Journal of Pediatric Surgery 50 (2015) 655–658
Contents lists available at ScienceDirect
Journal of Pediatric Surgery journal homepage: www.elsevier.com/locate/jpedsurg
Advantages of tubeless mini-percutaneous nephrolithotomy in the treatment of preschool children under 3 years old Guanglu Song a, Xiaoli Guo a, Gang Niu b, Yujie Wang a,⁎ a b
Department of urology, The First Hospital of Xinjiang Medical University, Urumqi 830054, China Department of urology, The Hospital of Kepin County, Akesu 843000, China
a r t i c l e
i n f o
Article history: Received 16 June 2014 Received in revised form 20 October 2014 Accepted 18 November 2014 Key words: Mini-percutaneous nephrolithotomy (MPCNL) Kidney stone Tubeless Preschool children
a b s t r a c t Background/Purpose: Tubeless mini-percutaneous nephrolithotomy (MPCNL) for treating renal calculi was introduced in response to concerns over the use of adult nephrolithotomy apparatus in small children. However, it is unclear whether tubeless mini-PCNL (MPCNL) is of any benefit in the treatment of children. This study therefore aimed to assess the possible benefits of MPCNL, as compared to standard PCNL, in preschool children. Methods: Seventy-eight preschool children under 3 years with renal calculi were randomized into two groups (PCNL and MPCNL). Operative time, hemoglobin decrease, blood transfusion rate, postoperative complications and length of hospital stay in the two groups were statistically compared. Results: Recovery time was significantly shorter for patients receiving MPCNL than those treated with standard PCNL (4.6 versus 7.7 days, P b 0.05). Conclusions: Treating preschool children with tubeless percutaneous nephrolithotomy has advantages over standard PCNL, including faster recovery and shorter hospital stay. © 2015 Published by Elsevier Inc.
Causes of renal calculi in young children include anatomical abnormalities, metabolic disorders and urinary tract infections; pediatric nephrolithiasis is increasing globally [1]. The incidence of renal calculi in children varies widely across the world. In developing nations, the rate is approximately 5%–15%, while in developed countries the occurrence is only between 1% and 5% [2]. In 1976, percutaneous pyelolithotomy was introduced by Fernströn and Johansson [3], revolutionizing the treatment of renal calculi. In 1985, Woodside et al. [4] were the first to report successful treatment of children with renal calculi using an adult-sized nephroscope. Although Badawy et al. [5] and Callaway et al. [6] showed that it was safe to adopt adult-sized percutaneous nephrolithotomy (PCNL) to treat children, Desai et al. pointed out that more complications and higher blood transfusion were observed in children [7,8]. To reduce complications such as hemorrhage and urinary extravasation, Helal and Jackman and their respective collaborators developed a technique called mini-perc. The mini-percutaneous method has been shown to significantly reduce the intraoperative and postoperative hemorrhage, renal parenchymal injury, post-operative pain and length of hospital stay [9,10]. After the PCNL procedure, placement of a nephrostomy tube is needed routinely for adequate urine drainage, and hemostasis, and to facilitate an additional PCNL to clear the residual stones. Bellman et al. [11] proposed a tubeless PCNL process, outlining its possible benefits such as shorter hospital stay, reduced patient discomfort, and lowered postoperative analgesia requirements. These advantageous properties ⁎ Corresponding author. Tel.: +86 9914362779; fax: +86 2164085875. E-mail address: [email protected] (Y. Wang). http://dx.doi.org/10.1016/j.jpedsurg.2014.11.042 0022-3468/© 2015 Published by Elsevier Inc.
were confirmed by other research groups. Indeed, the totally tubeless PCNL for pediatric population was shown to be safe and effective and to yield no complications; it was proposed as a standard and costbeneficial procedure [12,13]. However, studies assessing tubeless percutaneous nephrolithotomy in preschool children under 3 years are scarce. Therefore, the current randomized controlled case study aimed to assess the potential advantages of tubeless MPCNL in treating preschool children under 3 years. 1. Materials and methods 1.1. Preparations of the operation This study utilized a randomized case study design. Preschool children were randomized into MPCNL and standard PCNL groups by generation of a random number table. Surgical nurses randomly selected an envelope containing each patient's group. The envelope was then opened during the surgical procedure. Inclusion criteria were as follows: renal calculi was confirmed by spiral CT; patient's relatives or parents provided a signed informed consent; patient was 7–36 months old; the cumulative diameter of the stone was less than 4.5 cm; no previous use of extracorporeal shock wave lithotripsy (ESWL). Patients were excluded with renal anatomical abnormalities such as rotation of the kidney, ectopic kidneys (anterior to the colon, interior to the liver and spleen), ureteropelvic junction (UPJ) stenosis, pyonephrosis combined with stones, or isolated kidney. Preschool children who had the following conditions intra-operatively or postoperatively were withdrawn from the study as well: severe hemorrhage, severe perforation
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of the renal collecting system, and presence of large postoperative residual calculi ≥4 mm. The study was approved by the Ethics Committee of the First Affiliated Hospital of Xinjiang Medical University. Before operation, routine medical history review, physical examinations and laboratory inspections were conducted. Preoperative lab tests included blood biochemistry, urinalysis and culture, drug sensitivity test, blood routine test, and coagulation rates. Additional information obtained included age and gender; stone size, location and number; condition of hydronephrosis as detected by spiral CT, B-mode ultrasound and IVU. Antibiotics were administered until sterile urine was obtained. 1.2. Procedure of operation All patients were placed under general anesthesia. The preschool children were then placed into a lithotomy position and an F4 ureteral catheter was retrograde inserted into the affected renal pelvis through the pediatric cystoscope. A Foley catheter was placed and fixed to the ureteral catheter with surgical threads. Sterile saline was flushed into the kidney through the ureteral catheter to create an artificial hydronephrosis. The preschool child was then moved into a prone position, assuring that the chest and pubis were protected to avoid crushing wounds. After routine disinfection, an 18 G (gauge) biopsy needle was inserted at the posterior axillary line, at the level of the 12th rib and into the targeted renal pelvis. The ureteral catheter was expanded by a fascia dilator to F14 or F16 while the sheath was left in place. The pediatric nephroscope or ureteroscopy was then inserted, and the stones were smashed by holmium laser. The cracked fragments were picked out by clamps or washed out by lavage fluid. Real-time imaging of the affected renal pelvis and its residual stones were observed through Bmode ultrasound and any residual stones were removed completely or the second nephrostomy access tract for lithotripsy was selected for complete clearance. 