Efficacy and Safety of Tubeless Percutaneous Nephrolithotomy versus Standard Percutaneous Nephrolithotomy

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1 Print ISSN: Online ISSN: DOI: /SUR/2016/31 Original Article Efficacy and Safety of Tubeless Percutaneous Nephrolithotomy versus Standard Percutaneous Nephrolithotomy Sreedhar Dayapule 1, Suryaprakash Vaddi 2, G Vijaya Bhaskar 3, Ramamohan Pathapati 4 1 Assistant Professor, Department of Urology and Renal Transplantation, Narayana Medical College & Super Speciality Hospital, Nellore, Andhra Pradesh, India, 2 Professor and Head, Department of Urology and Renal Transplantation, Narayana Medical College & Super Speciality Hospital, Nellore, Andhra Pradesh, India, 3 Assistant Professor, Department of Urology and Renal Transplantation, Narayana Medical College & Super Speciality Hospital, Nellore, Andhra Pradesh, India, 4 Associate Professor, Department of Pharmacology, Narayana Medical College & Super Speciality Hospital, Nellore, Andhra Pradesh, India Abstract Introduction: We conducted a prospective study of tubeless percutaneous nephrolithotomy (PCNL) in selected patients and compared it with standard PCNL among patients with similar inclusion criteria and evaluated the efficacy and safety of tubeless PCNL over the standard PCNL. Methods: Between December 2009 and December 2011, a total of 298 patients underwent PCNL. 40 patients with stone size <2 cm underwent PCNL. In 20 patients, nephrostomy tube (N) was placed, and in another 20 patients, a exteriorized ureteral stent was placed and did not undergo nephrostomy (NN) (tubeless). These two groups were compared regarding the duration of hospital stay, post-operative pain, analgesic duration, complications, and estimated blood loss - hemoglobin (Hb) drop in g% (before and after PCNL). Results: Out of the 40 patients in the study, there were 13 (32.5%) females and 27 (67.5%) males. 7 patients (17.5%) had stones in calyx, 18 (45%) in pelvis, 3 (7.5%) in pelvi-ureteric junction, and 12 (30%) ureter. The mean age of patients was 41.3 year (7-55 years). The average size of stone was ± 4.02 mm. The duration of procedure of all patients was ± min. The duration of the procedure, visual analog pain score, duration of analgesia use, the length of hospital stay, and drop in Hb and found that in patients who underwent tubeless nephrolithotomy it was 38.5 ± 7.8 min, 2.3 ± 0.5 cm, 2.6 ± 0.5 days, 3.5 ± 0.8 days, and 0.3 ± 0.4 g%, respectively. Whereas it was 61.8 ± 11.7 (P < ), 3.7 ± 1.1 (P < ), 4.4 ± 0.9 (P < ), 0.3 ± 0.4, and 0.5 ± 0.5 (P = 0.13), respectively, in patients undergoing standard nephrolithotomy. One patient developed fever in each group. Conclusion: In properly selected patients, tubeless PCNL with only an externalized ureteral catheter demonstrates significant advantages over standard PCNL regarding post-operative discomfort, morbidity, hospital stay, and period of analgesia requirement. In near future, tubeless PCNL with externalized ureteral catheter can be recommended as a standard of care in the management of selected cases of renal calculi. Keywords: Percutaneous nephrolithotomy, Renal calculus, Tube, Tubeless Access this article online Month of Submission : Month of Peer Review : Month of Acceptance : Month of Publishing : INTRODUCTION kidney stone is a piece of solid material that forms in A the kidney when minerals in the urine become very concentrated. This disease is as widespread across the globe, particularly in countries with dry, hot climate. 1 In India, the worst affected are parts of North Western States of India 2 such as Maharashtra, Gujarat, Punjab, Haryana, Corresponding Author: Dr. Sreedhar Dayapule, Department of Urology and Renal Transplantation, Narayana Medical College & Super Speciality Hospital, Nellore , Andhra Pradesh. India. Phone: sreedh2003@gmail.com 16

