I Randomised control trail to compare the efficacy of ESWL versus URS for lower third ureteric stones by Sqn Ldr CR Rakesh Dissertation Submitted to the Rajiv Gandhi University Of Health Sciences, Karnataka, Bangalore In partial fulfillment of the requirements for the degree of Master of Surgery in General Surgery Under the guidance of Gp Capt (Dr) B Sivaramakrishna Department of Urology Command Hospital Bangalore 2008-2011 II Rajiv Gandhi University of Health Sciences DECLARATION BY THE CANDIDATE I hereby declare that this dissertation/thesis entitled “Relevance of Extracorporeal Shock Wave Lithotripsy(ESWL) in the era of Ureteroscopy for lower third ureteric stones " is a bonafide and genuine research work carried out by me under the guidance of Gp Capt B Sivaramakrishna Prof. (Sr Adv Surgery and Urology) Command hospital, Bangalore Date : Place: Sqn Ldr CR Rakesh CERTIFICATE BY THE GUIDE This is to certify that the dissertation entitled “Relevance of Extracorporeal Shock Wave Lithotripsy(ESWL) in the era of Ureteroscopy for lower third ureteric stones" is a bonafide research work done by Sqn Ldr CRRakesh in partial fulfillment of the requirement for the degree of Master of Surgery in General Surgery. Date : Place: Gp Capt B Sivaramakrishna Prof (Surgery and Urology) Dept of Surgery Command Hospital (AF) Bangalore III ENDORSEMENT BY THE HOD, PRINCIPAL/HEAD OF THE INSTITUTION This is to certify that the dissertation entitled “Randomised control trail to compare the efficacy of ESWL versus URS for lower third ureteric stones“ is a bonafide research work done by Sqn Ldr CR Rakesh under the guidance of Gp Capt B Sivaramakrishna Brig (Dr) Srinath Consultant Prof and Head Department of Surgery Command Hospital (Air Force) Bangalore Date : Place: A V M (Dr) A K Behl Principal Command Hospital (Air Force) Bangalore Date : Place: IV COPYRIGHT Declaration by the Candidate I hereby declare that the Rajiv Gandhi University of Health Sciences, Karnataka shall have the rights to preserve, use and disseminate this dissertation / thesis in print or electronic format for academic / research purpose. Date : Place: Sqn Ldr(Dr) CR Rakesh V ACKNOWLEDGMENT I am grateful to AVM (Dr) A K Behl, AVSM , VSM , Commandant, Command Hospital (AF), Bangalore for permitting me to carry out this study and for allowing me to utilize the facilities at this hospital. I feel deeply indebted and grateful to my esteemed Teacher, Mentor and Guide, Gp Capt (Dr) B Sivaramakrishna, Prof., Department of Urology for his guidance, support and constant encouragement throughout the period of this study. My sincere thanks and gratitude to Brig. (Dr) Srinath, HOD and senior advisor surgery and urology and all the other teaching staff whose knowledge and experience has guided, molded and infused in me a sense of confidence. I am very much grateful to Gp Capt.(Dr) GS Sethi, for his unstinting support and guidance , without whom this dissertation would not have been completed. I extend my sincere thanks to my postgraduate colleagues for their support and encouragement during the preparation of this dissertation. I also extend my thanks to the Nursing staff and ORAs of the department of Urology, who has helped me in every step of this dissertation. Finally, my special thanks to the patients of this study for their valuable cooperation, support and time despite their inconveniences. Place: Bangalore Date: 2009 Sqn Ldr (Dr) CR Rakesh VI LIST OF ABBREVIATIONS USED (in alphabetical order) Serial No 1. Abbreviation Full form AUA American Urological Association 2. CECT Contrast enhanced Computed Tomography 3 EAU European Association of Urology 4. ESWL Extra corporeal Shock Wave Lithotripsy 5. EHL Electo Hydraulic Lithotripsy 6. Ho:Yag Holmium:Yttrium-Aluminium-Garnet 7 IVP Intra Venous Pyelography 8 IVU Intra Venous Urography 9 KUB Kidney Ureter Bladder 10 Nd:YAG Neodymium:Yttrium-Aluminium-Garnet 11. NSAID Non Steroidal Anti Inflammatory Drug 12. NCCT Non Contrast Computed tomography 13. RCT Randomized Control Trail 14. USG Ultra Sonography 15. URS Ureteroscopy 16. UTI Urinary Tract Infection 17. VUJ Vesico-ureteric junction VII ABSTRACT Background- The aim was to compare the efficacy of ESWL versus URS in the treatment of lower third ureteric stones Methods- The study randomized patients with lower third ureteric stones to two groups, so as to undergo ESWL and URS. Extracorporeal Shock Wave Lithotripsy (ESWL) was performed by a Electro Magnetic Lithotripter under sedation and analgesia and Ureteroscopy (URS) was performed by using Semi rigid 7/8.5 F Richard Wolf Ureteroscope under spinal anesthesia. Follow-up 4 weeks evaluated the incidence of residual stones at the end of the treatment. Result- A total of 60 patients were treated, 30 in each group. At 4 week follow-up the stone clearance in both the groups were high (90% and 93.3% in ESWL and URS respectively), URS having a slightly higher clearance. However the difference was not statistically significant. DJS was done in all cases of URS and and 10 cases in ESWL group. No major complications were observed in both the groups. Conclusion- ESWL is as efficacious as URS in the treatment of lower third ureteric stones without the risks involved with Spinal anesthesia. Key words- Extracorporeal shock wave lithotripsy; Ureteroscopy; Stone clearance VIII TABLE OF CONTENTS 1. Introduction 1-3 2. Objectives 4 3. Review of Literature 5-38 4. Material and Methods 39-43 5. Results 44-46 6. Discussion 47-51 7. Conclusion 8. Bibliography 53-62 9. Annexures 63-66 and summary A- Assessment performa B- Consent form 52 IX LIST OF TABLES Table no Table Pages 1. Symptoms depending on the location of the calculus 7 2. Imaging modalities in the diagnosis of ureteral calculi 13-14 3. Complication rates following URS 23 4. Type of Lithotriptors 28 5. Comparison of Fluroscopy and ultrasonography 30 6. Complications of ESWL for Distal third ureteric stones 36 7. Stone free rates for ESWL and Ureteroscopy 37 8. Comparison and significance 45 9. Complications following procedures 46 X LIST OF FIGURES Sl.No Figures Pages 1 Ureteral stone with tip of probe of lithotripter 67 2 Ureteral stone post fragmentation 67 3 USG KUB - Hydronephrosis Lt Kidney 68 4 X-Ray KUB - Lt Lower third ureteric calculus 68 5 IVU-lower third ureteral calculus with hydoureteronephrosis 68 6 ESWL suite 69 7 Ureteroscope 69 XI 1 1. Introduction “I will not cut, even for the stone, but leave such procedures to the practitioners of the craft” Hippocrates Urinary calculi are the third most common affliction of the urinary tract. Exceeded only by the urinary tract infections and pathological conditions of the Prostate[1] Urinary stones have plagued mankind since ages, earliest recorded example being bladder stones detected in Egyptian mummies dated to 4800 B.C. Urolithiasis was recognized as a major health problem even way back in 12 century BC when Susruta performed perineal lithotomy. The Etiology of the stones however remained obscure. Only in the last two centuries have studies resulted in the identification of composition of urinary stones. Hereditary relationship of urinary stones was shown during the genetic studies performed by Resnik (1968) and McGeown (1960). Familial renal tubular acidosis is associated with nephrolithiasis and nephrocalcinosis in almost 70% of patients [1] . Males are more commonly afflicted than females (Male: female = 3:1). Increased testosterone levels in men causing increased endogenous oxalate production by the liver and protective increased urinary citrate concentrations in women have been postulated as causes for the same [2] .Various studies over time have shown the cause of urinary stones to be multi-factorial. Stones do not usually form in the ureter, but drop down from the pelvi-calyceal system while they are still small. They tend to increase in size as they remain in the 2 urinary passage. Most stones, smaller than 5 mm pass spontaneously [4,5]. However some stones may arrest in the ureter producing complications such as obstruction, colic, infection, haematuria and acute renal failure. Therefore urgent relief is to be given to these patients. The treatment of ureteral stones has undergone a remarkable evolution in the last 15 yrs. At one time open uretero-lithotomy and blind stone basket manipulation were the mainstay of surgical management, they have now been superseded by an array of superior modalities. Among them Ureteroscopy (URS) and Extracorporeal shock wave lithotripsy (ESWL) are the two most favored methods for the treatment of Ureteric stones [6,7] The earlier complications, like false passage, ureteral rupture; following rigid ureteroscopes was a limiting factor in the treatment of these stones. But with the introduction of flexible and smaller ureteroscopes, the complications have reduced considerably, with very high clearance rates, and patient satisfaction. ESWL was earlier preferred for the treatment of upper third Ureteric stones only with limited success in the management of lower third Ureteric stones. But with the modern lithotripters and better imaging, ESWL is being offered for the management of lower third stones too. However the management of lower third ureteral stone continues to evoke much controversy. Proponents of ureteroscopy emphasize that it is a simple, straightforward procedure in most hands, almost always yielding success. ESWL enthusiasts counter that although stone free rates are not as high as with ureteroscopy, ESWL is the less invasive 3 procedure with fewer complications and predictable success. Also the avoidance of anesthesia and admissions could be avoided. Both are accepted as management modalities for lower third ureteral stones. Patients however prefer the noninvasive modality over invasive modality in the treatment of Urolithiasis. Our hospital is a tertiary referral hospital and we are using in-house lithotriptors and ureteroscopes for the treatment of ureteric calculi. This is study that is therefore directed to assess the efficacy and safety of Ureteroscopy (URS) versus Extracorporeal shock wave lithotripsy (ESWL) in the management of lower third ureteric stones 4 2. Objectives Objectives of this study are 1. To compare and assess the safety and efficacy of Extracorporeal shock wave lithotripsy (ESWL) vis a vis ureteroscopy (URS) in the management of lower third ureteric stones. 2. Secondary objective – To look for complications, if any, which are specific to ESWL or ureteroscopy. 5 3. Review of Literature Urolithiasis has confronted clinicians since early days and lithotomy was one of the most dreaded surgeries with high mortality, which has resulted in the famous quote of Hippocrates. However over time, improved knowledge has changed the understanding and management of stones. Technological advancements have resulted in a changing trend from invasive treatment modalities like ureterolithotomy to lesser invasive management like ureteroscopy (URS) and Extracorporeal shock wave lithotripsy (ESWL). With such advancements, there has been a significant reduction in associated complications resulting in improved patient compliance, morbidity and mortality. EPIDEMIOLOGY Prevalence of urinary stone disease is estimated to be 2%-3% of general population, and the likelihood of a white man to develop stone disease by the age of 70 yrs is about 1 in 8. The recurrence rate without treatment for calcium oxalate stones is about 10% at one yr, 35% at 5 yrs and 50% at 10 yrs [10]. The peak incidence of urinary calculi occurs between the second decade to the fifth decade of life [11, 12]. The disease is three times more common in males than in females. Whites are affected more often than persons of Asian or African origin. It is also more frequent in the hot, arid areas than in the temperate regions. Two factors are involved in the relationship between water intake and Urolithiasis. One is the volume of water ingested and second is the mineral content of 6 water. Excessive water hardness, like calcium carbonate contributes to stone disease. Presence of certain trace elements in water has been implicated in the formation of urinary calculi. For example Zinc is an inhibitor of calcium crystallization and low zinc levels therefore increase tendency towards stone formation [13] DIET AND OCCUPATION Urinary stones are found to be more common in individuals who have sedentary occupations (professional and managerial groups). This was attributed to the increased consumption of meat which leads to increased urinary concentrations of calcium, oxalates and uric acid. However Curhan and associates examined the association between intake of calcium and other nutrients. It was observed that prevalence of stone disease was lowest in patients on high calcium diet [14]. However it is difficult to assess whether occupation is a primary factor of stone disease or it merely establishes other aspect of environment such as diet, heat exposure and water consumption. PRESENTATION AND DIFFERENTIAL DIAGNOSIS Urolithiasis should always be considered in the differential diagnosis of acute abdomen. Careful history taking and examination could reveal the possible location of the stone (Table I) However calculi of various sizes may be encountered in asymptomatic patients, found incidentally on imaging studies or during evaluation of microhematuria. Larger stones may be asymptomatic and smaller stones may be more symptomatic Differential diagnoses to be kept in mind are as follows 7 1. Urological lesions such as congenital pelvi-ureteric junction obstruction, renal or ureteral tumors and other causes of ureteral obstruction. 2. General causes of abdominal pain, such as appendicitis, cholecystitis, diverticulitis, colitis, constipation, hernias or even arterial aneurysms. 3. In women, gynecologic processes that must be considered include ovarian torsion, ovarian cyst and ectopic pregnancy. 4. In men, symptoms of testicular pathology like epididymitis or prostatitis. Table I: Symptoms depending on the location of the calculus Stone location Common symptoms Kidney Vague flank pain, haematuria Proximal ureter Flank pain radiating to upper abdominal/epigastrium Mid ureter Flank pain radiating to the groin Distal ureter Dysuria, urinary frequency, flank pain radiating to the testicle/labia VU Junction Increased frequency, Dysuria, Pain radiating to the tip of penis 8 CONFIRMATION OF THE DIAGNOSIS The diagnosis of urinary tract calculi begins with a focused history. Key elements include past or family history of calculi, duration and evolution of symptoms and signs of sepsis. Physical examination is most valuable to rule out non urological causes. Urine analysis should be performed in all cases of suspected urinary calculi. Aside from the typical microhematuria, important findings to note are the urine pH and the presence of crystals, which help in identification of the stone composition [15]. However this may not be feasible in all centers due to paucity of resources. Patients with uric acid stones usually present with acidic urine and those with stone formation resulting from infection have alkaline urine. Identification of bacteria is important in planning therapy, and urine culture should be routinely performed [15]. Limited pyuria is a fairly common response to irritation caused by a stone and in the absence of bactiuria, is not generally indicative of coexistent urinary tract infection. However in the presence of urosepsis secondary to Ureteric obstruction due to stone, one should not wait for control of the urinary infection and the patient may be taken up for urgent intervention to relieve the obstruction and possible definite treatment. IMAGING MODALITIES Because of the various presentations of renal/Ureteric colic and its broad differential diagnosis, an organized diagnostic imaging is essential to confirm or exclude the presence of urinary calculi. A diagnosis of renal colic cannot be based on the clinical findings alone. 9 Historically X-Ray KUB was the initial imaging modality for the diagnosis and follow up of ureteric stones. However over the past few decades better imaging methods have evolved, resulting in better sensitivity and specificity. However X-Ray KUB still holds an important place in the diagnosis of ureteric stones. Few important imaging methods are PLAIN FILM RADIOGRAPHY Plain film radiography of the kidney, ureter and bladder (KUB) may be sufficient to document the size and location of the radio opaque ureteral calculus. Stones that contain calcium, such as calcium oxalate and calcium phosphate stones are easiest to be detected by radiography. Less radio opaque stones, such as pure uric acid stones and stones composed mainly of cystine or magnesium ammonium phosphate, may be difficult if not impossible, to detect on plain radiographs. Unfortunately, even radio opaque calculi are frequently obscured by stool or bowel gas, and ureteral stone overlying the bony pelvis or transverse processes of vertebrae are particularly difficult to identify. This necessitates a proper bowel preparation prior to the radiograph. Furthermore, non urologic radio opacities, such as calcified mesenteric lymph node, gallstones, stool and phlebolith may be misinterpreted as stones. Although 90% of urinary calculi have historically been considered to be radio opaque, the sensitivity and specificity of KUB radiographs alone remain poor.(Sensitivity: 45-59%; Specificity: 71-77%) 10 KUB radiograph are useful in the initial evaluation of patients with known stone disease and in following the course with known radio opaque stones ABDOMINAL ULTRASONOGRAPHY Abdominal ultrasonography has limited use in the diagnosis and management of Urolithiasis. Although ultrasonography is readily available, quickly performed and sensitive to renal calculi (95%), it is virtually blind to ureteral stones (sensitivity: 19%), which are far more symptomatic than renal calculi. However if a ureteral stone is visualized by ultrasound, the finding is reliable (specificity: 97%). In one study up to one fourth of the patients with normal ultrasound studies were detected to have ureteric stones on urography while being evaluated for Ureteric colic [16] The ultra sound examination is highly sensitive to hydronephrosis, which may be a manifestation of ureteral obstruction, but it is frequently limited in defining the level or nature of obstruction. It is also useful in assessing renal parenchymal pathology, which may mimic renal colic. It has the added advantage of assessing the abdominal cavity for other pathology in the absence of an obvious renal/ureteral pathology as a cause of the symptoms. It has become the first-line imaging study to search for calculi during pregnancy [17]. Transvaginal ultrasonography may be performed next in those in whom transabdominal ultrasonography is initially non-informative [18] 11 INTRAVENOUS PYELOGRAPHY Intravenous Pyelography has been considered the standard imaging modality for urinary tract calculi. The intravenous pyelogram provides useful information about the stone (size, location and radio density) and its environment (calyceal anatomy, degree of obstruction), as well as the contra lateral renal unit (function, anomalies). Intravenous Pyelography is widely available, and its interpretation is well established. With this imaging modality, ureteral calculi can be easily distinguished from non urological opacities. The accuracy of Intravenous Pyelography can be maximized by proper bowel preparation, and the adverse renal effects of the contrast media can be minimized by ensuring that the patient is well hydrated. Unfortunately these preparatory steps take time and cannot be accomplished in an emergent situation. Compared with abdominal ultrasonography and KUB radiography, intravenous Pyelography has greater sensitivity (64-87%) and specificity (92-94%) for the detection of renal/ ureteral calculi. However the intravenous pyelogram can be confusing in the presence of non obstructing radiolucent stones, which may not demonstrate the level; of obstruction because of inadequate concentration of contrast material. The contrast media used in intravenous pyelogram carry the potential for adverse effects. Foremost is their well documented nephrotoxic effect. Serum Creatinine level must be measured before contrast media are administered. Although a Creatinine level greater than 1.5 mg/dl is not an absolute contraindication, the risks and benefits of using contrast media must be weighed carefully, particularly in patients with diabetes mellitus, cardiovascular diseases or multiple myeloma. 12 NONCONTRAST HELICAL CT (NCCT) NCCT is being increasingly used in the initial assessment of renal colic. This imaging is fast and accurate, and it readily identifies all stone types and locations. Its sensitivity (95-100%) and specificity (94-96 %) suggest that it may be definitely exclude stones in patient with abdominal pain. Associated signs, such as renal enlargement, perinephric or periureteral inflammation or ‘stranding” and distention of the collecting system or ureter; are sensitive indicators of the degree of ureteral obstruction. Hounsfield density of calculi may be used to distinguish cystine and uric acid stones from calcium bearing stones and is capable of further sub typing the calcium oxalate monohydrate and calcium oxalate into calcium phosphate and calcium oxalate monohydrate and calcium oxalate dehydrate stones. NCCT is also useful in diagnosing non urological causes of abdominal pain, such as abdominal aneurysm, cholelithiasis and appendicitis. The estimated sizes of renal calculi determined using this modality varies slightly from those obtained with KUB radiography. NCCT is generally more expensive than intravenous Pyelography, but the increased cost is certainly balanced by more definitive, faster diagnosis. Cost obviously varies from institution to institution and by accounting methods. CONTRAST ENHANCED CT (CECT) Intravenous contrast media are very helpful in visualization of the ureter. Precontrast images and a series of post contrast images are taken to evaluate all phases of 13 enhancement. Delayed views are useful to generate a CT Urogram. CT Urography can be used for enhanced reconstructed view of the ureter. CT urogram has a similar gross appearance from that of IVU. In addition, the reconstructions combined with the routine cross-sectional images are an alternative to IVU and ultrasound in evaluation of haematuria [9] The various imaging modalities have been summmarised in table II TABLE 2- Imaging modalities in the diagnosis of ureteral calculi Imaging Sensitivity Specificit modality (%) y (%) Plain 45-59 71-77 radiography Advantages Limitations Accessible and Radiolucent calculi, inexpensive extra urinary calcifications and nongenitourinary conditions. Bowel preparation required Ultra-sono graphy 19 97 Non invasive, no Poor visualization of ionizing radiation. ureteral stones Good for diagnosis of hydro-nephrosis. If no stone found aid in differential diagnosis 14 Intravenous 64-87 92-94 Pyelography Information on Variable-quality anatomy and function imaging. Bowel of kidney. preparation required. Both translucent and Poor visualization of radio-opaque stones non genitourinary can be identified conditions. Delayed images required in high grade obstruction Non contrast 95-100 94-96 More sensitive and Availability helical specific. Indirect Cost computed signs of obstruction. No direct measure of tomography Information on renal function (NCCT) genitourinary pathology Contrast 95-100 96-98 Same as NCCT. Availability and cost. enhanced Indirect measure of Limited role in computed renal function impaired renal tomography function states, (CECT) diabetics and patients with contrast allergy MANAGEMENT The management of patients with Urolithiasis has shown a changing trend over time from open surgery to relative non invasive management. Brief history of evolution of urolithiasis are enumerated below • Earliest documented urological surgery – Perineal lithotomy done in 4 century B.C. by Susrutha. 