Clinical trial NCT06106269: Outcomes and Quality of Life Following Rectal Artery Embolization for Bleeding Internal Hemorrhoids
Official title: Hemorrhoidal Embolization Trial-1 (HEMBO-1)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Internal Hemorrhoid
Keywords: Bleeding
Anemia
Hemorrhoid
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Terumo Corporation
First posted: 2023-10-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

Detailed 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

Eligibility criteria: 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.

Primary outcomes:
measure: Change in French bleeding score (FBS)
timeFrame: Baseline, 1, 3, 6 and 12 months
measure: Adverse Events
timeFrame: Day 1 and 1, 3, 6 and 12 months
measure: Diagnostic accuracy of pre-embolization Computed Tomography Angiography (CTA)
timeFrame: Baseline (pre-embolization)
Secondary outcomes:
measure: Visual Analog Scale (VSS) Pain
timeFrame: Baseline, 1, 3, 6 and 12 months
measure: Visual Analog Scale (VAS) for Quality of Life
timeFrame: Baseline, 1, 3, 6 and 12 months
measure: Goligher Prolapse Score
timeFrame: Baseline, 1, 3, 6 and 12 months
measure: Hemorrhoidal Bleeding Score (HBS)
timeFrame: Baseline, 1, 3, 6 and 12 months
measure: Hemorrhoidal Severity Score (HSS)
timeFrame: Baseline, 1, 3, 6 and 12 months
measure: Vaizey Incontinence Score
timeFrame: Baseline, 1, 3, 6 and 12 months
measure: Brief Pain Inventory (BPI) Short Form
timeFrame: Baseline, 1, 3, 6 and 12 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Minnesota
state: Minnesota
Study officials:
affiliation: Mayo Clinic, Vascular and Interventional Radiology
name: Scott Thompson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic, Colon and Rectal Surgery
name: Scott R Kelley, MD
role: PRINCIPAL_INVESTIGATOR
References: