| Background Urinary calculi was considered to be a worldwide disease and one of the most common disease in urology.The incidence was 5-15% approximately and the number keeps increasing annually.The latest epidemiological investigation has reported that the precisely incidence of urinary calculi in China was 6.06%.At the meanwhile,urinary calculi was also idendified to be a disease with high recurrence rate,previously research has reported that the recurrence rate within 5 years was about 30-50%,and the number was considered to be rising up to 75% within 20 years,which resulted in damages on the aspests of physical and mental health of patients,and a huge economic burden on the concern of society and government.Currently,with the rapid development of minimally invasive surgical technology,Percutaneous Neprolithotmy has replaced the traditional open surgery to become the mainstream in the field of management and intervention on kidney stone.Although Percutaneous Neprolithotmy was considered to be a mature minimally invasive surgery procedures while compared with the traditional open surgery,the former still accompany with certain defects such as invasive and traumatic,besides postoperative bleeding,infection and other types of complications could acted cooperatively caused the surgeon into dilemma.With the advancement of scientific technology and the development of surgical instruments,the traditional Percutaneous Neprolithotmy procedures has been improved and modified by some researchers.Hence,a new technique with a smaller diameter endoscope through a smaller percutaneous tract(11-20F)was performed and was named Minimally Invasive Percutaneous Neprolithotmy(mini-PCNL/MPCNL).Some studies demonstrated that mini-PCNL has been presented advantages over standard PCNL on managing intraoperative bleeding,relieving postoperative pain and reduceing the hospitalization,still there were also the possibility of disadvantage on the former such as extending operative time and increasing the risk of infection as well.For the menagement of 2-4cm kidney stones,in terms of technical effectiveness and surgical safety on the two surgical techniques of mini-PCNL and standard PCNL were remain unclear,there was still a lack of high-quality prospective randomized controlled trials.The aim of this study was to perform a prospective randomized controlled trail to evaluate the technical effectiveness and surgical safety in the manegement of 2-4cm kidney stone by compareing mini-PCNL and standard PCNL techniques,and provide the theoretical and experimental foundation for the menagement and intervention of kidney stone.Objective To perform a prospective randomized controlled trail on evaluateing the technical effectiveness as well as surgical safety of both minimally invasive percutaneous neprolithotmy(mini-PCNL)and standard PCNL in the management and intervention of2-4cm kidney stone.Materials and Methods The totel number of 477 patients initially diagnosed 2-4cm renal stone were recruited into this prospective randomized controlled trail from January 2016 to February 2017.These patients were randomly divided into Standard PCNL Group and mini-PCNL Group based on the random number table.The intraoperative channel performed in Standard PCNL Group was expanded to 24 F while mini-PCNL Group was 18 F.Factors including general condition of the patient,stone size,stone location,stone density,hydronephrosis,preoperative and postoperative white blood cells,hemoglobin,creatinine,operating time,stone composition,hospitalization,stone clearance and postoperative complications between the two groups were documented and analyzed respectively.The SPSS 13.0software was perfromed to statisticed and analyzed the database.The t test was perfromed to analyze measurement data,the Chi-square test was perfromed to analyze enumeration data,Mann-Whitney sum test was perfromed to analyze ranked data.Prospective analysis were performed based on the data documented the two groups of patients,the technical effectiveness as well as surgical safety between Standard PCNL and mini-PCNL on treating 2-4cm kidney stones were evaluated and compared.Results1.The prospective randomized controlled trail recruited 477 patients initially diagnosed 2-4cm kidney stone,235 in standard PCNL group and 242 in mini-PCNL group randomly.There were no statistical significance in the general conditions of these patients between the two groups,including age,gender,body mass index,coexisting history,stone location,stone size,stone density(CT value),grades of hydronephrosis,S.T.O.N.E nephrolithometry scoring,preoperative white blood cell,hemoglobin and creatinine.2.There were statistical significance of the intraoperative instruments between standard PCNL group and mini-PCNL group.The standard PCNL group was mainly composed of ultrasonic lithotripsy,accounted for 74.0%,while mini-PCNL group was mainly applied to pneumatic lithotripsy,accounted for 66.9%(p<0.05),respectively.The intraoperative puncture site was dominated by 11 intercostal and 12 ribs,the operative punctured target was mostly range from middle to lower kidney calices,and the primarily stone composition were calcium oxalate for both standard PCNL group and mini-PCNL group,hence,there were no statistical significance in the site of intraoperative puncture,target calyces and stone composition between the two groups.3.There were no statistical significance between standard PCNL group and mini-PCNL group on operating time(41.2±21.3min vs 42.1±24.3min)(p > 0.05),postoperative hemoglobin decreased rate(9.72±7.73% vs 9.52±7.9%)(p > 0.05),blood transfusion rate(3.88% vs 4.47%)(p > 0.05),fever(11.9% vs 13.6%)(p > 0.05),urinary sepsis(0.85% vs 1.24%)(p > 0.05),1day postoperative stone clearance rate(85.5% vs81.7%)(p>0.05),1month postoperative stone clearance rate(85.5% vs 84.7%)(p>0.05)and the needed adjuvant treatment rate(5.9% vs 6.2%)(p>0.05),respectively.4.There were statistical significant higher in mini-PCNL group than Standard PCNL group in terms of postoperative 24-hour comfort score(3.1±1.8 vs 2.5±0.9)(p<0.05)and tubeless rate(32.64% vs 11.91%)(p<0.05),respectively.There were statistical significant lower in mini-PCNL group of the postoperative use of painkillers(17.76% vs 25.53%)(p<0.05)and the hospitalization(4.2±2.2day vs 6.3±3.5day)(p<0.05)than the Standard PCNL group,respectively.Conclusion:In the management and intervention of 2-4cm kidney stone,there were no statistical significant between mini-PCNL and standard PCNL on operating time,stone clearance rate,postoperative hemoglobin decreased rate,blood transfusion rate,postoperative fever and urinary sepsis.But there were statistical significant when compared with standard PCNL,the proportion of tubeless rate of mini-PCNL was higher,the postoperative24-hour comfort score was higher,the postoperative use of painkillers was lower and the hospitalization time was relatively shorter.In conclusion,both standard PCNL and mini-PCNL techniques were considered to be efficient and safe methods for the treatment of 2-4cm kidney stone,but evidences showed that mini-PCNL could provided higher comfort score and a shorter hospitalization time. |
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