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

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ClinicalTrials.gov Identifier: NCT03805087
Recruitment Status : Not yet recruiting
First Posted : January 15, 2019
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
Humanitas Clinical and Research Center

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.

Condition or disease Intervention/treatment Phase
Hemorrhoids Embolization, Therapeutic Procedure: Transarterial coil embolization Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transarterial Coil Embolization of the Superior Rectal Arteries for Treatment of Stage II Hemorrhoids
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemorrhoids

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.




Primary Outcome Measures :
  1. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03805087


Contacts
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Contact: EZIO LANZA, MD 0282247383 eziolanza@gmail.com

Locations
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Italy
Humanitas Research Hospital Recruiting
Rozzano, Lombardia, Italy, 20089
Contact: EZIO LANZA, MD    3476247530    eziolanza@gmail.com   
Principal Investigator: EZIO LANZA, MD         
Sub-Investigator: PAOLA CAMPENNI, MD         
Sponsors and Collaborators
Humanitas Clinical and Research Center
Investigators
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Principal Investigator: EZIO LANZA, MD HUMANITAS RESEARCH HOSPITAL

Publications of Results:
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Responsible Party: Humanitas Clinical and Research Center
ClinicalTrials.gov Identifier: NCT03805087     History of Changes
Other Study ID Numbers: ICH-Emborrhoid
First Posted: January 15, 2019    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Humanitas Clinical and Research Center:
Hemorrhoids
Embolization, Therapeutic
Additional relevant MeSH terms:
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Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases