ISRA MEDICAL JOURNAL

Volume 5 Issue 2 Jun 2013

ORIGINAL ARTICLE

URETEROSCOPIC LITHOTRIPSY: A DAY-SURGERY PROCEDURE Abdul Rasheed Shaikh1, Mohamed Ali Sohail Memon2, A Saboor Soomro3, A. Hameed Bozdar4 ABSTRACT OBJECTIVE: To ascertain patient's safety and efficacy of ureterolithotripsy as a day-surgery procedure. STUDY DESIGN: An interventional study. PLACE AND DURATION: At Citi Medical Center Larkana, Ghulam Mohammed Mahar Medical College & Hospital Sukkur Peoples University of Medical & Health Sciences for Women Nawabshah between Dec: 2007 to Dec: 2012. METHODOLOGY: All the patients of either sex having ureteral stone less than 1.5 cm in diameter were selected on the basis of routine clinical examination, laboratory investigation like complete blood count and biochemistry, Ultra-sound and x-rays like intravenous urography (IVU) etc for ureteral lithotripsy. The Semi-rigid Ureteroscopic6.0 Fr with Swiss Lithoclast lithotripter was used. RESULTS: Our study comprises 320 selected patients. Male to female ratio was 1.6:1. Average age of patients was 30.5 year. The mean stone diameter was 1.2 cm. The stones were successfully disintegrated and completely pulverized in 95% (n=304) cases. In remaining 5%(n=16) cases, the procedure was deferred. Among them, ureteric catheter or JJ stent in 3% (n=9) and 2%(n=7) cases respectively had been left. Of them, former cases were due to failure of access to stone and ureteroscope did not negotiate at all and in later cases stone was presented in upper ureter and inadvertently floated up into the kidney (P< 0.05). The operative complications like simple mucosal injury occurred in 11%(n=35) and minor bleeding which did not cloud the field of vision occurred only in 13%(n=42) cases. The Mean operating time was 27(ranged from 22 to 55) minutes. Postoperative complications like urinary tract infection (sepsis) with fever and persisting haematuria had occurs in 5.5%(n=18) cases 9%(n=29) respectfully. The hospital stay was merely a day in all except 15% (n=47) cases who developed post-operative complications (P< 0.05). In 03 week follow-up, residual fragments were noted only in 6%(n=19) cases. These patients were managed conservatively except 2%(n=7) cases that underwent repeat ureteral catheterization for manipulation of fragments which were jammed together. remit CONCLUSION: Although, our study has documented high success rate and low morbidity with merely a day hospital stay but is dependent on many potentially modifiable and process-related factors KEY WORDS: Ureteral stone, Ureteroscope , Swiss Lithoclast INTRODUCTION Urolithiasis is known as the most common urological ailment1. A USA study reports that approximately 12% person of population will have stone disease at some point in their lives2. Primary stones have rarely formed in ureter. They have formed in kidney and trapped during its passage through ureter where they produce more symptoms and complications3. These, ureteral stones account for 20% of urolithiasis, and 70% of them are located in the lower third part of the ureter and are known 4 as distal ureteral stones ． Various modalities of treatment for ureteral stone like conservative, non-invasive extra-corporeal shock wave lithotripsy (ESWL), minimal invasive uretero-renoscopy (URS), laparoscopic and surgical are being practiced. 1 2 3 4

Professor GMC Sukkur Associate Professor Nawab Shah Assistant Professor GMC Sukkur Senior Registrar GMC Sukkur

Correspondence to: Dr. Abdul Saboor soomro Assistant Professor, GMC Sukkur Email: [email protected]

With all the options of treatment, the method of choice should be minimal invasive and successful5. The conservative method of treatment like expectant therapy with non-steroid anti-inflammatory analgesic drugs and hydration or medicalexpulsive therapy (MET) with an alpha 1-adrenoceptor blocker (tamsulosin), has been used for facilitating spontaneous passage of smaller stones (04 to 08 mm diameter in size) has been recommended for certain group of patients under restricted criteria6. The open surgery (ureterolithotomy) or laparoscopic method of treatment are the popular options for very large impacted, and /or multiple ureteral stones. These stones are difficult to manage with URS or ESWL7 alone. Among non-invasive and minimal invasive procedures like ESWL and retrograde ureteroscopy (URS) with lithoclast are the preferred methods7. Undoubtedly, ESWL has become a most valuable asset to the urologist and greatly benefits patients who had renal stones. Its use for ureteral stone is again limited8- 9. The endoscopic management for ureteral calculi with dormia basket is a rather challenging procedure but was popular in old days. From last 03 decades its use with or without fluoroscope had replaced with the advent of ureteroscope5.Over the time, there have been many advances in ureteroscope design has taken place. These are modern up-dated small size caliber ureteroscope with better

