Hemorrhoids
Conditions
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.
Interventions
DEVICERadiofrequency
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.
DEVICEArterial ligation then recto-anal repair with Doppler
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.
Sponsors
Elsan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Interventional, prospective, therapeutic, comparative, parallel group, randomised controlled open-label, superiority, single-centre, national study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 1-month visit | The Haemorrhoidal Disease and Anal Fissure questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| feasibility of the 2 techniques under simple antiplatelet agents, anti-vitamin K or oral anticoagulant. | 6-month visit | Success rate of radiofrequency procedure to be compared between patients taking or not taking AAP, AOD or VKA |
| Occurrence of a relapse | through study completion, an average of 6 months | date of relapse, if relapse |
| Pain evaluation | 1-month visit | Numerical scale (minimum: 0; maximum: 10) |
| Time to return to work | through study completion, an average of 6 months | Duration of work interruption (in days) |
| Safety evaluation | through study completion, an average of 6 months | Adverse event |
| Recording of specific symptoms that indicate improvement in hemorrhoidal disease | through study completion, an average of 6 months | Occurrence of bleeding / prolapse |
Countries
France
Contacts
Primary ContactPflieger Hannah, MD
Outcome results
None listed