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

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

Internal Hemorrhoid

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

Rectal Artery Embolization

Hemorrhoidal Embolization Trial-1 (HEMBO-1)

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)

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

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

Principal Investigator

Pain values reported by participants will be assessed using a visual analogue scale with
a line where each end is marked with "no pain" as 0 on the left, middle with "Moderate
pain" as 5, and "worst possible pain" as 10 on the right. Participants will identify
their pain level by indicating a point on the line between each end. Pain score 1-3 =
mild pain, minimal impact on activities of daily living (ADL's); 4-6 = moderate pain,
moderate impact on ADL's; 7-10 = severe pain, major impact on ADL's.

The quality-of-life score evaluates disease impact with scores ranging from 0 (absence of
discomfort) to 4 (permanent discomfort).

The Goligher classification asses the degree of internal hemorrhoid prolapse from I (no
prolapse) to IV (irreducible prolapse).

HBS is sensitive, specific, and reproducible. It can assess the severity of hemorrhoidal
bleeding. It also allows quantifying the extent of change in hemorrhoidal bleeding after
treatment.

The HSS comprises five items. All items included in a domain are scored between 0 and 3
(0 indicating best and 3 worst health status). A total score is obtained by summing the
answers to each item. Lower scores indicate better haemorrhoidal health

The Vaizey incontinence score questionnaire is a seven-item measure in detecting fecal
incontinence. The Vaizey consists of seven items, three of which ask about the frequency
of incontinence on a 4-point scale ranging from 0 = Never to 4= Daily, followed by a
single item about the extent to which symptoms alter lifestyle (using the same 4-point
scale). The final three items are concerned with the severity of incontinence using a
dichotomous No/Yes response scale (No=0, Yes=2 for items five and six, and 4 for item
seven). The Vaizey score is calculated by summing responses across the seven items. A
lower score indicates less fecal incontinence (e.g. 0=perfect continence, 24=totally
incontinent).

The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on
functioning.

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

About this trial

Study ID

Status

Type

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status