2 Delhi, and Rajasthan. In Andhra Pradesh, higher incidence of the stone disease is noted in the districts of Prakasam, Nellore, Nalgonda, Medak, and Anantapur. Renal stone management moved from open surgery to minimally invasive procedures with the aim of achieving maximum stone clearance with the least morbidity and mortality. The high risk of stone recurrence also favors minimally invasive treatment rather than repeated open surgery. 3 Percutaneous nephrolithotomy (PCNL) with conventional post-operative nephrostomy tube drainage is the standard treatment option in patients with renal calculi more than 2 cm. However, nephrostomy tube has been implicated in causing post-operative discomfort and morbidity, prolonged hospital stays and continuous urinary leakage. Our hospital is a tertiary care center comes in the endemic region and caters services to the surrounding three districts. Management of urolithiasis constitutes 40-50% of the urological workload in our hospitals. To reduce tube related morbidity and duration of hospital stay, we also use of smaller nephrostomy tube or avoiding it completely after an uncomplicated procedure with only ureteric catheter in situ termed as tubeless PCNL. 3-9 To this purpose, we assessed the influence of nephrostomy tube on post-operative morbidity, hospital stay, and analgesic requirement with tubeless PCNL and compared it with standard PCNL. METHODS At our center, we performed a total of 298 PCNL during December 2009 to December Both male and female patients between 0 and 65 years with renal calculi of size 2 cm or less either at calyceal, pelvic or upper ureter and undergoing PCNL were included. Patients, who required more than one percutaneous tract, having raised creatinine, staghorn calculus, solitary kidney, calculus in ectopic kidney, congenital anomalies such as horseshoe kidney, malrotated kidney, duplex moiety and who had a calyceal injury, extravasations, bleeding during the procedure, incomplete stone clearance was excluded from the study. All patients underwent standard PCNL procedure by the subcostal approach. They were categorized into two groups: Group-N with 20 patients in whom nephrostomy tube (N) was placed and Group-NN with 20 patients in whom a exteriorized ureteral stent 10 was placed and removed on 2 nd post-operative day, and no nephrostomy (NN) was placed (tubeless). These groups were compared about duration of hospital stay, post-operative pain, analgesic duration, complications, and estimated blood loss - hemoglobin (Hb) drop in g% (before and after PCNL). Statistical Analysis Raw data entered in the case record forms were transferred to Microsoft Excel spreadsheet 2007 (Microsoft Corp, Seattle, Washington). The statistical analysis was computed by Sigma graph pad prism software, USA Version-4, and SPSS version-11. The data were summarized in tabular form. Continuous data were presented as a mean and standard deviation and between groups; the analysis was carried out using t-test. Categorical data were presented as actual numbers and percentages. Categorical variables were analyzed with Chi-square test. For statistical significance, the two-tailed P < 0.05 was considered. RESULTS In our study, there were 13 (32.5%) females and 27 (67.5%) males. 7 patients (17.5%) had stones in calyx, 18 (45%) in pelvis, 3 (7.5%) in pelvi-ureteric junction, and 12 (30%) in upper ureter. The mean age of patients was 7-55 years. The average size of stone was ± 4.02 mm. The duration of procedure of all patients was ± min. In 20 (50%) of patients, stones were present in right side, whereas in rest on the left side. 11 (27.5%) had stones between 8 and 10 mm, 14 (35%) between 11 and 15 mm, and 15 (37.5%) between 16 and 20 mm. There was no difference between the two groups regarding stone size, location, and age. The duration of the procedure, visual analog pain score (VAS), duration of analgesia use, the length of hospital stay, and drop in Hb and found that in patients who underwent tubeless nephrolithotomy it was 38.5 ± 7.8 min, 2.3 ± 0.5 cm, 2.6 ± 0.5 days, 3.5 ± 0.8 days, and 0.3 ± 0.4 g%, respectively. Whereas it was 61.8 ± 11.7 (P < ), 3.7 ± 1.1 (P < ), 4.4 ± 0.9 (P < ), 0.3 ± 0.4, and 0.5 ± 0.5 (P = 0.13), respectively, in patients undergoing standard nephrolithotomy. One patient developed fever in each group (Table 1 and Figure 1). Figure 1: Comparison of visual analog pain score, duration of analgesic use and length of hospital stay between patients undergoing tubeless (no nephrostomy) and tube (nephrostomy) 17