1.3. Other treatments For the 3 qualified children with bilateral renal calculi, two separate operations were performed after random assignment to the two surgery groups. The ureteral and Foley catheters were kept for 24 h routinely for both groups. On day 1 postoperatively, blood analyses were carried out. On day 3 postoperatively, B-mode ultrasound of the urinary systems was reexamined for the presence and size of residual stones as well as complications of perirenal effusions or hematomas. The state of the nephrostomy tube of the standard group was also determined by the results of B-mode ultrasound. If no abnormalities such as pain or fever were present 24 h later, the nephrostomy tube could be removed. Residual stones ≤4 mm were considered negligible [14]. CT or B-mode ultrasound of the urinary systems was carried out 1, 3, 6 and 12 months postoperatively to assess the presence of residual stones. 1.4. Statistical analysis All statistical analyses were performed with SPSS 11.0. A chi-squared test was carried out to compare postoperative complication rates, stone clearance rate, blood transfusion rate and age. Alternatively, the Mann– Whitney U-test was used for analyzing discrete data such as operative time and length of hospital stay. Student's t-test was used for continuous measured values, including stone diameter and hemoglobin levels. P b 0.05 indicated statistical significance. 2. Results Of the 111 children with renal calculi admitted between September 2009 and September 2012, 97 matched the inclusion criteria. A total of 19 patients were excluded for renal anatomical abnormalities,
pyonephrosis combined with stones, renal dysfunction or isolated kidney. An additional 8 were withdrawn because of severe intraoperative or postoperative hemorrhage, serious perforation of the renal collecting system, or the presence of postoperative residual stones ≥4 mm. Finally, 70 cases which matched the criteria remained for inclusion in the study (Fig. 1). Characteristics and preoperative indices, including age, stone diameter, stone position and preoperative hemoglobin level, are summarized in Table 1. Of the two groups, 30 kidneys had single calculi of the pelvis or calyx, 5 children had multiple calculi of the pelvis or calyx, and 3 of them had residual stones (≤4 mm). Of the 3 with residual stones, 1 self-discharged the stones after 6 months; the residual stones in the remaining 2 had increased to 1 cm with hydronephrosis, but they both were cured after a second mini-PCNL. In the two groups, 3 kidneys had 2 access tracts. No intraoperative of postoperative blood transfusions were performed. The average patient ages were 20.3 and 20.1 months for the tubeless and standard groups, respectively. The stone clearance rate of the tubeless group was 97.8%; this parameter was 95.3% in the standard group. The mean operative times were 51.97 and 55.00 minutes for the tubeless and standard procedure groups, respectively. Mean stone diameters were 2.32 and 2.40 cm for the tubeless and standard groups, respectively. Mean preoperative hemoglobin level in the tubeless group was 11.2 g/dL; a value of 11.0 g/dL was obtained for this parameter in the standard group. Meanwhile, postoperative hemoglobin decreases were 0.9 ± 0.2 g/dL in patients treated with tubeless MPCNL and 0.8 ± 0.2 g/dL in those receiving the standard procedure. Postoperative fever rate was 5.7% after tubeless MPCNL treatment and 8.6% in patients administered standard PCNL (Table 2). Age, gender, stone diameter, stone clearance rate, postoperative hemoglobin decrease and operative time of the two groups had no statistical significances. Finally, the hospital stay in tubeless MPCNL patients was significantly shorter than that obtained in the standard group (4.6 versus 7.7 days). 3. Discussion The aim of this study was to examine the possible benefits of utilizing a tubeless MPCNL procedure in children under 3 years for the treatment of renal calculi, as compared to a standard tube placement. The results of this study showed that, while most parameters are similar in the two procedures, recovery time and length of hospital stay were significantly reduced in tubeless MPCNL patients. Placement of a nephrostomy tube is typically required after treating renal calculi with PCNL. If there is no obvious hemorrhage 24–48 h postoperatively, and no signs of residual stones, complications of perirenal effusions or hematomas detected by X-ray KUB or B-mode ultrasound, the nephrostomy tube can be clamped for 24 h. Further, if no subsequent signs of osphyalgia or fever appear, the nephrostomy tube can be removed. Nephrostomy tube placement has been shown to greatly improve postoperative urine drainage, hemostasis, clearing any residual stones in a second PCNL procedure and avoiding any obstructions in the ureter caused by blood clots and stone fragments. The nephrostomy tube placement can, however, also lead to adverse effects, such as increases in postoperative pain and discomfort, longer hospital stays, more analgesia requirements, heavier psychological burdens and deeper fears in the minds of the patients. In 1997, Bellman et al. [11] proposed the concept of tubeless percutaneous nephrolithotomy (PCNL) and subsequently proved that tubeless PCNL did not increase the complications of standard PCNL either intraoperatively or postoperatively, and could reduce the adverse effects caused by nephrostomy tubes. Zeren et al. [7] found that intraoperative and postoperative hemorrhage was the most threatening factors of the tubeless PCNL procedure. Yuan et al. [15] and Ni et al. [16], however, showed the safety and efficacy of tubeless PCNL in treating noncomplex renal calculi in adults via comparisons of average length of hospital stay, postoperative complications, and pain. Similarly, Zilberman et al. [17] pointed out that tubeless PCNL appeared to be a safe alternative in children. They did caution, however, that nephrostomy tube placement should still be considered in certain
G. Song et al. / Journal of Pediatric Surgery 50 (2015) 655–658
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Fig. 1. Flowchart of subjects.