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optical visualization and have sufficient working channel10． More over recently, another timely advance in progression of endoscope with development of prototypes flexible ureteroscope has occurred. It lead to allow access to entire upper urinary tract and supposed to be a final version which incorporated >3000 primary active deflection10. Thus, today uretero-renoscopy continues to gain popularity with ever-increasing indication. Its use, both for diagnostic as well as therapeutic purposes are well documented6-10. Nowadays, worldwide trend has started to perform this procedure on an out-patient basis and has been well suggested11－12． In our set-up, Majority of our patients comes either from rural or far-flung areas and they do not have access to advanced medical services. Therefore, the objective of our study was to ascertain patient's safety and efficacy of ureterolithotripsy as a daysurgery procedure. METHODOLOGY This multicentral study was conducted at Citi Medical Center Larkana, Ghulam Mohamed Mahar Medical College & Hospital Sukkur and Peoples University of Medical & Health Sciences for Women Nawabshah between Dec: 2007 to Dec: 2012. All the patients, enrolled from OPD of either sex having ureteral stone radiological diameter less than 1.5 cm in size were selected prior to day of admission. Then, we evaluated and documented factors into 03 components: (1) Patient factors (e.g., patient wellness); It based on complete history, clinical examination and investigation like urine analysis, Urine culture, hemoglobin, complete blood count, bleeding profile and Biochemistry like serum cretinine, Random blood sugar, ultrasound, x-ray chest, ECG and intravenous urography. The patients fulfilling our selection requirement were admitted on the afternoon of the day of procedure. Those patients, who were more than 40 year age or found hypertensive, were further assessed by cardiologist and anesthetist. The patients, who were under 12 years of age, having bleeding disorder or with major comorbidities included ischemic heart disease, un-controlled diabetic mellitus, chronic obstructive airway disease, obvious infection, pregnant women and those becomes unfit by cardiologist and anesthetist were postpone or excluded from the study. (2) Structural and process factors (e.g. Suitability in hospital bed and operating rooms schedule system); (3) evaluated the outcome and patient interviewed to confirmed the emotional and financial impact. The procedure was attempted under spinal or general anesthesia in modified lithotomic position. Preoperative broad spectrum Antibiotics coverage has given in all cases. A semi-rigid ureteroscope 6.0 Fr or 7.5Fr (Karl Storz, Germany) and Swiss pneumonatic lithotripter (Lithoclast) were used. Preliminary check cystoscopy has done to assess the status of the lower urinary tract and

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ureteral orifice. Ureteroscopy has proceeded. Unless difficulty was encountered in inserting the ureteroscope through ureteral orifice then ureteral dilatation was performed with balloon or ureteral catheter (5-7 Fr) dilators. Once ureteroscope was in the ureter, further it passed up to stone carefully using a least amount of irrigation fluid (0.9 Glysine) consistent with good vision to prevent the float up of the stone. For this purpose other precautions include intravenous frusamide infusion of 40mg with 500ml dextrose water and raising the operative table from cranial side was taken. The 0.8mm probe of Lithoclast was passed through working channel of ureteroscope. The treatment procedure was started and stone was pulverized under direct vision till complete fragmentation has achieved. The fragments were left in situ (smash & go).At the end of procedure, ureteral catheter (4Fr) or JJ stent (4.7Fr) was left. The ureteral catheter was tied around the 18 or 16Fr Foley's catheter. These were removed after 18 hours where as JJ stent was kept for 06 week. The majority of patients were discharged on the following day after the procedure. All patients were followed up routinely at weekly interval for 2-3 week. The KUB x-ray was advised to assess the outcome of the procedure. The numerical data has analyzed, using a commercially available SPSS version 11.5. The analysis of variance (ANOVA) test, chi-square test or Fisher test when appropriate was used to determine any statistical significant. RESULTS Our study comprises 320 selected patients. Among them 208(65%) were males and 112(35%) were female (Table - I). Male to female ratio was 1.6:1. Their mean age was 30.5year (ranged from 16 to 58 years). The stone was presented in 195(61%) cases on right and 125(39%) cases on left side. The further distribution of stone location at lower, Middle and upper ureter was 183(57%), 102(32%) and 35(11%) respectively (Figure - I). Mean stone diameter was 1.2 cm Figure - 1: Distribution of stone location

(range 0.6 to1.6 cm). No significant difference was found in size between proximal and distal ureteral stones (P=NS).

