A non-inferiority study to analyze the safety of totally tubeless percutaneous nephrolithotomy

Abstract

Background. Totally tubeless percutaneous nephrolithotomy (ttPCNL) becomes increasingly frequently utilized in the treatment of kidney stones. This procedure emerged as an answer for patients' needs to minimize hospitalization time, pain intensity and discomfort due to nephrostomy tube. However, ttPCNL may be less safe for patients, as without nephrostomy tube bleeding from renal vessels is potentially more severe. Objectives. The purpose of our study was to retrospectively evaluate the safety parameters of ttPCNL collected in a prospective manner. Material and methods. This was a single tertiary care center, non-inferiority study with 2 arms (55 patients in each arm). The 1st group consisted of patients who underwent ttPCNL with the application of TachoSil® (Takeda, Osaka, Japan) as sealing material, while in the 2nd group, conventional PCNL with nephrostomy tube (cPCNL) was utilized. The primary goal was to prove that hemoglobin drop after surgery, as equivalent of safety, was not inferior than 1 g/dL. The secondary endpoints comprised visual analogue scale (VAS) of pain, additional pain treatment and hospital stay. Results. The mean hemoglobin drop after ttPCNL was insignificantly lower in comparison with cPCNL group (mean: -0.35 g/dL; confidence interval (CI): -0.8, 0.21). Visual analogue scale of pain and pain treatment were comparable between groups. Hospital stay was significantly shorter in the ttPCNL group. Conclusions. Totally tubeless PCNL can be considered a safe option after uncomplicated lithotripsy - what is important, it is characterized by a shorter hospitalization time. Postoperatively, pain intensity is comparable between both groups.