3 Table 1: Clinical profile and outcome of patients undergoing percutaneous nephrolithotomy Parameter Tubeless no nephrostomy (n=20) Tube nephrostomy (n=20) All patients (n=40) (%) Gender Female (32.5) 1.0 Male (67.5) Side Right (50) 0.52 Left (50) Position Calyx (17.5) 0.14 Pelvis (45) PUJ (7.5) Upper ureter (30) Fever (5) 1.0 Size (mm) (27.5) (35) (37.5) Age (year) 43.4± ± ± Size (mm) 13.9± ± ± Duration of procedure (min) 38.5± ± ±15.34 < Pain score VAS (cm) 2.3± ± ±1.09 < Analgesic duration (days) 2.6± ± ±1.18 < Hospital stay (days) 3.5± ± ±0.97 < Drop in hemoglobin (g %) 0.3± ± ± VAS: Visual analog score, PUJ: Pelvi ureteric junction P DISCUSSION PCNL has become an integral part of renal stone management. The placement of percutaneous nephrostomy tube after the completion of the procedure has been considered the standard practice to aid in hemostasis to ensure proper drainage of urine and to facilitate easy access in case repeat PCNL is required. Despite these apparent advantages, nephrostomy tube has been implicated in post-operative discomfort and morbidity. To reduce discomfort and tube related morbidity, modifications have been made to the use of smaller nephrostomy tube or avoiding it completely after an uncomplicated procedure using double-j stent/ureteral catheter as tubeless PCNL. 11 Bellman et al. 12 described 50 patients who had early removal of the nephrostomy tube after PCNL. The first 30 patients had a nephrostomy tube removed within 2-3 h after surgery, and the remaining 20 patients had the nephrostomy tube removed in the operating room. All patients had a double-j stent placed during PCNL, and a Foley catheter was left in place for 24 h. Patients with the significant residual stone burden, procedures longer than 2 h, multiple accesses, perforation of the collecting system or significant bleeding were excluded. The authors reported no significant complications in this cohort, and hospitalization, analgesia requirements, and time to return to normal activity were significantly reduced in the group with double-j stent drainage compared with a control group in whom nephrostomy tubes were placed. However, no data were presented regarding the post-operative assessment of residual calculi possibly necessitating secondary PCNL. Goh and Wolf 13 reported on 10 of 26 renal units treated with an internal stent or externalized ureteral catheter placed for 1 or 2 days after PCNL. They reported a reduction in hospital stay and morbidity in the tubeless group compared to that of patients with standard nephrostomy tube drainage. However, 4 mm residual fragments were noted in two patients. Delnay and Wake 14 described 33 patients in whom an internal stent was placed instead of a nephrostomy tube after PCNL with the use of similar exclusion criteria. Average hospital stay was 1.5 days, and no significant complications occurred, but several patients harbored residual calculi that necessitated additional procedures (shockwave lithotripsy [SWL]) after PCNL. Limb and Bellman 5 described 112 patients undergoing tubeless PCNL; strict criteria were used to select these patients, who had a mean stone burden of 3.30 cm 2. They reported a 93% stone-free rate and an average length of hospitalization of 1.56 days; 7% required subsequent SWL ancillary treatments. 18

4 Feng et al. 15 performed a randomized controlled study comparing standard PCNL, mini-pcnl, and tubeless PCNL. They found no advantage for the mini-pcnl over the standard PCNL and also discovered that the tubeless cohort experienced the least morbidity. Desai et al. 16 (2004) also performed a prospective randomized study of patients undergoing PCNL with conventional large-bore nephrostomy drainage, smallbore nephrostomy drainage, or no nephrostomy drainage. The authors reported that tubeless PCNL was associated with the least pain. However, they did not comment on the need for ancillary procedures or the stone-free