Prospective HemorrhoIdaL EmboliSation (PILES) Registry
Purpose
The goal of this observational study (prospective registry) is to collect long-term real-world data on the effectiveness and safety of hemorrhoid artery embolization (HAE) for symptomatic bleeding internal hemorrhoids in adults aged 18 years or older that have not responded to medical therapy. The main question it aims to answer are: 1) Does HAE lead to sustained improvement in bleeding (HDSS scores over 12-36 months? Participants will: - Undergo HAE as part of their routine clinical care. - Complete clinical follow-up assessments at 1, 3, 6, 12, 18, 24, and 36 months after treatment, including symptom and quality-of-life questionnaires. - Have safety outcomes tracked according to Society of Interventional Radiology guidelines. There is no comparison group; results will be analyzed to identify predictors of success and inform best practices for patient selection and treatment.
Conditions
- Hemorrhoid
- Internal Hemorrhoids
- Hemorrhoid Bleeding
- Hemorrhoidal Bleeding
- Internal Hemorrhoid
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Adults (≥18 years) with symptomatic bleeding internal hemorrhoids refractory to medical therapy, referred for HAE.
Exclusion Criteria
- Pregnancy, coagulopathy, severe comorbidities, or inability to consent.
Study Design
- Phase
- Study Type
- Observational [Patient Registry]
- Observational Model
- Cohort
- Time Perspective
- Prospective
Recruiting Locations
Libertyville, Illinois 60048
More Details
- Status
- Recruiting
- Sponsor
- Joint & Vascular Institute