Clinical trial NCT04896268: Efficacy and Safety of RAdiofrequency Versus HAL- RAR DOppler in Hemorrhoidal Pathology
Official title: Prospective, Multicentric, Randomized, Open-label Study Comparing the Efficacy, in Terms of Quality of Life, and Safety of RAdiofrequency Versus HAL- RAR DOppler in Hemorrhoidal Pathology
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hemorrhoids
Lead sponsor: Elsan
Sponsor class: OTHER
First posted: 2021-05-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Interventional, prospective, therapeutic, comparative, parallel group, randomised controlled open-label, superiority, single-centre, national study.
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 1-month visit
Secondary outcomes:
measure: Pain evaluation
timeFrame: 1-month visit
measure: Pain evaluation
timeFrame: 6-month visit
measure: feasibility of the 2 techniques under simple antiplatelet agents, anti-vitamin K or oral anticoagulant.
timeFrame: 6-month visit
measure: Occurrence of a relapse
timeFrame: through study completion, an average of 6 months
measure: Recording of specific symptoms that indicate improvement in hemorrhoidal disease
timeFrame: through study completion, an average of 6 months
measure: Time to return to work
timeFrame: through study completion, an average of 6 months
measure: Safety evaluation
timeFrame: through study completion, an average of 6 months
Other outcomes:
Locations:
city: Saint-Doulchard
country: France
facility: Private hospital Guillaume de Varye
city: Soyaux
country: France
facility: Centre Clinical
Study officials:
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