BackgroundIn the guidelines on management of urolithiasis from the European Association of Urology(EAU)and International Alliance of Urolithiasis(IAU),percutaneous nephrolithotomy(PCNL)is recommended as the standard procedure for renal stones >2 cm.With the advances of endoscopic instruments and surgical technology,PCNL began to develop towards the direction of more minimally invasive.A series of miniaturized PCNL techniques and devices had been widely applied in clinical practice and mini-PCNL(MPCNL)in particular.Theoretically speaking,compared to the traditional standard PCNL(SPCNL),MPCNL was better for reducing renal parenchyma trauma and bleeding during peri-operation.However,smaller sheaths faced potentially the decreased stone free rate(SFR),increased operation time and higher renal pelvic pressure followed by fever or urosepsis.The problem mentioned above was well resolved with a multi-functional suction sheath.The previous study reported that,compared to conventional MPCNL,the suction mini-PCNL(SMP)could keep a lower renal pelvic pressure and a higher stone removal efficiency.Currently,SPCNL with EMS ultrasound lithotripsy system is considered as the first-line treatment for >2cm renal stone,because of the higher stone removal efficiency and shorter operation time.But the surgery cost is relatively expensive.However,the SMP with pneumatic lithotripsy could keep higher stone removal efficiency and cut the patients’ medical expense.While in the present regard,whether suction MPCNL play a more efficient and safer role in the management of 2-4cm kidney stones was worthy of further study.So,we would like to have a prospective randomized controlled study to certify our hypothesis.PurposeTo certify the efficacy and safety of SMP for the management of 2-4cm kidney stones,a prospective randomized controlled study was conducted with the comparison of SMP and SPCNL.Patients and methodsThe patients with 2–4 cm renal stone were enrolled after a strict screening according to the inclusion and exclusion criteria from August 2021 to March 2023.The SFR,operation time,hemoglobin drop,postoperative fever,hospitalization time and so on were compared between SMP group and SPCNL+EMS group.Statistical analysis was performed using IBM SPSS 26.0,and P<0.05 was considered statistically significant.Result114 patients were enrolled in the prospective randomized controlled study,including 56 patients in SPCNL+EMS group and 58 patients in SMP group.There was no statistical difference of demographic characteristics,stone characteristics and preoperative evaluation between both groups(all P<0.05).The SMP group and SPCNL+EMS group had a similar SFR(Initial SFR: 83.9% vs.86.2%,P=0.733;Final SFR: 89.3% vs.89.7%,P=0.949),operation time(50.07±19.35 min vs.44.11±18.30 min,P=0.094)and complication rate(Clavien Ⅰ:12.1% vs.10.7%,P=0.820;ClavienⅡ:1.7% vs.1.8%,P=0.980).Compared with SPCNL+EMS group,SMP group had a higher tubeless rate(36.2% vs.8.9%,P=0.001),better Bruggrmann comfort scale(BCS)(At 6h post-operation: 2.02±0.48 vs.1.50±0.51,P<0.001;At 24 h post-operation: 2.83±0.38 vs.2.61±0.56,P=0.016)and Visual Analogue Scale(VAS)(At 6h post-operation: 3.50±1.08 vs.4.25±1.08,P<0.001;At 24 h post-operation:1.81±0.98 vs.2.63±0.56,P<0.001).In additional,SMP group was shorter than SPCNL+EMS group in hospitalization stay.ConclusionThe SMP was safe and highly efficient in managing 2-4cm renal stones.Compared with SPCNL+EMS group,SMP group have a similar SFR,operation time and complication rate,but with the advantages of increased tubeless rate,less postoperative pain and shorter hospitalization stay. |