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Polidocanol Foam in Hemorrhoidal Disease in Patients With Liver Cirrhosis

NCT05807425 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-04-11

No results posted yet for this study

Summary

Hemorrhoidal disease (HD) is a common health problem, affecting up to 38,9% of adult population. HD is also a common finding in up to 36% of cirrhotic patients, as hemorrhoidal plexus is a possible site of portosystemic venous anastomosis. Cirrhotic patients represent a group often neglected in clinical trials so, little is known about the optimal treatment for HD these patients. The objective of this study is to prospectively evaluate the efficacy and safety of treatment of grade I, II and III internal HD with polidocanol foam in cirrhotic patients.

Conditions

Interventions

PROCEDURE

Polidocanol foam sclerotherapy

The preparation of the foam is done according to the Tessari's technique using 2 disposable 20ml syringe, a three-way tap and a 10cm reusable extender adapted to intravenous needle. The sclerosant is applied according to the Blanchard's technique through a disposable transparent anoscope with the patient in jack-knife (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).

Sponsors & Collaborators

  • Universidade do Porto

    lead OTHER

Principal Investigators

  • Paulo Salgueiro, MD PhD · Centro Hospitalar Universitário de Santo António

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-31
Primary Completion
2023-09-30
Completion
2023-12-31

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 NCT05807425 on ClinicalTrials.gov