Hemorrhoidal Artery Embolization: Longitudinal Impact On Symptoms (HELIOS)

LO ESENCIAL

De qué trata este estudio

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Tipo de estudio: De intervención
Fase: No aplica
Rango de edad: 18 años - 90 años
Sexo admitido: Todos los sexos
Voluntarios sanos: No aceptados
Participantes: 22 Estimado

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

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.

Leer la descripción completa

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.

¿Quién podría participar?

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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

Entiende la evaluación inicial

Tratamiento, grupos y participación

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Asignación: No aplica
Enmascaramiento: Sin enmascaramiento

Hemorrhoidal artery embolization

Patients in this arm will undergo hemorrhoidal artery embolization (HAE) for treatment of symptomatic internal hemorrhoids

Procedure: Hemorrhoidal artery embolization

Hemorrhoidal artery embolization PROCEDURE

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.

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Proportion of patients with decrease in bleeding related symptoms of internal hemorrhoids as defined as a two-point decrease in French Bleeding Score