SRAE With Embospheres for Hemorrhoids.

Eskisehir Osmangazi University

Status: Unknown

Conditions: Embolization; Hemorrhoids

Treatments: Device: Embolization with tri-acryl gelatin (Embosphere) particles

Study type: Interventional

Funder types: Other

Identifiers

NCT03740321

80558721/237

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups

Embospheres 500-700 microns

Experimental group

Description:

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.

Treatment:

Device: Embolization with tri-acryl gelatin (Embosphere) particles

Embospheres 700-900 microns

Experimental group

Description:

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.

Treatment:

Device: Embolization with tri-acryl gelatin (Embosphere) particles