Evaluating a new treatment for hemorrhoids using artery embolization
A Randomized Comparative Evaluation of Superior Rectal Arterial Embolization in Hemorrhoidal Disease
This study is testing a new, less invasive treatment for hemorrhoids called artery embolization to see if it works as well as current methods for reducing bleeding and symptoms in adults with hemorrhoids.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitair Ziekenhuis Brussel Academic / other |
| Drugs / interventions | Radiation |
| Locations | 1 site (Jette) |
| Trial ID | NCT05697562 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with grades I-III hemorrhoids experiencing significant rectal bleeding.
Not a fit: Patients with permanent hemorrhoidal prolapse, rectal prolapse, or a history of proctological surgery for hemorrhoids may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a safer and less invasive option for patients suffering from hemorrhoidal disease.
How similar studies have performed: Previous studies have shown promising results for SRAE, but this trial aims to confirm its efficacy in a randomized controlled setting.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Jette
- UZ Brussel — Jette, Belgium (Recruiting)
Study contacts
- Study coordinator: Magali Surmont
- Email: magali.surmont@uzbrussel.be
- Phone: +32 2 477
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.