Outcomes and Quality of Life Following Rectal Artery Embolization for Bleeding Internal Hemorrhoids (HEMBO-1)

Mayo Clinic

Status: Enrolling

Conditions: Internal Hemorrhoid

Treatments: Device: Rectal Artery Embolization

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06106269

23-002845

Details and patient eligibility

About

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

Full description

This is a prospective, single-arm, single center phase I/IIa observational study to systematically investigate outcomes and quality of life in patients with grade II or III bleeding predominant internal hemorrhoids referred to Vascular and Interventional Radiology (VIR) by Colorectal Surgery (CRS) for clinically indicated rectal artery embolization. 20 adult patients who meet the inclusion and exclusion criteria will be consented and enrolled in the study.

During the study, the subject will undergo 6 study visits, one before and five after their clinical rectal artery embolization procedure. Patients referred from the Colorectal Surgery Clinic who are scheduled to undergo rectal artery embolization (RAE) as part of standard clinical care will be enrolled. Baseline anoscopy and clinical evaluation will be performed per standard clinical care in the Colorectal Surgery Clinic and baseline patient reported outcomes and quality of life questionnaires administered. A research pelvis CTA will be performed on a clinical CT scanner per standard clinical imaging protocol for assessment of the rectal arteries prior to embolization. Following rectal artery embolization, subjects will undergo a day 1 post-procedure clinical evaluation in Interventional Radiology followed by repeat anoscopy and clinical evaluation per standard clinical care in the Colorectal Surgery Clinic as well as repeat patient reported outcomes and quality of life questionnaires at 1, 3, 6 and 12 months post rectal artery embolization with a clinical research study coordinator in Vascular and Interventional Radiology, either in person or virtually (video or phone).

The aims of the study are:

Aim 1. To determine the 12-month efficacy of rectal artery embolization with particles + coils for treatment of symptomatic bleeding predominant hemorrhoidal disease

Aim 2. To determine the 12-month safety of rectal artery embolization with particles + coils for treatment of symptomatic bleeding predominant hemorrhoidal disease.

Aim 3. To determine the feasibility of pre-embolization CTA in identifying the hemorrhoidal arteries supplying the hemorrhoidal cushion

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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).

Exclusion criteria

• 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.