Superior Rectal Artery Embolization With Tri-acryl Gelatin Particles for Treatment of Symptomatic Hemorrhoids: Safety and Efficacy
Phase: NA
Conditions: Embolization, Hemorrhoids
Sponsor: Eskisehir Osmangazi University

13 Nisan 2013 tarih ve 28617 sayılı Resmi Gazetede yayınlanan İlaç Ve Biyolojik Ürünlerin Klinik Araştırmaları Hakkında 
Yönetmelik: 
(*) y) Sorumlu araştırmacı: Araştırma konusu ile ilgili dalda uzmanlık veya doktora eğitimini tamamlamış olup, 
araştırmanın yürütülmesinden sorumlu olan hekim veya diş hekimini, 
(**) cc) (Ek:RG-25/6/2014-29041) Koordinatör: Çok merkezli bir araştırmada bu merkezlerin sorumlu araştırmacıları ile 
etik kurul, destekleyici veya destekleyicinin yasal temsilcisi ve gerekirse bunlar ile Kurum arasındaki koordinasyonun 
sağlanmasından sorumlu, uzmanlığını veya doktorasını tamamlamış hekim veya diş hekimini, 
 
T.C 
ESKİŞEHİR OSMANGAZİ ÜNİVERSİTESİ 
KLİNİK ARAŞTIRMALAR ETİK KURULU 
(LOCAL ETHIC BOARD-STUDY PROTOCOL) 
 
Version date:15/07/2017 
Version number: 1 
 
 
TITLE: Superior Rectal Artery Embolization With Tri-acryl Gelatin Particles for 
Treatment of Symptomatic Hemorrhoids: Safety and Efficacy 
 
Principle investigator-coordinator (**): 
Prof.Dr.Fahrettin Küçükay (**) 
Investigators: 
Assoc.Prof.Dr. Necdet Fatih Yaşar 
Ass.Prof.Dr.Bartu Badak 
Assoc.Prof. Dr. Tuncer Temel 
Location: Eskisehir Osmangazi University, Faculty of Medicine, Interventional Radiology, 
Gastroenterology, General Surgery, Eskisehir/Turkey 
Study design: Double arm, parallel, single blinded, blocked randomized ,prospective study 
Unique Protocol ID: 80558721/237 
 
INTRODUCTION 
 
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.  

[Metni yazın] 
 
 
The purpose of this study is to compare safety and efficacy of 500-700 and 700-900 
micron microspheric particles in superior rectal artery embolization. 
 
MATERIALS AND METHODS  
This is a double arm, parallel, single blinded, blocked randomized , prospective study. 
In each arm there will be 25 patients (any sex, between 18-75 years old).  Local ethic board 
approved the study. Written informed consent will be obtained from the patients ıncluded in 
the study. Study will be conducted between December 2018 and Deecember 2019.  
Inclusion criteria as follows: 
-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 as follows: 
- 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 
 
 
In experimental arms interventional embolization with 500-700 and 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. 
 
Primary Outcome Measures are as follow:  
-Incidence of procedure related mortality (safety)   [Time Frame: 12 month]. The 
mortality rate among the patients during 12 months related with interventional procedure. 
 
- Incidence of procedure related complications (safety)   [Time Frame: 12 month]. The 
morbidity rate among the patients during 12 months related with interventional procedure. 
 
- Incidence of the patients' being free of symptoms from hemorrhoidal disease 
(efficacy)   [Time Frame: 12 month]. The efficacy and clinical success of the procedure will 
be evaluated. 

[Metni yazın] 
 
Secondary Outcome Measures: 
-Technical success   [Time Frame: On the day of intervention]. The rate of 
interventions that were performed successfully. 
 
- Recurrence   [Time Frame: 3-6-12. months]. Recanalization or collateralization of 
the previously embolized rectal arteries. 
Goligher’s classification scale (prolapse stage), Bleeding severity score (French), 
Qulity of life score, Visual analog scale score for pain will be used for follow ups. 
Appropriate statistical analysis of primary and secondary outcomes will be used to 
describe the results of data obtained. 
 
REFERENCES: 
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V. Safety and efficacy of superior rectal artery embolization with particles and metallic coils 
for the treatment of hemorrhoids (Emborrhoid technique). Diagn Interv Imaging. 2016 
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27597728. 
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Emborrhoid: a new concept for the treatment of hemorrhoids with arterial embolization: the 
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1017-8. Epub 2014 Nov 4. PubMed PMID: 25366092. 
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emborrhoid technique): a new concept and challenge for interventional radiology. Diagn 
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PubMed PMID: 24589187. 
4: Galkin E. [X-ray endovascular embolization of the superior rectal artery: New  
potentialities in the surgical management of chronic hemorrhoids]. Vestn Rentgenol Radiol. 
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5: Galkin EV, Iavisia AM, Vdovenko PA. [Interventional radiology for chronic hemorrhoids 
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[Metni yazın] 
 
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