Actively Recruiting
Evaluation of Superior Rectal Arterial Embolization in Hemorrhoidal Disease
Led by Universitair Ziekenhuis Brussel · Updated on 2025-12-18
80
Participants Needed
1
Research Sites
395 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Evaluation of Superior Rectal Arterial Embolization in Hemorrhoidal Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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)
AI-Screening
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Trial Site Locations
Total: 1 location
1
UZ Brussel
Jette, Belgium, 1090
Actively Recruiting
Research Team
M
Magali Surmont
CONTACT
V
Virgini Van Buggenhout
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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