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Radiological Grade–1 and Grade-2 hydronephrosis and dilated ureter were presented only in 121(38%) and in 80(25%) cases respectively. In remaining 119(37%) cases, the hydronephrosis and dilated ureter were not presented. The ureteral dilatation with balloon ureteric dilator or with ureteric catheter no: 5 and 6 Fr was needed only in 59(18.5%) cases versus 261(81.5%) cases that did not require so. The stones were successfully disintegrated and completely fragmented in 304(95%) cases (Table - 2). Remaining 16(5%) cases, the procedure was deferred.

Among them, ureteric catheter or JJ stent in 9(3%) and 07(2%) cases respectively had been left. Of them, former cases were due to failure of access to stone and ureteroscope did not negotiate at all and in later cases stone was presented in upper ureter and were easily floated up into the kidney (P< 0.05).The operative complications like simple mucosal injury occurred in 35(11%) and slight bleeding which did not cloud the field of vision occurred in 42(13%) cases. The Mean operating time was 27(ranged from 22 to 55) minutes. Postoperative complications like urinary tract infection (sepsis) with fever and mild persisting haematuria had occurred in 18(5.5%) cases 29(9%) respectfully. The hospital stay was merely a day in all (Pie - I) except 47(15%) cases who developed post-operative complications. These patients stayed in hospital for 03 day (Pie - 1).Mean hospital stay was 1.28 day. Statistically significant difference (P=NS) was not found in regard to hospital stay. In 02 week follow-up, residual fragments were noted only in 19(6%) cases. These patients were managed conservatively except 7(2%) cases that underwent repeat ureteral catheterization for manipulation of fragments which were jammed together. DISCUSSION The advent of new urological armamentarium has made ureteroscopy (URS) a safe, efficacious and more popular procedure6-10 and its application has followed very fast. In this context, we also presented our early experience in

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20075. As a contribution to the growing data for all size of stone with minimal stay at hospital, it is the need of time to evaluate surgical procedures at lesser stay and eventually it reflects on cost of patient and burden on hospital beds. In our series a total of 320 selected ureteroscopies were attempted. The stones were successfully pulverized in 304(95%) cases and in remaining 16(5%) cases, the procedure was deferred. Of them, the failure of access to stone had occurred in 09(3%) cases due to constricted lower ureter and ureteroscope did not negotiate at all means. These cases were simply managed by inserting 04Fr ureteric catheter and were successfully treated by second attempt after 03-05 day. In remaining 07(2%) cases, stone was presented in upper ureter and after partial disintegration incidentally floated up into the kidney even we have applied all traditional measures i-e keeping the proximal part of patient body tilts with head up of operating table at 30 to 45 degree and using intravenous frusamide 40mg infusion. Therefore, only in these cases JJ stent had been left. More or less similar positive results were reported from many wellknown centers all around the globe (Table -II) and had been documented in the international literature 4, 7, 14, 16-17, 19-22． We did not come across with any major operative complications like profuse bleeding or ureteral perforation. It may be because of our up-to-date replacement of 06Fr semirigid ureteroscope and achievement of perfection in skill. There or thereabouts, this sort of favorable outcome was reported from many distinguished centers of the world4-9, 14-22 but is almost similar to Mugiya et al7 in 2006, who also did not stumble upon any complication. Nonetheless, more recent studies published from our country by Adeel etal16, 2011 and Ikramullah etal17, 2011, who were bump into with major operative complications namely ureteral perforation and ureteric wall avulsion in 2% and 1% of their cases respectively. The former complication may be justified on the basis that both scholars were still using 9.5Fr ureteroscope in the era where 6Fr one are easily available. However, for later complication, we could not find any good reason because this is the known complication of dormia basket therapy. Our study also disagree with methodology of former author16 that they have inserted JJ 6Fr stent all even in successful cases. Because this requires another endoscopic procedure for its removal, therefore, we routinely keep ureteral catheter which has tied with Foley's catheter. Moreover, it could be removed effortlessly. In this context, we do agree with later author17 who recommended JJ stent only in difficult and adverse situation. We do also encountered with some anticipated minor and insignificant operative complications like simple mucosal injury and bleeding which did not cloud the field of vision that had occurred only in 35(11%) and 42(13%) cases respectively. These were not creating any difficulty to go through the procedure. The factor responsible was, unexpected striking of lithoclast probe with mucosa of ureter. These minor operative complications in present series are comparable and nearer to other studies 4-9, 14-21. In this context, Knispel et al15 has recommended that the constant direct

