentre Hospitalier Universitaire
Nantes, France
RECRUITINGClinique Jules Verne
Nantes, France
NOT_YET_RECRUITINGHôpital Saint Joseph
Paris, France
RECRUITING...and 6 more locations
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.
Time frame: one year post-operatively
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