Polidocanol Foam VS Artery Ligation in Hemorrhoidal Disease

NCT04675177 | Completed Phase 2

• 1 other identifier: 514741899
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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

Hemorrhoids

Keywords

Hemorrhoids; Sclerotherapy; polidocanol foam; Doppler-guided hemorrhoidal artery ligation

Outcome Measures

Primary Outcomes (2)

• Therapeutic success

  Efficacy indicator composed by Sodergren score and bleeding grade: * Complete (Sodergren score = 0 and bleeding grade \<= 1); * Partial (Sodergren score \> 0 and bleeding grade \> 1 but, at least, one of them with improvement, regarding the initial score, and none of them worse); * Therapeutic failure (participants that, one month after the last instrumental treatment or one month after surgery, worsened or maintained the initial Sodergren score and bleeding grade);

  3 months

• Safety evaluation

  Record of complications resulting from the therapy: * Mild (e.g. pain/discomfort, pruritus, bleeding grade 1) * Moderate (e.g., external hemorrhoidal thrombosis, bleeding without hemodynamic instability, no blood transfusion, no need for haemostasis or urgent surgery): do not endanger the patient's life or leave long term sequelae; * Severe (e.g. sepsis, Fournier's gangrene, perineal abscess, bleeding with hemodynamic instability, transfusional need or urgent surgery, sexual impotence in man): they put the patient's life at risk.

  3 Months

Secondary Outcomes (4)

• Professional life implications

  3 months

• Personal life implications

  3 months

• Number of treatment sessions

  3 months

• Recurrence

  6 Months

Study Arms (2)

Polidocanol foam sclerotherapy

ACTIVE COMPARATOR

Patients submitted to polidocanol foam sclerotherapy

Drug: Polidocanol foam sclerotherapy

Doppler-guided hemorrhoidal artery ligation

ACTIVE COMPARATOR

Patients submitted to doppler-guided hemorrhoidal artery ligation

Procedure: Doppler-guided hemorrhoidal artery ligation

Interventions

Polidocanol foam sclerotherapy DRUG

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;

Also known as: Aethoxysklerol 3%)

Polidocanol foam sclerotherapy

Doppler-guided hemorrhoidal artery ligation PROCEDURE

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.

Also known as: HAL-RAR

Doppler-guided hemorrhoidal artery ligation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Cirrhosis
• Pregnant or breast-feeding women
• Known allergy to polidocanol
• Another perianal disease that can cause symptoms similar to hemorrhoidal disease
• Colorectal malignancy
• Antiplatelet or hypocoagulant medication
• Hematological disorders
• Immunosuppressive states
• Inflammatory bowel disease
• Patients unable to have general or spinal anesthetic

Sponsors & Collaborators

• Universidade do Porto: lead

Study Sites (1)

Centro Hospitalar Universitário do Porto

Porto, 4050-000, Portugal

Location

Related Publications (58)

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MeSH Terms

Conditions

Hemorrhoids

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Paulo Salgueiro, MD

  Centro Hospitalar Universitário do Porto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective, unicentric study (Centro Hospitalar Universitário do Porto (CHUP)) which is aimed to compare the efficacy and safety of the treatment techniques in patients with hemorrhoidal disease grade II and III. Patients referred to consultation were randomly allocated to one of the two treatments (polidocanol foam sclerotherapy and hemorrhoid artery ligation +- rectoanal repair).

Study Record Dates

• First Submitted: December 14, 2020
• First Posted: December 19, 2020
• Study Start: September 1, 2019
• Primary Completion: February 1, 2020
• Study Completion: March 25, 2020
• Last Updated: February 10, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Upon request
• Access Criteria: Justified request (investigation, meta-analysis, medical education)

Locations

PT (1)