Evaluation of Superior Rectal Arterial Embolization in Hemorrhoidal Disease

Hemorrhoids Clinical Trial

Official title: A Randomized Comparative Evaluation of Superior Rectal Arterial Embolization in Hemorrhoidal Disease

Status Recruiting

Clinical Trial Summary

SRAE is a promising treatment of bleeding HD as a minimally invasive approach without sphincter damage nor direct mucosal anorectal trauma. Feasibility, efficacy and safety were studied in several trials. A randomized controlled study should confirm the benefits of this technique and will define its therapeutic role in HD.

Embolization and DG-HAL are based on the same concept of vascular occlusion of hemorrhoidal branches of the rectal artery. Furthermore, DG-HAL and RBL are equally effective procedures. The assumption is that treatment with SRAE is not inferior in comparison to RBL or DG HAL in respectively patients without or with antiplatelet/anticoagulation therapy in terms of symptom control and bleeding (non-inferiority study).

Clinical Trial Description

Hemorrhoidal disease (HD) is the most common anorectal pathology. Therapeutic management of HD ranges from conservative treatment and instrumental treatment to surgical approach. Beside these, certain minimally invasive techniques such as radiofrequency ablation, laser coagulation and Superior Rectal Artery Embolization (SRAE) are gaining interest. SRAE is a promising treatment of bleeding HD as a minimally invasive approach without sphincter damage nor direct mucosal anorectal trauma. Feasibility, efficacy and safety were studied in several trials. A randomized controlled study should confirm the benefits of this technique and will define its therapeutic role in HD. Embolization and DG-HAL are based on the same concept of vascular occlusion of hemorrhoidal branches of the rectal artery. Furthermore, DG-HAL and RBL are equally effective procedures. The assumption is that treatment with SRAE is not inferior in comparison to RBL or DG HAL in respectively patients without or with antiplatelet/anticoagulation therapy in terms of symptom control and bleeding (non-inferiority study). ;

Related Conditions & MeSH terms

• Hemorrhoids

• NCT number: NCT05697562
• Study type: Interventional
• Source: Universitair Ziekenhuis Brussel
• Contact: Magali Surmont
• Phone: +32 2 477
• Email: magali.surmont@uzbrussel.be
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Completion date: December 15, 2026