15 • Simon in 1871 performed nephrectomy for stone disease. • In 1968 Vernon Smith and Boyce performed anatropic nephrolithotomy. • In 1976 Fernstorm and Johanson describes planned percutaneous nephrolithotomy. • In1980, Chaussy first used ESWL for the treatment of patient with renal stones, PerezCastro examined the renal pelvis through ureteroscope. • Ureteroscopic manipulation was reported by Das in the 1981. • ESWL came as a mainstay treatment for urinary stones following FDA approval in 1984 EMERGENCY MANAGEMENT IN URETERIC CALCULUS The first step is to identify patients who require emergency urologic consultation. For example, sepsis in conjunction with an obstructing stone represents a true emergency. Other emergency conditions are anuria and acute renal failure secondary to bilateral obstruction or unilateral obstruction in a patient with a single functioning kidney. Hospital admission may be required in patients who are unable to maintain oral intake because of refractory nausea/vomiting, debilitated medical status or extremes of age, or for patients with severe pain that does not respond to outpatient narcotic therapy. Placement of A stent may be useful temporizing measure in patients with refractory symptoms. For all other patients’ ambulatory management of renal calculi should be adequate. The cornerstones of ambulatory management are adequate analgesia, timely 16 urological consultation and follow up. Antibiotic may be necessary in cases of suspected urinary tract infection. ANALGESIA Pain relief is usually the therapeutic step that needs to be taken most urgently in patients with an acute stone episode Diclofenac, Ibuprofen and Indometacin are the preferred first line drugs for pain relief. Clinical trials have shown that NSAIDs, (e.g. Diclofenac) provide effective relief in patients who have acute stone colic [19-23]. Moreover, the resistant index was reduced in patients with renal colic when NSAID treatment was given [24]. Alternative drugs are used if the pain persists. Hydromorphone and other opiates are associated with an increased risk of vomiting, and should not be given without simultaneous administration of atropine. TREATMENT MODALITIES FOR TREATMENT OF URETERIC CALCULUS 1. Watchful expectancy 2. Medical expulsive therapy 3. Ureteroscopy 4. ESWL 5. Percutaneous antegrade ureteroscopy 17 6. Laparoscopic stone removal, and 7. Open ureterolithotomy 1. Watchful expectancy Most ureteral stones can be observed with a reasonable expectation of uneventful stone passage and this strategy is generally less costly and less invasive than any other option, if successful[25]. Ureteral stones with a diameter less than 5 mm will pass in up to 68% of cases; however, for stones with a greater diameter the overall chances of spontaneous passage are lower [26]. 2. Medical Expulsive therapy Medical expulsive therapy (MET) has recently emerged as an appealing option for the initial management of ureteral stones [27]. Several pharmacological approaches have been proposed in recent years aiming to act on possible causes of stone retention [30]. Both α-antagonists and calcium channel blockers have been shown to inhibit the contraction of ureteral muscle responsible for ureteral spasms while allowing ante grade stone progression [28, 29]. The addition of α-antagonists to routine analgesia has been proposed to facilitate stone passage by inhibiting basal tone, peristaltic frequency and ureteral contractions through their action on the α-1 adrenergic receptors in ureteral smooth muscle [31] . Meta 18 analysis from 16 clinical trials including 1235 patients with distal ureteral stones between 3 and 18 mm suggest a benefit in stone expulsion [32]. The most commonly used agent was Tamsulosin 0.4 mg taken daily for one month. However other agents which have been used are Terazosin, Doxazosin and Alfuzocin, with similar efficacy. Therefore the benefit is probably a class effect rather than an effect specific to Tamsulosin [33]. Metaanalysis of alpha blockers versus control showed an absolute increase of 29% in the stone-passage rate [34] Calcium channel blockers (Nifedepine) acts as a suppressing mechanism of the fast component of ureteral contraction leaving the peristaltic rhythm unchanged. However meta-analysis of the available RCTs showed an absolute increase of 9% in stone-passage rates, which was not statistically significant [34] 3. Percutaneous Antegrade Ureteroscopy Percutaneous ante grade ureteroscopy is an acceptable first-line treatment in select cases. Instead of a retrograde endoscopic approach to the ureteral stone, percutaneous ante grade access can be substituted [35]. This treatment option is indicated: 1. In select cases with large impacted stones in the upper ureter 2. In combination with renal stone removal 3. In cases of ureteral stones after urinary diversion [36] 4. In select cases resulting from failure of retrograde ureteral access to large, impacted upper ureteral stones [37]. Indications for Removal of Stone 19 The size, site and shape of the stone at the initial presentation influence the decision for operative intervention. The likelihood of spontaneous passage must also be evaluated. Spontaneous stone passage can be expected in up to 80% in patients with stones ≤ 4 mm in diameter. For stones with increasing diameters, the chance for spontaneous passage is decreased [38-41]. However if the stone does not pass and though asymptomatic, will eventually cause clinical problems [42]. Indications for considering active stone removal 1. Stone diameter >7 mm (because of the chance of spontaneous passage is very low) 2. Adequate pain relief cannot be achieved 3. Stone obstruction is associated with infection* 4. Risk of pyonephrosis or urosepsis* 5. Single kidneys with obstruction* 6. Bilateral obstruction* * Diversion of urine with a percutaneous nephrostomy catheter or bypassing the stone with a stent are minimal requirements in these patients The majority small stones pass spontaneously within four to six weeks. This was demonstrated by Miller and Kane[25], who reported that of stones < 2 mm, 2 to 4 mm and 4 to 6 mm in size, 95% of those which passed did so by 31, 40, and 39 days, respectively. In a choice between active stone removal and conservative treatment, it is important to take into account all individual circumstances that may affect treatment decisions 4. Ureteroscopy 20 Ureteroscopy is defined as urinary tract endoscopy performed most commonly with an endoscope passed through the uretra, bladder and then directly into the upper urinary tract. During the past 20 years, ureteroscopy (URS) has dramatically changed the management of ureteral calculi and is now used extensively in urology centers worldwide The progression from cystoscope to upper urinary tract endoscope was natural with pediatric cystoscopes being employed as the first rigid rod lens ureteroscopes. Relatively large rod lens endoscopes (12F) combined with ultrasonic and electro-hydrolic lithotripsy probes became the first commonly accepted ureteroscopic equipment combination used to treat distal ureteral calculi. Rigid ureteroscopes progressed from rod lens imaging to fiber optic imaging with outer dimension miniaturization. Where the narrow and delicate distal ureter once required vigorous balloon dilatation for ureteroscopic access, the fiber optic based rigid endoscopes were small enough by 1989 (averaging 7 F in diameter). Flexible ureteroscopes was an attractive alternate to rigid ureteroscopes in that the more proximal ureter and intra renal collecting system was theoretically more easily accessible. The application of flexible ureteroscopy was first reported by Marshal in 1964[43] A 9 F fiberoscope manufactured by American cystoscope makers (Pelham Manor, NY) was passed into the ureter to visualize impacted ureteral calculus. These first flexible ureteroscopes did not have a working channel thus permitting only the most primitive diagnostic maneuvers. 21 Presently Rigid and flexible ureteroscopes are available. In most cases, miniaturization (and regular pre-stenting of the ureter) avoid the need to dilate the intramural ureter and associated complications [4, 43]. The small tip diameters (5.0-7.5 F) allow easier and safer progression of rigid ureteroscopes up to the proximal ureter. Flexible ureteroscopes (5-7.5 F) are used mainly to access to the upper part of the ureter and renal collecting system, without dilatation of the intramural ureter in most cases [42, 45]. The addition of laser energy applied through optical quartz fibers passed through the working channel of the endoscope has helped in the management of Urolithiasis. Ureteroscopic removal of small ureteral stones with a basket or forceps is a relatively quick procedure with a lower morbidity rate than that associated with lithotripsy [48,49] . Several new endoscopic stone retrieval baskets are available. The use of thin ureteroscopes has resulted in reduced dilatation (0-40%), operating time and post-operative ureteral stenting. Ureteral access sheaths are used widely to facilitate retrograde manipulation in the proximal ureter and the kidney. URS is, however, a more invasive technique than ESWL, and the treatment of choice for ureteral stones is therefore controversial ANTIBIOTIC PROPHYLAXIS Before URS, antibiotic prophylaxis should be administered to ensure sterile urine[34] STENTING 22 Stent placement at the end of the procedure is optional and debatable [50]. Most urologists leave the stent for variable periods from 1-6 weeks, although there is no evidence regarding the optimal interval. Patients should be followed up by plain abdominal film (IVU), CT or USG KUB. Studies have shown that stenting can reduce post procedure pain and subsequent obstruction due to residual stones and its complications. Indications for stenting after the completion of URS include: • Ureteral injury • Stricture • Solitary kidney • Renal insufficiency • Large residual stone burden. However, complications associated with ureteral stenting, include: • Stent migration • Urinary tract infection • Breakage • Encrustation • Obstruction. COMPLICATIONS A meta-analysis published by the EAU-AUA Guidelines panel has evaluated the most relevant complications of sepsis, steinstrasse, stricture, ureteral injury and urinary tract infection (UTI). URS for ureteral calculi had minimal side-effects 9[54-55]. Serious complications, including death and loss of kidney, were rare, and data from which to 23 estimate their rates of occurrence were not available. Complication rates for the overall population by treatment and size, for distal third stones are shown in Table 3[34] Significant acute complication rates 9% have been reported for the distal ureter [54, 55]. Ureteral strictures were the only long-term complication (estimated rate 1%). There is a pronounced relationship between the complication rate, equipment used, and / or expertise of the urologist[56]. The overall complication rates reported in the recent literature are 5–9%, with a 1% rate of significant complications [56-62]. The major acute complication remains ureteral avulsion [58-64]; autologous transplantation or ureteroileoplasty are the methods of choice in these cases. Ureteral perforation at the site of the stone is the primary risk factor for stricture. Most perforations seen during the procedure are successfully treated with approximately 2 weeks of stenting [56, 59, and 61]. Table 3: Complication rates following URS URS(95% CI) Sepsis 2% /(1 - 4)% Steinstrasse - Stricture 1%(1 - 2)% Ureteral Injury 3%(3 - 4)% UTI 4% (2 - 7)% URS can be carried out safely in patients for whom stopping anticoagulants is unsafe [64]. In addition, the success of URS is not affected by patient habitus. Morbidly obese patients can be treated with success rates and complication rates similar to those in the general population [65, 66] and has been used safely during pregnancy 67-68]. 