Polidocanol Foam Sclerotherapy Versus Rubber Band Ligation in Hemorrhoidal Disease Grades I/II/III: Randomized Trial

BACKGROUND: Rubber band ligation and sclerotherapy are considered the office-based procedures of choice in hemorrhoidal disease. However, there are no studies comparing rubber band ligation and polidocanol foam sclerotherapy. OBJECTIVE: We aimed to evaluate the efficacy and safety of polidocanol foam sclerotherapy compared with rubber band ligation. DESIGN: This study was a randomized open-label study with 1-year follow-up. SETTINGS: The study was conducted in the colorectal unit of a tertiary hospital. PATIENTS: One hundred twenty patients with hemorrhoidal disease grades I to III were included. INTERVENTIONS: Patients were stratified by hemorrhoidal disease grade and randomly assigned (1:1) to treatment with either rubber band ligation (n = 60) or polidocanol foam sclerotherapy (n = 60). MAIN OUTCOME MEASURES: Efficacy outcomes included therapeutic success and recurrence. Safety outcomes included the occurrence of complications related to the procedures. RESULTS: Therapeutic success was not significantly different between the groups (polidocanol foam sclerotherapy 93.3% vs rubber band ligation 85.0%, p = 0.14). However, complete success rate was higher in the polidocanol foam sclerotherapy group (88.3% vs 66.7%, p = 0.009) with fewer office-based sessions (mean +/- SD: 1.32 +/- 0.60 vs 1.62 +/- 0.76, p = 0.02). Recurrence rates were lower in the polidocanol foam sclerotherapy group (16.1% vs 41.2%, p = 0.004). Most recurrences were mild (83.3%). Complications were more frequent in the rubber band ligation group (30.0% vs 10.0%, p = 0.01) and were mostly minor (91.7%). No severe complications were observed in either group. LIMITATIONS: This study was performed in a single center, and both patients and investigators were not blinded to the treatment group. CONCLUSIONS: Both procedures are effective in the treatment of hemorrhoidal disease grades I to III. Polidocanol foam sclerotherapy was more effective than rubber band ligation when considering complete success. Patients in the polidocanol foam sclerotherapy group needed fewer treatment sessions, had lower recurrence rates, and were less likely to have complications.

Automated summary

Rubber band ligation and polidocanol foam sclerotherapy are both effective office-based procedures for the treatment of hemorrhoidal disease. Polidocanol foam sclerotherapy is more effective than rubber band ligation in terms of complete success, requiring fewer treatment sessions, having lower recurrence rates, and being less likely to result in complications.