Transarterial Coil Embolization of the Superior Rectal Arteries for Treatment of Stage II Hemorrhoids
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 24, 2018
CompletedStudy Start
First participant enrolled
January 1, 2019
CompletedFirst Posted
Study publicly available on registry
January 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedJanuary 15, 2019
January 1, 2019
11 months
December 24, 2018
January 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Coil embolization
EXPERIMENTALTransarterial coil embolization of the superior rectal arteries via a transradial left arterial access.
Interventions
Transarterial coil embolization of the superior rectal arteries via a transradial left arterial access.
Eligibility Criteria
You may qualify if:
- Patients with at least grade II Hemorrhoids (Banov et al. 1985), agreeing to undergo the Embhorroid technique.
You may not qualify if:
- Absolute contraindications to an angiographic procedure.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Humanitas Research Hospital
Rozzano, Lombardy, 20089, Italy
Related 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. doi: 10.1007/s00270-006-0179-4.
PMID: 17334848RESULTVidal 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.
PMID: 24589187RESULTTradi 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.
PMID: 29724519RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
EZIO LANZA, MD
Humanitas Research Hospital IRCCS, Rozzano-Milan
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 24, 2018
First Posted
January 15, 2019
Study Start
January 1, 2019
Primary Completion
December 1, 2019
Study Completion
December 1, 2021
Last Updated
January 15, 2019
Record last verified: 2019-01