Mini-Endoscopic Combined Intrarenal Surgery vs Percutaneous Nephrolithotomy in the Management of Complex Nephrolithiasis: A Randomized Controlled Trial.

Objective: To evaluate mini-endoscopic combined intrarenal surgery (mECIRS) vs percutaneous nephrolithotomy (PCNL) in managing complex renal stones. Material and Methods: A randomized controlled study was conducted at our tertiary center between July 2022 and July 2024, involving 100 patients with complex renal stones who were randomly allocated for PCNL or mECIRS. The stone burden was determined based on Guy's score using a non-contrast computed tomography of the urinary tract; patients with Guy's Stone Score of III or IV were included in our study. Our primary objective was to assess grade A single session stone-free rate (SS-SFR) in both procedures after 1 month, defined as no stone residual after a single session procedure. Secondary outcomes included grade A (≤2 mm residual), Grade C (2.1-4 mm residual), and overall SFRs, complication rates (per Clavien-Dindo classification), operative time, fluoroscopy time, hospital stay, and overall cost. Results: Patient and stone characteristics were similar in both groups. Grade A SS-SFR revealed a statistically significant difference in favor of the mECIRS group compared with the PCNL group (51% vs 32.6%, respectively, p-value = 0.0275). However, the final grade A SFR after auxiliary procedures was comparable (40.8% for the PCNL group compared with 51% for the ECIRS group, p-value = 0.557). The mECIRS showed a less operative and fluoroscopy time. The complication rate was 38.77% vs 14.28% in the PCNL and mECIRS, respectively, where it was higher in the former, with a statistically significant value (p-value = 0.006). The mECIRS group experienced shorter hospital stay and comparable cost-effectiveness. Conclusion: mECIRS is effective and safe in managing patients with complex renal stones in a single session with fewer comorbidities than standard PCNL. The study was registered at Clinicaltrial.gov with a registration number: NCT06085794.