SRAE With Embospheres for Hemorrhoids.

Not Applicable

• Conditions: Hemorrhoids; Embolization
• Interventions: Device: Embolization with tri-acryl gelatin (Embosphere) particles

• Registration Number: NCT03740321
• Lead Sponsor: Eskisehir Osmangazi University

Brief Summary

In this study , safety and efficacy of superior rectal artery embolization with embospheres will be researched prospectively.

Detailed Description

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.

Study Timeline

• Status Verified: 2018-11
• Study First Submitted: 2018-11-08
• Study First Submitted QC: 2018-11-09
• Last Update Submitted: 2018-11-09
• Study First Posted: 2018-11-14
• Last Update Posted: 2018-11-14
• Study Start: 2018-12-01
• Primary Completion: 2019-12-01
• Study Completion: 2020-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Embospheres 500-700 microns	Embolization with tri-acryl gelatin (Embosphere) particles	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.
Embospheres 700-900 microns	Embolization with tri-acryl gelatin (Embosphere) particles	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.

Primary Outcome Measures

Name	Time	Method
Incidence of procedure related mortality (safety)	12 month	The mortality rate among the patients during 12 months related with interventional procedure.
Incidence of procedure related complications (safety)	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)	12 month	The efficacy and clinical success of the procedure will be evaluated

Secondary Outcome Measures

Name	Time	Method
Technical success	On the day of intervention	The rate of interventions that were performed successfully.
Recurrence	3-6-12. months	Recanalization or collateralization of the previously embolized rectal arteries.

Trial Locations

Locations (1)

Eskisehir Osmangazi University, Faculty of Medicine, Department of Interventional Radiology; 🇹🇷 Eskişehir, Turkey