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www.wjpps.com Vol 7, Issue 9, 2018.
1087
Philipraj et al. World Journal of Pharmacy and Pharmaceutical Sciences
A PROSPECTIVE RANDOMIZED TRIAL COMPARING OUTCOMES
OF EXTRACORPOREAL SHOCKWAVE LITHOTRIPSY(ESWL) AND
PERCUTANEOUS NEPHROLITHOTOMY(PCNL) IN RENAL
CALCULI OF SIZE BETWEEN 1-2 CENTIMETERS
Dr. S. Brahadeeswaran, *Prof. S. Joseph Philipraj, Dr. Vishnuvardhan R.
Department of Urology, Mahatma Gandhi Medical College and Research Institute, Sri Balaji
Vidyapeeth University.
*Department of Statistics, Pondicherry University Pondicherry, South India.
INTRODUCTION
Nephrolithiasis is a highly prevalent disease worldwide with rates
ranging from 7 to 13% in North America, 5-9% in Europe, and 1-5%
in Asia.[1]
The lifetime risk of developing a symptomatic stone event
has continued to increase over the last several decades. On an average
6% woman and 12% men are affected with renal stone. Recurrence
rate of nephrolithiasis is 70-80% in males and 47-60% in females.
Currently evidences suggests that nephrolithiasis is associated with
systemic diseases like Obesity, Diabetes, and Cardiovascular disease.
Nephrolithiasis places a significant burden on the health care system,
which is likely to increase with time.[2]
The increasing prevalence of urolithiasis necessitates safe, efficacious, and affordable
treatment. The three most common procedures performed to remove upper urinary tract
stones are shockwave lithotripsy (SWL), Retrograde Intra Renal Surgery(RIRS), and
percutaneous nephrolithotomy (PCNL). Technological advances and changing treatment
patterns have had an impact on current treatment recommendations, which have clearly
shifted towards Endo urologic procedures. It is well known and has been proven in several
studies that ESWL is the first choice of treatment in renal calculus of less than 1cm and
PCNL for Renal calculus more than 2 cm. The management of calculi measuring between 1
and 2 cm continues to evoke debate and the ideal treatment remains controversial.[3,4]
This
prospective study is done to compare ESWL and PCNL for Renal calculus of size 1-2 cms.
WORLD JOURNAL OF PHARMACY AND PHARMACEUTICAL SCIENCES
SJIF Impact Factor 7.421
Volume 7, Issue 9, 1087-1108 Research Article ISSN 2278 – 4357
Article Received on
11 July 2018,
Revised on 01 August 2018,
Accepted on 21 August 2018
DOI: 10.20959/wjpps20189-12322
*Corresponding Author
Prof. S.Joseph Philipraj
Department of Urology,
Mahatma Gandhi Medical
College and Research
Institute, Sri Balaji
Vidyapeeth University.
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Aims and Objectives
To compare the efficacy of both ESWL and PCNL in terms of,
- Stone free rate post procedure in Renal stone of size between 1 and 2cms.
- Requirement of Secondary interventions.
- Incidence of Complications Clavien Dindo Grading system.
METHODOLOGY
This is a Prospective Randomized trial conducted in the Department of Urology at Mahatma
Gandhi Medical College, Pondicherry a tertiary referral centre between April 2014 and
September 2015. A total of 100 patients with solitary Renal calculus of size between 1 and 2
cms were enrolled during the study period. Patients were Randomised with computer
generated numbers in to Percutaneous Nephrolithotomy (PCNL) and Extracorporeal
Shockwave Lithotripsy (ESWL) groups.
Sample Size
The sample size was designed as Binary outcome superiority trial. Taking a significance level
(α) as 5% and power (1-β) of the study as 80%, percentage success of ESWL as 70-75% and
percentage success of PCNL as 90-95% (depending on previous studies), sample size was
calculated. 94 patients are required (47 in each group) to have a 80% chance of detecting, as
significant at the 5% level, an increase in the primary outcome measure.
ESWL Procedure
• Patient was placed in supine position.
• Procedure was done under fluoroscopic guidance.
• Procedure was done under sedation (Pentazocine 30mg IM) or under local anaesthesia
(Prilocaine + Lidocaine).
• A maximum of 3000 shocks were given.
• Initial 500 shocks were given at low intensity & gradually increased for the next 1000-2500
shocks.
• Adequate hydration and analgesia were given during and after the procedure.
ESWL Machine was Siemens Modularis Varistar.
PCNL Procedure
• The Procedure was done under general anaesthesia in prone position under fluoroscopic
guidance.
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• Ureteric catheter was passed and retrograde pyelography was done in lithotomy position for
initial assessment.
• 16Fr Foleys catheter was placed in the urinary bladder.
• Patient was then turned to prone position.
• Targeted calyx was accessed either by subcostal or supracostal approach by bulls eye
technique.
• Tract was dilated up to 12-18F with Teflon dilators or metal dilators in case of MINI PCNL.
• Tract was dilated up to 22-26F for standard PCNL.
• Nephroscope was passed to survey the kidney and the calculus.
• Calculus fragmented using pneumatic lithoclast.
• DJ stent and Nephrostomy tube were placed based on intra operative finding.
RESULTS
The data was collected from the patients who underwent PCNL and ESWL in a solitary
Renal calculus of size between 1 and 2 cms in Mahatma Gandhi Medical College and
Research Institute.
Table I- Age Group.
Age in years PCNL Group ESWL Group
Number % Number %
18-20 4 8 1 2
21-30 9 18 8 16
31-40 14 28 16 32
41-50 10 20 14 28
51-60 8 16 3 6
61-70 5 10 6 12
71-75 0 0 2 4
Total 50 100% 50 100%
Mean ± SD 40.96±14.08 42.16±14.33
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Mean age in both the groups were similar. Majority were in 20-50 age group.
Table II- Gender Distribution.
Gender Group PCNL Group ESWL
No % No %
Female 10 20.0 13 26.0
Male 40 80.0 37 74.0
Total 50 100.0 50 100.0
This There was a male preponderance, 80% and 20% in PCNL group, whereas 74% and 26%
in ESWL group.
Table III- Location of stone.
Side Group PCNL Group ESWL
No % No %
Left 30 60.0 29 58.0
Right 20 40.0 21 42.0
Total 50 100.0 50 100.0
There was similarity in the sides in both the groups. L > R.
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Table IV- Size of the calculus.
PRE-OP USG &
X-RAY KUB
SIZE (CMS)
Group PCNL Group ESWL
No % No %
1.0-1.5 23 46.0 24 48.0
1.6-2.0 27 54.0 26 52.0
Total 50 100.0 50 100.0
The size of the Calculus size was divided in two groups (1.0-1.5cm and 1.6-2.0cm). The
percentage of Renal units harbouring Calculus of 1-1.5 cm stone was 46% PCNL group and
48% in ESWL group. The calculus between 1.6-2 cm was 54% in PCNL and 52% in ESWL
group.
Table V: Location of calculus based on USG.
USG
Location
Group PCNL Group ESWL
No % No %
UP 10 20.0 08 16.0
MP 12 24.0 13 26.0
LP 14 28.0 12 24.0
Pelvis 14 28.0 17 34.0
Total 50 100.0 50 100.0
Mmajority of the calcului were present in the pelves in both PCNL and ESWL groups.
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Table VI: Post-Operative assessment by X-ray and USG.
Post-op X-RAY with USG
correlation (cms)
(Immediately after procedure 48
hours for PCNL & 5 days for
ESWL)
Group PCNL
(n=50)
Group ESWL
(n=50)
No % No %
CALCULUS ABSENT 47 94.0 21 42.0
CALCULUS PRESENT 3 6.0 29 58.0
TOTAL 50 100.0 50 100.0
Post-operatively, 6% of patients in PCNL group showed residual calculi whereas 58% of
patients in ESWL group showed residual calculus.
Table VI: Post-operative assessment by X-ray and USG at 1 month follow-up.
X-RAY KUB WITH USG
CORRELATION (CMS) AT 1
MONTH
Group PCNL
(n=48)
Group ESWL
(n=45)
No % No %
CALCULUS ABSENT 46 96.0 28 62.0
CALCULUS PRESENT 2 4.0 17 38.0
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All the patients in both the groups were assessed at one month follow-up, 4% in PCNL group
and 38% in ESWL group had residual calculi based on X-ray and Ultrasound.
Table VII: Incidence of complications.
COMPLICATIONS
Group PCNL
(n=48)
Group ESWL
(n=45)
No % No %
NIL 32 64.0 43 86.0
YES 16 32.0 2 4.0
CD GRADE 1 14 28 1 2
CD GRADE 2 2 4 1 2
CD – Clavien Dindo Grading system
Figure : 9
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In PCNL group, 32% of patients had complications (CD Grade I – 28% & CD Grade II -
4%) and in ESWL group, Only 4% of patients had complications( CD Grade I – 2% & CD
Grade II – 2%).
In PCNL group, both the patients had bleeding which was treated by inj. Tranexemic acid
500mg iv for one patient and the other patient was treated with blood transfusion whereas in
the ESWL group, one patient had peri-renal hematoma during the second session of ESWL
who also required blood transfusion.
Table VIII: Secondary interventions.
SECONDARY
INTERVENTIONS
Group PCNL
(n=48)
Group ESWL
(n=45)
No % No %
NIL 46 96 32 71
YES 2 4 13 29
ESWL 1 2 0 0
RIGHT URSL 1 2 1 2.2
LEFT URSL 0 0 1 2.2
PCNL 0 0 5 11.1
RIRS 0 0 6 13.3
In PCNL group, two patients required secondary intervention where as in the ESWL group,
thirteen patients required secondary intervention.
Table IX- Distribution of secondary interventions in ESWL groups.
ESWL
GROUP
(n=45)
Total
number
No secondary
Intervention
Secondary
Intervention
Secondary
Intervention %
1.0-1.5cm 23 21 2 9
1.6-2.0cm 22 11 11 50
Total 45 32 13 59
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(1.0-1.5 vs 1.6-2.0 cm)
Out of 23 patients with calculus between 1and 1.5cm, only 2 patients required secondary
intervention whereas in out of 22 patients in calculus between 1.6 and 2 cm, 11 patients
required secondary intervention.
Table X- ESWL Failure rates.
Number Total UP MP LP PELVIS
1.0-1.5cm 23 4 4 6 9
FAILED 0 1 1 0
1.6-2.0cm 22 2 7 5 8
FAILED 0 4 4 3
In calculus measuring between 1 and 1.5cm in ESWL group, 23 patients required secondary
intervention in which 2 patients failed to succeed (1 patient with calculus in mid pole and1
patient with calculus in lower pole). In calculus measuring more than 1.5cm, 22 patients
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required secondary intervention in which 11 patients failed to succeed. 4 patients with
calculus in mid pole, 4 patients with calculus in lower pole and 3 patients with calculus in
pelvis.
Table XI: ESWL Vs PCNL (1.0-1.5cm) Secondary Intervention.
Procedure Number of
patients
Secondary
Intervention
ESWL 23 2
PCNL 22 1
Total 45 3
In renal calculus of less than 1.5cm, 2 out of 23 patients in ESWL group required secondary
intervention whereas 1 out of 22 patients in PCNL group required secondary intervention.
Table XII: ESWL VS PCNL (1.6 - 2.0 cm) Secondary Intervention.
Procedure Number of
patients
Secondary
Intervention
ESWL 22 11
PCNL 26 1
Total 48 12
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In renal calculus of more than 1.5cm, 11 out of 22 patients in ESWL group required
secondary intervention whereas 1 out of 26 patients in PCNL group required secondary
intervention.
Table XIII: Calculus (1.0 – 1.5 cm) Stone Free Rates.
Groups Calculus absent Calculus present Total
ESWL 21 2 23
PCNL 21 1 22
TOTAL 42 3 45
“P” Value – 0.576 (not significant)
With regards to stone free rates in calculus less than 1.5cm, 2 out of 23 patients in ESWL
group had residual calculus whereas in PCNL group 1 out 22 patients had residual calculus.
Table XIV: Calculus (1.6 – 2.0 cm) Stone Free Rates.
Groups Calculus absent Calculus present Total
ESWL 11 11 22
PCNL 25 1 26
TOTAL 36 12 48
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With regards to stone free rates in calculus more than 1.5cm, 11 out of 22 patients in ESWL
group had residual calculus whereas in PCNL group 1 out 26 patients had residual calculus.
Table XV: Hospital Stay.
Group < 2 Days >2 days Total
ESWL 40 5 45
PCNL 2 46 48
TOTAL 42 51 93
In ESWL group, 40 patients in ESWL group got discharged in less than 2 days whereas in
PCNL group only 2 patients got discharged within 2 days.
Statistical Analysis
This study was conducted to compare the stone free rate, complications and Hospital stay (in
days) pertaining to two procedures ESWL and PCNL in Renal stones of size between 1 and 2
cms. In order to make comparison between the ESWL and PCNL with respect to stone free
rate and complications, the appropriate statistical test is Z-test for two proportions, since the
data is in terms of proportions and Independent samples t test is for comparing the average
hospital stay (in days). The entire analysis was carried out using IBM SPSS 19.0 version and
results are compared at 0.05 level.
From the results it is noticed that there is a significant difference between the two procedures
in having stone free rates (p-value <0.05) and are indicated using subscripts „a‟ and „b‟. Of
the 72 records under stone free rate, 47 cases (65.3%) are observed with PCNL procedure,
whereas the ESWL resulted in 25 cases (34.7%). From this we can conclude that PCNL
provides good amount of stone free rates when the stone size is between 1-2 cms, compared
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to ESWL. However, similar kind of comparison is carried out by categorizing the stone size
in to „1-1.5 cms‟ and „1.5-2 cms‟. The results are shown in tables 2 and 3 with corresponding
multiple bar diagram representation.
Table 1: Comparison between ESWL and PCNL w.r.t Stone free rate.
Post \Op X Ray-USG
Immediate * Procedure
procedure Total
ESWL PCNL
Post Op X Ray-
USG
Immediate
NO
ROS
Count 25a 47b 72
% within
Post op X Ray-USG
Immediate
34.7% 65.3% 100.0%
% within Procedure 50.0% 94.0% 72.0%
ROS
Count 25a 3b 28
% within
Post Op Xray-USG
Immediate
89.3% 10.7% 100.0%
% within Procedure 50.0% 6.0% 28.0%
Total
Count 24 50 50
% within Post Op XRay -
USG
Immediate
52.2% 50.0% 50.0%
% within Procedure 100.0% 100.0% 100.0%
From the results in Table 2, it is evident that there is a significant difference between the two
procedures in having stone free rates (p-value <0.05) and are indicated using subscripts „a‟
and „b‟. Of the 35 records under stone free rate, 21 cases (60%) are observed with PCNL
procedure, whereas the ESWL resulted in 14 cases (40%). From this we can conclude that
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PCNL provides good amount of stone free rates when the stone size is between 1-1.5 cms,
compared to ESWL.
Table 2: Comparison between ESWL and PCNL w.r.t Stone free rate (1-1.5 cms).
POSTOPXRAY_USG
IMMEDIATE * PROCEDURE w.r.t SIZE 1.5-2 cm
1-1.5 cm Total
ESWL PCNL
POSTOPXRAY_USG
IMMEDIATE
NO
ROS
Count 14a 21b 35
% within
POSTOPXRAY_USG
IMMEDIATE
40.0% 60.0% 100.0%
% within PROCEDURE 58.3% 95.5% 76.1%
ROS
Count 10a 1b 11
% within
POSTOPXRAY_USG
IMMEDIATE
90.9% 9.1% 100.0%
% within PROCEDURE 41.7% 4.5% 23.9%
Total
Count 24 22 46
% within
POSTOPXRAY_USG
IMMEDIATE
52.2% 47.8% 100.0%
% within PROCEDURE 100.0% 100.0% 100.0%
Each subscript letter denotes a subset of PROCEDURE categories whose column
proportions do not differ significantly from each other at the .05 level.
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Table 3: Comparison between ESWL and PCNL w.r.t Stone free rate (1.5-2 cms).
POSTOPXRAY_USG
IMMEDIATE * PROCEDURE w.r.t SIZE 1.5-2 cm*
1.5-2 cm Total
ESWL PCNL
POSTOPXRAY_USG
IMMEDIATE
NO
ROS
Count 11a 26b 37
% within
POSTOPXRAY_USG
IMMEDIATE
29.7% 70.3% 100.0%
% within PROCEDURE 42.3% 92.9% 68.5%
ROS
Count 15a 2b 17
% within
POSTOPXRAY_USG
IMMEDIATE
88.2% 11.8% 100.0%
% within PROCEDURE 57.7% 7.1% 31.5%
Total
Count 26 28 54
% within
POSTOPXRAY_USG
IMMEDIATE
48.1% 51.9% 100.0%
% within PROCEDURE 100.0% 100.0% 100.0%
Each subscript letter denotes a subset of PROCEDURE categories whose column proportions
do not differ significantly from each other at the .05 level.
