Evaluating a new treatment for hemorrhoids using artery embolization

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness and safety of Superior Rectal Artery Embolization (SRAE) as a minimally invasive treatment for hemorrhoidal disease (HD) characterized by significant rectal bleeding. The study aims to compare SRAE with established treatments like Rubber Band Ligation (RBL) and Doppler-Guided Hemorrhoidal Artery Ligation (DG-HAL) to determine if SRAE is equally effective in controlling symptoms and bleeding. Participants will include adults with grades I-III hemorrhoids, and the trial will assess the feasibility of SRAE while ensuring no damage to the sphincter or mucosal tissue occurs. The results will help define the therapeutic role of SRAE in managing HD.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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's running

• UZ Brussel
  Jette, Belgium Recruiting

Study contacts

• Study coordinator: Magali Surmont
• Email: magali.surmont@uzbrussel.be
• Phone: +32 2 477

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Ligasure vs. Conventional Diathermy in Hemorrhoidectomy

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• Ultrasound-guided sacral erector spinae plane block versus saddle block for anesthesia during hemorrhoidectomy

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.