Internal Hemorrhoids, HAE
Conditions
Brief summary
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.
Detailed description
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. However, the initial data is limited due to variations in embolization techniques, few studies with prospective long-term follow-up, and studies focusing on patients with only severe symptoms. Further research is needed to understand the specific long-term effectiveness of different embolization materials in a population that more accurately reflects the large number of patients with hemorrhoidal disease who would likely benefit from HAE. The proposed research project includes 22 patients with symptomatic internal hemorrhoids. 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.
Interventions
PROCEDUREHemorrhoidal artery embolization
Hemorrhoidal 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.
Sponsors
University of California, Los Angeles
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* 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 * Refusal of or contraindication to other minimally invasive hemorrhoid treatments * Grade I to III hemorrhoids * Previous anoscopy or colonoscopy demonstrating internal hemorrhoids within 1 year * Supply of the CCR from either the SRA or MRA on intra-procedural angiogram prior to embolization
Exclusion criteria
* Asymptomatic patients * Patients who ever had previous colorectal surgery * Grade IV hemorrhoids * Colorectal disease other than hemorrhoids that could result in bleeding * Anatomic findings on CTA that would preclude successful embolization * Contraindication to iodinated contrast * Inability to give written informed consent * Active infection or malignancy * Recent (within 12 months) or active cigarette use * History of inflammatory bowel disease * Uncorrectable bleeding diathesis * Presence of portal hypertension or rectal varices seen on pre-procedure CTA or anoscopy/colonoscopy * No SRA or MRA supply to the CCR seen intra-procedural angiogram
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with decrease in bleeding related symptoms of internal hemorrhoids as defined as a two-point decrease in French Bleeding Score | From baseline to 12 months post procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of technically successful HAE procedures | From baseline to 12 months post procedure | — |
| Change in non-bleeding related symptoms of internal hemorrhoids as measured by the Hemorrhoid Disease Symptom Score (HDSS) | From baseline to 12 months post procedure | 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. |
| Change in non-bleeding related symptoms of internal hemorrhoids as measured by the Short Health Scale-Hemorrhoidal Disease (SHSHD) | From baseline to 12 months post procedure | 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. |
| Change in pain related to as measured by the Visual Analog Scale (VAS) | From baseline to 12 months post procedure | 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. |
| Change in concomitant hemorrhoid medical therapy | From baseline to 12 months post procedure | — |
| Level of patient satisfaction after HAE as determined by patient satisfaction questionnaire | From baseline to 12 months post procedure | Patient satisfaction will be determined by a patient satisfaction questionnaire with the following four options: very satisfied, satisfied, a little satisfied, and unsatisfied |
| Proportion of patients requiring subsequent non-surgical internal hemorrhoid procedures | From baseline to 12 months post procedure | — |
| Proportion of patients requiring surgical management of their internal hemorrhoids | From baseline to 12 months post procedure | — |
Countries
United States
Contacts
CONTACTRenato Escobar
CONTACTLucas Cusumano, MD
PRINCIPAL_INVESTIGATORLucas Cusumano, MD
University of California, Los Angeles
Outcome results
None listed