Outcomes and Quality of Life Following Rectal Artery Embolization for Bleeding Internal Hemorrhoids

NCT06106269 | Recruiting DMC

• 1 other identifier: 23-002845
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study will assess how effective and safe rectal artery embolization works to treat symptomatic bleeding predominant internal hemorrhoids.

Conditions

Internal Hemorrhoid

Keywords

Bleeding; Anemia; Hemorrhoid

Outcome Measures

Primary Outcomes (3)

• Change in French bleeding score (FBS)

  The French bleeding score assesses the intensity of hemorrhoidal bleeding with scores ranging from 0 (no bleeding) to 9 (daily bleeding with anemia requiring blood transfusions)

  Baseline, 1, 3, 6 and 12 months

• Adverse Events

  Number of subjects to experience adverse events defined by 1) Common Terminology Criteria for Adverse Events (CTCAE) v6.0, 2) Society of Interventional Radiology \[SIR\] classifications of postoperative complications and 3) Clavien-Dindo Classification

  Day 1 and 1, 3, 6 and 12 months

• Diagnostic accuracy of pre-embolization Computed Tomography Angiography (CTA)

  Diagnostic accuracy and inter-rater agreement of pre-embolization CTA in identifying the hemorrhoidal arteries supplying the hemorrhoidal cushion

  Baseline (pre-embolization)

Secondary Outcomes (7)

• Visual Analog Scale (VSS) Pain

  Baseline, 1, 3, 6 and 12 months

• Visual Analog Scale (VAS) for Quality of Life

  Baseline, 1, 3, 6 and 12 months

• Goligher Prolapse Score

  Baseline, 1, 3, 6 and 12 months

• Hemorrhoidal Bleeding Score (HBS)

  Baseline, 1, 3, 6 and 12 months

• Hemorrhoidal Severity Score (HSS)

  Baseline, 1, 3, 6 and 12 months

Interventions

Rectal Artery Embolization DEVICE

Subjects will undergo planned rectal artery embolization (RAE) in Vascular and Interventional Radiology per standard clinical protocol.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects referred from the Colon and Rectal Surgery who are scheduled to undergo rectal artery embolization (RAE) as part of their standard clinical care at the Mayo Clinic in Rochester, Minnesota.

You may qualify if:

• Grade II or III hemorrhoidal disease as determined by a board-certified colorectal surgeon.
• Persistent or recurrent symptoms following hygiene and dietary measures or medication.
• Bleeding predominant ± pain symptoms.
• Undergoing planned rectal artery embolization (RAE) per standard clinical care.
• Male or female with age greater than 18 years, with the capacity and willingness to provide a written informed consent.
• Negative pregnancy test (if applicable).

You may not qualify if:

• Prior hemorrhoid surgery.
• Grade IV hemorrhoidal disease.
• Acute hemorrhoid complications.
• Chronic anal or perianal fissures.
• History of colorectal surgery or pelvic radiation.
• Inflammatory bowel disease.
• Portal hypertension or mesenteric venous congestion/occlusion.
• Inferior mesenteric artery (IMA) or internal iliac artery (IIA) stenosis or occlusion.
• Contraindication to iodinated contrast.
• Pregnant and/or breast-feeding subjects. A negative pregnancy test within 48 hours of the procedure per clinical care.

Sponsors & Collaborators

• Mayo Clinic: lead
• Terumo Corporation: collaborator

Study Sites (1)

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Hemorrhage; Anemia; Hemorrhoids

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematologic Diseases; Hemic and Lymphatic Diseases; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Scott Thompson, MD, PhD

  Mayo Clinic, Vascular and Interventional Radiology

  PRINCIPAL INVESTIGATOR

• Scott R Kelley, MD

  Mayo Clinic, Colon and Rectal Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Desirae Howe-Clayton

CONTACT

507-255-0111; Howe.Desirae@mayo.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: October 30, 2023
• Study Start: June 7, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)