Evaluation of Superior Rectal Arterial Embolization in Hemorrhoidal Disease

Launched by UNIVERSITAIR ZIEKENHUIS BRUSSEL · Jan 24, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment called Superior Rectal Arterial Embolization (SRAE) for people suffering from hemorrhoids, especially those experiencing significant bleeding. SRAE is a minimally invasive procedure that aims to stop bleeding without causing damage to the surrounding tissues. The goal of the trial is to find out how effective and safe this method is compared to other treatments for hemorrhoids. Researchers are looking for participants who are at least 18 years old and have bleeding hemorrhoids classified as Grade I-III, meaning they have symptoms but not severe complications.

If you decide to participate in this trial, you will be among those receiving SRAE to see how well it works for controlling symptoms and bleeding. The trial is currently recruiting participants of all genders. However, there are some criteria that could exclude you, like having very severe hemorrhoids (Grade IV), certain previous surgeries, or specific medical conditions. This study could help clarify how SRAE might be a beneficial option for patients with hemorrhoids in the future, potentially leading to better treatment choices.

Gender

ALL

Eligibility 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)