cases, such as those with more than 2 nephrostomy access tracts, those necessitating a second look and those with intraoperative complications such as significant bleeding or collecting system perforation. While several studies have reported no differences between children, or even preschool children, and adults in postoperative complications and stone clearance rate in PCNL using adult-sized devices [18,19], Gunes et al. [20] found that hemorrhage during PCNL for treating renal calculi in children aged b7 years was associated with the number of the nephrostomy access tracts and size of the sheath. Crook et al. [21] randomized adults with renal calculi into a nephrostomy placement group and a tubeless PCNL group, and found that hospital stay, postoperative analgesic requirement and urinary extravasation were significantly different, while aspects of stone clearance rate, postoperative fever and blood transfusion had no difference [22]. Additionally, Unsal et al. [23] showed that the size of the dilating access tract was significantly associated with hemoglobin decrease. They therefore stated that sheath size and number of the nephrostomy access tracts may be the most important factors of intraoperative hemorrhage. In other words, they concluded that the smaller the sheath for younger patients, the less chance of postoperative complications [23]. The kidneys of Table 1 Preoperative data of the patients.
Age (months) BUN (mmol/L) Cr (μmol/L) Stone diameter (cm) Hemoglobin (g/dL) Stone position Upper calyx Middle calyx Lower calyx Renal pelvis Upper ureter
Table 2 Postoperative data of the patients.
Tubeless group (n = 35)
Standard group (n = 35)
P value
20.30 ± 6.35 2.80 ± 0.61 19.93 ± 2.87 2.32 ± 1.07 11.20 ± 1.28
20.10 ± 7.22 2.90 ± 0.34 20.38 ± 2.31 2.40 ± 1.39 11.06 ± 1.47
0.944 0.402 0.554 0.833 0.712
4 3 8 17 5
3 5 9 14 7
Note: BUN, blood urea nitrogen; Cr, creatinine.
children are small in size, crisp in texture and great in degree of excursion, therefore, chances of intraoperative and postoperative hemorrhage must be greater when the adult-sized devices are used in PCNL for children with renal calculi. Application of the mini-percutaneous technique for treating preschool children with renal calculi proposed by Helal et al. [24] greatly reduced the postoperative complications of PCNL, which made MPCNL an ideal approach for treating children with renal calculi, Based on these previous studies, F14-16 (mini PCNL) sheaths were selected for use with the preschool child patients in the current study. As expected, no significant differences were seen in postoperative hemoglobin decrease (0.90 ± 0.20 g/dL versus 0.81 ± 0.21 g/dL) and operative time (51.97 ± 11.70 min versus 55.00 ± 14.45 min) in the two patient groups. Moreover, to raise the stone clearance rate and avoid the second PCNL for residual stones, Bmode ultrasound was used for real-time detections and guides, which could trace the positions and sizes of the residual stones in real time and raise the stone clearance rate. Additionally, stone clearance rates in this study were 97.8% in the tubeless group and 94.3% in the standard group, which is higher than those in other studies [17,25]. Salem et al. [26] compared other parameters such as the pain score (mean 4.6 for
Tubeless (n = 35) Operative time (min) 51.97 ± 11.70 Hemoglobin decrease ± SD (g/dL) 0.90 ± 0.20 Blood transfusion rate 0 Perirenal fluid presence 3 (8.6%) Postoperative fever 2 (5.7%) Stone clearance rate 34 (97.8%) Length of hospital stay (days) 4.60 ± 0.74 Second operation 0 Numbers of nephrostomy access tracts 1 34 2 1
Standard group (n = 35)
P value
55.00 ± 14.45 0.81 ± 0.21 0 0 3 (8.6%) 33 (94.3%) 7.74 ± 0.78 0
0.339 0.063
34 1
0.238
b0.001
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G. Song et al. / Journal of Pediatric Surgery 50 (2015) 655–658
tubeless versus 5.5 for standard), hospital stay (mean of 1.7 days for tubeless versus 2.8 days for standard) and concluded that tubeless PCNL is safe and feasible for children. Bilen et al. [27] retrospectively analyzed the outcomes of tubeless MPCNL in 28 preschool children and found that hospital stay of tubeless group was significantly shorter than that of the control group (4.9 days versus 3.1 d days) and considered MPCNL was an effective alternative approach for treating renal calculi in preschool children. Although pain scores are not obtainable in preschool children, the present study confirms the other measured parameters, therefore strengthening the argument that tubeless MPCNL is advantageous over the standard procedure. Previous studies have found that the most common postoperative complications were fever (30%) and blood transfusion (0–23.90%) [28].In this study, however, postoperative fever rate was 5.7% in the tubeless group and 8.6% in the standard group with no significant differences between them. Additionally, no blood transfusions were performed in either of the two groups. These results indicate a small sheath size and the tubeless PCNL reduce the chances of complications during small child renal calculi treatment and speed the rate of recovery. In summary, tubeless MPCNL in treating preschool children less than 3 years old has accelerated postoperative recovery, reduced the psychological fears in children, shortened hospital stays, lowered the treatment costs, and does not increase postoperative complications such as hemorrhage, fever, or urinary extravasation. Further studies with larger sample sizes should be conducted to confirm our findings and solidify the use of tubeless MPCNL for the treatment of small children with renal calculi.
