Actively Recruiting
A Randomized Comparative 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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Hemorrhoidal disease (HD) is a common anorectal condition that causes bleeding and discomfort. Researchers are evaluating Superior Rectal Artery Embolization (SRAE), a minimally invasive treatment that avoids damage to the sphincter and anorectal mucosa. This randomized controlled trial aims to confirm the benefits of SRAE and define its role compared to other treatments like Rubber Band Ligation (RBL) and Doppler-Guided Hemorrhoidal Artery Ligation (DG-HAL), especially in patients with or without antiplatelet or anticoagulation therapy. Participants will be assigned to one of four groups: those without anticoagulation therapy receiving RBL or SRAE, and those with anticoagulation therapy receiving DG-HAL or SRAE. RBL involves applying rubber bands to hemorrhoids during outpatient visits, with up to three bands per session and repeat sessions every six weeks. SRAE is performed under local anesthesia during a one-day hospital stay, where an interventional radiologist blocks blood flow in hemorrhoidal arteries using microcoils. If SRAE fails after 12 weeks, a repeat procedure including additional artery embolization may be done. DG-HAL is also done under anesthesia during a one-day stay, using Doppler guidance to locate and ligate hemorrhoidal arteries via a proctoscope. During the study, participants will be monitored for symptom control at baseline, three months, and up to 12 months. Researchers will assess patient-reported effectiveness, clinical outcomes, complications, need for re-intervention, and fecal incontinence. The study involves evaluations through clinical visits and questionnaires to track bleeding and symptom relief. The total participation duration can extend up to one year, allowing long-term follow-up of treatment results and safety.
CONDITIONS
Brief 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 with significant bleeding defined as HBS of 5 or higher
- Age greater than 18 years old
- All sexes are eligible
- Hemorrhoidal disease grade I to III according to the Goligher classification with rectal bleeding as the main symptom
- Prior instrumental treatment of hemorrhoidal disease does not exclude participation
- Able to understand and read Dutch, French, or English
You will not qualify if you...
- Permanent hemorrhoidal prolapse or grade IV hemorrhoidal disease
- Rectal prolapse
- Previous proctological surgery for hemorrhoidal disease
- Acute complicated hemorrhoidal disease such as acute thrombosis or perianal hematoma
- Anal stenosis, whether congenital or acquired
- Chronic anal fissure
- Active rectal inflammation including peri-anal abscess or inflammatory bowel disease
- History of colorectal or anal cancer
- History of rectal or sigmoidal resection
- Portal hypertension and liver cirrhosis classified as Child Pugh C
- Radiation-induced rectitis
- Neurological disease affecting anal sphincter muscles
- Severe psychiatric disorders
- Pregnancy
- Allergy to iodinated contrast agents
- Colorectal neoplasia causing bleeding confirmed by colonoscopy within the last year
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 18 weeks depending on treatment sessions and possible repeat procedures
Participants receive one of the following treatments based on their group: Rubber Band Ligation (RBL) with up to 3 sessions spaced 6 weeks apart, Superior Rectal Artery Embolization (SRAE) performed under local anesthesia with possible repeat after 12 weeks if needed, or Doppler-Guided Hemorrhoidal Artery Ligation (DG-HAL) performed under anesthesia during one-day hospitalization.
Up to 3 treatment sessions for RBL spaced 6 weeks apart; 1 initial SRAE procedure with possible repeat after 12 weeks; 1 DG-HAL procedure
Duration - Up to 12 months
Participants are monitored for symptom control, effectiveness, and potential complications following treatment.
Periodic visits for assessments up to 12 months
Trial Site Locations
Total: 1 location
1
UZ Brussel
Jette, Belgium, 1090
Actively Recruiting
Research Team
M
Magali Surmont
V
Virgini Van Buggenhout
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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