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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03805087
Other study ID # ICH-Emborrhoid
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 2019
Est. completion date December 2021

Study information

Verified date January 2019
Source Humanitas Clinical and Research Center
Contact EZIO LANZA, MD
Phone 0282247383
Email eziolanza@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date December 2021
Est. primary completion date December 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Transarterial coil embolization
Transarterial coil embolization of the superior rectal arteries via a transradial left arterial access.

Locations

Country Name City State
Italy Humanitas Research Hospital Rozzano Lombardia

Sponsors (1)

Lead Sponsor Collaborator
Humanitas Clinical and Research Center

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. — View 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. — View 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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in the severity of symptoms of hemorrhoidal disease A symptom-based severity score (Sordegren scoring system) will be used before and after intervention. It is a questionnaire composed by 4 questions with a final scoring of 0-14 where 14 is the highest possible severity of symptoms.
The questionnaire will be administered the day before procedure, one week after procedure and one year after procedure.
1 years
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