status of the patients. In our study, Group-N patients (standard PCNL) had an average VAS pain score of 3.7 cm compared with 2.3 cm in Group-NN patients (tubeless PCNL), the difference between the groups is significant (P < 0.001). A study by Agarwal et al. 17 also reported a VAS score of 5.9 ± 0.51 in the regular group to 3.7 ± 0.48 in the tubeless group which was statistically significant (P < 0.01). We have found that duration of the procedure is also significantly (P < ) less in the Group-NN (tubeless PCNL) compared to Group-N patients (standard PCNL) 61.8 min and 38.5 min, respectively. In Group-N patients (standard PCNL), average duration of hospital stay is 4.4 days compared with 3.5 days in Group-NN patients (tubeless PCNL), the difference between the groups is statistically significant (P < ). In a study by Agarwal et al., in which the length of stay was only 21 h, in a study by Desai et al. 16 it was 3.4 days in tubeless PCNL. Lojanapiwat et al. 6 showed near similar results as in our study (3.63 days and 3.5 days of hospital stay in tubeless group, respectively). The analgesic requirement in our study was decided by VAS two times a day and used a combination of tramadol (50 mg) and paracetamol (650 mg) to control pain. We found that the duration of the analgesic requirement in Group-N (standard PCNL) was 4.4 days and 2.6 days in Group-NN (tubeless) which was statistically significant (P < ). In our study, the stone clearance was checked by post OP X-ray KUB. In both the groups, it was 100%. Similar results were found in studies by Singh et al. 18 and Agarwal et al. 17 In a study by Feng et al., 15 stone clearance rate in tubeless PCNL was 85.7%. In our study, the Hb drop was 0.4 ± 0.3 g% in Group-N (standard PCNL) compared to 0.5 ± 0.5 g% in Group-NN (tubeless) which was not statistically significant (P = 0.13). Studies by Agarwal et al., 17 Feng et al., 15 and Desai et al. 16 showed similar results. One patient in each group developed a fever which was managed conservatively; no other complication was observed in both the groups. A study by Singh et al. 18 showed UTI in 2 patients and stent dysuria in 2 patients. As we used, an external ureteral catheter which was removed after 48 h, no stent-related complications were noted. CONCLUSION In properly selected patients, tubeless PCNL with only an externalized ureteral catheter demonstrates statistically significant advantages over standard PCNL regarding post-operative discomfort, morbidity, hospital stay, and period of analgesia requirement. In near future, tubeless PCNL with externalized ureteral catheter can be recommended as a standard of care in the management of selected cases of renal calculi. REFERENCES 1. Shah J, Whitfield HN. Urolithiasis through the ages. BJU Int 2002;89: López M, Hoppe B. History, epidemiology and regional diversities of urolithiasis. Pediatr Nephrol 2010;25: Moe OW. Kidney stones: Pathophysiology and medical management. Lancet 2006;367: Aghamir SM, Hosseini SR, Gooran S. Totally tubeless percutaneous nephrolithotomy. 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5 15. Feng MI, Tamaddon K, Mikhail A, Kaptein JS, Bellman GC. Prospective randomized study of various techniques of percutaneous nephrolithotomy. Urology 2001;58: Desai MR, Kukreja RA, Desai MM, Mhaskar SS, Wani KA, Patel SH, et al. A prospective randomized comparison of type of nephrostomy drainage following percutaneous nephrostolithotomy: Large bore versus small bore versus tubeless. J Urol 2004;172: Agrawal MS, Agrawal M, Gupta A, Bansal S, Yadav A, Goyal J. A randomized comparison of tubeless and standard percutaneous nephrolithotomy. J Endourol 2008;22: Singh I, Kumar A, Kumar P. Ambulatory PCNL (tubeless PCNL under regional anesthesia) -- A preliminary report of 10 cases. Int Urol Nephrol 2005;37:35-7. How to cite this article: Dayapule S, Vaddi S, Bhaskar GV, Pathapati R. Efficacy and Safety of Tubeless Percutaneous Nephrolithotomy versus Standard Percutaneous Nephrolithotomy. IJSS Journal of Surgery 2016;2(4): Source of Support: Nil, Conflict of Interest: None declared. 20