At a glance
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Sclerotherapy With Polidocanol Foam Versus Hemorrhoidal Artery Ligation With Recto Anal Repair in the Treatment of Second and Third-grade Hemorrhoidal Disease: a Prospective Study
In Brief
A Phase 3 clinical trial evaluating Polidocanol foam sclerotherapy and Doppler-guided hemorrhoidal artery ligation for Hemorrhoids. Completed, enrolled 45 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
i. Patients underwent preparation, two hours before the intervention, with cleaning enema (Disodium phosphate). No antibiotic prophylaxis was prescribed. ii. Preparation of the polidocanol (Aethoxysklerol 3%) foam according to Tessari technique immediately before application, so that the "microbubbles" of the foam did not disintegrate; iii. The procedure was performed in the medical office. Application according to the Blanchard technique through a disposable transparent anoscope, in jackknife position, using a 20mL disposable syringe of the mixture (polidocanol + air) and a reusable 10 cm syringe extender adapted to an intravenous needle; iv. Patients were treated in a maximum of 3 sessions, at 3 weeks intervals; v. Maximum dose per treatment session of 20mL of mixture of 4mL of polidocanol 3% with 16mL of air; i. In each session, the sclerosant was injected in one or more hemorroidary cushion;
i. Patients underwent preparation with cleaning enema (Disodium phosphate). No antibiotic prophylaxis was prescribed. ii. The procedure was performed in the operating room of an outpatient surgery unit, under regional anestesia. iii. A proctoscope with a Doppler transducer in its tip was introduced inside the anal canal to search for the superior rectal artery. iv. Each branch was ligated with suture above the dentate line. The device was rotated slowly in clockwise direction to locate further arteries at that level. v. Rectoanal repair consisted in a continuous running suture was applied longitudinally just over every prolapsed hemorrhoid.