24 However, URS should be limited to carefully selected patients. Finally, in selected cases, URS can be used safely to treat bilateral ureteral stones simultaneously [69, 70]. DEVICES FOR ENDOSCOPIC DISINTEGRATION OF STONES Ballistic Lithotripsy Ballistic lithotripsy involves a device in which alternating compression caused by air or electromechanical forces is transmitted to a metal rod. Pulses drive a metallic bullet that bumps the end of the rod against the stone. Rods are 2.4-6 F in diameter and can be used through a semi-rigid ureteroscope and all rigid endoscopes. A similar effect is obtained by alternating mechanical displacement. Ultrasonic Lithotripsy These commercially available units consist of a power generator, an US transducer and a probe, forming the sonotrode. A piezo-ceramic element in the handle of the sonotrode is stimulated to resonate, and this converts electrical energy into US waves (at a frequency of 23,000- 27,000 Hz). The US waves are transmitted along the hollow metal probe to create a vibrating action at its tip. When the vibrating tip is brought into contact with the surface of a stone, the calculus can be disintegrated. The probes, which are available in sizes 10 F and 12 F, are passed through the straight working channel of a rigid ureteroscope or nephroscope. Suction tubing can be connected to the end of the sonotrode. 25 Electrohydraulic Lithotripsy The electrohydraulic lithotripsy (EHL) unit has a probe, a power generator and a foot pedal. The probe consists of a central metal core and two layers of insulation with another metal layer between them. Probes are flexible and available in many sizes. The electrical discharge is transmitted to the probe where it generates a spark at the tip. The intense heat produced in the immediate area surrounding the tip results in a cavitation bubble, which produces a shock wave that radiates spherically in all directions. EHL will effectively fragment all kinds of urinary stones, including very hard stones composed of cystine, uric acid and calcium oxalate monohydrate. Recently, a 1.6 F EHL probe was developed. It has been quite successful in fragmenting ureteral and intrarenal stones. It has superior flexibility compared to the laser fibre. Laser Lithotripsy Today, Neodymium:Yttrium-Aluminium-Garnet (Nd:YAG) or Holmium :YAG (Ho:YAG) lasers are used as sources for laser lithotripsy units. The reported results indicate that the Ho: YAG efficacy is superior to the Nd: YAG and does effectively fragment all types of urinary stones, wherever they are located and whatever their composition, including cystine stones. The Ho: YAG system produces light of 2100 nm, with a tissue penetration of less than 0.5 mm and complete absorption in water. The Nd: YAG is used frequency-doubled and produces light of 1064 nm, with a tissue penetration of 4 mm. Fibers for ureteroscopy are available for both lasers at 200 and 365 µm in diameter. 26 In combination with the actively deflectable, flexible ureteroscope, the Ho:YAG laser has proven to be ideally suited for fragmenting stones in the upper ureter. Potential complications of the Ho:YAG laser when used to fragment ureteral stones include possible perforation of the ureteral wall and consecutive formation of stricture. EXTRACORPOREAL SHOCK WAVE LITHOTRIPSY (ESWL) Lithotripsy is the use of high-energy shock waves to fragment and disintegrate ureteral stones. The shock wave, created by using a high-voltage -spark or an electromagnetic impulse, is focused on the stone. This shock wave shatters the stone and this allows the fragments to pass through the urinary system. Since the shock wave is generated outside the body, the procedure is termed extracorporeal shock wave lithotripsy, or ESWL. Initial use of SWL was described by Chausey in 1982. Since then there has been a tremendous progress in the development of newer and better lithotripters. Each lithotriptor requires the coordination of several different functions for effective operation. Shock wave generation, focusing, coupling and stone localization are coordinated by a computer Evolution of Shockwave Lithotriptors The Dornier HM3, originally designed to test supersonic aircraft parts, was the first shockwave lithotripter introduced in the United States. Despite being somewhat dated, it is still one of the most effective lithotriptors and has become the standard to which other devices are compared. The design of the HM3 is based on an electro 27 hydraulic shockwave generator; the shockwaves are focused via an ellipsoid metal waterfilled tub in which both the patient and the generator are submerged. Biplanar fluoroscopy is used for localization, allowing placement of the calculi to be fragmented in the target zone. Second-generation lithotripters typically use piezoelectric or electromagnetic generators as the energy source. When coupled with the appropriate focusing device, these shockwave generators commonly have a smaller focal zone. Although a smaller focal zone may minimize damage to the surrounding tissue, this comes at a price. During respiratory excursion, the stone may move in and out of the focal zone; this may compromise fragmentation rates. The coupling device in a secondgeneration lithotriptor is silicone-encased water cushion that co-apts to the patient, a design that greatly simplifies the positioning of patients. The newest-generation lithotriptors have been designed to offer greater portability and adaptability. These systems often provide imaging with both fluoroscopy and ultrasonography. The ability to alternate between imaging modalities allows the urologist to compensate for the deficiencies of either system. In our hospital we are using the Compact Sigma lithotripter. The Compact Sigma is a modular lithotripter combining Extracorporeal Shock Wave Lithotripsy (ESWL) with a multi-functional patient table and X-ray C-arm. C-arm interface to the Compact Sigma is secured through mechanical coupling and laser guided alignment. The flexible therapy head introduces shock waves from different orientations allowing all treatments to be 28 conducted with patients positioned comfortably on their back, a unique feature of this lithotripter The isocentric design allows both the shock wave and the imaging system to revolve around a single point. This ensures precise alignment of the targeting system and the shockwave focus at all times. Most current lithotriptors are powered by an electromagnetic generator. Electromagnetic generators and their focusing units are capable of delivering shockwaves that are similar in intensity to those of the HM3, but usually to a smaller focal zone. The advantage is of minimizing damage to surrounding soft tissue. However, because of the smaller focal zone, respiration may cause the stone to move out of the target zone and the shockwaves applied while the stones are out of the target zone do not cause fragmentation. Thus, certain second- and third-generation machines are associated with higher failure rates, incomplete treatment, and the need for retreatment Lithotripters are classified by the type of shock wave generation they employ. Their advantages and disadvantages are as shown in Table 4 Table 4: Type of Lithotriptors Shock Wave generator Advantages Disadvantages Spark gap electrode Wide range of energy Short life span(2000-4000 Flexible aperture shock waves) Long lifespan Limited energy range Piezo electric 29 Variable shock wave Large aperture frequency Electromagnetic Wide range and continuous Metallic membrane must be graduation of energy periodically replaced Long life span COUPLING MECHANISMS In the propagation and transmission of a wave, energy is lost at interfaces with differing densities. As such, a coupling system is needed to minimize the dissipation of energy of a shockwave as it traverses the skin surface. The usual medium used is water, as this has a density similar to that of soft tissue and is readily available. In first-generation lithotriptors (Dornier HM3), the patient was placed in a water bath. However, with second- and third-generation lithotriptors, small water-filled drums or cushions with a silicone membrane are used instead of large water baths to provide air-free contact with the patient's skin. This innovation facilitates the treatment of calculi in the kidney or the ureter, often with less anesthesia than that required with the first-generation devices. IMAGING SYSTEMS Both radiography and ultrasonography are use for the localization of the ureteral calculus Radiography 30 Majority of lithotripters use real time fluoroscopy for imaging. Early lithotripters used two fluoroscopes arrayed at oblique angles to the patient and 90 degrees from each other to localize the stone. Later models use antro- posterior and cranio-caudal fluoroscopes to limit interference from the spine. Ultrasonography Its use in lithotripters was triggered by the development of multifunctional lithotriptors for the treatment of both urinary and biliary calculi (Rassweiler et al 1990). Because of the translucency of biliary stones the ultrasound imaging was preferred. Comparison of fluoroscopy via a vis ultrasound is as per table 5 TABLE 5: Comparison of Fluroscopy and ultrasonography Modality Fluroscopy Advantage Familiarity to urologist Disadvantage Inability to visualize Radio opaque stones visible radiolucent stones without throughout the urinary tract contrast Radiographic contrast Radiation exposure material may be used to aid Higher maintenance costs visualization Ultrasound Continuous real time Steeper learning curve monitoring of treatment Inability to visualize most Visualization of radiolucent ureteral stones stones Lower maintenance costs MECHANISM OF STONE FRAGMENTATION 31 Fragmentation occurs when the tensile strength of a calculus is overcome by opposing forces created by shock waves (Frosman-1977) Shock wave may accomplish stone fragmentation by five mechanisms1. Compressive fracture 2. Spallation 3. Acoustic cavitation 4. Dynamic fatigue 1. Compressive fracture - As shock wave strikes the anterior aspect of stones it creates two forces. One component is reflected backward toward the shock wave-Tensile component. The second component referred to as the compressive component proceeds forward through the stone. These opposing forces create a pressure gradient and cause fragmentation and erosion 2. Spalling - As the compressive component strikes the posterior stone surface, similar phenomenon occurs. Newly generated opposing force act on the posterior surface, resulting in the separation of a spherical cap from the posterior surface. (Chuong-1992) 3. Acoustic Cavitation is an acoustic phenomenon in which the pressure changes cause the rapid expansion of gaseous bubble in a liquid medium These bubbles are extremely unstable and collapse explosively when struck by ensuing shock waves. This leaf to the 32 formation of micro jets which strike the stone surface at high velocities causing erosions and microscopic fractures (crum-1988 and delius-1988). This induces small fissure and a forceful blow similar to a shock wave can the fracture the stone cleanly 4. Dynamic fatigue - Shear stress will be generated by shear waves (also termed transverse waves) that develop as the shockwave passes into the stone. The shear waves propagate through the stone and will result in regions of high shear stress inside the stone. Shear wave results in translation of molecules transverse to the direction of propagation, and therefore the molecules are not compressed but are shifted sideways by the wave. Many materials are weak in shear, particularly if they consist of layers, as the bonding strength of the matrix between layers often has a low ultimate shear stress. Calcium oxalate stones commonly possess alternating layers of mineral and matrix, and the shear stress induced by the transverse wave could cause such stones to fail. Studies have shown that shear wave mechanism will lead to a tensile strain in cylindrical stones that is 5 to 10 times larger than that induced by spall [71]. They also suggest