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

NCT04188171 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2020-08-19

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Universidade do Porto

    lead OTHER

Principal Investigators

  • Paulo Salgueiro, MD · Centro Hospitalar Universitário do Porto

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-01
Primary Completion
2020-02-01
Completion
2021-02-01

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 NCT04188171 on ClinicalTrials.gov