Hemorrhoidal Artery Embolization: Longitudinal Impact On Symptoms (HELIOS)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorUniversity of California, Los Angeles
About this trial
Hemorrhoidal artery embolization (HAE) is a novel treatment for symptomatic internal hemorrhoids. HAE involves the deliberate blockage (embolization) of enlarged rectal or hemorrhoidal arteries leading to reduction of abnormal blood flow to the hemorrhoidal tissue. The aim of HAE is to the improve hemorrhoid related symptoms, especially bleeding. Initial reports of HAE have demonstrated that it both safe and effective. Following an initial clinic visit to determine trial candidacy, enrolled patients will be subsequently treated with HAE. Patients will be followed for a year with clinic follow-up visits at 1, 3, 6 and 12 months.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 to 90 years
Ability to give written informed consent and to comply with the follow-up visits
Symptomatic hemorrhoidal disease with French Bleeding Score (FBS) of at least four out of nine
Refusal of or contraindication to surgery
Disqualifiers
Asymptomatic patients
Patients who ever had previous colorectal surgery
Grade IV hemorrhoids
Colorectal disease other than hemorrhoids that could result in bleeding
Trial design
Design model
Single group
Treatments tested in this trial
Hemorrhoidal artery embolization
Procedure/SurgeryHemorrhoidal artery embolization (HAE) involves the deliberate blockage of enlarged rectal or hemorrhoidal arteries leading to reduction of abnormal blood flow to the hemorrhoidal tissue. The aim of HAE is to the improve symptoms related to internal hemorrhoids, especially bleeding.
Treatment groups
22 Participants
are divided into 1 treatment groupGroup A: Hemorrhoidal artery embolizationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of patients with decrease in bleeding related symptoms of internal hemorrhoids as defined as a two-point decrease in French Bleeding Score
Time frame
From baseline to 12 months post procedureSecondary outcomes
1
Proportion of technically successful HAE procedures
Time frame
From baseline to 12 months post procedure2
Change in non-bleeding related symptoms of internal hemorrhoids as measured by the Hemorrhoid Disease Symptom Score (HDSS)
The Hemorrhoidal Disease Symptom Score (HHDS) is a widely used questionnaire used by health professionals to evaluate the condition of patients with hemorrhoids. It can be self-administered and asks patients to rate the frequency and intensity of five primary symptoms: pain, itching, bleeding, soiling, and prolapse. Each symptom is rated on a scale of 0 to 4, with 0 indicating no symptoms and 4 indicating the most severe symptoms. The total HDSS score ranges from 0 to 20, with higher scores indicating more severe hemorrhoidal disease.
Time frame
From baseline to 12 months post procedure3
Change in non-bleeding related symptoms of internal hemorrhoids as measured by the Short Health Scale-Hemorrhoidal Disease (SHSHD)
The Short Health Scale-Hemorrhoidal Disease questionnaire is a validated tool used to assess the impact of hemorrhoidal disease on a patient's health-related quality of life. It can be self-administered and measures four key dimensions: symptom load, functional status, disease-specific worries, and general well-being. Each symptom is rated on a scale of 1 to 7, with 1 indicating no symptoms and 7 indicating the most severe symptoms. The total SHSHD score ranges from 4 to 28, with higher scores indicating more severe hemorrhoidal disease.
Time frame
From baseline to 12 months post procedure4
Change in pain related to as measured by the Visual Analog Scale (VAS)
The Visual Analog Scale (VAS) is a validated commonly used pain score. The VAS ranges from 0 to 10, with higher scores indicated higher pain levels.
Time frame
From baseline to 12 months post procedureSponsors and contacts
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Source ClinicalTrials.gov