Polidocanol Foam VS Artery Ligation in Hemorrhoidal Disease

• Status: Completed
• Trial end date: 2020-03-25
• Target enrollment: 0
• Participant gender: All

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 includes a conservative approach, office-based treatments and surgery.

This study is aimed to evaluate and compare the efficacy and safety of the treatment of hemorrhoidal disease with non-surgical office-based method polidocanol foam sclerotherapy (SP) and the surgical technique doppler-guided hemorrhoidal artery ligation with recto-anal repair.

Methods: Prospective, unicentric study including patients with symptomatic hemorrhoidal disease grade II and III refractory to conservative therapy, submitted either to SP (n=24) or to HAL-RAR procedure (n=21), during a recruitment period of 6 months.

Patients were evaluated for efficacy (Sodergren's scale of symptoms and severity of bleeding) and safety (complications and implication in personal and professional life), up to one month after treatment. In follow-up period (6 months) participants were evaluated for hemorrhoidal disease recurrence.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universidade do Porto
• Treatments: Polidocanol

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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