Status:
COMPLETED
Polidocanol Foam Versus Rubber Band Ligation in the Treatment of Hemorrhoidal Disease
Lead Sponsor:
Universidade do Porto
Conditions:
Hemorrhoids, Internal
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Background: Hemorrhoidal disease is a common benign condition seen frequently in clinical settings. Rubber band ligation and sclerotherapy have proven to be the office-based procedures of choice in he...
Detailed Description
INTRODUCTION Hemorrhoids are normal vascular structures in the anal canal, arising from a cushion of dilated arteriovenous channels and connective tissues, that drains into the superior and inferior h...
Eligibility Criteria
Inclusion
- Patients referred to proctologic consultation of Centro Hospitalar Universitário do Porto (CHUP) older than 18 years;
- Clinical diagnosis of hemorrhoidal disease grade I, II and III (Goligher's classification);
- Refractory to conservative management (dietary modification, intestinal transit modifiers, topical and phlebotonic medications) for a period of no less than 4 weeks.
Exclusion
- Hepatic cirrhosis;
- Pregnant or breast-feeding women;
- Known allergy to polidocanol
- Another perianal disease that can cause symptoms similar to hemorrhoidal disease;
- Concomitant presence of external hemorrhoidal disease and/or hemorrhoidal thrombosis;
- Office-based or surgical treatment for hemorrhoids within 6 months prior to inclusion;
- Antiplatelet or hypocoagulant medication;
- Inherited bleeding disorders;
- Immunosuppressive states ;
- Inflammatory bowel disease.
Key Trial Info
Start Date :
August 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2020
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04091763
Start Date
August 1 2018
End Date
July 1 2020
Last Update
August 21 2020
Active Locations (1)
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1
Centro Hospitalar Universitário do Porto
Porto, Portugal, 4050-000