Sclerotherapy With Polidocanol Foam In The Treatment Of Hemorrhoidal Disease In Patients With Bleeding Disorders

NCT04188171 | Unknown Phase 2

• 1 other identifier: 12422301
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 3

Brief Summary

Treatment of hemorrhoidal disease includes a conservative approach (dietary and behavioral measures, venotropic and topical medication), office-based treatments and surgery. Rubber banding is currently considered the instrumental method of choice in the treatment of hemorrhoidal disease grades I to III (Goligher's classification). However, its use in patients with bleeding disorders is not recommended. Sclerotherapy can be performed in these patients since the hemorrhagic risk is very low. The most commonly used agent for sclerotherapy is liquid polidocanol. Polidocanol foam seems to be more effective than the liquid formulation and is safe in the treatment of hemorrhoidal disease even in patients with coagulation disorders. This study is aimed to evaluate the efficacy and safety of polidocanol foam sclerotherapy in the treatment of hemorrhoidal disease grades I to III in patients with bleeding disorders.

Conditions

Hemorrhoids; Bleeding Disorder

Keywords

Sclerotherapy; Polidocanol foam; Hemorrhoidal disease

Outcome Measures

Primary Outcomes (2)

• Effectiveness evaluation (therapeutic success)

  For efficacy evaluation during the intervention period the outcomes will be compared between groups A and B. Therapeutic success is a compound variable of Sodergren symptom score and bleeding grade and is subdivided in: * Complete (Sodergren score = 0 and bleeding grade ≤ 1); * Partial (Sodergren score\> 0 and bleeding grade\> 1 but with improvement over initial score); - Therapeutic failure (participants that, after 3 sessions of office-based treatment worsened or maintained the initial Sodergren score and bleeding grade).

  3 months

• Safety evaluationL occurrence of complications

  Comparison of the occurrence of complications in both groups A and B. Complications are classified as: * Mild (e.g. pain/discomfort, minor bleeding, external hemorrhoidal thrombosis not requiring surgical intervention); * Moderate (e.g. external hemorrhoidal thrombosis requiring surgical intervention, moderate bleeding not requiring blood transfusion, urgent hemostasis or urgent surgery); * Severe (e.g. sepsis, Fournier's gangrene, perineal abscess, bleeding with hemodynamic instability, transfusional need or urgent surgery, sexual impotence in man).

  12 months

Secondary Outcomes (2)

• Effectiveness evaluation (Goligher classification)

  3 months

• Effectiveness evaluation (number of office-based sessions)

  3 months

Study Arms (1)

Polidocanol foam sclerotherapy

EXPERIMENTAL

During the intervention period the participants are observed at 3-week intervals (maximum of 3 sessions). The required number of polidocanol foam sclerotherapy sessions (maximum of 3) is determined by clinical and anoscopic evaluation (if the participant is non-symptomatic and/or there is no significant hemorrhoidal disease on anoscopy, the patient will not be a candidate for additional instrumental therapy moving directly to the follow-up period). After each session all patients were instructed to adopt dietary measures and adequate hydration maintaining therapy with systemic venotropic, topical and laxative if necessary. After the intervention period, a one-year follow-up is scheduled with medical appointments performed every 3 months.

Procedure: Polidocanol foam sclerotherapy

Interventions

Polidocanol foam sclerotherapy PROCEDURE

* Preparation of the foam is done according to the Tessari technique (2 disposable 20ml syringe, a three-way tap, reusable extender adapted to intravenous needle). * Sclerosant applied according to the Blanchard technique through a disposable transparent anoscope (patient in knee-chest position). * In each session, treatment can be performed on more than one hemorrhoidal cushion. The maximum dose per treatment session is 20ml (mixture of 4ml of polidocanol 3% with 16ml of air). * During the intervention period the participants are observed at 3-week intervals. The required number of sessions (maximum of 3) is determined by clinical and anoscopic evaluation. * After the intervention period, a one-year follow-up is scheduled with medical appointments performed every 3 months.

Polidocanol foam sclerotherapy

Eligibility Criteria

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

You may qualify if:

• Adult patients with symptomatic internal hemorrhoidal disease grades I to III submitted to sclerotherapy with polidocanol foam in three Portuguese health institutions (Centro Hospitalar Universitário do Porto, Hospital Senhora da Oliveira - Guimarães and Hospital Prof. Doutor Fernando da Fonseca, EPE - Amadora);
• Hemorrhoidal disease refractory to conservative therapy (dietary modification, intestinal transit modifiers, topical and venotropic drugs) during a period no less than 4 weeks;

You may not qualify if:

• Known allergy to polidocanol;
• Liver cirrhosis;
• Pregnant or lactating women;
• Inflammatory bowel disease;
• Other concomitant symptomatic perianal disease;
• History of office-based or surgical treatment of hemorrhoidal disease in the last 6 months;
• Immunosuppression.

Sponsors & Collaborators

• Universidade do Porto: lead

Study Sites (3)

Hospital Prof. Doutor Fernando da Fonseca, EPE

Amadora, 2720-276, Portugal

Location

Hospital Senhora da Oliveira

Guimarães, 4800-000, Portugal

Location

Centro Hospitalar Universitário do Porto

Porto, 4050-000, Portugal

Location

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MeSH Terms

Conditions

Hemorrhoids; Hemostatic Disorders

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Paulo Salgueiro, MD

  Centro Hospitalar Universitário do Porto

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Longitudinal prospective study including adult patients, with or without bleeding disorders, with hemorrhoidal disease grades I to III submitted to polidocanol foam sclerotherapy in three health institutions during an inclusion period of 1.5 years. Efficacy and safety outcomes will be compared between two groups of patients: with bleeding disorders (Group A) and without bleeding disorders (Group B).

Study Record Dates

• First Submitted: December 2, 2019
• First Posted: December 5, 2019
• Study Start: August 1, 2018
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2021
• Last Updated: August 19, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

PT (3)