References [1] Elderwy AA, Gadelmoula M, Elgammal MA, et al. Percutaneous nephrolithotomy in children: a preliminary report. Urol Ann 2014;6:187–91. [2] Mahmud M, Zaidi Z. Percutaneous nephrolithotomy in children before school age: experience of a Pakistani centre. BJU Int 2004;94:1352–4. [3] Fernströn I, Johansson B. Percutaneous pyelolithotomy. A new extraction technique. Scand J Urol Nephrol 1976;10:257–9. [4] Woodside JR, Stevens GF, Stark GL, et al. Percutaneous stone removal in children. J Urol 1985;134:1166–7. [5] Badawy H, Salama A, Eissa M, et al. Percutaneous management of renal calculi: experience with percutaneous nephrolithotomy in 60 children. J Urol 1999;162:1710–3. [6] Callaway TW, Lingardh G, Basata S, et al. Percutaneous nephrolithotomy in children. J Urol 1992;148:1067–8.
[7] Zeren S, Satar N, Bayazit Y, et al. Percutaneous nephrolithotomy in the management of pediatric renal calculi. J Endourol 2002;16:75–8. [8] Desai MR, Kukreja RA, Patel SH, et al. Percutaneous nephrolithotomy for complex pediatric renal calculus disease. J Endourol 2004;18:23–7. [9] Jackman SV, Docimo SG, Cadeddu JA, et al. The “mini-perc” technique: a less invasive alternative to percutaneous nephrolithotomy. World J Urol 1998;16:371–4. [10] Jackman SV, Hedican SP, Peters CA, et al. Percutaneous nephrolithotomy in infants and preschool age children: experience with a new technique. Urology 1998;52: 697–701. [11] Bellman GC, Davidoff R, Candela J, et al. Tubeless percutaneous renal surgery. J Urol 1997;157:1578–82. [12] Aghamir SM, Salavati A, Aloosh M, et al. Feasibility of totally tubeless percutaneous nephrolithotomy under the age of 14 years: a randomized clinical trial. J Endourol 2012;26:621–4. [13] Ozturk A, Guven S, Kilinc M, et al. Totally tubeless percutaneous nephrolithotomy: is it safe and effective in preschool children? J Endourol 2010;24:1935–9. [14] Rassweiler JJ, Renner C, Eisenberger F. The management of complex renal stones. BJU Int 2000;86:919–28. [15] Yuan H, Zheng S, Liu L, et al. The efficacy and safety of tubeless percutaneous nephrolithotomy: a systematic review and meta-analysis. Urol Res 2011;39:401–10. [16] Ni S, Qiyin C, Tao W, et al. Tubeless percutaneous nephrolithotomy is associated with less pain and shorter hospitalization compared with standard or small bore drainage: a meta-analysis of randomized, controlled trials. Urology 2011;77:1293–8. [17] Zilberman DE, Lipkin ME, de la Rosette JJ, et al. Tubeless percutaneous nephrolithotomy—the new standard of care? J Urol 2010;184:1261–6. [18] Guven S, Istanbulluoglu O, Ozturk A, et al. Percutaneous nephrolithotomy is highly efficient and safe in infants and children under 3 years of age. Urol Int 2010;85: 455–60. [19] Nouralizadeh A, Basiri A, Javaherforooshzadeh A, et al. Experience of percutaneous nephrolithotomy using adult-size instruments in children less than 5 years old. J Pediatr Urol 2009;5:351–4. [20] Gunes A, Yahya Ugras M, Yilmaz U, et al. Percutaneous nephrolithotomy for pediatric stone disease—our experience with adult-sized equipment. Scand J Urol Nephrol 2003;37:477–81. [21] Crook TJ, Lockyer CR, Keoghane SR, et al. A randomized controlled trial of nephrostomy placement versus tubeless percutaneous nephrolithotomy. J Urol 2008;180:612–4. [22] Mandhani A, Goyal R, Vijjan V, et al. Tubeless percutaneous nephrolithotomy—should a stent be an integral part? J Urol 2007;178:921–4. [23] Unsal A, Resorlu B, Kara C, et al. Safety and efficacy of percutaneous nephrolithotomy in infants, preschool age, and older children with different sizes of instruments. Urology 2010;76:247–52. [24] Helal M, Black T, Lockhart J, et al. The Hickman peel-away sheath: alternative for pediatric percutaneous nephrolithotomy. J Endourol 1997;11:171–2. [25] Bogris S, Papatsoris AG. Status quo of percutaneous nephrolithotomy in children. Urol Res 2010;38:1–5. [26] Khairy Salem H, Morsi HA, Omran A, et al. Tubeless percutaneous nephrolithotomy in children. J Pediatr Urol 2007;3:235–8. [27] Bilen CY, Gunay M, Ozden E, et al. Tubeless mini percutaneous nephrolithotomy in infants and preschool children: a preliminary report. J Urol 2010;184:2498–502. [28] Boormans JL, Scheepe JR, Verkoelen CF, et al. Percutaneous nephrolithotomy for treating renal calculi in children. BJU Int 2005;95:631–4.
