ARTerial EMbolization for haemorrhoIdal disease; the ART.EM.I Study
Research type
Research Study
Full title
Transcatheter ARTerial EMbolization for haemorrhoIdal disease; ART.EM.I study
IRAS ID
209159
Contact name
Raman Uberoi
Contact email
Sponsor organisation
Oxford University Hospitals NHS Foundation Trust
Duration of Study in the UK
3 years, 0 months, 1 days
Research 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. 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 (Videl 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-embolization for these patients and we hope to evaluate this important aspect of treatment as well.
This study will provide us with results regarding the efficacy and safety of arterial embolization 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 their quality of life. This study will also be the largest study to this date and if successful will pave the way for a large randomised controlled trial comparing the gold standard surgical treatment to the embolization treatment.
The embolization 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 we 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.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
18/SC/0601
Date of REC Opinion
23 Nov 2018
REC opinion
Favourable Opinion