Long-Term Observational Study Collecting Data on Hemorrhoid Artery Embolization for Adults with Bleeding Internal Hemorrhoids

What this Trial Is About

This observational study is designed to gather long-term real-world data on the effectiveness and safety of hemorrhoid artery embolization HAE in adults aged 18 years or older who have symptomatic bleeding internal hemorrhoids that have not improved with medical treatment. The main goal is to determine if HAE leads to sustained improvement in bleeding symptoms over 12 to 36 months. The study is sponsored by the Joint & Vascular Institute and follows patients as part of routine clinical care without a comparison group. During the study, participants will undergo HAE, a minimally invasive, image-guided procedure that delivers embolic agents to reduce blood flow in the superior rectal arteries, aiming to shrink swollen hemorrhoidal tissue and reduce bleeding and discomfort. There is no experimental treatment phase since the procedure is part of standard care. Follow-up assessments will take place at 1, 3, 6, 12, 18, 24, and 36 months after the treatment. Participants will complete symptom and quality-of-life questionnaires at each follow-up visit, and safety outcomes will be monitored according to established guidelines. The main outcome measured is the Hemorrhoidal Disease Symptom Score HDSS over the enrollment period. Secondary outcomes include other bleeding and health scales. The total participation time may extend up to three years, during which researchers will track symptom improvement and any safety concerns.

Prospective HemorrhoIdaL EmboliSation (PILES) Registry