Contents lists available at ScienceDirect
Journal of Pediatric Surgery journal homepage: www.elsevier.com/locate/jpedsurg
Advantages of tubeless mini-percutaneous nephrolithotomy in the treatment of preschool children under 3 years old Guanglu Song a, Xiaoli Guo a, Gang Niu b, Yujie Wang a,⁎ a b
Department of urology, The First Hospital of Xinjiang Medical University, Urumqi 830054, China Department of urology, The Hospital of Kepin County, Akesu 843000, China
a r t i c l e
i n f o
Article history: Received 16 June 2014 Received in revised form 20 October 2014 Accepted 18 November 2014 Key words: Mini-percutaneous nephrolithotomy (MPCNL) Kidney stone Tubeless Preschool children
a b s t r a c t Background/Purpose: Tubeless mini-percutaneous nephrolithotomy (MPCNL) for treating renal calculi was introduced in response to concerns over the use of adult nephrolithotomy apparatus in small children. However, it is unclear whether tubeless mini-PCNL (MPCNL) is of any benefit in the treatment of children. This study therefore aimed to assess the possible benefits of MPCNL, as compared to standard PCNL, in preschool children. Methods: Seventy-eight preschool children under 3 years with renal calculi were randomized into two groups (PCNL and MPCNL). Operative time, hemoglobin decrease, blood transfusion rate, postoperative complications and length of hospital stay in the two groups were statistically compared. Results: Recovery time was significantly shorter for patients receiving MPCNL than those treated with standard PCNL (4.6 versus 7.7 days, P b 0.05). Conclusions: Treating preschool children with tubeless percutaneous nephrolithotomy has advantages over standard PCNL, including faster recovery and shorter hospital stay. © 2015 Published by Elsevier Inc.
Causes of renal calculi in young children include anatomical abnormalities, metabolic disorders and urinary tract infections; pediatric nephrolithiasis is increasing globally [1]. The incidence of renal calculi in children varies widely across the world. In developing nations, the rate is approximately 5%–15%, while in developed countries the occurrence is only between 1% and 5% [2]. In 1976, percutaneous pyelolithotomy was introduced by Fernströn and Johansson [3], revolutionizing the treatment of renal calculi. In 1985, Woodside et al. [4] were the first to report successful treatment of children with renal calculi using an adult-sized nephroscope. Although Badawy et al. [5] and Callaway et al. [6] showed that it was safe to adopt adult-sized percutaneous nephrolithotomy (PCNL) to treat children, Desai et al. pointed out that more complications and higher blood transfusion were observed in children [7,8]. To reduce complications such as hemorrhage and urinary extravasation, Helal and Jackman and their respective collaborators developed a technique called mini-perc. The mini-percutaneous method has been shown to significantly reduce the intraoperative and postoperative hemorrhage, renal parenchymal injury, post-operative pain and length of hospital stay [9,10]. After the PCNL procedure, placement of a nephrostomy tube is needed routinely for adequate urine drainage, and hemostasis, and to facilitate an additional PCNL to clear the residual stones. Bellman et al. [11] proposed a tubeless PCNL process, outlining its possible benefits such as shorter hospital stay, reduced patient discomfort, and lowered postoperative analgesia requirements. These advantageous properties ⁎ Corresponding author. Tel.: +86 9914362779; fax: +86 2164085875. E-mail address: [email protected] (Y. Wang). http://dx.doi.org/10.1016/j.jpedsurg.2014.11.042 0022-3468/© 2015 Published by Elsevier Inc.
were confirmed by other research groups. Indeed, the totally tubeless PCNL for pediatric population was shown to be safe and effective and to yield no complications; it was proposed as a standard and costbeneficial procedure [12,13]. However, studies assessing tubeless percutaneous nephrolithotomy in preschool children under 3 years are scarce. Therefore, the current randomized controlled case study aimed to assess the potential advantages of tubeless MPCNL in treating preschool children under 3 years. 1. Materials and methods 1.1. Preparations of the operation This study utilized a randomized case study design. Preschool children were randomized into MPCNL and standard PCNL groups by generation of a random number table. Surgical nurses randomly selected an envelope containing each patient's group. The envelope was then opened during the surgical procedure. Inclusion criteria were as follows: renal calculi was confirmed by spiral CT; patient's relatives or parents provided a signed informed consent; patient was 7–36 months old; the cumulative diameter of the stone was less than 4.5 cm; no previous use of extracorporeal shock wave lithotripsy (ESWL). Patients were excluded with renal anatomical abnormalities such as rotation of the kidney, ectopic kidneys (anterior to the colon, interior to the liver and spleen), ureteropelvic junction (UPJ) stenosis, pyonephrosis combined with stones, or isolated kidney. Preschool children who had the following conditions intra-operatively or postoperatively were withdrawn from the study as well: severe hemorrhage, severe perforation
656
G. Song et al. / Journal of Pediatric Surgery 50 (2015) 655–658
of the renal collecting system, and presence of large postoperative residual calculi ≥4 mm. The study was approved by the Ethics Committee of the First Affiliated Hospital of Xinjiang Medical University. Before operation, routine medical history review, physical examinations and laboratory inspections were conducted. Preoperative lab tests included blood biochemistry, urinalysis and culture, drug sensitivity test, blood routine test, and coagulation rates. Additional information obtained included age and gender; stone size, location and number; condition of hydronephrosis as detected by spiral CT, B-mode ultrasound and IVU. Antibiotics were administered until sterile urine was obtained. 1.2. Procedure of operation All patients were placed under general anesthesia. The preschool children were then placed into a lithotomy position and an F4 ureteral catheter was retrograde inserted into the affected renal pelvis through the pediatric cystoscope. A Foley catheter was placed and fixed to the ureteral catheter with surgical threads. Sterile saline was flushed into the kidney through the ureteral catheter to create an artificial hydronephrosis. The preschool child was then moved into a prone position, assuring that the chest and pubis were protected to avoid crushing wounds. After routine disinfection, an 18 G (gauge) biopsy needle was inserted at the posterior axillary line, at the level of the 12th rib and into the targeted renal pelvis. The ureteral catheter was expanded by a fascia dilator to F14 or F16 while the sheath was left in place. The pediatric nephroscope or ureteroscopy was then inserted, and the stones were smashed by holmium laser. The cracked fragments were picked out by clamps or washed out by lavage fluid. Real-time imaging of the affected renal pelvis and its residual stones were observed through Bmode ultrasound and any residual stones were removed completely or the second nephrostomy access tract for lithotripsy was selected for complete clearance. 