SRAE With Embospheres for Hemorrhoids.

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

Detailed Description
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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.

Official Title
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Superior Rectal Artery Embolization With Tri-acryl Gelatin Particles for Treatment of Symptomatic Hemorrhoids: Safety and Efficacy

Conditions
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Embolization, Hemorrhoids

Intervention / Treatment
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* Device: Embolization with tri-acryl gelatin (Embosphere) particles


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Blocked randomized, single blind, prospective study
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Embospheres 500-700 microns<br>Intervention.Embolization with 500-700 micron particles will be performed with 1 ml vials. Embolization procedure will be continued with vials until the stasis in SRAE will be achieved. Procedure will be performed only one time. | Device: Embolization with tri-acryl gelatin (Embosphere) particles<br>* 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.<br>* Other names: Embosphere;|
| Experimental: Embospheres 700-900 microns<br>Intervention.Embolization with 700-900 micron particles will be performed with 1 ml vials. Embolization procedure will be continued with vials until the stasis in SRAE will be achieved. Procedure will be performed only one time. | Device: Embolization with tri-acryl gelatin (Embosphere) particles<br>* 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.<br>* Other names: Embosphere;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of procedure related mortality (safety) | The mortality rate among the patients during 12 months related with interventional procedure. | 12 month | 
| Incidence of procedure related complications (safety) | The morbidity rate among the patients during 12 months related with interventional procedure. | 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 | 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success | The rate of interventions that were performed successfully. | On the day of intervention | 
| Recurrence | Recanalization or collateralization of the previously embolized rectal arteries. | 3-6-12. months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemorrhoids, Superior rectal artery, embolization, microspheric particles