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

NCT ID: NCT03805087

Last Updated: 2019-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-31

Study Completion Date

2021-12-31

Brief Summary

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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

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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

Conditions

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Hemorrhoids Embolization, Therapeutic

Study Design

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Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Coil embolization

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

Group Type EXPERIMENTAL

Transarterial coil embolization

Intervention Type PROCEDURE

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

Interventions

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Transarterial coil embolization

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Humanitas Clinical and Research Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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EZIO LANZA, MD

Role: PRINCIPAL_INVESTIGATOR

Humanitas Research Hospital IRCCS, Rozzano-Milan

Locations

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Humanitas Research Hospital

Rozzano, Lombardy, Italy

Site Status

Countries

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Italy

Central Contacts

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EZIO LANZA, MD

Role: CONTACT

0282247383

Facility Contacts

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EZIO LANZA, MD

Role: primary

3476247530

References

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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.

Reference Type RESULT
PMID: 17334848 (View on PubMed)

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.

Reference Type RESULT
PMID: 24589187 (View on PubMed)

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.

Reference Type RESULT
PMID: 29724519 (View on PubMed)

Other Identifiers

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ICH-Emborrhoid

Identifier Type: -

Identifier Source: org_study_id

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