Polidocanol Foam VS Artery Ligation in Hemorrhoidal Disease

NCT04675177 PHASE2, PHASE3 COMPLETED

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.

Details

Lead sponsor	Universidade do Porto
Phase	PHASE2, PHASE3
Status	COMPLETED
Enrolment	45
Start date	Sun Sep 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Wed Mar 25 2020 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Hemorrhoids

Interventions

• Polidocanol foam sclerotherapy
• Doppler-guided hemorrhoidal artery ligation

Countries

Portugal