Haemorrhoids are composed of tissue rich in blood vessels and are present in all individuals inside the anus (internal haemorrhoids) or under the skin of the anus (external haemorrhoids). Haemorrhoidal disease (HD) occurs when haemorrhoids become troublesome and cause symptoms such as pain, bleeding, prolapse or oozing. In case of failure of medical treatment, instrumental procedures or extensive disease, surgical treatment can be considered. There are two classic surgical techniques. The first is the pedicle haemorrhoidectomy of the Milligan and Morgan type. The second classic surgical technique is the Longo stapled anopexy. Recently, less invasive surgical techniques such as arterial ligation (HAL, with or without Doppler) followed by recto-anal repair (RAR for "Recto Anal Repair") and sometimes associated with mucopexy, which allows the excess mucosa to be ligated and the muco-haemorrhoidal tissue to be fixed to the rectal wall, have developed. The use of radiofrequency current (Rafaelo technique) in the treatment of haemorrhoidal disease is an innovative technique of haemorrhoidal thermocoagulation. It is a mini-invasive technique, which can be performed under sedation or short general anaesthesia (GA), with little pain, allowing a rapid return to normal life and a short time off work. Although this technique is already used in other European countries: Poland, Germany, Belgium, Great Britain (UK), there is now a Polish, German, Spanish and English study in the process of publication. There have been no studies in France to evaluate this new technique and assess its good tolerance, the duration of work stoppage, the improvement in quality of life and the evaluation of its effectiveness.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Rafaelo's technique consists of delivering a low-temperature 4 MHz radiofrequency wave current into the haemorrhoidal vascular tissue using a large single-use needle with microfibre electrodes at the end.
The aim of arterial ligation is to "de-arterialise" the haemorrhoids by reducing the arterial flow of the haemorrhoidal plexuses while avoiding obstructing the venous return.
Private hospital Guillaume de Varye
Saint-Doulchard, France
RECRUITINGCentre Clinical
Soyaux, France
NOT_YET_RECRUITINGTo demonstrate an increase in quality of life, at 1 month post-procedure, when haemorrhoidal disease is managed with radiofrequency versus HAL-RAR with Doppler
The Haemorrhoidal Disease and Anal Fissure questionnaire
Time frame: 1-month visit
Pain evaluation
Numerical scale (minimum: 0; maximum: 10)
Time frame: 1-month visit
Pain evaluation
Numerical scale (minimum: 0; maximum: 10)
Time frame: 6-month visit
feasibility of the 2 techniques under simple antiplatelet agents, anti-vitamin K or oral anticoagulant.
Success rate of radiofrequency procedure to be compared between patients taking or not taking AAP, AOD or VKA
Time frame: 6-month visit
Occurrence of a relapse
date of relapse, if relapse
Time frame: through study completion, an average of 6 months
Recording of specific symptoms that indicate improvement in hemorrhoidal disease
Occurrence of bleeding / prolapse
Time frame: through study completion, an average of 6 months
Time to return to work
Duration of work interruption (in days)
Time frame: through study completion, an average of 6 months
Safety evaluation
Adverse event
Time frame: through study completion, an average of 6 months
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