Polidocanol Foam Versus Rubber Band Ligation in the Treatment of Hemorrhoidal Disease

• Status: Completed
• Trial end date: 2020-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universidade do Porto
• Treatments: Polidocanol

Criteria

Inclusion Criteria:

• Patients referred to proctologic consultation of Centro Hospitalar Universitário do Porto (CHUP) older than 18 years;

• Clinical diagnosis of hemorrhoidal disease grade I, II and III (Goligher's classification);

• Refractory to conservative management (dietary modification, intestinal transit modifiers, topical and phlebotonic medications) for a period of no less than 4 weeks.

Exclusion Criteria:

• Hepatic cirrhosis;

• Pregnant or breast-feeding women;

• Known allergy to polidocanol

• Another perianal disease that can cause symptoms similar to hemorrhoidal disease;

• Concomitant presence of external hemorrhoidal disease and/or hemorrhoidal thrombosis;

• Office-based or surgical treatment for hemorrhoids within 6 months prior to inclusion;

• Antiplatelet or hypocoagulant medication;

• Inherited bleeding disorders;

• Immunosuppressive states ;

• Inflammatory bowel disease.