Study Comparing Quality of Life and Safety of Radiofrequency Versus HAL-RAR Doppler in Hemorrhoidal Disease

What this Trial Is About

Researchers are evaluating two surgical techniques for treating hemorrhoidal disease, which causes symptoms like pain, bleeding, and prolapse when hemorrhoids become problematic. The study compares a newer radiofrequency method called Rafaelo with the established arterial ligation followed by recto-anal repair (HAL-RAR with Doppler). This trial aims to assess the quality of life, safety, and effectiveness of these treatments in patients who have not responded to medical or instrumental therapies. The trial involves two groups: one receiving the Rafaelo radiofrequency treatment, which uses a low-temperature radiofrequency current to reduce hemorrhoidal tissue through controlled vaporization and fibrosis, and the other undergoing the HAL-RAR procedure that reduces arterial blood flow to the hemorrhoids and restores anatomical position without excision. Both techniques are minimally invasive and aim to improve symptoms with less pain and quicker recovery. Participants will be monitored for quality of life improvements one month after treatment and followed up to six months to assess pain levels, relapse occurrence, safety, and time to return to work. The study includes evaluations of symptoms and feasibility of treatments in patients on certain blood-thinning medications. Overall, the study offers a structured assessment of these two methods to better understand their impact on patient well-being and recovery.

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