Health TrialsbyHealthPanel

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

ConditionInternal Hemorrhoid
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorMayo Clinic

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Prior hemorrhoid surgery.

Grade IV hemorrhoidal disease.

Acute hemorrhoid complications.

Chronic anal or perianal fissures.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Rectal Artery Embolization

    Device

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

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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)

Time frame
Baseline, 1, 3, 6 and 12 months
2

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

Time frame
Day 1 and 1, 3, 6 and 12 months
3

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

Time frame
Baseline (pre-embolization)

Secondary outcomes

1

Visual Analog Scale (VSS) Pain

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.

Time frame
Baseline, 1, 3, 6 and 12 months
2

Visual Analog Scale (VAS) for Quality of Life

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

Time frame
Baseline, 1, 3, 6 and 12 months
3

Goligher Prolapse Score

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

Time frame
Baseline, 1, 3, 6 and 12 months
4

Hemorrhoidal Bleeding Score (HBS)

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.

Time frame
Baseline, 1, 3, 6 and 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Terumo Corporation

Collaborator

Source ClinicalTrials.gov
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