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Polidocanol Foam VS Artery Ligation in Hemorrhoidal Disease

NCT04675177 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2021-02-10

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Universidade do Porto

    lead OTHER

Principal Investigators

  • Paulo Salgueiro, MD · Centro Hospitalar Universitário do Porto

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2020-02-01
Completion
2020-03-25

Countries

  • Portugal

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04675177 on ClinicalTrials.gov