Clinical trial NCT03805087: Transarterial Coil Embolization of the Superior Rectal Arteries for Treatment of Stage II Hemorrhoids
Official title: Transarterial Coil Embolization of the Superior Rectal Arteries for Treatment of Stage II Hemorrhoids
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemorrhoids
Embolization, Therapeutic
Keywords: Hemorrhoids
Embolization, Therapeutic
Lead sponsor: Humanitas Clinical and Research Center
Sponsor class: OTHER
First posted: 2019-01-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This study will evaluate short , mid and long term efficacy of transarterial coil embolization of the superior rectal arteries (Emborrhoid techinque) for treatment the hemorrhoidal disease.

Detailed description: The 'emborrhoid' technique is the embolization of the hemorrhoidal arteries. The endovascular arterial occlusion is performed using coils placed in the terminal branches of the superior rectal arteries The emborrhoid technique has been modeled after elective transanal Doppler-guided hemorrhoidal artery ligation, which has been shown to be safe and effective for hemorrhoidal disease.

To date, there are few reports regarding emborrhoid, particularly lacking in long-term follow-up. Additionally, all procedures reported so far have used a transfemoral access route, which requires at least one day of hospital stay.

The aims of this study are:

To increase data regarding safety and efficacy of the Emborrhoid technique To report changes in the quality of life of patients at short and long-term To quantify recurrences at one-year follow-up To validate the use of the radial access for the Emborrhoid technique To validate the Emborrhoid technique as a "one-day" hospital procedure

Eligibility criteria: Inclusion Criteria:

* Patients with at least grade II Hemorrhoids (Banov et al. 1985), agreeing to undergo the Embhorroid technique.

Exclusion Criteria:

* Absolute contraindications to an angiographic procedure.

Primary outcomes:
measure: Changes in the severity of symptoms of hemorrhoidal disease
timeFrame: 1 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Humanitas Research Hospital
state: Lombardia
Study officials:
affiliation: Humanitas Research Hospital IRCCS, Rozzano-Milan
name: EZIO LANZA, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Berczi V, Gopalan D, Cleveland TJ. Embolization of a hemorrhoid following 18 hours of life-threatening bleeding. Cardiovasc Intervent Radiol. 2008 Jan-Feb;31(1):183-5. doi: 10.1007/s00270-006-0179-4.
citation: Vidal V, Louis G, Bartoli JM, Sielezneff I. Embolization of the hemorrhoidal arteries (the emborrhoid technique): a new concept and challenge for interventional radiology. Diagn Interv Imaging. 2014 Mar;95(3):307-15. doi: 10.1016/j.diii.2014.01.016. Epub 2014 Feb 28.
citation: Tradi F, Louis G, Giorgi R, Mege D, Bartoli JM, Sielezneff I, Vidal V. Embolization of the Superior Rectal Arteries for Hemorrhoidal Disease: Prospective Results in 25 Patients. J Vasc Interv Radiol. 2018 Jun;29(6):884-892.e1. doi: 10.1016/j.jvir.2018.01.778. Epub 2018 Apr 30.