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3% polidocanol foam sclerotherapy versus hemorrhoidal artery ligation with recto anal repair in hemorrhoidal disease grades II-III: a randomized, pilot trial.

PURPOSE
We aimed to compare polidocanol foam sclerotherapy (SP) versus doppler-guided hemorrhoidal artery ligation with recto-anal repair (HAL-RAR) in the treatment of hemorrhoidal disease (HD).


METHODS
Prospective, randomized study including patients with HD grades II and III. Participants were randomly assigned (1:1) into SP or HAL-RAR, during a recruitment period between September 2019 and February 2020. Therapeutic success (Sodergren's and bleeding scores) was the primary outcome. Other outcomes evaluated complications and implication in professional life. Efficacy and safety outcomes were evaluated during the 8 weeks after the surgery or the final SP session.


RESULTS
Forty-six patients were allocated either to SP (n=22) or HAL-RAR (n=24). Most patients achieved therapeutic success (SP 100% vs. HAL-RAR 90.9%, p=0.131). Complete success was higher in SP group (91.7% vs. 68.2%, p=0.045). SP patients had less complications (25% vs. 68.2%, p=0.003). HAL-RAR had a greater negative impact in patients' work activity.


CONCLUSION
SP was more effective and safer than HAL-RAR. SP patients had less impact on their work activity. Clinicaltrials identifier NCT04675177.