Status:
COMPLETED
Feasibility of Superior Rectal Artery Embolization for the Treatment of Hemorrhoidal Disease
Lead Sponsor:
Assistance Publique Hopitaux De Marseille
Conditions:
Hemorrhoidal Disease
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
With an estimated prevalence between 4 and 35%, the hemorrhoidal disease is the most frequent proctologic disease. Its symptoms are mainly rectorrhagia, externalization of the hemorrhoidal cushions (m...
Eligibility Criteria
Inclusion
- Suffering from a symptomatic hemorrhoidal disease stage II or III (history of prior medical treatment or instrumental do not prohibit the inclusion in the study)
- Patient agreeing to participate in the study and who signed an informed consent
- Patient willing to lend to post-operative monitoring for a year
- Patient assured social
Exclusion
- Diseases and colorectal proctologic / History proctologic
- Acute Complication hemorrhoidal disease course (thrombosis)
- History of proctology surgery for hemorrhoidal disease
- Anal stenosis congenital or acquired
- Chronic anal fissure, anal suppuration associated
- Chronic Inflammatory Bowel Disease
- History of colorectal cancer
- History of rectal resection and / or sigmoid
- Rectal prolapse
- Comorbidities
- Portal hypertension
- Severe atherosclerotic pathology (significant stenosis in aorto-iliac-femoral artery or branches for visceral).
- General Affection responsible for a disorder of hemostasis objective (hemophilia, von Willebrand disease thrombocytopenia) and anticoagulants.
- Psychiatric disorder making it impossible informed of and / or postoperative care
- Neurological disease directly or indirectly involving the rectosphinctérienne motor (multiple sclerosis, spinal cord injury or nerve root, polyneuropathy).
- Patients whose condition appears too insecure or taking steroids or immunosuppressive leading to an unacceptable surgical risk.
- Background
- Pregnancy declared (the existence of effective contraception will be checked for women of childbearing age)
- Major Trust
- Patients who do not speak French, refusing or unfit for monitoring proposed in the study
Key Trial Info
Start Date :
December 14 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2018
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT02303925
Start Date
December 14 2014
End Date
June 30 2018
Last Update
July 27 2018
Active Locations (1)
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1
Assistance Publique Hopitaux de Marseille
Marseille, France, 13005