SRAE With Embospheres for Hemorrhoids.

Eskisehir Osmangazi University50 enrolled

Overview

In this study , safety and efficacy of superior rectal artery embolization with embospheres will be researched prospectively.

Symptomatic hemorrhoidal disease is a still important public health problem although there are many surgical and nonsurgical minimal invasive treatment methods. Treatment methods are not satisfactory or invasive in some percent of the patients. Superior rectal artery embolization(SRAE) for hemorrhoids is an adapted technique derived from Doppler-guided hemorrhoidal artery ligation (DGHAL). In this technique, the distal branches of the superior rectal artery arising from the inferior mesenteric artery is occluded endovascularly with coils. Its feasibility and safety were supported by articles. Collateralization and recurrence was seen following coil embolization. To prevent this , tri-acryl gelatin microspheres in 500-700 and 700-900 micrometers in size will be used. Safety and efficacy of embolization and using different sized particles will be evaluated.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Embolization Hemorrhoids

Interventions

Embolization with tri-acryl gelatin (Embosphere) particlesDEVICE

Left, right and posterior branches of superior rectal artery will be embolized with tri-acryl gelatin particles in 500-700 and 700-900 micrometers in size until homeostasis will be achieved.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with symptoms of hemorrhoidal disease * Patients with written informed consent * Patients refusing surgery or other interventional methods * Patients with high risk for surgery * Patients accepting follow ups Exclusion Criteria: * Previous intervention * Colorectal diseases other than hemorrhoids * Patients with anal stenosis * Patients with rectal prolapsus * pregnant patients * Patients with contraindications for technical steps or contrast usage. * Patients do nor or could not give written informed consent

Locations (1)

Eskisehir Osmangazi University, Faculty of Medicine, Department of Interventional Radiology

Eskişehir, Turkey (Türkiye)

RECRUITING

Outcomes

Primary Outcomes

Incidence of procedure related mortality (safety)

The mortality rate among the patients during 12 months related with interventional procedure.

Time frame: 12 month

Incidence of procedure related complications (safety)

The morbidity rate among the patients during 12 months related with interventional procedure.

Time frame: 12 month

Incidence of the patients' being free of symptoms from hemorrhoidal disease (efficacy)

The efficacy and clinical success of the procedure will be evaluated

Time frame: 12 month

Secondary Outcomes

Technical success

The rate of interventions that were performed successfully.

Time frame: On the day of intervention

Recurrence

Recanalization or collateralization of the previously embolized rectal arteries.

Time frame: 3-6-12. months

Central Contacts

Fahrettin Kucukay, Prof.

CONTACT

+905325875318 fkucukay@hotmail.com

Data from ClinicalTrials.gov

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