Superior Rectal Artery Embolization With Tri-acryl Gelatin Particles for Treatment of Symptomatic Hemorrhoids: Safety and Efficacy
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Incidence of procedure related mortality (safety)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Embolization with tri-acryl gelatin (Embosphere) particles (Device)
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.
Intervention: Embolization with tri-acryl gelatin (Embosphere) particles (Device)
Outcomes
Primary Outcomes
Incidence of procedure related mortality (safety)
Time Frame: 12 month
The mortality rate among the patients during 12 months related with interventional procedure.
Incidence of procedure related complications (safety)
Time Frame: 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)
Time Frame: 12 month
The efficacy and clinical success of the procedure will be evaluated
Secondary Outcomes
- Technical success(On the day of intervention)
- Recurrence(3-6-12. months)
Investigators
Fahrettin Kucukay,MD
Prof.Dr.
Eskisehir Osmangazi University