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

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.     

Effectiveness of totally tubeless percutaneous nephrolithotomy in selected patients: a prospective randomized study

Objectives  Compared with the standard technique, the number of percutaneous nephrolithotomy (PCNL) operations without a drainage catheter is increasing in recent years. In this prospective randomized study, we compared the morbidity of totally tubeless (tubeless and stentless) PCNL operations with the standard operation technique in a single center with a selected patient population. Methods  Ninety patients who fulfilled the criteria were included. Forty-five patients underwent totally tubeless PCNL (Group 1) and a 14F malecot nephrostomy catheter was used in another set of 45 patients (Group 2). Inclusion criteria for the study were no serious bleeding or perforation in the collecting system during the operation, stone free or clinically insignificant residual fragments (CIRF <4 mm), and no more than one access. Results  When two groups were compared with regard to age, stone volume, postoperative hemoglobin change, transfusion rate, and operation time, no significant differences were found between the two groups. However, a significant difference was found in hospitalization time between the two groups (P < 0.05). The amount of non-steroidal analgesic (tenoxicam) needed and non-steroidal analgesia-resistant pain which was resolved with narcotic analgesics (meperidine) were significantly lower in Group 1 (P < 0.05). Complications were observed in two patients (4.5%) in Group 1 (one retroperitoneal hematoma, one long-lasting renal colic) and in six patients (13.3%) in Group 2 (five prolonged urine drainage, one long-lasting fever) (P < 0.05). Conclusions  Tubeless and stentless PCNL is a safe method and reduces hospitalization time and analgesic requirement, and promotes quality of life in selected patients.     

完全无管化和不置肾造瘘管部分无管化经皮肾镜取石术的对照研究

目的比较完全无管化组（既不留置肾造瘘管也不留置双J管）与不置造瘘管（部分无管化,单置双J管）的经皮肾镜取石术（PCNL）的临床效果,评价完全无管化PCNL的临床可行性及应用价值。方法选择2010年11月至2011年9月符合特定筛选条件的上尿路结石患者72例,按手术次序的奇偶数分为完全无管化PCNL组和部分无管化PCNL组。比较两组患者手术时间、术后血红蛋白下降值、镇痛药物的需求、平均住院时间及并发症的发生率、医疗费用、术后恢复正常生活及工作时间等指标的区别。结果 72例患者手术均一期顺利完成,完全无管化PCNL组手术时间、术后血红蛋白下降值、镇痛药物的需求、平均住院时间及并发症的发生率等与部分无管化组PCNL组相当（P〉0.05）,两组在医疗费用分别为（9 566.4±523.7）元和（11 351.2±825.3）元、术后恢复正常生活及工作时间分别为（9.6±1.6）d和（16.8±1.2）d,完全无管化PCNL组要优于部分无管化PCNL组（P〈0.05）。结论有条件地实施完全无管化PCNL是安全的,与部分无管化PCNL相比,并不增加术后相关并发症风险,既节约了医疗成本,又缩短了术后恢复正常生活及工作的时间,有一定的临床应用价值,值得推广应用。     

Totally tubeless percutaneous nephrolithotomy: a prospective randomized controlled study

The purpose of this study was to perform a randomized controlled trial to evaluate the role, safety, and effectiveness of totally tubeless PCNL and whether this procedure is less morbid in terms of analgesia requirement, related complications and convalescence. A total of 131 patients, with impacted ureteropelvic junction stone or single renal pelvic stone larger than 20 mm, were prospectively randomized (using random numbers table) into two groups, and underwent conventional (63 patients) or totally tubeless (68 patients) PCNL. Preoperative data included urinalysis, urine culture, complete blood count, biochemistry study, renal ultrasonography, intravenous urography and Tc 99m DTPA clearance for determination of selective glomerular filtration rate. Intraoperative findings, operative time, and outcome were also recorded. All patients were followed regularly at clinic every 3 months during year 1 and every 6 months, thereafter, and Tc 99m DTPA clearance for the determination of selective glomerular filtration rate, renal ultrasonography and intravenous urography was performed to assess the kidney function 6 months later. There was no difference between the groups with regard to serum creatinine change, hemoglobin decrease, morphology improvement, resumption of normal activity and complication grading. The length of stay, pain visual analog scale and analgesic requirements favored the tubeless group with statistical significance. There was significant statistical difference in relative perfusion rate between preoperative and postoperative in both groups. This trial demonstrates that totally tubeless PCNL is safe and well tolerated in selected patients and associated with decreases in length of stay, postoperative pain and analgesia requirement. Most importantly, patients undergoing uncomplicated PCNL are not mandated to have a nephrostomy or ureteral stent placed for specific indications.     

