Evaluation of Superior Rectal Arterial Embolization in Hemorrhoidal Disease

Recruiting now · Not applicable

Conditions studied: Hemorrhoids

In brief

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).

Key facts

Study ID

NCT05697562

Run by

Universitair Ziekenhuis Brussel

People needed

80

Starts

2023-06-01

Expected to finish

2030-12-31

Last updated by the study team

2025-12-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All patients referred for Hemorrhoidal disease with bleeding are eligible. Significant bleeding is defined as a HBS of ≥ 5.
• Age > 18 years old;
• Sexes eligible for study: all
• Hemorrhoidal disease grade I-III according the Goligher classification with rectal bleeding as predominant symptom
• History of prior instrumental treatment of HD does not prohibit inclusion
• Able to understand and read Dutch, French or English

You may not qualify if…

• Permanent hemorrhoidal prolapse/grade IV hemorrhoidal disease
• Rectal prolapse
• History of proctological surgery for HD
• Acute complicated course of HD i.e. acute thrombosis (fluxio hemorrhoidalis or perianal hematoma)
• Anal stenosis, congenital of acquired
• Chronic anal fissure
• Active rectal inflammation, including peri-anal abscess (e.g. Inflammatory Bowel Disease, infectious,…)
• History of colorectal or anal cancer
• History of rectal or sigmoidal resection
• Portal hypertension and liver cirrhosis Child Pugh C
• Radiation rectitis
• Neurological disease involving anal sphincter musculature
• Severe psychiatric disorder
• Pregnancy
• Allergy to iodinated contrast agents
• Colorectal neoplasia as the cause of bleeding (excluded with a (virtual) colonoscopy in the last year)

Where it is running

• UZ Brussel — Jette, Belgium (enrolling)

Full record on ClinicalTrials.gov

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