Clinical trial NCT04229784: Multicentrique Prospective Evaluation of Radiofrequency Surgical Treatment of Homorrhoidal Disease
Official title: Multicentrique Prospective Evaluation of Radiofrequency Surgical Treatment of Homorrhoidal Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemorrhoids
Surgical Procedure, Unspecified
Keywords: hemorrhoids
radiofrequency surgery
Lead sponsor: Ramsay Générale de Santé
Sponsor class: OTHER
Collaborators: name: Dr Abramowitz
First posted: 2020-01-18
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Hemorrhoids consist of a tissue rich in blood vessels and are present in all individuals inside the anus. Hemorrhoidal disease (HD) is when hemorrhoids become troublesome and cause symptoms such as pain, bleeding, prolapse or seepage.

The first steps in the treatment of HD involve either drugs or instrumental gestures (sclerosis, ligation). In the event of failure or of a disease that is significant from the outset, it is possible to envisage a surgical treatment.

The use of a radiofrequency is a new technique, already used frequently by vascular surgeons in the treatment of varicose veins of the lower limbs. This technique has been developed for radiofrequency destruction of hemorrhoidal vascular tissue.

In France, no studies have been carried out to evaluate this new technique.

Detailed description: Hemorrhoids consist of a tissue rich in blood vessels and are present in all individuals inside the anus (internal hemorrhoids). Hemorrhoidal disease (HD) is when hemorrhoids become troublesome and cause symptoms such as pain, bleeding, prolapse or seepage.

The first steps in the treatment of HD involve either drugs or instrumental gestures (sclerosis, ligation). In the event of failure or of a disease that is significant from the outset, it is possible to envisage a surgical treatment.

The use of a radiofrequency current (Rafaelo technique) in the treatment of hemorrhoidal disease is a new technique, already used frequently by vascular surgeons in the treatment of varicose veins of the lower limbs. This technique has been developed for radiofrequency destruction of hemorrhoidal vascular tissue.

Although radiofrequency destruction of hemorrhoidal vascular tissue is already used in other European countries such as Poland, Germany, Belgium and Great Britain, there are very few studies on this minimally invasive surgical technique. This is particularly the case in France where no studies have been carried out to evaluate this new technique.

Eligibility criteria: Inclusion Criteria:

* Male and female consultant for a grade II or III haemorrhoidal pathology after failure of medical-instrumental treatments.
* Age \> 18 years old and \< 75 years old
* Patient having signed an informed consent
* Affiliate or beneficiary of a social security scheme
* For patients taking anti-vitamin K (AVK) or oral anticoagulants (OACs) a short stop will be recommended according to HAS recommendations.
* For patients on antiplatelet agents (APA), the relay and stopping procedures will be carried out according to the current recommendations of the HAS (26)
* Patient eligible to be an outpatient

Exclusion Criteria:

* Patient with IBD (inflammatory bowel diseases)
* Patient with haematological disease at risk of bleeding
* Patient with anal fistulas
* Patient unable to interrupt VKAs, OACs or APAs.
* Patient with an associated anal fissure
* External hemorrhoidal pathology
* Patient participating in another clinical study
* Pregnant or lactating women
* Patient with pacemaker or implantable defibrillator
* Protected patient: adult under guardianship, trusteeship or other legal protection, deprived of liberty by judicial or administrative decision

Primary outcomes:
measure: HEMO-FISS-QoL
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: BLOMET clinic
state: IDF
Study officials:
References: