Randomised control trail to compare the efficacy of ESWL versus

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