that cracks will be initiated in the center of the stone and grow in a direction perpendicular to the axis of the stone. CONTRAINDICATIONS Absolute contraindications to extracorporeal shockwave lithotripsy (ESWL) include the following: • Acute urinary tract infection or urosepsis • Uncorrected bleeding disorders or coagulopathies • Pregnancy 33 • Uncorrected obstruction distal to the stone Relative contraindications include the following: • Body habitus: Morbid obesity and orthopedic or spinal deformities prevent proper positioning. • Renal ectopy or malformations (eg, horseshoe kidneys and pelvic kidneys) • Complex intrarenal drainage (eg, infundibular stenosis) • Poorly controlled hypertension (due to increased bleeding risk) • Gastrointestinal disorders: In rare cases, may be exacerbated after ESWL • Renal insufficiency: Stone-free rates in patients with renal insufficiency (57%) (Serum creatinine level of 2–2.9 mg/dL) were significantly lower than in patients with better renal function (66%) (Serum creatinine level <2 mg/dL). Preexisting pulmonary and cardiac problems are not contraindications, provided they are appropriately addressed both preoperatively and intra operatively. In patients with a history of cardiac arrhythmias, the shockwave can be linked to electrocardiography (ECG), thus firing only on the R wave in the cardiac cycle (ie, gated lithotripsy). Cardiac pacemakers are also not contraindicated. Patients with implanted cardioverter defibrillators must be managed with special care, as some devices need to be deactivated during ESWL; however, this might not be necessary with the use of newgeneration lithotripters [72]. Oral anticoagulants (Clopidogrel and Warfarin ) and Asprin containing product should be discontinued to allow normalization of clotting parameters and platelet 34 function. ESWL is feasible and safe after correction of the underlying coagulopathy [7375] STENTING Routine stenting is not recommended as part of ESWL[76]. Earlier it was a common practice to place a ureteral stent for more efficient fragmentation of ureteral stones when using ESWL. However, the data analyzed showed no improved fragmentation with stenting[76]. Studies assessing the efficacy of SWL treatment with or without internal stent placement have consistently noted frequent symptoms related to stents [77-80]. ESWL remains the primary treatment for most uncomplicated upper urinary tract calculi. The meta-analysis published by the AUA Nephrolithiasis Guideline Panel in 1997 documented that the stone-free rate for ESWL for distal ureter, with a stone-free rate of 85% (66 studies, 9,422 patients) necessitating 1.29 primary and secondary procedures per patient. There was no significant difference between various ESWL techniques (SWL with pushback, SWL with stent or catheter bypass, or SWL in situ). However current meta-analysis (2007-08) conducted by the same panel analyzed SWL stone-free results for three locations in the ureter (proximal, mid, distal). The SWL stone-free results are 74% in the distal ureter (50 studies). These indicate a statistically 35 significant worsening of results in the distal ureter from the earlier results. No change is shown for the proximal ureter. The cause of this difference was not clear. Preoperative Details Several factors related to the stone, including stone burden (size and number), composition, and location, affect the outcome of extracorporeal shockwave lithotripsy (ESWL). Stone size As stone size approaches 2 cm, the likelihood of success with ESWL decreases, and the need for retreatment and adjunctive therapy increases. In patients with a large stone burden, pre-ESWL stenting may secure drainage and prevent obstructive urosepsis. Stone composition The density and ability of a stone to resist ESWL is based in part on the composition of the stone. Stones composed of calcium oxalate dihydrate, magnesium ammonium phosphate, or uric acid tend to be softer and to fragment more easily with ESWL. Stones composed of calcium oxalate monohydrate or cystine, are less susceptible to ESWL. ESWL monotherapy is more likely to be effective against stones with a lower 36 radio-opacity (551 Hounsfield units [HU]) than those with a higher radio-opacity (926 HU). In addition, certain radiolucent stones (uric acid, indinavir) are difficult to visualize on fluoroscopy and therefore require either ultrasonography-guided localization or the addition of retrograde or intravenous contrast to localize a calculus. Intraprocedure Details The optimal shockwave lithotripsy treatment is thought to be about 80-90 shocks per minute. Faster rates have been shown to be associated with decreased stone-free rates, especially for larger stones (11-20 mm). The difference in stone-free rates is less significant for smaller stones. Conversely, slower rates obviously increase the total operative time. During shockwave lithotripsy, tracking the stone burden becomes an important issue in renal calculus, because during respiration, there is movement of the stone burden in and out of the focal zone. However in lower third ureteric stones, this does not pose a problem as the ureter does not move. Postprocedure Details Common adverse effects associated with ESWL include flank petechiae, hematuria, and passage of stone fragments with associated renal colic [34]. Many patients are issued a urine strainer to help collect stone fragments, which can later be chemically analyzed to assist with prevention of future stones. Hydration and analgesia alleviate most flank discomfort and symptoms caused by the passage of fragments. Some groups 37 have initiated trials of pharmacologic aids similar to those involved in medical stonepassage protocols to facilitate stone passage. TABLE 6 : Complications of ESWL for Distal third ureteric stones ESWL(95% CI) Sepsis 3% /(2 - 5)% Steinstrasse 4% /(0 - 17)% Stricture 0%/(0 - 1)% Ureteral Injury 1%/ (0 - 5)% UTI 4% (1 - 12)% EFFICACY The stone clearance rates of URS and ESWL for Lower third ureteric stones are given in table 7 [34] TABLE 7: Stone free rates for ESWL and Ureteroscopy Treatment Stone clearance rates STONE SIZE <10mm STONE SIZE >10mm ESWL 86%(79-92)% 74%(56-88)% Ureteroscopy - Semi flexible 97%(88-100)% 79%(50-96)% Percutaneous Antegrade Ureteroscopy Percutaneous antegrade removal of ureteral stones is a consideration in selected 38 cases, for example, for the treatment of very large (>15 mm diameter) impacted stones in the proximal ureter between the uretero-pelvic junction and the lower border of the fourth lumbar vertebra. Percutaneous antegrade removal of ureteral stones is an alternative when ESWL is not indicated or has failed and when the upper urinary tract is not amenable to retrograde URS; for example, in those with urinary diversion or renal transplants Laparoscopic and Open Stone Surgery Shock-wave lithotripsy, URS, and percutaneous antegrade URS can achieve success for the vast majority of stone cases. In extreme situations or in cases of simultaneous open surgery for another purpose, open surgical ureterolithotomy might rarely be considered. For most cases with very large, impacted, and/or multiple ureteral stones in which ESWL and URS have either failed or are unlikely to succeed, laparoscopic ureterolithotomy or open surgery may be attempted. 39 4. Material and Methods All patients presenting to the hospital with symptoms of ureteric colic/calculi were evaluated. Of them a total of sixty successive patients who on evaluation had lower third ureteric stones of 5mm and above were included in this study as per the flow chart given below. Ureteric colic Evaluate for urolithiasis Positive for lower third ureteric stones 40 Exclusion criteria (We define lower third ureteric stones as those stones seen from below the Sacroiliac joint upto the uretero-vesicular junction on IVU) Inclusion criteria 1. Stones of sizes - 5 to 15 mm 2. Normal renal function Exclusion criteria 1. Pregnant women. 2. Calculi less than 4 mm 3. Patient presenting with features of urinary tract infection / urosepsis 4. Patients with deranged renal function ( Serum creatinine > 1.8 mg/dl) 5. Patients with bilateral ureteric calculi 6. Patients with radiolucent calculi 7. Patients below 18 yrs of age 8. Patients with bleeding disorders 9. Obstructive Calculus 41 Consent Consent was taken from all patients after explaining the merits and demerits of each procedure. The choice of procedure was as per the choice of the patient. Admission policy All cases of URS were admitted and treated as inpatients. Most of the patients of ESWL were treated on OPD basis except those who had come from outstation for the treatment. Pre Operative Prophylaxis All patients were given Inj Gentamicin (1.5 mg/Kg body weight) just before the procedure. Antibiotics were changed if necessary in event of complications. In addition, Post procedure, all patients were covered with Tab Ciprofloxacin 500mg twice daily for 3 days Investigations done preoperatively 1. Hb, TLC, DLC 2. Urine routine, microscopy, culture and antibiotic sensitivity. 3. Blood sugar level 4. Blood urea and Serum creatinine 5. X-ray KUB and USG KUB 6. Intravenous Urography (IVU) 7. NCCT ( in selective cases) 42 PROCEDURE Ureteroscopy was performed using Semirigid 7/8.5, 10 degree F Richard Wolf (TM) (GmBh) Ureteroscope along with EMS Lithoclast and stone retrieval device (Forceps). All the patients were treated as inpatients. The position of the patient was Lithotomy and all the cases were done under spinal anesthesia. Procedure for URS is as follows (as per standard laid down procedure - AUA guidelines 2007). • Fluoroscopic equipment was available in the operating room. • Pre-operative imaging of urinary tract (X-ray KUB) was done to confirm location of stone. • Under general anesthesia, spinal anesthesia or intravenous sedation, patient placed in lithotomy position. • Rigid cystoscopy was first done • Double guide wire (non-hydrophylic, floppy tip-0.038 inch Terumo guide wire) under endoscopic and fluoroscopic control was passed into the ureter and secured to drapes.(The safety guide wire prevents the risk of false passage) • Intramural ureteral dilatation was not routinely done. • Ureteroscopes was introduced by passing it over the previously placed guide wires. • Endoscopic lithotripsy was used to break the stone into fragments small enough for extraction. • During the whole procedure continuous irrigation was done to achieve a clear field 43 EMS Lithoclast was used for fragmentation of the stone and maximum fragments were retrieved. Smaller size stones were left behind to pass spontaneously. Post procedure all patients were stented as a procedure protocol in this study. ESWL was performed by a Electro Magnetic Lithotripter (Make- Dornier Compact S (TM) manufactured by Dornier Med Tech) (GmBh). All patients in this group were treated as out-patients except those who were referred to our centre from out station. The procedure was done under analgesia. All the patients were given Inj Tramadol 50 mg IV, and Inj Gentamicin 1.5 mg/kg IV half an hour prior to the procedure. The procedure was done in supine position focusing through the greater Sciatic foramen and also in prone position depending on the ease of localization of stone. Fluroscopy was used for localization of the stone. Post procedure patient was sent back home. Post procedure Tab Co- trimoxazole DS was prescribed twice a day for three days. A maximum of 3000 shocks per sitting at a cycle of 70-90/ min with a intensity of 30-40 kV was given. Max of 5 sittings spaced apart, not less than 3 days was given. The procedure was done under analgesia. DJ stenting was done in selective cases on individual merit. Procedure Failure 44 Maximum of two attempts for URS and five sittings for ESWL was permitted after which the procedure was termed failure in the presence of non-fragmentation of stone and cross over or alternate method was used to clear the stone Procedure was also deemed as failure if residual calculi were present at end of 4 weeks on X-ray KUB. However patient was followed up at 8 wks and 12 wks with X-ray KUB, USG KUB and urine culture. ANALYSIS All relevant data was maintained on a Performa (appendix A) and data was tabulated on a spread sheet for statistical evaluation. T test and Fishers exact test was used to calculate the significance. P value of 0.05 or less was considered significant 5. 