Transarterial Coil Embolization of the Superior Rectal Arteries for Treatment of Stage II Hemorrhoids

Study Overview
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Brief Summary
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This study will evaluate short , mid and long term efficacy of transarterial coil embolization of the superior rectal arteries (Emborrhoid techinque) for treatment the hemorrhoidal disease.

Detailed Description
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The 'emborrhoid' technique is the embolization of the hemorrhoidal arteries. The endovascular arterial occlusion is performed using coils placed in the terminal branches of the superior rectal arteries The emborrhoid technique has been modeled after elective transanal Doppler-guided hemorrhoidal artery ligation, which has been shown to be safe and effective for hemorrhoidal disease. To date, there are few reports regarding emborrhoid, particularly lacking in long-term follow-up. Additionally, all procedures reported so far have used a transfemoral access route, which requires at least one day of hospital stay. The aims of this study are: To increase data regarding safety and efficacy of the Emborrhoid technique To report changes in the quality of life of patients at short and long-term To quantify recurrences at one-year follow-up To validate the use of the radial access for the Emborrhoid technique To validate the Emborrhoid technique as a one-day hospital procedure

Official Title
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Transarterial Coil Embolization of the Superior Rectal Arteries for Treatment of Stage II Hemorrhoids

Conditions
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Hemorrhoids, Embolization, Therapeutic

Intervention / Treatment
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* Procedure: Transarterial coil embolization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with at least grade II Hemorrhoids (Banov et al. 1985), agreeing to undergo the Embhorroid technique. Exclusion Criteria: Absolute contraindications to an angiographic procedure.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Coil embolization<br>Transarterial coil embolization of the superior rectal arteries via a transradial left arterial access. | Procedure: Transarterial coil embolization<br>* Transarterial coil embolization of the superior rectal arteries via a transradial left arterial access.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the severity of symptoms of hemorrhoidal disease | A symptom-based severity score (Sordegren scoring system) will be used before and after intervention. It is a questionnaire composed by 4 questions with a final scoring of 0-14 where 14 is the highest possible severity of symptoms. The questionnaire will be administered the day before procedure, one week after procedure and one year after procedure. | 1 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemorrhoids, Embolization, Therapeutic