NCT04896268

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Elsan · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hemorrhoids

Interventions

Type	Name	Description
DEVICE	Radiofrequency	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.
DEVICE	Arterial 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.

Timeline

• Start date: 2023-01-03
• Primary completion: 2025-01-01
• Completion: 2025-08-01
• First posted: 2021-05-21
• Last updated: 2024-06-18

Locations

2 sites across 1 country: France