Almost totally tubeless percutaneous nephrolithotomy: further evolution of the technique.

BACKGROUND AND OBJECTIVES: There is renewed interest in the concept of foregoing placement of the postoperative nephrostomy tube (PNT) after percutaneous nephrolithotomy (PCNL) with the intent of reducing postoperative discomfort and hospital stay. We have omitted the PNT and placed an internal ureteral stent or externalized ureteral catheter after PCNL in selected patients. We reviewed our experience in order to assess the efficacy and safety of this practice. PATIENTS AND METHODS: Primary PCNL was performed in 26 renal units in 21 patients (5 bilateral PCNL, 4 of which were simultaneous) by one surgeon at the University of Michigan and the Ann Arbor Veterans Affairs Medical Center. A postoperative nephrostomy tube was placed if the stone burden was >3 cm, more than one access site was used, the renal anatomy was obstructive, significant bleeding or perforation was noted, or a second look was required. RESULTS: No PNT was placed in 10 renal units in 8 patients (no-PNT group). In six no-PNT kidneys, internal ureteral stents were used, and in four, externalized ureteral stents were placed for 1 to 2 days. The mean stone size in the PNT and no-PNT patients was 3.0 and 1.8 cm, respectively. Of the 16 kidneys in the PNT group, 4 were initially eligible for omission of PNT, but a PNT was placed because of bleeding or other access-related problem. All patients were rendered stone free except for three (one PNT and two no-PNT) patients, who each had a fragment < or =4 mm. Omission of PNT placement resulted in decreased mean length of stay (2.3 days in the no-PNT group v 3.6 days in the PNT group). There were four complications, all managed with delayed stenting (one in a no-PNT patient and the remaining three in the PNT group). CONCLUSION: Omission of PNT placement in selected patients may reduce morbidity without compromising efficacy and safety, but further study is needed.     

Re: Totally tubeless percutaneous nephrolithotomy: a prospective randomized controlled study

The study is unique in terms of defining the safety of totally tubeless percutaneous nephrolithotomy (PNL). Furthermore, the authors state that the tubeless group has an advantage of less pain. However, we interpreted the results of pain-related comparisons different than that the authors had. In our opinion, the results gained show that there is no difference in terms of pain in both groups. The authors state that they have inserted a double J catheter to patients that were included in the tubeless group in addition to the nephrostomy as a conventional procedure. However, routine Double-J placement in addition to nephrostomy is not a common procedure. Additionally, the large-bore nephrostomy tube preferred is certain to cause pain, as stated in the previous studies. It has been shown that small-bore tubes cause less pain. It may have been more appropriate to compare the groups in such a manner. Even though we have stated our comments with respect to pain issues, it is evident that the study is unique in terms of defining the safety of a totally tubeless procedure.     

A randomized comparison of tubeless and standard percutaneous nephrolithotomy

PURPOSE: We present a randomized study of tubeless or nephrostomy-free percutaneous nephrolithotomy (PCNL), a modification of the standard technique, compared with standard PCNL to evaluate the role of tubeless PCNL in minimizing postoperative discomfort and reducing duration of hospital stay. PATIENTS AND METHODS: Two hundred and two patients undergoing PCNL were randomized to two groups: Group A (standard PCNL) with nephrostomy tube placement postoperatively, and group B (tubeless PCNL) with antegrade placement of a Double-J stent without nephrostomy. Inclusion criteria were: normal renal functions, single tract procedure with complete clearance, and minimal bleeding at completion. The two groups were comparable in age and sex and in metabolic and anatomic features. Factors evaluated included postoperative pain, analgesia requirement, blood loss, postoperative morbidity, hospital stay, and time to recovery. RESULTS: All patients had an uneventful postoperative recovery. The average visual analogue scale pain score on postoperative day 1 for group A patients was 59 +/- 5.1 compared with 31 +/- 4.8 in group B (P < 0.01). The mean analgesia requirement for group A (meperidine 126.5 +/- 33.3 mg) was significantly more compared with group B (meperidine 81.7 +/- 24.5 mg) (P < 0.01). The difference in average blood loss and urinary infection for the two groups was not statistically significant. The incidence of urinary leakage from the nephrostomy site was significantly less for the tubeless group (0/101), compared with the standard PNL group (7/101). The average hospital stay in the tubeless group (21.8 +/- 3.9 hours) was significantly shorter than that of the standard PCNL group (54.2 +/- 5 hours) (P < 0.01). Tubeless group patients took 5 to 7 days for complete convalescence whereas standard PCNL patients recovered in 8 to 10 days. No long-term sequelae were noticed in the median follow-up period of 18 months in any patient. CONCLUSION: Nephrostomy-free or tubeless PCNL reduces postoperative urinary leakage and local pain related to the drainage tube. It also minimizes hospital stay; the majority of patients were discharged from the hospital in fewer than 24 hours.     