1.3. Other treatments For the 3 qualified children with bilateral renal calculi, two separate operations were performed after random assignment to the two surgery groups. The ureteral and Foley catheters were kept for 24 h routinely for both groups. On day 1 postoperatively, blood analyses were carried out. On day 3 postoperatively, B-mode ultrasound of the urinary systems was reexamined for the presence and size of residual stones as well as complications of perirenal effusions or hematomas. The state of the nephrostomy tube of the standard group was also determined by the results of B-mode ultrasound. If no abnormalities such as pain or fever were present 24 h later, the nephrostomy tube could be removed. Residual stones ≤4 mm were considered negligible [14]. CT or B-mode ultrasound of the urinary systems was carried out 1, 3, 6 and 12 months postoperatively to assess the presence of residual stones. 1.4. Statistical analysis All statistical analyses were performed with SPSS 11.0. A chi-squared test was carried out to compare postoperative complication rates, stone clearance rate, blood transfusion rate and age. Alternatively, the Mann– Whitney U-test was used for analyzing discrete data such as operative time and length of hospital stay. Student's t-test was used for continuous measured values, including stone diameter and hemoglobin levels. P b 0.05 indicated statistical significance. 2. Results Of the 111 children with renal calculi admitted between September 2009 and September 2012, 97 matched the inclusion criteria. A total of 19 patients were excluded for renal anatomical abnormalities,
pyonephrosis combined with stones, renal dysfunction or isolated kidney. An additional 8 were withdrawn because of severe intraoperative or postoperative hemorrhage, serious perforation of the renal collecting system, or the presence of postoperative residual stones ≥4 mm. Finally, 70 cases which matched the criteria remained for inclusion in the study (Fig. 1). Characteristics and preoperative indices, including age, stone diameter, stone position and preoperative hemoglobin level, are summarized in Table 1. Of the two groups, 30 kidneys had single calculi of the pelvis or calyx, 5 children had multiple calculi of the pelvis or calyx, and 3 of them had residual stones (≤4 mm). Of the 3 with residual stones, 1 self-discharged the stones after 6 months; the residual stones in the remaining 2 had increased to 1 cm with hydronephrosis, but they both were cured after a second mini-PCNL. In the two groups, 3 kidneys had 2 access tracts. No intraoperative of postoperative blood transfusions were performed. The average patient ages were 20.3 and 20.1 months for the tubeless and standard groups, respectively. The stone clearance rate of the tubeless group was 97.8%; this parameter was 95.3% in the standard group. The mean operative times were 51.97 and 55.00 minutes for the tubeless and standard procedure groups, respectively. Mean stone diameters were 2.32 and 2.40 cm for the tubeless and standard groups, respectively. Mean preoperative hemoglobin level in the tubeless group was 11.2 g/dL; a value of 11.0 g/dL was obtained for this parameter in the standard group. Meanwhile, postoperative hemoglobin decreases were 0.9 ± 0.2 g/dL in patients treated with tubeless MPCNL and 0.8 ± 0.2 g/dL in those receiving the standard procedure. Postoperative fever rate was 5.7% after tubeless MPCNL treatment and 8.6% in patients administered standard PCNL (Table 2). Age, gender, stone diameter, stone clearance rate, postoperative hemoglobin decrease and operative time of the two groups had no statistical significances. Finally, the hospital stay in tubeless MPCNL patients was significantly shorter than that obtained in the standard group (4.6 versus 7.7 days). 3. Discussion The aim of this study was to examine the possible benefits of utilizing a tubeless MPCNL procedure in children under 3 years for the treatment of renal calculi, as compared to a standard tube placement. The results of this study showed that, while most parameters are similar in the two procedures, recovery time and length of hospital stay were significantly reduced in tubeless MPCNL patients. Placement of a nephrostomy tube is typically required after treating renal calculi with PCNL. If there is no obvious hemorrhage 24–48 h postoperatively, and no signs of residual stones, complications of perirenal effusions or hematomas detected by X-ray KUB or B-mode ultrasound, the nephrostomy tube can be clamped for 24 h. Further, if no subsequent signs of osphyalgia or fever appear, the nephrostomy tube can be removed. Nephrostomy tube placement has been shown to greatly improve postoperative urine drainage, hemostasis, clearing any residual stones in a second PCNL procedure and avoiding any obstructions in the ureter caused by blood clots and stone fragments. The nephrostomy tube placement can, however, also lead to adverse effects, such as increases in postoperative pain and discomfort, longer hospital stays, more analgesia requirements, heavier psychological burdens and deeper fears in the minds of the patients. In 1997, Bellman et al. [11] proposed the concept of tubeless percutaneous nephrolithotomy (PCNL) and subsequently proved that tubeless PCNL did not increase the complications of standard PCNL either intraoperatively or postoperatively, and could reduce the adverse effects caused by nephrostomy tubes. Zeren et al. [7] found that intraoperative and postoperative hemorrhage was the most threatening factors of the tubeless PCNL procedure. Yuan et al. [15] and Ni et al. [16], however, showed the safety and efficacy of tubeless PCNL in treating noncomplex renal calculi in adults via comparisons of average length of hospital stay, postoperative complications, and pain. Similarly, Zilberman et al. [17] pointed out that tubeless PCNL appeared to be a safe alternative in children. They did caution, however, that nephrostomy tube placement should still be considered in certain
G. Song et al. / Journal of Pediatric Surgery 50 (2015) 655–658
657
Fig. 1. Flowchart of subjects.
