Status:
COMPLETED
Polidocanol Foam VS Artery Ligation in Hemorrhoidal Disease
Lead Sponsor:
Universidade do Porto
Conditions:
Hemorrhoids
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
Background: Hemorrhoidal disease is extremely frequent in the adult population and, as a benign pathology, the treatment should be guided by the patient's symptoms. Treatment of hemorrhoidal disease i...
Detailed Description
INTRODUCTION: Instrumental office-based procedures are usually indicated for internal hemorrhoidal disease grade I and II which are refractory to conservative medical treatments and in selected cases...
Eligibility Criteria
Inclusion
- Patients older than 18 years with symptomatic hemorrhoidal disease grade II and III (Goligher's classification)
- Refractory to conservative therapy (dietary modification, intestinal transit modifiers, topical and phlebotonic medications) for a period of not less than 4 weeks
Exclusion
- Cirrhosis
- Pregnant or breast-feeding women
- Known allergy to polidocanol
- Another perianal disease that can cause symptoms similar to hemorrhoidal disease
- Colorectal malignancy
- Concomitant presence of external hemorrhoidal disease and/or hemorrhoidal thrombosis - - Office or surgical treatment for hemorrhoids within 6 months prior to inclusion
- Antiplatelet or hypocoagulant medication
- Hematological disorders
- Immunosuppressive states
- Inflammatory bowel disease
- Patients unable to have general or spinal anesthetic
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 25 2020
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04675177
Start Date
September 1 2019
End Date
March 25 2020
Last Update
February 10 2021
Active Locations (1)
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1
Centro Hospitalar Universitário do Porto
Porto, Portugal, 4050-000