无管化经皮肾镜碎石取石术的临床应用进展

正近30年以来,经皮肾镜碎石取石术(percutaneous nephrolithotomy,PCNL)作为一种微创术式已经在对肾和输尿管上段结石的治疗上广泛应用。微创经皮肾镜碎石取石术(minimally invasive PCNL,MPCNL)是在传统的PCNL的基础上发展而来的。它以较小扩张的微通道代替传统的较大的通道,并用输尿管镜以及3 F超细肾镜替代传统肾镜。较小的通道显著降低了术中大出血和肾皮     

Use of Surgicel for sealing nephrostomy tract after totally tubeless percutaneous nephrolithotomy

BACKGROUND AND PURPOSE: Fibrin glue and gelatin matrix have been used to seal nephrostomy tracts to reduce bleeding and extravasation after tubeless percutaneous nephrolithotomy (PCNL). In this study, Surgicel (oxidized cellulose) was used to seal the nephrostomy tract after totally tubeless PNL. PATIENTS AND METHODS: Twenty patients with kidney calculi were treated with totally tubeless PNL. According to randomization, at the conclusion of surgery, the nephrostomy tracts were sealed with Surgicel in ten patients and left unsealed in the other ten. Postoperatively, the two groups were compared with respect to hematocrit changes and extravasation as detected by abdominal ultrasonography and wound-dressing inspection. RESULTS: There was statistically significant decrease in the hematocrit in both the study (P = 0.017) and the control (P = 0.003) group. When the two groups were compared with respect to the decrease in hematocrit, no statistically significant difference was seen (P = 0.241). Similarly, extravasation from the nephrostomy tract was not significantly different in the two groups. CONCLUSION: Sealing the nephrostomy tract with Surgicel after totally tubeless PNL did not decrease bleeding or extravasation from the tract.     

Ultrasonographic versus fluoroscopic access for percutaneous nephrolithotomy: a randomized clinical trial

PURPOSE: Achieving access to the pyelocaliceal system in percutaneous nephrolithotomy (PCNL) is routinely performed using fluoroscopic guidance. We compared ultrasonography-guided access for PCNL with conventional fluoroscopy-guided access. PATIENTS AND METHODS: In a clinical trial, 100 patients with no abnormality of the upper urinary tract were selected from among candidates for PCNL and randomly assigned to two 50-patient groups: ultrasonography-guided access (group 1) versus fluoroscopy-guided access (group 2). In group 1, location of the target calix was identified in the transverse and sagittal planes by real-time ultrasonography when patients were in the prone position. Puncture of the target calix was attempted with a Chiba needle attached to the side of the ultrasound probe. If access to the collecting system was achieved, the site of puncture was controlled using fluoroscopy. In group 2, access was achieved using fluoroscopy guidance. Tract dilatation and stone extraction were the same in both groups. The mean age of patients was 40.7 +/- 12 years and 41.6 +/- 13.7 years in groups 1 and 2, respectively (P = 0.4). The male to female ratio in groups 1 and 2 was 34/16 and 31/19, respectively (P = 0.5). RESULTS: On average, duration of access was 11 +/- 3.5 minutes and 5.5 +/- 1.7 minutes in groups 1 and 2, respectively (P = 0.0001). Duration of radiation exposure, on average, was 0.69 +/- 0.26 minutes and 0.95 +/- 0.44 minutes in groups 1 and 2, respectively (P = 0.0001). CONCLUSION: Access for PCNL using ultrasonography guidance is an acceptable alternative to fluoroscopy and decreases radiation hazards.     

Simultaneous bilateral tubeless percutaneous nephrolithotomy of staghorn stones: a prospective randomized controlled study

A randomized controlled study was performed to evaluate the feasibility and outcome of staged versus simultaneous bilateral tubeless PCNL for bilateral renal staghorn stones. A total of 99 patients, with bilateral renal staghorn stones, were prospectively randomized into two groups, and underwent staged tubeless PCNL (49 patients) or simultaneous bilateral tubeless PCNL (50 patients). Preoperative data included urinalysis, urine culture, complete blood count, biochemistry study, renal ultrasonography, intravenous urography, and Tc 99m DTPA clearance for the determination of selective glomerular filtration rate. Intraoperative findings, operative time, and outcome were also recorded. All patients were followed regularly at clinic every 3 months during year 1 and every 6 months thereafter, and Tc 99m DTPA clearance for determination of selective glomerular filtration rate was performed to assess the kidney function 6 months later. There was no difference between the groups with regard to serum creatinine change, hemoglobin decrease, and complication grading. The length of stay, convalescence period, pain visual analog scale, analgesic requirements, and direct cost favored the simultaneous bilateral tubeless group with statistical significance. There was no significant statistical difference in relative perfusion rate between preoperative and postoperative in both groups. This study demonstrates that simultaneous bilateral tubeless PCNL is a safe, efficacious, and cost-effective option in bilateral renal staghorn calculi, which is associated with low morbidity, short hospital stay, high stone-free rate, and early return-to-normal activity.     

