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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04188171
Recruitment Status : Recruiting
First Posted : December 5, 2019
Last Update Posted : December 5, 2019
Sponsor:
Information provided by (Responsible Party):
Paulo Sérgio Durão Salgueiro, Universidade do Porto

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.

Condition or disease Intervention/treatment Phase
Hemorrhoids Bleeding Disorder Procedure: Polidocanol foam sclerotherapy Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Intervention Model Description: 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).
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sclerotherapy With Polidocanol Foam In The Management Of First, Second And Third-Grade Hemorrhoidal Disease In Patients With Bleeding Disorders: A Prospective Cohort Study
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : February 1, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Polidocanol

Arm Intervention/treatment
Experimental: Polidocanol foam sclerotherapy

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
  • 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.




Primary Outcome Measures :
  1. Effectiveness evaluation (therapeutic success) [ Time Frame: 3 months ]

    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).

  2. Safety evaluationL occurrence of complications [ Time Frame: 12 months ]

    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).


Secondary Outcome Measures :
  1. Effectiveness evaluation (Goligher classification) [ Time Frame: 3 months ]

    For efficacy evaluation during the intervention period the outcomes will be compared between groups A and B.

    Variation of Goligher classification before and after the intervention.


  2. Effectiveness evaluation (number of office-based sessions) [ Time Frame: 3 months ]
    Number of office-based therapy sessions and polidocanol foam dose applied during the intervention period (comparing groups A and B).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Participants will be recruited from August 1st, 2018 until February 1st, 2020.

Inclusion Criteria:

  • 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;

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04188171


Contacts
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Contact: Paulo Salgueiro, MD 917209020 paulosalgueiro@gmail.com

Locations
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Portugal
Hospital Prof. Doutor Fernando da Fonseca, EPE Recruiting
Amadora, Portugal, 2720-276
Contact: Ana Oliveira, MD       anaoliveira.hff@gmail.com   
Hospital Senhora da Oliveira Recruiting
Guimarães, Portugal, 4800-000
Contact: Bruno Rosa, MD       bruno.joel.rosa@gmail.com   
Principal Investigator: Bruno Rosa, MD         
Centro Hospitalar Universitário do Porto Recruiting
Porto, Portugal, 4050-000
Contact: Paulo Salgueiro, MD       paulosalgueiro@gmail.com   
Principal Investigator: Paulo Salgueiro, MD         
Principal Investigator: Fernando Castro-Poças, MD, PhD         
Sponsors and Collaborators
Universidade do Porto
Investigators
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Principal Investigator: Paulo Salgueiro, MD Centro Hospitalar Universitário do Porto

Publications of Results:

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Responsible Party: Paulo Sérgio Durão Salgueiro, Principal Investigator, Universidade do Porto
ClinicalTrials.gov Identifier: NCT04188171    
Other Study ID Numbers: 12422301
First Posted: December 5, 2019    Key Record Dates
Last Update Posted: December 5, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Paulo Sérgio Durão Salgueiro, Universidade do Porto:
Sclerotherapy
Polidocanol foam
Hemorrhoidal disease
Additional relevant MeSH terms:
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Hemorrhoids
Hemostatic Disorders
Blood Coagulation Disorders
Hemorrhagic Disorders
Hemorrhage
Pathologic Processes
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Hematologic Diseases
Polidocanol
Sclerosing Solutions
Pharmaceutical Solutions