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ARTerial EMbolization for haemorrhoIdal Disease (ART.EM.I. Study)

NCT04684251 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-08-18

No results posted yet for this study

Summary

Haemorrhoidal disease is amongst the most common rectal conditions causing significant distress to the affected patients. Current surgical techniques for the treatment of internal haemorrhoids are associated with several drawbacks and sometimes high recurrence rates. The purpose of this study is to assess the safety and efficacy of a new minimally invasive technique that is based on blocking the arteries that feed the haemorrhoids and thus potentially leading to a decrease in their size. A recently published paper with 14 patients showed good results in terms of safety(Vidal et. al.). Despite the promising preliminary evidence, there is still a need for more studies and additional data. Furthermore, at the current time, there are no studies assessing quality of life changes post embolisation for these patients and the investigators hope to evaluate this important aspect of treatment as well.

This study will provide the investigators with results regarding the efficacy and safety of arterial embolisation for advanced haemorrhoid disease. This will be the first study to provide data on short and long term efficacy (in terms of re-bleeding and re-operation rates) as well as to provide evidence on the effect of this novel treatment on quality of life. This study will also be the largest study to date and if successful will pave the way for a large randomised controlled trial comparing the gold standard surgical treatment to the embolisation treatment.

The embolisation of haemorrhoid vessel is not an experimental technique and it has been used in the past in cases of uncontrollable hemorrhoidal- related bleeding with good results and without morbidity. However, this is the first time that the investigators will use this technique as a first line treatment for haemorrhoids and part of this study is to assess the feasibility and safety of this approach.

Conditions

  • Haemorrhoidal Bleeding

Interventions

PROCEDURE

Coil embolisation of hemorrhoidal arteries.

Coil embolisation of hemorrhoidal arteries as previously described.

Sponsors & Collaborators

  • Oxford University Hospitals NHS Trust

    lead OTHER

Principal Investigators

  • Raman Uberoi, FRCR · John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust, Headington, Oxford OX3 9DU

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-25
Primary Completion
2022-05-24
Completion
2022-05-24

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04684251 on ClinicalTrials.gov