完全无管化与标准经皮肾镜治疗肾结石的Meta分析

目的系统评价完全无管化经皮肾镜碎石取石术(PCNL)与标准PCNL治疗肾结石的有效性和安全性。方法检索PubMed、Embase、Cochrane Library数据库。检索时限为从建库到2018年2月28日关于完全无管化PCNL和标准PCNL治疗肾结石的随机对照试验或回顾性病例对照试验,2名作者独立进行文献筛查和数据提取,运用RevMan 5.3软件进行Meta分析。结果共纳入5篇随机对照研究,2篇病例对照研究,共计781例患者,其中完全无管化PCNL组379例,标准PCNL组402例。Meta分析结果显示:完全无管化PCNL组的手术时间短于标准PCNL组(WMD:-2.72;95%CI:-4.05^-1.39;P<0.001);住院时间短于标准PCNL组(WMD:-1.48;95%CI:-1.84^-1.11;P<0.001);术后镇痛需求低于标准PCNL组(WMD:-6.91;95%CI:-9.00^-4.82;P<0.001);两组在结石清除率、术后血红蛋白丢失量及输血率方面差异均无统计学意义。结论完全无管化PCNL在治疗选择性肾结石患者方面优于标准PCNL,可以明显减少手术时间、住院时间和术后镇痛需求,而且不会增加手术相关的并发症。医师应根据患者的实际情况,个体化选择治疗方案。     

Randomized prospective trial of tubeless versus conventional minimally invasive percutaneous nephrolithotomy

Purpose

To evaluate the effectiveness and safety of minimally invasive percutaneous nephrolithotomy (mPCNL) without nephrostomy drainage tubes.

Methods

We prospectively enrolled 32 eligible patients with kidney stones at our hospital. Patients were randomly assigned to a conventional mPCNL group (ureteric Double-J stents and nephrostomy drainage tubes) or a tubeless mPCNL group (ureteric catheter but no drainage tubes). A single experienced surgeon performed all operations.

Results

At baseline, the two groups had similar age, maximum stone diameter, and gender distribution. There were no significant differences in operation time, presence of postoperative fever, stone clearance, and level of postoperative serum hemoglobin. However, the tubeless mPCNL group had significantly shorter hospital stays (3 vs. 4 days, p = 0.032) and significantly less back pain (5 patients vs. 14 patients, p = 0.003) than the conventional mPCNL group.

Conclusions

No significant differences were found between conventional and tubeless mPCNL in safety issues and stone clearance rate. However, patients treated with tubeless mPCNL had shorter hospitalization stays and were less likely to experience back pain.     

Predictors of excessive renal displacement during access in percutaneous nephrolithotomy: a randomized clinical trial

To determine the magnitude of renal displacement (a major cause of access failure or loss) during the renal access steps in percutaneous nephrolithotomy (PCNL), investigate predictors of excessive renal displacement, and compare the effect of one-stage versus gradual dilation on renal displacement during access. Sixty-six adult patients undergoing PCNL were randomized into two groups containing 33 patients each: Group 1 underwent gradual tract dilation with Alken metal dilators, and Group 2 received one-stage tract dilation. In each patient, maximum renal displacement was measured in three planes (cephalocaudal, anteroposterior, and mediolateral) during the three access steps (needle puncture, Alken guide insertion, and dilator advancement). The patients’ demographic data and intraoperative parameters were compared. In both groups, net renal displacement during the three access steps was in the cephalad, medial, and anterior directions. There were no significant differences in the magnitude of renal displacement in patients with gradual versus one-stage tract dilation. Renal displacement was significantly more pronounced in all planes and in all access steps in female patients and in those with no previous history of open stone surgery on the ipsilateral kidney. High body mass index (BMI) showed a significant negative correlation with cephalad and anterior renal displacement, but not with medial displacement. Three-dimensional movement of the kidney during percutaneous access in PCNL is similar when gradual versus one-stage tract dilation is used. Inherent patient characteristics, such as female sex, BMI, and a previous ipsilateral flank scar are major determinants of the magnitude of renal displacement during the PCNL access steps.