Embolization, Hemorrhoids
Conditions
Keywords
Hemorrhoids, Superior rectal artery, embolization, microspheric particles
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.
Interventions
DEVICEEmbolization 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.
Sponsors
Eskisehir Osmangazi University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Intervention model description
Blocked randomized, single blind, prospective study
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Turkey (Türkiye)
Contacts
Primary ContactFahrettin Kucukay, Prof.
Outcome results
None listed