Efficacy and Safety of RAdiofrequency Versus HAL- RAR DOppler in Hemorrhoidal Pathology

Study Overview
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Brief Summary
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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.

Official Title
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Prospective, Monocentric, Randomized, Open-label Study Comparing the Efficacy, in Terms of Quality of Life, and Safety of RAdiofrequency Versus HAL- RAR DOppler in Hemorrhoidal Pathology

Conditions
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Hemorrhoids

Intervention / Treatment
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* Device: Radiofrequency
* Device: Arterial ligation then recto-anal repair with Doppler


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or Female consulting for hemorrhoidal pathology (grade II or III) after failure of medico-instrumental treatments. Age ≥ 18 years and < 75 years Mandatory affiliation to a health insurance system. Patient having been informed of the study and having given informed consent Exclusion Criteria: Patients with chronic inflammatory bowel disease Patients with suspected gastro-colic pathology Haematological diseases Anal fistulas Patients unable to discontinue anti-vitamin K or oral anticoagulants Associated anal fissure External haemorrhoidal disease Pregnant or breastfeeding women Patients under legal protection

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Interventional, prospective, therapeutic, comparative, parallel group, randomised controlled open-label, superiority, single-centre, national study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiofrequency<br>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<br>* 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.<br>|
| Active Comparator: Arterial ligation then recto-anal repair with Doppler<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1-month visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain evaluation | Numerical scale (minimum: 0; maximum: 10) | 1-month visit | 
| Pain evaluation | Numerical scale (minimum: 0; maximum: 10) | 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 | 6-month visit | 
| Occurrence of a relapse | date of relapse, if relapse | through study completion, an average of 6 months | 
| Recording of specific symptoms that indicate improvement in hemorrhoidal disease | Occurrence of bleeding / prolapse | through study completion, an average of 6 months | 
| Time to return to work | Duration of work interruption (in days) | through study completion, an average of 6 months | 
| Safety evaluation | Adverse event | through study completion, an average of 6 months |