cases, such as those with more than 2 nephrostomy access tracts, those necessitating a second look and those with intraoperative complications such as significant bleeding or collecting system perforation. While several studies have reported no differences between children, or even preschool children, and adults in postoperative complications and stone clearance rate in PCNL using adult-sized devices [18,19], Gunes et al. [20] found that hemorrhage during PCNL for treating renal calculi in children aged b7 years was associated with the number of the nephrostomy access tracts and size of the sheath. Crook et al. [21] randomized adults with renal calculi into a nephrostomy placement group and a tubeless PCNL group, and found that hospital stay, postoperative analgesic requirement and urinary extravasation were significantly different, while aspects of stone clearance rate, postoperative fever and blood transfusion had no difference [22]. Additionally, Unsal et al. [23] showed that the size of the dilating access tract was significantly associated with hemoglobin decrease. They therefore stated that sheath size and number of the nephrostomy access tracts may be the most important factors of intraoperative hemorrhage. In other words, they concluded that the smaller the sheath for younger patients, the less chance of postoperative complications [23]. The kidneys of Table 1 Preoperative data of the patients.
Age (months) BUN (mmol/L) Cr (μmol/L) Stone diameter (cm) Hemoglobin (g/dL) Stone position Upper calyx Middle calyx Lower calyx Renal pelvis Upper ureter
Table 2 Postoperative data of the patients.
Tubeless group (n = 35)
Standard group (n = 35)
P value
20.30 ± 6.35 2.80 ± 0.61 19.93 ± 2.87 2.32 ± 1.07 11.20 ± 1.28
20.10 ± 7.22 2.90 ± 0.34 20.38 ± 2.31 2.40 ± 1.39 11.06 ± 1.47
0.944 0.402 0.554 0.833 0.712
4 3 8 17 5
3 5 9 14 7
Note: BUN, blood urea nitrogen; Cr, creatinine.
children are small in size, crisp in texture and great in degree of excursion, therefore, chances of intraoperative and postoperative hemorrhage must be greater when the adult-sized devices are used in PCNL for children with renal calculi. Application of the mini-percutaneous technique for treating preschool children with renal calculi proposed by Helal et al. [24] greatly reduced the postoperative complications of PCNL, which made MPCNL an ideal approach for treating children with renal calculi, Based on these previous studies, F14-16 (mini PCNL) sheaths were selected for use with the preschool child patients in the current study. As expected, no significant differences were seen in postoperative hemoglobin decrease (0.90 ± 0.20 g/dL versus 0.81 ± 0.21 g/dL) and operative time (51.97 ± 11.70 min versus 55.00 ± 14.45 min) in the two patient groups. Moreover, to raise the stone clearance rate and avoid the second PCNL for residual stones, Bmode ultrasound was used for real-time detections and guides, which could trace the positions and sizes of the residual stones in real time and raise the stone clearance rate. Additionally, stone clearance rates in this study were 97.8% in the tubeless group and 94.3% in the standard group, which is higher than those in other studies [17,25]. Salem et al. [26] compared other parameters such as the pain score (mean 4.6 for
Tubeless (n = 35) Operative time (min) 51.97 ± 11.70 Hemoglobin decrease ± SD (g/dL) 0.90 ± 0.20 Blood transfusion rate 0 Perirenal fluid presence 3 (8.6%) Postoperative fever 2 (5.7%) Stone clearance rate 34 (97.8%) Length of hospital stay (days) 4.60 ± 0.74 Second operation 0 Numbers of nephrostomy access tracts 1 34 2 1
Standard group (n = 35)
P value
55.00 ± 14.45 0.81 ± 0.21 0 0 3 (8.6%) 33 (94.3%) 7.74 ± 0.78 0
0.339 0.063
34 1
0.238
b0.001
658
G. Song et al. / Journal of Pediatric Surgery 50 (2015) 655–658
tubeless versus 5.5 for standard), hospital stay (mean of 1.7 days for tubeless versus 2.8 days for standard) and concluded that tubeless PCNL is safe and feasible for children. Bilen et al. [27] retrospectively analyzed the outcomes of tubeless MPCNL in 28 preschool children and found that hospital stay of tubeless group was significantly shorter than that of the control group (4.9 days versus 3.1 d days) and considered MPCNL was an effective alternative approach for treating renal calculi in preschool children. Although pain scores are not obtainable in preschool children, the present study confirms the other measured parameters, therefore strengthening the argument that tubeless MPCNL is advantageous over the standard procedure. Previous studies have found that the most common postoperative complications were fever (30%) and blood transfusion (0–23.90%) [28].In this study, however, postoperative fever rate was 5.7% in the tubeless group and 8.6% in the standard group with no significant differences between them. Additionally, no blood transfusions were performed in either of the two groups. These results indicate a small sheath size and the tubeless PCNL reduce the chances of complications during small child renal calculi treatment and speed the rate of recovery. In summary, tubeless MPCNL in treating preschool children less than 3 years old has accelerated postoperative recovery, reduced the psychological fears in children, shortened hospital stays, lowered the treatment costs, and does not increase postoperative complications such as hemorrhage, fever, or urinary extravasation. Further studies with larger sample sizes should be conducted to confirm our findings and solidify the use of tubeless MPCNL for the treatment of small children with renal calculi.