6. Results Total of 60 patients were treated for lower third ureteric calculus, 30 by ESWL and 30 by URS. The mean age in patients with ESWL was 38 yrs (20-68 yrs), and in URS group was 38.06 (20-72 yrs).The maximum number of patients was in the age group between 30-40 yrs in both the study groups. Difference between the mean age was not statistically significant (Table 8) In both the groups the number of male patients was far more than the female patients (Table 8). 45 The mean stone size for the ESWL group was 8.41mm (6 mm - 12 mm) and for the URS group 8.24mm (5mm - 15mm). Differences between the mean age, sex distribution and stone was not statistically significant (Table 9). For the ESWL maximum number of sitting was 5 done on three patients. (Mean 2.1). Ten patients underwent DJ stent due to incomplete fragmentation/ incomplete expulsion of the fragmented stone. DJ stent removal of the same was done after 4 weeks. In the ESWL group, stone fragmentation was unsuccessful in three patients. URS was done for these patients with successful stone removal. In the URS group, the procedure was done twice in four patients. Twice it was because of technical problems (Ureteroscope became unserviceable). Twice the stone could not be reached due to poor visibility and edema. In all the instances the stone was successfully cleared in the second attempt. In URS group, stone removal failed in two patients. In the first patient, the stone was found to be impacted and could not be dislodged or fragmented. Open procedure (ureterolithotomy) was done for the same (Table 8). In the second patient there was proximal migration of stone which could not be retrieved by URS. Stone had migrated into the pelvis. ESWL was done after one week with successful fragmentation of stone. Follow up X-rays, USG KUB and urine investigations done at 8 and 12 weeks, did not reveal any residual stone in any of the 60 patients. 46 P value using Fishers exact test is 1.00 which is not statistically significant with stone clearance rates of 90% for ESWL and 93.34% for URS (Table 8). Table 8- Comparison and significance Age Stone size URS ESWL P 38.06(20-72) 39(20-68) 0.73 8.24(15-5) 8.41 (12-6) Male: female 25:5(5:1) 24:6(4:1) Successful 28(93.3%) 27(90%) Failures 2 3 DJ stent 30 10 No of sittings 1.13(1-2) 2.1(1-5) 0.72 1.00 clearance DJ stenting was done in all cases of URS as a laid down protocol in this study. In the ESWL group, DJS was done for 10 cases (33%). Three patients were those in which ESWL was not successful and had to be taken for URS. For the remaining cases DJ stenting was done due to large residual stone burden and ureteric colic. In all cases stent removal was done under Local anesthesia after 4 weeks. Table 9 –Complications following procedures Hematuria URS ESWL 21 8 47 UTI 2 0 Steinstrasse 0 2 There was no incidence of any major complication following URS. However 21 patients developed hematuria which subsided by the second or third day. Almost all the patients had discomfort in the loin while passing urine. There was no incidence of ureteral avulsion or false passage during the procedure. None of the patients had post procedure fever or sepsis. There was proximal migration of stone in one of the patient. The stone migrated into the pelvis. The stone could not be retrieved through URS. ESWL was done and the stone successfully removed. In the ESWL group eight patients developed haematuria. Of them, six patients had been stented. Two patients not stented developed both hematuria and steinstrasse. No patients developed any petechie following ESWL 7. Discussion Both ESWL and URS are accepted treatment modalities for lower third ureteric calculus, with URS having a better clearance rates compared to ESWL in the available literature(95% for URS versus 86% ESWL for stones less than 10 mm)[34]. However URS is associated with know complications such as ureteral injury, avulsion and false passage in addition to requiring spinal or general anesthesia. 48 30 patients each participated in each arm of the study. No patients were lost to follow up. Urolithiasis has been reported in literature to be more common in the Second to fourth decade and the same was demonstrated by the study (Chart 1 and 2), the mean age of the patients being 39 yrs in ESWL arm and 38.06 yrs in the URS arm. The difference was not statistically significant (p=0.73). The affliction (Urolithiasis) is four times more common in males than females in the general population; the same corroborated with our study, the number of male patients were more than female patients in both groups (4:1 for ESWL and 5:1 for URS) The maximum size stone in the URS group was 15 mm on IVU, the smallest stone was 5 mm (mean 8.24 mm). In the ESWL group the largest and smallest stone was 12 mm and 6 mm respectively (Mean size 8.41mm) (Chart 3). The difference of the stone size in both groups were not statistically significant (p = 0.72). The stone clearance rate for ESWL was 90% with the procedure being unsuccessful in 3 patients. This was probably due to hard stones. Of these, 2 underwent URS successfully and one patient underwent open ureterolithotomy. The clearance rates by our study were higher than the meta-analysis of AUA (86% and 74% for stone sizes below 10mm and more than 10 mm respectively). However, clearances rates following ESWL were comparable to various studies using the same equipment (Dornier compact S lithotripter) [82]. In the URS group, there was a 93.34% stone clearance with two patients failing the procedure. One was due to impaction of stone which was later removed by ureterolithotomy. In the second case, there was proximal migration of stone which migrated into the pelvis. ESWL was used for fragmentation and removal of the stone. 49 The success rates are comparable to the clearance rates of other studies as showed by the meta-analysis conducted by the AUA group (97% and 79% for stones less than 10mm and more than 10 mm respectively). Stenting was done in all cases in the URS group in this study. There are however conflicting reports in literature regarding the usefulness of DJ stenting the ureter routinely following URS [34]. Hematuria was noted in most of the patients (21 patients) in the URS group and eight patients in the ESWL group. This was transient and subsided after 2-3 days. Two patients developed Urinary tract infection following URS. E coli were grown in both the patients. Both were treated with antibiotics based on the culture sensitivity reports. . No patient in the ESWL group developed UTI/ sepsis. 50 4, 13% 10, 34% 20‐29 30‐39 40‐49 >50 6, 20% 10, 33% Chart 1: URS – AGE WISE BREAK UP 51 7, 23% 6, 20% 20‐29 30‐39 40‐49 >50 7, 23% Chart 2: AGE WISE BREAKUP-ESWL 10, 34% 52 16 14 12 10 URS ESWL 8 6 4 2 0 5‐7mm 8‐10mm >10mm Chart 3: STONE SIZE- URS and ESWL 53 8. Summary and Conclusion. Our clearance rates after URS and ESWL are comparable to other similar studies which have shown high clearance rates for either of the methods[81,82] (Andankar M. et al reported a clearance rate of 98.7% vs. 90% at the end of 3 months for URS and ESWL respectively) URS has a slightly better clearance rate compared to ESWL in our study, which was however not statistically significant. There was no major surgical complication that was noted following either of the procedures. Symptoms related to stent placement were noted. Disadvantage of URS is that the procedure has to be performed under spinal or general anesthesia compared to ESWL which can be done under sedation with analgesia. This exposes the patient to the risks of anesthesia for URS. Also URS is an invasive procedure. Added advantage is that, ESWL patients are treated on OPD basis, while the patients undergoing URS will require inpatient care which amounts to financial loss to the individual and increasing the workload at the hospital. Therefore URS while it offers a higher clearance rate, and remains as the first line treatment for lower third ureteric stones, ESWL may also be offered as a primary modality treatment for the same. This may be more relevant at the government hospitals where there is excessive inpatient load compounding acute shortage of manpower. 54 References 1. Sutton and Walker, 1980. Sutton RA, Walker VR: Responses to hydrochlorothiazide and acetazolamide in patients with calcium stones: Evidence suggesting a defect in renal tubular function. N Engl J Med 1980; 302:709-713 2. Morse RM, Resnick MI. Ureteral calculi: Natural history and treatment in the era of advanced technology. J Urol 1991;145:263-5, and Glowacki LS, Beecroft ML, Cook RJ, Pahl D, Churchill DN. The natural history of asymptomatic urolithiasis. J Urol 1992;147:319-21 3. Segura JW, Preminger GM, Assimos DG, et al. Ureteral Stones Clinical Guidelines Panel summary report on the management of ureteral calculi. The American Urological Association. J Urol 1997; 158: 1915-21. 4. Ehreth JT, Drach GW, Arnett ML, et al. Extracorporeal shock wave lithotripsy: Multicenter study of kidney and upper ureter versus middle and lower ureter treatments. J Urol 1994; 152: 1379-85. 5. Tawfiek ER, Bagley DH. Management of upper urinary tract calculi with ureteroscopic techniques. Urology 1999; 53:25-31. 6. Pearle MS, NadlerR, BercowskyE, ChenC, Dunn M, Figenshau RS,et al: Prospective randomized control trial comparing shock wave lithotripsy versus ureteroscopy in the treatment of lower third ureteral calculi .J urol. 2001;166: 1255-60 7. Segura JW, Preminger GM, Assimos DG, Dretler SP, Kahn, RI, Lingerman et al.: Ureteral stone s clinical guidelines panel summary report on the management of ureteral calculi. The American Urological Association. J urol. 1997;158:1915-21 55 8. Ilker Y, Turkeri LN, Korten V, Tarcan T, Akdas A: Any microbial prophylaxis in the treatment of urinary tract stones by ESWL: Is it necessary? Urology.1995;46 165-7 9. Worster A, Preyra I, Weaver B, Haines T. The accuracy of noncontrast helical computed tomography versus intravenous pyelography in the diagnosis of suspected acute urolithiasis: a meta-analysis. Ann Emerg Med 2002;40(3):280-6. 10. Uribarri et al., 1994. Uribarri J, Oh MS, Pak CY: Renal stone risk factors in patients with type IV renal tubular acidosis. Am J Kidney Dis 1994; 23:784-787. 11. Pak, 1987. Pak CY: Citrate and renal calculi. Miner Electrolyte Metab 1987; 13:257266. 12. Blacklock, 1969. Blacklock NJ: The pattern of urolithiasis in the Royal Navy. In: Hodgkinson A, Nordin BEC, ed. Renal Stone Research Symposium, London: J & A Churchill; 1969:33-47 13. Elliot JS, Eusebio E : Calcium oxalate solubility: Effects of trace metals. Invest Urol 1967;4:428-430 14. Curhan et al., 1999. Curhan GC, Willett WC, Speizer FE, Stampfer MJ: Intake of vitamins B6 and C and the risk of kidney stones in women. J Am Soc Nephrol 1999; 10:840-845 15. Straub M, Strohmaier WL, Berg W, Beck B, Hoppe B, Laube N, Lahme S, Schmidt M, Hesse A, Koehrmann KU. Diagnosis and metaphylaxis of stone disease. Consensus concept of the National Working Committee on Stone Disease for the upcoming German Urolithiasis Guideline. World J Urol 2005;23(5):309-23. 16. Menon M : Editorial comment to Choyke PL: Urogram: are rumours of its death premature? J Urol 1993;149:431 56 17. Butler, EL, Cox, SM, Eberts, EG, Cunningham, FG. Symptomatic nephrolithiasis complicating pregnancy. Obstet Gynecol 2000; 96:753 18. Laing, FC, Benson, CB, DiSalvo, DN, et al. Distal ureteral calculi: detection with vaginal US. Radiology 1994; 192:545. 19. Holmlund D, Sjödin J-G. Treatment of ureteral colic with indomethacin. J Urol 1978;120(6):676-7. 