Polidocanol Foam VS Artery Ligation in Hemorrhoidal Disease

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

September 1, 2019

Primary Completion Date

February 1, 2020

Study Completion Date

March 25, 2020

Conditions
Hemorrhoids
Interventions
DRUG

Polidocanol foam sclerotherapy

"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;"

PROCEDURE

Doppler-guided hemorrhoidal artery ligation

"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."

Trial Locations (1)

4050-000

Centro Hospitalar Universitário do Porto, Porto

All Listed Sponsors
lead

Universidade do Porto

OTHER

NCT04675177 - Polidocanol Foam VS Artery Ligation in Hemorrhoidal Disease | Biotech Hunter | Biotech Hunter