Polidocanol Foam Versus Rubber Band Ligation in the Treatment of Hemorrhoidal Disease
Status:
Completed
Trial end date:
2020-07-01
Target enrollment:
Participant gender:
Summary
Background: Hemorrhoidal disease is a common benign condition seen frequently in clinical
settings. Rubber band ligation and sclerotherapy have proven to be the office-based
procedures of choice in hemorrhoidal disease, with various studies reporting rubber band
ligation as being more effective but also more painful and bleeding prone than sclerotherapy
with liquid polidocanol. However, there are no studies comparing rubber band ligation and
sclerotherapy with polidocanol foam, a new type of sclerosant agent that has already proved
to be more effective and safer than liquid polidocanol in grade I hemorrhoidal disease.
The present study was designed to establish the clinical effectiveness and safety of
sclerotherapy with polidocanol foam compared with rubber band ligation.
Methods: This randomized controlled trial includes patients with symptomatic hemorrhoidal
disease grades I to III. The participants were randomly assigned (in a 1:1 ratio) to either
rubber band ligation or sclerotherapy with polidocanol foam, stratified by grade of
hemorrhoidal disease. During the intervention period the patients are submitted to one of the
office-based procedures and, afterwards, in the follow-up period, evaluated every three
months for a total period of one year.
The efficacy outcomes include symptom resolution, number of treatment sessions needed to
achieve therapeutic success and evolution of hemorrhoidal disease grade in the intervention
period and, during follow-up, recurrence incidence. Primary safety outcomes include the
occurrence of any complication related to the office-based procedures.