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

January 11, 2019 updated by: Humanitas Clinical and Research Center
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Lombardia
      • Rozzano, Lombardia, Italy, 20089
        • Humanitas Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Coil embolization
Transarterial coil embolization of the superior rectal arteries via a transradial left arterial access.
Procedure: Transarterial coil embolization
Transarterial coil embolization of the superior rectal arteries via a transradial left arterial access.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in the severity of symptoms of hemorrhoidal disease
Time Frame: 1 years

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Humanitas Clinical and Research Center

Investigators

  • Principal Investigator: EZIO LANZA, MD, Humanitas Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2019

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

December 24, 2018

First Submitted That Met QC Criteria

January 11, 2019

First Posted (Actual)

January 15, 2019

Study Record Updates

Last Update Posted (Actual)

January 15, 2019

Last Update Submitted That Met QC Criteria

January 11, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICH-Emborrhoid

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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