Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2018-12-01
2020-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Embospheres 500-700 microns
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.
Embolization with tri-acryl gelatin (Embosphere) particles
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.
Embospheres 700-900 microns
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.
Embolization with tri-acryl gelatin (Embosphere) particles
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.
Interventions
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Embolization with tri-acryl gelatin (Embosphere) particles
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with written informed consent
* Patients refusing surgery or other interventional methods
* Patients with high risk for surgery
* Patients accepting follow ups
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Eskisehir Osmangazi University
OTHER
Responsible Party
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Fahrettin Kucukay,MD
Prof.Dr.
Principal Investigators
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Fahrettin Kucukay
Role: STUDY_CHAIR
Eskisehir Osmangazi University, Faculty of Medicine, Department of Interventional Radiology
Locations
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Eskisehir Osmangazi University, Faculty of Medicine, Department of Interventional Radiology
Eskişehir, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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Zakharchenko A, Kaitoukov Y, Vinnik Y, Tradi F, Sapoval M, Sielezneff I, Galkin E, Vidal 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 Nov;97(11):1079-1084. doi: 10.1016/j.diii.2016.08.002. Epub 2016 Aug 31.
Vidal V, Sapoval M, Sielezneff Y, De Parades V, Tradi F, Louis G, Bartoli JM, Pellerin O. Emborrhoid: a new concept for the treatment of hemorrhoids with arterial embolization: the first 14 cases. Cardiovasc Intervent Radiol. 2015 Feb;38(1):72-8. doi: 10.1007/s00270-014-1017-8. Epub 2014 Nov 4.
Vidal V, Louis G, Bartoli JM, Sielezneff I. Embolization of the hemorrhoidal arteries (the emborrhoid technique): a new concept and challenge for interventional radiology. Diagn Interv Imaging. 2014 Mar;95(3):307-15. doi: 10.1016/j.diii.2014.01.016. Epub 2014 Feb 28.
Galkin E. [X-ray endovascular embolization of the superior rectal artery: New potentialities in the surgical management of chronic hemorrhoids]. Vestn Rentgenol Radiol. 2001 Nov-Dec;(6):44-9. Russian.
Tradi F, Louis G, Giorgi R, Mege D, Bartoli JM, Sielezneff I, Vidal V. Embolization of the Superior Rectal Arteries for Hemorrhoidal Disease: Prospective Results in 25 Patients. J Vasc Interv Radiol. 2018 Jun;29(6):884-892.e1. doi: 10.1016/j.jvir.2018.01.778. Epub 2018 Apr 30.
Venturini M, De Nardi P, Marra P, Panzeri M, Brembilla G, Morelli F, Melchiorre F, De Cobelli F, Del Maschio A. Embolization of superior rectal arteries for transfusion dependent haemorrhoidal bleeding in severely cardiopathic patients: a new field of application of the "emborrhoid" technique. Tech Coloproctol. 2018 Jun;22(6):453-455. doi: 10.1007/s10151-018-1802-5. Epub 2018 May 24. No abstract available.
Primo Romaguera V, Gregorio Hernandez A, Andreo Hernandez L, de la Morena Valenzuela E. Selective embolization of the superior rectal artery: An alternative to hemorrhoid surgery? Cir Esp (Engl Ed). 2018 Apr;96(4):239-241. doi: 10.1016/j.ciresp.2017.08.005. Epub 2017 Oct 14. No abstract available. English, Spanish.
Provided Documents
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Document Type: Study Protocol
Related Links
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Device descriptions, Instructions for use
Other Identifiers
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80558721/237
Identifier Type: -
Identifier Source: org_study_id
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