K64
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients with symptomatic internal hemorrhoids 2nd / 3rd degree, lack of response to prior therapies (conservative basic treatment, medication, endoscopic procedures, minimally invasive procedures, contraindication to surgery and failed surgical/endoscopic treatment, negative colonoscopic correlation (during the past 24 months), no existing promising alternative endovascular/surgical therapeutic option, platelet count = 50.000 / µl, PTT < 50 s, INR < 1,5, age-adjusted normal serum creatinine or creatinine clearance = 30 ml/min / 1,73 m² for safe application of contrast media.
Exclusion criteria
Exclusion criteria: feasible surgical or endoscopic treatment, hemorrhoidal disease 1st and 4th degree, fixed prolaps, absent access via superior mesenteric artery (e.g. after hemicolectomy), after rectal resection, after endovascular aortic repair (EVAR), acute diseases like fissures, infections, abscesses etc., anatomic contraindications: stenoses, fistula, vascular occlusions, prior colorectal surgery, colorectal anomalies, allergic reactions to contrast media, severe kidney failure, pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of the therapeutic efficacy of the embolization of hemorroidal arteries by applying the French Bleeding Score and VAS 6 months post-interventionally. | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement of quality of life. Pain scale for determining the severity of the symptoms caused by the hemorrhoids | — |
Countries
Germany
Contacts
Klinik und Poliklinik für Radiologie Klinikum der Universität München Campus Großhadern