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effect on patient emotional satisfaction, as well as on perception of quality of care. Moreover, it confirms the financial impact. More recently, worldwide current trend is to perform the procedure on an out-patient basis has in progressed. Many studies justify its feasibility on the basis that the same day planned and unplanned re-admission rate was reported only as low as in 1.5% and 3.6% cases respectively11-12．These authors concluded that successfully out-patient ureterolithotripsy may be performed only at well established medical institution having backup with developed infrastructure. The complications may be minimized by using flexible ureteroscope and Holmium Laser lithotripter. In our set-up, Majority of our patients comes either from rural or farflung areas and they do not have access to nearby advanced medical services. Hence, we do not perform this procedure on out-patient basis. We also have a belief that, this practice may only be suitable for local resident because of unappropriate infrastructure in our country which supposed to be the key for a successful out-patient service. Although, we recommend it as a primary first-line treatment modality for ureteral calculi but requires fully established equipped medical care centre with experts and trained staff for such a short stay surgery. CONCLUSION

vision must be maintained and no energy is applied until and unless there is contact between stone and probe to avoid the mucosal injury and bleeding during the procedure. The post operative recovery was uneventful in majority of our 273(85%) cases except 47(15%) cases who developed febrile urinary tract infection or persisting but self-remitting haematuria. These were resolved within 72 hours of conservative treatment. The hospital stay was merely a day in all except who developed sepsis and haematuria. The mean hospital stay was 03 day in these patients. In this context, our study contradicts with Ikramullah et al17 2011, who reported 06 day mean hospital stay in their cases that developed complications. It may be reasonable on the basis that their patient went through major operative complications. This study dominated our former study presented in 2007 (Rasheed et al5) consisting with our early experience of ureteroscopy. In that series, we had achieved an 88% success rate with major operative complications. It was due to our initial learning phase and using rather larger diameter 7.5Fr (Karl Storz, Germany) and 8.5 (Wolf, Germany) ureteroscope. Then, we replaced it with new up-to-date 6.0 Fr (Karl Storz, Germany) one. Furthermore improvement in our judgment and surgical skill led to even better results with insignificant operative complications. This has given us courage to deal our cases on day care basis. The initial results are not only very much encouraging and authenticate but also prove the positive

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Although, our study has documented high success and low complication rates with merely a day indoor stay but is consistent with many potentially modifiable and processrelated factors. It has not only positive effect on patient satisfaction but also reflects the cost-effectiveness． REFERENCES 1. Ramello A, Vitale C, Marangella M. Epidemiology of nephrolithiasis. J Nephrol 2000;13:45-50. 2. Rasheed SA, Nisar SA and Saiyal AR. Extra-corporeal Shock Wave Lithotripsy; Early Experience with Chinese Lithotriptor at Larkana. The Prof: 475 Medical J: 08 (01) 2001; 71-75. 3. Naqvi SA. Khalique M, Zafar MN and Rizvi SAH. Treatment of ureteric stones. Comparison of laser and pneumatic lithotripsy. BJU 1994. 74, 694-698 4. Meng-yuan Z, Sen-tai D, jia-ju L, Yan-he L, Hui Z and Qing-hua X. Comparison of tamsulosin with extracorporeal shock wave lithotripsy in treating distal ureteral stones. Chin Med J 2009;122 (7):798-801. 5. Rasheed SA, Qurban A, Fatah A, Iqbal M, Nisar A and Altaf H. Uretero lithotripsy with semi-rigid ureteroscope: An early experience with 100 cases. JSP (int:) 2007;12 (3) 98-101. ６． Bierkens AF, Handrikx AJ, De La, Rossete JJ, Stultiens GN, Beerlage GN, et al. Treatment of mid and lower ureteric calculi: Extracorporeal Shockwave Lithotripsy vs laser ureteroscopy. A comparison of cost, morbidity

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