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

Last updated: June 17, 2024
Sponsor: Elsan
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hemorrhoids

Treatment

Arterial ligation then recto-anal repair with Doppler

Radiofrequency

Clinical Study ID

NCT04896268
RADO study
  • Ages 18-75
  • All Genders

Study 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

Inclusion Criteria:

  • Male or Female consulting for hemorrhoidal pathology (grade II or III) after failureof 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

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

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Arterial ligation then recto-anal repair with Doppler
Phase:
Study Start date:
January 03, 2023
Estimated Completion Date:
August 31, 2025

Connect with a study center

  • Private hospital Guillaume de Varye

    Saint-Doulchard, 18230
    France

    Active - Recruiting

  • Centre Clinical

    Soyaux, 16800
    France

    Site Not Available

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