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

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

• Visual Analog Scale (VSS) Pain [Срок оценки: Baseline, 1, 3, 6 and 12 months]
• Visual Analog Scale (VAS) for Quality of Life [Срок оценки: Baseline, 1, 3, 6 and 12 months]
• Goligher Prolapse Score [Срок оценки: Baseline, 1, 3, 6 and 12 months]
• Hemorrhoidal Bleeding Score (HBS) [Срок оценки: Baseline, 1, 3, 6 and 12 months]
• Hemorrhoidal Severity Score (HSS) [Срок оценки: Baseline, 1, 3, 6 and 12 months]
• Vaizey Incontinence Score [Срок оценки: Baseline, 1, 3, 6 and 12 months]
• Brief Pain Inventory (BPI) Short Form [Срок оценки: Baseline, 1, 3, 6 and 12 months]