20. Lundstam SO, Leissner KH, Wåhlander LA, Kral JG. Prostaglandin-synthetase inhibition of diclofenac sodium in the treatment of renal colic: comparison with use of a narcotic analgesic. Lancet 1982;1(8281):1096-7. 21. Lundstam SO, Wåhlander LA, Kral LG. Treatment of ureteral colic by prostaglandinsynthetase inhibition with diclofenac sodium. Curr Ther Res 1980;28:355-8. 22. Walden M, Lahtinen J, Elvander E. Analgesic effect and tolerance of ketoprofen and diclofenac in acute ureteral colic. Scand J Urol Nephrol 1993;27(3):323-5. 23. Cohen E, Hafner R, Rotenberg Z, Fadilla M, Garty M. Comparison of ketorolac and diclofenac in the treatment of renal colic. Eur J Clin Pharmacol 1998;54(6):455-8. 24. Shokeir AA, Abdulmaaboud M, Farage Y, Mutabagani H. Resistive index in renal colic: the effect of nonsteroidal anti-inflammatory drugs. BJUInt 1999;84(3):249-51 25. Miller OF, Kane CJ. Time to stone passage for observed ureteral calculi: A guide for patient education. J Urol. 1999;162:688–91 26. Autorino R, Osorio L, Lima EA. Rapid extracorporeal shock wave lithotripsy for proximal ureteral calculi in colic versus noncolic patients. Eur Urol. 2007;52:1264–5 57 27. Hollingsworth JM, Rogers MA, Kaufman SR, Bradford TJ, Saint S, Wei JT, et al. Medical therapy to facilitate urinary stone passage: A metaanalysis. Lancet. 2006;368:1171–9. 28. Davenport K, Timoney AG, Keeley FX. A comparative in vitro study to determine the beneficial effect of calcium-channel and alpha 1-adrenoceptor antagosim on human ureteric activity. BJU Int.2006;98:651–5. 29. Troxel SA, Jones AW, Magliola L, Benson JS. Physiologic effect of nifedipine and tamsulosin on contractility of distal ureter. J Endourol. 2006;20:565–8. 30. Cooper JT, Stack GM, Cooper TP. Intensive medical management of ureteral calculi. Urology.2000;56:575–8 31. Sigala S, Dellabella M, Milanese G, Fornari S, Faccoli S, Palazzolo F, et al. Evidence for the presence of alpha1 adrenoceptor subtypes in the human ureter. Neurourol Urodyn. 2005;24:142–8. 32. L Osorio, E Lima, R Autorino, F Marcelo. Emergency management of ureteral stones: Recent advances. Indian J Urol. 2008 Oct–Dec; 24(4): 461–466. 33. Singh A, Alter HJ, Littlepage A. A systematic review of medical therapy to facilitate passage of ureteral calculi. Ann Emerg Med. 2007;50:552–67 34. EU guidelines: Guidelines on Urolithiasis; H-G. Tiselius, P. Alken, C. Buck, M. Gallucci, T. Knoll, K. Sarica, Chr. Türk: Update Mar 2008 35. Maheshwari PN, Oswal AT, Andankar M, Nanjappa KM, Bansal M: Is antegrade ureteroscopy better than retrograde ureteroscopy for impacted large upper ureteral calculi? J Endourol 1999;13(6):441-4. 58 36. el-Nahas AR, Eraky I, el-Assmy AM, Shoma AM, el-Kenaey MR, Abdel-Latif M, Mosbah A, Abol-Enein H, Shaaban AA, Mohsen T, el-Kappany HA. Percutaneous treatment of large upper tract stones after urinary diversion. Urology 2006;500-4. 37. Kumar V, Ahlawat R, Banjeree GK, Bhaduria RP, Elhence A, Bhandari M: Percutaneous ureterolitholapaxy: the best bet to clear large bulk impacted upper ureteral calculi. Arch Esp Urol 1996; 49(1):86-91 38. Sandegard E. Prognosis of stone in the ureter. Acta Chir Scand Suppl 1956; 219:1-67. 39. Morse RM, Resnick MI. Ureteral calculi: natural history and treatment in an era of advanced technology. J Urol 1991;145(2):263-5. 40. Ibrahim AI, Shetty SD, Awad RM, Patel KP. Prognostic factors in the conservative treatment of ureteric stones. Br J Urol 1991;67(4):358-61. 41. Miller OF, Kane CJ. Time to stone passage for observed ureteral calculi: a guide for patient education. J Urol 1999;162(3 Pt 1):688-90. 42. Andersson L, Sylven M. Small renal caliceal calculi as a cause of pain. J Urol 1983;130(4):752-3. 43. Marshall, 1964. Marshall VF: Fiber optics in urology. J Urol 1964; 91:110-114. 44. Morse RM, Resnick MI. Ureteral calculi: Natural history and treatment in the era of advanced technology. J Urol 1991;145:263-5, 45. Tawfiek ER, Bagley DH. Management of upper urinary tract calculi with ureteroscopic techniques. Urology 1999; 53:25-31. 59 46. Lam JS, Greene TD, Gupta M. Treatment of proximal ureteral calculi: Holmium:YAG laser ureterolithotripsy versus extracorporeal shock wave lithotripsy. J Urol 2002; 167: 1972-6. 47. UribarriJManS, Carroll JH: The first kidney stone.Ann Inter Med 1989;111:1006-1009 48. Monga M. Accessory instrumentation for ureteroscopy. Curr Opin Urol 2004; 14(2):1079. 49. Portis AJ, Rygwall R, Holtz C, Pshon N, Laliberte M. Ureteroscopic laser lithotripsy for upper urinary tract calculi with active fragment extraction and computerized tomography followup. J Urol 2006; 175(6):2129-33. 50. El-Assmy A, El-Nahas AR, Sheir KZ. Is pre-shock wave lithotripsy stenting necessary for ureteral stones with moderate or severe hydronephrosis. J Urol 2006;176(5):205962;discussion 2062 51. Grabe M. Perioperative antibiotic prophylaxis in urology. Curr Opin Urol 2001;11(1):815. 52. Francesca F, Scattoni V, Nava L, Pompa P, Grasso M, Rigatti P. Failures and complications of transurethral ureteroscopy in 297 cases: conventional rigid instruments vs. small caliber semirigid ureteroscopes. Eur Urol 1995;28(2):112-5. 53. Yaycioglu O, Guvel S, Kilinc F, Egilmez T and Ozakardes H: Results with 7.5F versus 10F rigid ureteroscopes in treatment of ureteral calculi. Urology 2004;64(4):643-6. 54. Preminger GM, Tiselius HG, Assimos DG, Alken P, Buck C, Gallucci M, Knoll T, Lingeman JE, Nakada SY, Pearle MS, Sarica K, Türk C, Wolf JS Jr; 60 EAU/AUANephrolithiasis Guideline Panel. 2007 guideline for the management of ureteral calculi. J Urol 2007;178(6):2418-34. 55. Preminger GM, Tiselius HG, Assimos DG, Alken P, Buck C, Gallucci M, Knoll T, Lingeman JE, Nakada SY, Pearle MS, Sarica K, Türk C, Wolf JS Jr; American Urological Association Education and Research, Inc; European Association of Urology. 2007 guideline for the management of ureteral calculi. Eur Urol 2007;52(6):1610-31. 56. Geavlete P, Georgescu D, Nita G, Mirciulescu V, Cauni V. Complications of 2735 retrograde semirigid ureteroscopy procedures: a single-center experience. J Endourol 2006;20(3):179-85. 57. Harmon WJ, Sershon PD, Blute ML, Patterson DE, Segura JW. Ureteroscopy: current practice and long-term complications. J Urol 1997;157(1):28-32 58. Puppo P, Ricciotti G, Bozzo W, Introini C. Primary endoscopic treatment of ureteric calculi. Areview of 378 cases. Eur Urol 1999;36(1):48-52 59. Sözen S, Küpeli B, Tunc L, Senocak C, Alkibay T, Karao lan U, Bozkirli I. Management of ureteral stones with pneumatic lithotripsy: report of 500 patients. J Endourol 2003;17(9):721-4. 60. Turk TM, Jenkins AD. Acomparison of ureteroscopy to in situ extracorporeal shock wave lithotripsy for the treatment of distal ureteral calculi. J Urol 1999;161(1):45-6. 61. Aridogan IA, Zeren S, Bayazit Y, Soyupak B, Doran S. Complications of pneumatic ureterolithotripsy in the early postoperative period. J Endourol 2005;19(1):50-3. 61 62. Roberts WW, Cadeddu JA, Micali S, Kavoussi LR, Moore RG. Ureteral stricture formation after removal of impacted calculi. J Urol 1998;159(3):723-6. 63. Martin X, Ndoye A, Konan PG, Feitosa Tajra LC, Gelet A, Dawahra M, Dubernard JM. [Hazards of lumbar ureteroscopy: apropos of 4 cases of avulsion of the ureter.] Prog Urol 1998;8(3):358-62. 64. Watterson JD, Girvan AR, Cook AJ, Beiko DT, Nott L, Auge BK, Preminger GM, Denstedt JD. Safety and efficacy of holmium: YAGlaser lithotripsy in patients with bleeding diatheses. J Urol 2002;168(2):442-5. 65. Dash A, Schuster TG, Hollenbeck BK, Faerber GJ, Wolf JS Jr. Ureteroscopic treatment of renal calculi in morbidly obese patients: a stone-matched comparison. Urology 2002;60(3):393-7. 66. Andreoni C, Afane J, Olweny E, Clayman RV. Flexible ureteroscopic lithotripsy: firstline therapy for proximal ureteral and renal calculi in the morbidly obese and superobese patient. J Endourol 2001;15(5):493-8. 67. Watterson JD, Girvan AR, Beiko DT, Nott L, Wollin TA, Razvi H, Denstedt JD. Ureteroscopy and holmium:YAGlaser lithotripsy: an emerging definitive management strategy for symptomatic ureteral calculi in pregnancy. Urology 2002;60(3):383-7. 68. Lifshitz DA, Lingeman JE. Ureteroscopy as a first-line intervention for ureteral calculi in pregnancy. J Endourol 2002;16(1):19-22. 62 69. Deliveliotis C, Picramenos D, Alexopoulou K, Christofis I, Kostakopoulos A, Dimopoulos C. Onesession bilateral ureteroscopy: is it safe in selected patients?. Int Urol Nephrol 1996;28(4):481-4. 70. Hollenbeck BK, Schuster TG, Faerber GJ, Wolf JS Jr. Safety and efficacy of samesession bilateral ureteroscopy. J Endourol 2003;17(10):881-5. 71. Sapozhnikov et al., 2003. Sapozhnikov OA, Cleveland RO, Bailey MR, et al: Modeling of stresses generated by lithotripter shock wave in cylindrical kidney : Chapelon JY, Lafon C, ed. Proceedings of the 3rd International Symposium of Therapeutic Ultrasound, Lyon: INSERM; 2003:323-328. 72. Bhatta KM, Prien EL Jr, Dretler SP. Cystine calculi: two types. In: Lingeman JE, Newman DM, eds. Shock Wave Lithotripsy 2: Urinary and Biliary Lithotripsy. Vol 1. New York: Plenum Press, 1989, pp. 55-59. 73. Becopoulos T, Karayannis A, Mandalaki T, Karafoulidou A, Markakis C. Extracorporeal lithotripsy in patients with hemophilia. Eur Urol 1988;14(4):343-5. 74. Ruiz Marcellán FJ, Mauri Cunill A, Cabré Fabré P, Argentino Gancedo Rodríguez V, Güell Oliva JA, Ibarz Servio L, Ramón Dalmau M. [Extracorporeal shockwave lithotripsy in patients with coagulation disorders]. Arch Esp Urol 1992;45(2):135-7. 75. Ishikawa J, Okamoto M, Higashi Y, Harada M. Extracorporeal shock wave lithotripsy in von Willebrand’s disease. Int J Urol 1996;3(1):58-60 63 76. Segura JW, Preminger GM, Assimos DG, Dretler SP, Khan RI, Lingeman JE, Macaluso JNJr. Ureteral Stones Clinical Guidelines Panel summary report on the management of ureteral calculi. The American Urological Association. J Urol 1997; 158(5):1915-21. 77. Byrne RR, Auge BK, Kourambas J, Munver R, Delvecchio F, Preminger GM. Routine ureteral stenting is not necessary after ureteroscopy and ureteropyeloscopy: a randomized trial. J Endourol 2002;16(1):9-13. 78. Pryor JL, Jenkins AD. Use of double-pigtail stents in extracorporeal shock wave lithrotripsy. J Urol 1990; 143(3):475-8. 79. Preminger GM, Kettelhut MC, Elkins SL, Seger J, Fetner CD. Ureteral stenting during extracorporeal shock wave lithotripsy: help or hindrance? J Urol 1989; 142(1):32-6. 80. Low RK, Stoller ML, Irby P, Keeler L, Elhilali M. Outcome assessment of double-J stents during extracorporeal shockwave lithotripsy of small solitary renal calculi. J Endourol 1996;10(4):341-3. 81. Andankar MG, Maheshwari PN, Saple AL, Mehta V, Varshney A, Bansal B. Symptomatic small non-obstructing lower ureteric calculi: comparison of ureteroscopy and extra corporeal shock wave lithotripsy. J Postgrad Med 2001;47:177 82. Ibrahim F Ghalayini, Mohammed A Ai-Ghazo, Yousef S. Khader: Extracorporeal shockwave lithotripsy versus ureteroscopy for distal ureteric calculi: efficacy and patient Satisfaction: Int Braz J Urol. 2006; 32: 656-67 64 ANNEXURES Annx-A PROTOCOL OF ASSESSMENT OF PATIENTS TREATED WITH URETEROSCOPY/ESWL Name………………… DOA DOD BRIEF CLINICAL NOTES Age…………. Sex………… Date……….. 65 PAST HISTORY INVESTIGATION Hb % TLC DLC UREA CREATININE URINE CULTURE USG SIZE BACKPRESSURE CHANGES X-ray KUB IVU NCCT SIZE OF STONE 5-10MM >10MM URETEROSCOPY DATE OF OPERATION RESULT COMPLICATONS PAIN HAEMATURIA UTI FALSE PASSAGE AVULSION OTHERS HOSPITAL STAY ESWL 66 I SESSION II III IV V DATE SHOCKS INTENSITY COMPLICATONS ECCHYMOSIS PAIN HAEMATURIA UTI OTHERS HOSPITALISATION IF ANY CAUSE PATIENT COMPLIANCE Annx- B INFORMED CONSENT AND REQUEST FOR ESWL / URETEROSCOPY Name Ser No Age Name Sex Relation Unit I, _______________________________, request Dr. Col Srinath and his associates to perform upon me (name of procedure): 67 Diagnosis and procedure: The following has been explained to me in general terms and I understand that; a) I am participating in a study which compares the efficacy of ESWL and ureteroscopy(URS) b) Both the above mentioned methods are universally accepted procedures to treat my condition [mentioned below] c) I may choose either of the procedures [ESWL or ureteroscopy] for the treatment of my condition . My condition has been diagnosed as : Lower third ureteric stone The nature of the procedure : ESWL/URS The purpose of the procedure is to : Remove the ureteric stone General Risks of procedure: As a result of the performance of this procedure there may be general risks involved such as: INFECTION, ALLERGIC REACTION, CARDIAC ARREST, OR DEATH. In addition to these general risks there may be other possible risks involved in this procedure. These risks and/ or complications may include but are not limited to such complications as: 1. Avulsion of the ureter, false passage, bleeding and retained stones during ureteroscopy. 