An interventional study of Radiofrequency and Arterial ligation then recto-anal repair with Doppler in Hemorrhoids, sponsored by Elsan. Recruiting at 2 sites in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-06-18.
Sponsored by Elsan · Not applicable, Interventional, and Treatment
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.
238 studies on the registry are indexed under Hemorrhoids; 73 are open to participants now.
This study's planned enrollment of 100 is close to the median of 100 across 183 interventional studies indexed under Hemorrhoids.
Browse Hemorrhoids studies →Elsan is the lead sponsor of 68 studies on the registry; 35 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 intracellular water in the tissue and the injection of a locally injectable Xylocaine cushion serve as resistance to the vaporisation waves without releasing water vapour, thus avoiding the damage usually encountered in electrosurgery. The delayed phenomenon is cell volatilisation. Vaporisation of the tissue allows significant haemostasis without burns. Tissue changes will depend directly on the temperature emitted and the duration of exposure to the radiofrequence current. The fibrosis process starts during the session and continues for several days to weeks, allowing the reduction of the haemorrhoidal cushions.
Device: Radiofrequency
Arterial ligation aims to "de-arterialise" the haemorrhoids by selectively decreasing the arterial flow of the haemorrhoidal plexuses while avoiding obstructing the venous return. It is distinguished from mucopexy or recto anal repair (RAR®) which fixes the prolapsed hemorrhoidal plexus. Instead of excising the haemorrhoids, the principle is to reduce their size and to restore the anatomical relationships of the haemorrhoidal plexuses in the anal canal.
Device: Arterial ligation then recto-anal repair with Doppler
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.
To 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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