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无管化经皮肾镜取石术可行性和安全性及疗效的随机对照研究

Feasibility, safety and efficacy of tubeless percutaneous nephrolithotomy: a randomized controlled trial

摘要目的 通过随机对照临床试验,研究无管化PCNL的可行性、安全件和疗效. 方法 2010年5-8月行PCNL患者,术中取石完毕,随机数字法将患者随机分为试验组(无管化PCNL,即只留置双J管,不留置肾造瘘管)与对照组(传统PCNL,留置双J管及肾造瘘管).排除标准:严重出血需输血者;明显结石残留需行二期碎石取石i者;重度肾积水,肾实质厚度<5 mm者;肾盂穿刺液为脓件者;合并输尿管狭窄或肾盂输尿管连接处狭窄;集合系统严重穿孔者.共50例患者被纳入研究,试验组和对照组各25例,两组患者的年龄、性别、结石大小差异均正统计学意义(P>0.05).所有手术均由一位医生主刀.评价指标包括术后疼痛、Hb下降量、输血率、发热发生率、肾周血肿发生率、住院时间等. 结果 术后第1天试验组疼痛视觉模拟评分(VAS)为2.24,对照组为5.04(P<0.01);试验组术后平均住院时间3.04 d,对照组6.88 d,两组差异有统计学意义(P<0.01);两组术后Hb下降量、结石清除率差异无统计学意义(P>0.05).两组输血率(1/25与3/25,P>0.05)、肾周血肿发生率(6/27与7/27,P>0.05)、发热发生率(3/25与4/25,P>0.05)比较差异亦无统计学意义.两组患者术后穿刺通道部位均无漏尿发生. 结论 无管化PCNL安全,能显著减轻患者术后疼痛不适,缩短住院时间,且不增加出血、漏尿等并发症发生率,但需恰当掌握其适应证,对术中大出血、肾积脓、输尿管梗阻、集合系统严重穿孔、结石残留需二期手术者禁用.

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abstractsObjective To evaluate the feasibility,safety and efficacy of tubeless percutaneous nephrolithotomy ( PCNL).Methods Patients who underwent PCNL were randomized into 2 groups by extracting a random number generated from random number table,tubeless PCNL group and traditional PCNL group when the stones were cleared.Each patient in tubeless PCNL group was treated with insertion of a F5 ureteral double pigtail stent without placement of nephrostomy tube,while both double pigtail stent and F16 nephrostomy tube were placed in patients in traditional PCNL group.Exclusion criteria were severe bleeding requiring blood transfusion,stone residual requring a second PCNL,severe hydronephrosis with the thickness of renal parenchyma less than 5 mm,pyonephrosis,stricture of ureter or ureteropelvic junction,and severe perforation of the collecting system.A total of 50 patients were enrolled in this study.Tubeless PCNL and traditional PNCL were performed in 25 patients,including 27 kidney units,respectively.The two groups had comparable demographic data.All the operations were performed by the same surgeon.Evaluation factors included postoperative pain,decreased hemoglobin,blood transfusion rate,incidence of fever and perirenal hematoma,and duration of hospitalization.Results The average visual analogue scale (VAS) score on postoperative day 1 in tubeless PCNL group was 2.24 compared with 5.04 in traditional PCNL group (P < 0.01 ).The average hospital stay in tubeless PC NL group (3.04 d) was significantly shorter than that in traditioal PCNL group (6.88 d) (P <0.01 ).The differences in average hemoglobin drop and stone clearance in the 2 groups were not significant.The differences between the 2 groups in blood transfusion ( 1/25 in tubeless PCNL group vs 3/25 in traditional PCNL group,P >0.05),renal hematomas rate (6/27 in tubeless PCNL group vs 7/27 in traditional PCNL group,P > 0.05) and fever rate (3/25 in tubeless PCNL group vs 4/25 in traditional PCNL group,P >0.05 ) were not significant.There was no incidence of urinary leakage from the nephrostomy site in the 2 groups.Conclusions Tubeless PCNL can significantly decrease postoperative pain and discomfort and shorten the duration of hospitalization without increase of complications.Tubeless PCNL is safe,effective and performable,but the contraindications such as massive haemorrhage,pyonephrosis,ureteral obstruction,severe perforation of the collecting system,residual stone requring a second PCNL,should be kept in mind.

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