2. Bruising of the skin, bleeding and retained stones following ESWL Likelihood of Success: good/ fair/ poor/ not predictable Prognosis: If I choose not to have the above procedure, my prognosis (future medical condition) is persistence of stones with effects thereof such as pain, infection and kidney failure. Alternative Forms of treatment with less success such as: 1. Trial with Tamsulosin 2. Do nothing and accept the present condition 3. These alternative treatments have been explained to me and I have agreed to undergo the above mentioned treatment. I understand and accept that during the procedure unexpected or unforeseen circumstances may make it necessary to do an extension of the original procedure that is 68 not named above. I request Dr Col Srinath and his associates of his choice to perform those procedures that they judge necessary. BY SIGNING THIS FORM, I ACKNOWLEDGE THAT I HAVE READ OR HAD THIS FORM READ AND EXPLAINED TO ME AND THAT I FULLY UNDERSTAND ITS CONTENTS. I HAVE BEEN GIVEN AMPLE OPPORTUNITY TO ASK QUESTIONS AND ANY QUESTIONS I HAVE ASKED HAVE BEEN ANSWERED OR EXPLAINED IN A SATISFACTORY MANNER. ALL BLANKS OR STATAMENTS REQUIRING COMPLETION WERE FILLED IN AND ALL STATEMENTS WITH WHICH I DISAGREE WERE MARKED OUT BEFORE I SIGNED THIS FORM. I accept that medicine is not an exact science and understand that no guarantees can be given as to the results. Understanding these limitations, I request that Dr Col N Srinath and his associates to proceed with the procedure. ___________________________ __________________________ Witness Person giving consent Date: _______________________ Additional materials used, if any during the informed consent process for this procedure include: Date:________________________ Witness:_______________________ 69 Fig 1: Ureteral stone with tip of probe of lithotriptor Fig 2: Ureteral stone post fragmentation 70 Fig 3: USG KUB Hydronephrosis Lt Kidney Fig 4: X-Ray KUB - Lt Lower third ureteric calculus Fig 5: IVU-lower third ureteral calculus with hydoureteronephrosis 71 Fig 6: ESWL Suite (Dornier Compact S) Fig 7: Ureteroscope (7/8.5, 10 degree F Richard Wolf) Xray/USG KUB/IVU Unit 413 AFSLt L 1/3 calculus Sl no 1 Name HP yadav Age 23 RelationshRank self LAC Number 903466 2 3 PK Sharma P Kartik 42 47 self f/o Sgt Sep 69668 410 AFSLt L 1/3 calculus 15788788 19 AD Rt L 1/3 calculus 4 G singh 34 self Hav 5 6 7 8 9 PM Kumar Shibu Kumar K Kumar B Pun Bisht 51 35 48 30 38 self w/o self self w/o u/ ao Nk Ex Sep l/nk Lt Col 943 15391461 1448188 5348073 IC 54056 ICGS poRt L 1/3 calculus 24 MBS Rt l1/3 calculus R/o Arty Lt L 1/3 calculus 214 gr Rt l1/3 calculus Rt l1/3 calculus dssc 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 JK Joshi 32 KP Ananda 60 Sunil Kumar 33 G singh 19 VRK Naidu 40 bharadwaj 35 G Lakshman 20 BB Talukdar 47 Gajraj Yadav 54 Satish 30 Saravana Kuma 34 MJK Thampi 50 Manohar Singh 26 Kamal Sharma 21 AJITH 36 praveen 41 Raju BBN 22 B Singh 44 AK tripathy 37 BN sen 53 SK Yadav 60 self w/o self self self Self self f/o M/o self self self Self Self self self w/o self self self self chera ex l/nk L/Nk AC[U/T] Ex NK Dy comdt Spr Sep p navik l nk nk Gp Capt Rfn AC[U/T] Lnk Hav Sep CPO SGT MWO Ex Sep 181069 13831720 2597811 8815542 6470923 598 3456764 4352273 2919 15477536 15315293 16632 16017979 8912182 12627883 12435378 17266822 9388 3627881 2653767 256636 Coy NavRt UV Jn Calculus r/o ASC Lt UV jn calculus MRC Rt L 1/3 calculus 410 AFSRt L 1/3 calculus r/o GayaRt Lower 1/3 ureteric calculus 747 Sqn Rt L 1/3 calculus ASC Lt L 1/3 calculus 3N det Rt L 1/3 calculus pnr coy Lt L 1/3 calculus 75 armd Rt L 1/3 calculus MEG Rt L 1/3 calculus 17 FBSULt L 1/3 calculus 3 RR Rt l 1/3 calculus MTI AF Rt l 1/3 calculus ASC Rt l 1/3 calculus 2 para Lt L 1/3 calculus CMP Lt L 1/3 calculus CABS Rt l 1/3 calculus CTI Rt L 1/3 calculus MTI AF Lt l 1/3 calculus R/o MEGLt L 1/3 calculus PRTC Rt L 1/3 calculus s Stone sizeDate Procedure Result 8.4 18/09/08 CPE+Lt URS poor visibility/broken lens 13/10/08 Rpt URS successful 10 11/8/2008 CPE+Lt URS+ISWL successful 7 25/09/08 URS stone not reached 3/10/2008 URS+ISWL successful 8 25/09/08 URS Rt Scope u/s 13/10/08 Rpt Urs+iswl successful 8 16/10/09 URS Rt +ISWL successful 10 20,26/10/08 URS Rt +ISWL unsuccessful 6 6/11/2008 URS Lt +ISWL successful 7 4/12/2009 CPE+Attempted URS+DJ successful 6.5 23/01/09 CPE+URS+ISWL 28/05/09 URS+ ISWL successful 6.3 22/01/09 CPE+DJS successful 7 29/01/09 CPE+URS+ISWL successful 8 12/2/2009 CPE+URS+ISWL successful 10 16/02/09 CPE+URS+ISWL successful 12 17/4/2009 CPE+URS+ISWL successful 8 11/5/2009 CPE+URS+ISWL successful 10 4/6/2009 URS+ISWL successful 6 13/06/09 URS+ISWL successful 7 09/0709 CPE+URS+ISWL successful 10 16/07/09 CPE+URS+ISWL successful 9 20/07/09 CPE+URS+ISWL successful 5 5/8/2009 CPE+URS+ISWL successful 15 6/8/2009 CPE+URS+ISWL successful 8 3/9/2009 CPE+URS+ISWL successful 6 12/9/2009 CPE+URS+ISWL successful 6 10/10/2009 CPE+URS+ISWL successful 7 12/10/2009 CPE+URS+ISWL successful 6 8/11/2009 CPE+URS+ISWL successful 10 16/11/2009 CPE+URS+ISWL unsuccessful 11 30/11/2009 CPE+URS+ISWL successful 9 7/12/2009 CPE+URS+ISWL successful DJS yes Yes yes yes yes yes yes Yes yes yes yes yes yes yes yes yes yes yes yes yes yes yes yes yes yes yes yes yes yes yes DJR remarks 12/11/2008 post ESWL 30/09/08 1/11/2008 1/11/2008 post ESWL Intraop Post op UTI 8wk follow12 wk follow up hematuria hematuria No calcului No calcului No calcului No calcului hematuria hematuria hematuria No calcului No calcului ureterolithotomy on 01/1 impacted hematuria yes No calcului No calcului No calcului No calcului No calcului No calcului No calcului No calcului No calcului No calcului hematuria 19/02/09 10/3/2009 10/3/2009 hematuria 10/3/2009 hematuria 11/5/2009 post ESWL hematuria 10/6/2009 hematuria 28/06/09 hematuria yes 24/08/09 hematuria 27/08/09 31/08/09 10/9/2009 10/9/2009 hematuria 1/9/2009 hematuria 1/10/2009 hematuria 6/10/2009 1/11/2009 hematuria 1/11/2009 hematuria 12-Dec 4/12/2009 proximal migration-ESWL on 22/11/ hematuria 30/12/2009 hematuria 30/12/2009 hematuria No calcului No calcului No calcului No calcului No calcului No calcului No calcului No calcului No calcului No calcului No calcului No calcului No calcului No calcului No calcului No calcului No calcului No calcului No calcului No calcului No calcului No calcului No calcului No calcului No calcului No calcului No calcului No calcului No calcului No calcului No calcului No calcului No calcului No calcului No calcului No calcului No calcului No calcului No calcului No calcului No calcului No calcului No calcului No calcului 6/11/2008 28/12/08 31/11/08 22/12/08 20/06/09 Sl nName 1 HP yadav Age 23 Relati Rank self LAC Number 903466 Unit 413 AFS 2 Sounderraju 21 s/o Ex- Hav 1255684 Nasik 3 4 5 A Edwin 68 Gurdeep Singh 34 G singh 34 m/o self self Nk Hav Hav 2598160 MRC 13619781 PRTC 9829930 PRTC 6 7 B srinivas AK singh 29 28 self self Sgt lLS 776346 n 122HF 128220 K INHS Sana 8 Sam Joseph 9 Praveen 10 N Jangir 35 58 33 W/0 m/o self CHM Sgt PO 14259334 15 Inf btn 712006 CHAFB 174306A INLCU 38 11 GK Gupta 12 VRK Naidu 26 40 self self Cpl Ex NK 793163 6470923 109 HU r/o Gaya 13 K baaradwaj 33 self Dy cmdt 0598 J 747 Sqn 14 15 16 17 18 25 37 22 35 34 w/o self self self self Sep Ex Hav AC[U/T] CHM Nk 217518 14614311 8912182 1425938 2892382A ND school R/o EME 15 inbde 3 RR 19 D Ram 40 self PNvk 04161 M CABS 20 21 22 23 24 25 26 42 35 45 44 49 41 36 self w/o self self self self self LNk Hav Hav L Nk l/ nk Hav l nk 15480315 70 Armd 14802197XASC 2606335 MRC REC 9413666 Y 924 DSC p 2894024 MEG 9287718 CMP 2677738 ASC 49 self Hav 9238848 N Ibomcha Ajith Kumar Kamal Sharma Sam Joseph J Singh Manimaran S Randhir Singh Ravi KS Rai Manoj prekask p vishal singh 27 praveen ASC 28 babu b r 29 M Singh 51 44 m/o self sea JWO 3455 266378 INS shivaji 413 AFS 30 Riaz shiek 49 self CPO 29388 CABS Xray KUB/USG KUB/IVU Lt L 1/3 calculus Stone sizedate No of SW Rate 9.5 21/08/08 5 3000 80 24/08/08 3000 80 27/08/08 3000 70 30/08/08 3000 90 3/9/2008 3000 80 B/L urteric calculus, Rt renal Calculus optd 9 13/08/08 5 3000 90 13/08/08 3000 80 20/08/08 3000 70 23/08/08 3000 90 26/08/08 3000 80 13/09/08 3000 80 Lt ureteric Calculus 6.5 6/9/2008 1 3000 80-90 Rt ureteric calcus 7 27/09/08 1 3000 70-80 Rt L 1/3 calculus 8 2/9/2008 5 3000 80 9/9/2008 3000 80 14/9/2008 3000 90 17/9/2008 3000 90 21/9/2008 3000 90 Rt UV jn calculus 7 14/01/09 1 3000 80-90 LT Lower 1/3 ureteric calculus 9 7/2/2009 2 3000 80-90 18/02/09 3000 70-100 LT Lower 1/3 ureteric calculus 10 4/3/2009 1 3000 70-90 Rt Lower 1/3 ureteric calculus 11 14/03/09 1 3000 70-90 LT Lower 1/3 ureteric calculus 11 25/03/09 2 3000 80 30/03/09 3000 80 Rt UV junction calculus 9 9/4/2009 1 3000 70-90 Rt Lower 1/3 ureteric calculus 12 10/4/2009 5 2500-300070-90 13,17/04/09 3000 80 23,27/04/09 3000 90 Rt Lower 1/3 ureteric calculus 10 18/04/09 4 3000 70-90 23/04/09 3000 70-90 29/04/09 3000 70-80 6/5/2009 3000 70-120 Rt Lower 1/3 ureteric calculus 6 7/5/2009 1 3000 70-100 Rt Lower 1/3 ureteric calculus 6.8 29/08/09 1 2500 70-80 Rt Lower 1/3 ureteric calculus 10 2/9/2009 1 3000 80 3000 80 Lt Lower 1/3 ureteric calculus 7 9,12,16/9/203 8 26-Sep-09 3500 70-90 Lt Lower 1/3 ureteric calculus 30/09/09 2 3000 70-90 8.5 30/10/09 2 3000 80 Rt Lower 1/3 ureteric calculus 11-Feb-09 7 22/09/09 1 3000 80 Rt Lower 1/3 ureteric calculus Lt Lower 1/3 ureteric calculus 7 1/10/2009 1 3000 80 Rt Lower 1/3 ureteric calculus 10 5,8/10/2009 2 3000 80 Rt Lower 1/3 ureteric calculus 8 5,9/10/2009 2 3000 80 Lt Lower 1/3 ureteric calculus 7 13/10/2009 1 3000 80 6 22,26/10/20 2 3000 80 Rt Lower 1/3 ureteric calculus 7 30/10/2009 3 3000 80 Rt Lower 1/3 ureteric calculus 02,05/11/09 6 4/11/2009 1 3000 80 Rt Lower 1/3 ureteric calculus Lt Lower 1/3 ureteric calculus Rt Lower 1/3 ureteric calculus 8 11 Lt Lower 1/3 ureteric calculus 10 12/11/2009 1 2,29,/11/2003 2/12/2009 10/12/2009 2 3000 3000 70-90 80 3000 70-90 Result unsuccessful urs done DJS yes DJR URS successful Yes 23/10/2009No Hematuria No Calculi No Calculi successful successful unsuccessful urs done Yes no yes 8/10/2008 No No URS hematuria No Calculi No Calculi No Calculi No Calculi successful successful No No No No No Calculi No Calculi No Calculi No Calculi successful successful successful No No No No No No No Calculi No Calculi No Calculi No Calculi No Calculi No Calculi successful failed No No No urs done successful yes yes URS No 11/6/2009 No 16/10/09 No No No No No No No No Calculi No Calculi No Calculi hematuria No Calculi No Calculi successful successful No No No Yes No no no successful successful successful successful successful successful successful no no Yes no no no Yes No No 30/10/2009No No No No 26/11/2009No No Calculi No Calculi No Calculi steinstrass No Calculi No Calculi No Calculi No Calculi successful No successful successful successful UTI/SepsisOther com8 wk follow12 wk follow up No No Calculi No Calculi hematuria hematuria No Calculi No Calculi No Calculi No Calculi No Calculi No Calculi No Calculi No Calculi No Calculi No Calculi No Calculi No Calculi No Calculi No Calculi No Calculi No Calculi No Calculi No Calculi successful successful no Yes successful no No 28/12/2009No No Calculi No Calculi hematuria No Calculi No Calculi No steinstrass No Calculi No Calculi
© Copyright 2024