Introduction: The goal of this study was to evaluate the efficacy and safety of needle-perc-assisted endoscopic surgery (NAES) in the treatment of staghorn renal stones via a single-center prospective randomized controlled study. Methods: A total of 219 patients with partial or complete staghorn renal stones were prospectively randomized into two groups between January 2020 and April 2022. In group A (n = 112), patients were treated with traditional standard access, multiple if necessary, and in group B (n = 107), only one standard access was made, and needle-perc was assisted to remove the residual stones in the same stage. All procedures were guided under ultrasound totally. Stone size, operating time, blood loss, pain score, complications, and other related characteristics were monitored and analyzed. Results: Procedures were successful in all patients. The baseline characters were similar between the groups. The mean stone size was comparable (4.5 ± 1.4 vs. 4.7 ± 1.7, p = 0.35). The 1-month stone-free status was achieved in 85 patients (75.9%) in group A and 80 (74.8%) patients in group B (p = 0.72). The operation time was shorter in group A than B (75.1 ± 28.1 min vs. 97.2 ± 20.4 min, p = 0.02). A less blood loss (p = 0.01), shorter hospital stay (p = 0.04), lower pain score (p = 0.04), and lower severe complication rates (p = 0.03) were observed in group B. Conclusion: NAES reveals better postoperative recurrence compared with traditional multiple tracts method for treating staghorn renal stones. The stone-free rate was comparable between the two groups.

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