SRAE With Embospheres for Hemorrhoids.

NCT ID: NCT03740321

Last Updated: 2018-11-14

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2020-12-01

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.

Conditions

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Embolization Hemorrhoids

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blocked randomized, single blind, prospective study
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

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.

Group Type EXPERIMENTAL

Embolization with tri-acryl gelatin (Embosphere) particles

Intervention Type DEVICE

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.

Group Type EXPERIMENTAL

Embolization with tri-acryl gelatin (Embosphere) particles

Intervention Type DEVICE

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.

Intervention Type DEVICE

Other Intervention Names

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Embosphere

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eskisehir Osmangazi University

OTHER

Sponsor Role lead

Responsible Party

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Fahrettin Kucukay,MD

Prof.Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

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)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Fahrettin Kucukay, Prof.

Role: CONTACT

+905325875318

Facility Contacts

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Fahrettin Kucukay, Prof.

Role: primary

+905325875318

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.

Reference Type RESULT
PMID: 27597728 (View on PubMed)

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.

Reference Type RESULT
PMID: 25366092 (View on PubMed)

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.

Reference Type RESULT
PMID: 24589187 (View on PubMed)

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.

Reference Type RESULT
PMID: 11858033 (View on PubMed)

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.

Reference Type RESULT
PMID: 29724519 (View on PubMed)

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.

Reference Type RESULT
PMID: 29797246 (View on PubMed)

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.

Reference Type RESULT
PMID: 29042023 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Related Links

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Other Identifiers

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80558721/237

Identifier Type: -

Identifier Source: org_study_id

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