Transarterial Coil Embolization of the Superior Rectal Arteries for Treatment of Stage II Hemorrhoids

Hemorrhoids Clinical Trial

Official title:

Transarterial Coil Embolization of the Superior Rectal Arteries for Treatment of Stage II Hemorrhoids

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03805087
• Other study ID #: ICH-Emborrhoid
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Embolization, Therapeutic
• Hemorrhoids

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