Hemorrhoids Clinical Trial
Official title:
Superior Rectal Artery Embolization With Tri-acryl Gelatin Particles for Treatment of Symptomatic Hemorrhoids: Safety and Efficacy
In this study , safety and efficacy of superior rectal artery embolization with embospheres will be researched prospectively.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 1, 2020 |
Est. primary completion date | December 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Eskisehir Osmangazi University, Faculty of Medicine, Department of Interventional Radiology | Eskisehir |
Lead Sponsor | Collaborator |
---|---|
Eskisehir Osmangazi University |
Turkey,
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. — View Citation
Primo Romaguera V, Gregorio Hernández A, Andreo Hernández L, de la Morena Valenzuela E. Selective embolization of the superior rectal artery: An alternative to hemorrhoid surgery? Cir Esp. 2018 Apr;96(4):239-241. doi: 10.1016/j.ciresp.2017.08.005. Epub 20 — View Citation
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. — View Citation
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 app — View Citation
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 — View Citation
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. — View Citation
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 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of procedure related mortality (safety) | The mortality rate among the patients during 12 months related with interventional procedure. | 12 month | |
Primary | Incidence of procedure related complications (safety) | The morbidity rate among the patients during 12 months related with interventional procedure. | 12 month | |
Primary | 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 | Technical success | The rate of interventions that were performed successfully. | On the day of intervention | |
Secondary | Recurrence | Recanalization or collateralization of the previously embolized rectal arteries. | 3-6-12. months |
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