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

Primary Purpose

Hemorrhoids, Embolization, Therapeutic

Status

Unknown status

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Transarterial coil embolization

About this trial

This is an interventional treatment trial for Hemorrhoids focused on measuring Hemorrhoids, Embolization, Therapeutic

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Humanitas Research Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Coil embolization

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03805087

First Posted

December 24, 2018

Last Updated

January 11, 2019

Sponsor

Humanitas Clinical and Research Center

1. Study Identification

Unique Protocol Identification Number

NCT03805087

Brief Title

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

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Unknown status

Study Start Date

January 2019 (Anticipated)

Primary Completion Date

December 2019 (Anticipated)

Study Completion Date

December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Humanitas Clinical and Research Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hemorrhoids, Embolization, Therapeutic

Keywords

Hemorrhoids, Embolization, Therapeutic

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Coil embolization

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Transarterial coil embolization

Intervention Description

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

Primary Outcome Measure Information:

Title

Changes in the severity of symptoms of hemorrhoidal disease

Description

Time Frame

1 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

EZIO LANZA, MD

Phone

0282247383

eziolanza@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

EZIO LANZA, MD

Organizational Affiliation

Humanitas Research Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Humanitas Research Hospital

City

Rozzano

State/Province

Lombardia

ZIP/Postal Code

20089

Country

Italy

Facility Contact:

First Name & Middle Initial & Last Name & Degree

EZIO LANZA, MD

Phone

3476247530

eziolanza@gmail.com

First Name & Middle Initial & Last Name & Degree

EZIO LANZA, MD

First Name & Middle Initial & Last Name & Degree

PAOLA CAMPENNI, MD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

17334848

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.

Results Reference

result

PubMed Identifier

24589187

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.

Results Reference

result

PubMed Identifier

29724519

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.

Results Reference

result

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

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