References [1] Elderwy AA, Gadelmoula M, Elgammal MA, et al. Percutaneous nephrolithotomy in children: a preliminary report. Urol Ann 2014;6:187–91. [2] Mahmud M, Zaidi Z. Percutaneous nephrolithotomy in children before school age: experience of a Pakistani centre. BJU Int 2004;94:1352–4. [3] Fernströn I, Johansson B. Percutaneous pyelolithotomy. A new extraction technique. Scand J Urol Nephrol 1976;10:257–9. [4] Woodside JR, Stevens GF, Stark GL, et al. Percutaneous stone removal in children. J Urol 1985;134:1166–7. [5] Badawy H, Salama A, Eissa M, et al. Percutaneous management of renal calculi: experience with percutaneous nephrolithotomy in 60 children. J Urol 1999;162:1710–3. [6] Callaway TW, Lingardh G, Basata S, et al. Percutaneous nephrolithotomy in children. J Urol 1992;148:1067–8.
[7] Zeren S, Satar N, Bayazit Y, et al. Percutaneous nephrolithotomy in the management of pediatric renal calculi. J Endourol 2002;16:75–8. [8] Desai MR, Kukreja RA, Patel SH, et al. Percutaneous nephrolithotomy for complex pediatric renal calculus disease. J Endourol 2004;18:23–7. [9] Jackman SV, Docimo SG, Cadeddu JA, et al. The “mini-perc” technique: a less invasive alternative to percutaneous nephrolithotomy. World J Urol 1998;16:371–4. [10] Jackman SV, Hedican SP, Peters CA, et al. Percutaneous nephrolithotomy in infants and preschool age children: experience with a new technique. Urology 1998;52: 697–701. [11] Bellman GC, Davidoff R, Candela J, et al. Tubeless percutaneous renal surgery. J Urol 1997;157:1578–82. [12] Aghamir SM, Salavati A, Aloosh M, et al. Feasibility of totally tubeless percutaneous nephrolithotomy under the age of 14 years: a randomized clinical trial. J Endourol 2012;26:621–4. [13] Ozturk A, Guven S, Kilinc M, et al. Totally tubeless percutaneous nephrolithotomy: is it safe and effective in preschool children? J Endourol 2010;24:1935–9. [14] Rassweiler JJ, Renner C, Eisenberger F. The management of complex renal stones. BJU Int 2000;86:919–28. [15] Yuan H, Zheng S, Liu L, et al. The efficacy and safety of tubeless percutaneous nephrolithotomy: a systematic review and meta-analysis. Urol Res 2011;39:401–10. [16] Ni S, Qiyin C, Tao W, et al. Tubeless percutaneous nephrolithotomy is associated with less pain and shorter hospitalization compared with standard or small bore drainage: a meta-analysis of randomized, controlled trials. Urology 2011;77:1293–8. [17] Zilberman DE, Lipkin ME, de la Rosette JJ, et al. Tubeless percutaneous nephrolithotomy—the new standard of care? J Urol 2010;184:1261–6. [18] Guven S, Istanbulluoglu O, Ozturk A, et al. Percutaneous nephrolithotomy is highly efficient and safe in infants and children under 3 years of age. Urol Int 2010;85: 455–60. [19] Nouralizadeh A, Basiri A, Javaherforooshzadeh A, et al. Experience of percutaneous nephrolithotomy using adult-size instruments in children less than 5 years old. J Pediatr Urol 2009;5:351–4. [20] Gunes A, Yahya Ugras M, Yilmaz U, et al. Percutaneous nephrolithotomy for pediatric stone disease—our experience with adult-sized equipment. Scand J Urol Nephrol 2003;37:477–81. [21] Crook TJ, Lockyer CR, Keoghane SR, et al. A randomized controlled trial of nephrostomy placement versus tubeless percutaneous nephrolithotomy. J Urol 2008;180:612–4. [22] Mandhani A, Goyal R, Vijjan V, et al. Tubeless percutaneous nephrolithotomy—should a stent be an integral part? J Urol 2007;178:921–4. [23] Unsal A, Resorlu B, Kara C, et al. Safety and efficacy of percutaneous nephrolithotomy in infants, preschool age, and older children with different sizes of instruments. Urology 2010;76:247–52. [24] Helal M, Black T, Lockhart J, et al. The Hickman peel-away sheath: alternative for pediatric percutaneous nephrolithotomy. J Endourol 1997;11:171–2. [25] Bogris S, Papatsoris AG. Status quo of percutaneous nephrolithotomy in children. Urol Res 2010;38:1–5. [26] Khairy Salem H, Morsi HA, Omran A, et al. Tubeless percutaneous nephrolithotomy in children. J Pediatr Urol 2007;3:235–8. [27] Bilen CY, Gunay M, Ozden E, et al. Tubeless mini percutaneous nephrolithotomy in infants and preschool children: a preliminary report. J Urol 2010;184:2498–502. [28] Boormans JL, Scheepe JR, Verkoelen CF, et al. Percutaneous nephrolithotomy for treating renal calculi in children. BJU Int 2005;95:631–4.
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