Non-Doppler hemorrhoidal artery ligation and hemorrhoidopexy combined with pudendal nerve block for the treatment of hemorrhoidal disease: a non-inferiority randomized controlled trial.

ABSTRACT

BACKGROUND: In this study, we proposed a combined outpatient treatment modality for hemorrhoidal disease. METHODS: This study was a prospective non-inferiority randomized controlled trial (RCT). The experimental group included the dearterialization and hemorrhoidopexy under pudendal nerve block, whereas the comparator consisted of the standard Doppler guided hemorrhoidal artery ligation and hemorrhoidopexy, under spinal anesthesia. As primary hypothesis, we considered the non-inferiority of the proposed modality in terms of the presenting symptom remission rate (non-inferiority margin 10%). Randomization was based on a 11 ratio. Blinding was confined to the patient and the investigator. RESULTS: Overall, 60 patients were enrolled. The primary hypothesis of this RCT (96.7% vs 73.3%) was validated. The experimental group was associated with a lower operation duration and an expedited onset of mobilization and feeding. Moreover, a favorable profile regarding short-term morbidity and analgesia was identified. The control group displayed a higher pile recurrence rate and a suboptimal patient satisfaction. A significant effect of the treatment modality in most of the SF-36 components was confirmed. CONCLUSIONS: The proposed treatment modality was associated with favorable short and long-term outcomes. Due to specific limitations, further RCTs, with a larger sample size, are required. Trial Registration ClinicalTrials.gov NCT03298997.