From the results in Table 3, it is also seen that there is a significant difference between the
two procedures in having stone free rates (p-value <0.05) and are indicated using subscripts
„a‟ and „b‟. Of the 37 records under stone free rate, 26 cases (70.3%) are observed with
PCNL procedure, whereas the ESWL resulted in 11 cases (29.7%). From this we can
conclude that PCNL provides good amount of stone free rates when the stone size is between
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1.5-2 cms, compared to ESWL. Now, when compared to 1-1.5 cms and 1.5-2 cms, the PCNL
is giving better results when the stone size is in between 1.5-2 cms.
Table 4: Comparison between ESWL and PCNL w.r.t COMPLICATIONS.
COMPLICATIONS * PROCEDURE PROCEDURE
Total ESWL PCNL
COMPLICATIONS
NIL
Count 43a 32b 75
% within
COMPLICATIONS 57.3% 42.7% 100.0%
% within PROCEDURE 95.6% 69.6% 82.4%
% of Total 47.3% 35.2% 82.4%
CD
GRADE 1
Count 1a 13b 14
% within
COMPLICATIONS 7.1% 92.9% 100.0%
% within PROCEDURE 2.2% 28.3% 15.4%
% of Total 1.1% 14.3% 15.4%
CD
GRADE 2
Count 1a 1a 2
% within
COMPLICATIONS 50.0% 50.0% 100.0%
% within PROCEDURE 2.2% 2.2% 2.2%
% of Total 1.1% 1.1% 2.2%
Total
Count 45 46 91
% within
COMPLICATIONS 49.5% 50.5% 100.0%
% within PROCEDURE 100.0% 100.0% 100.0%
% of Total 49.5% 50.5% 100.0%
Each subscript letter denotes a subset of PROCEDURE categories whose column proportions
do not differ significantly from each other at the .05 level.
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In Table 4, analysis showed that there exist a statistical significance (p-value<0.05) between
PCNL and ESWL in terms of complications recorded on the subjects. The distribution of
proportions across the categories of complications are NIL (82.4%), CD Grade 1 (15.4%) and
CD Grade 2 (2.2%) respectively. This gives rise to the meaning that majority of the patients
were not having complications with respect to any of the procedure but of the patients who
had complication of CD Grade 1 are observed with PCNL procedure (92.9%). Similar
structure of analysis is performed for two stone size categories to see whether the same
phenomena are noticed or not (see Table 5 and 6).
Table 5: Comparison between ESWL and PCNL w.r.t Complications (1-1.5 cms).
Complications * Procedure w.r.t 1-1.5 cm Procedure
Total ESWL PCNL
Complications
NIL
Count 20a 16a 36
% within
Complications 55.6% 44.4% 100.0%
% within Procedure 95.2% 76.2% 85.7%
% of Total 47.6% 38.1% 85.7%
CD Grade
1
Count 1a 5a 6
% within
Complications 16.7% 83.3% 100.0%
% within Proedure 4.8% 23.8% 14.3%
% of Total 2.4% 11.9% 14.3%
Total
Count 21 21 42
% within
Complications 50.0% 50.0% 100.0%
% within Procedure 100.0% 100.0% 100.0%
% of Total 50.0% 50.0% 100.0%
Each subscript letter denotes a subset of Procedure categories whose column proportions do
not differ significantly from each other at the .05 level.
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In Table 5, there exist no difference (p-value>0.05) between two procedures with respect to
different categories of complications. It can be interpreted that the proportion of subjects are
almost equally distributed in two procedures relating to each category of complication. From
the outcomes of Table 6 it is witnessed that there is a difference between PCNL and ESWL.
It is observed that, of the total cases, 39 (79.6%) cases does not have Complications, 8
(16.3%) are of CD Grade 1 and 2 (4.1%) are of CD Grade 2 respectively. Of the 39 around
23 (59%) cases belong to ESWL procedure and the rest are of PCNL. Under CD Grade 1, all
the 8 cases are observed with PCNL Procedure and with respect to CD Grade 2, there is a
equal distribution of cases in ESWL and PCNL, that is one case in each procedure. On the
whole, it is understood that complications are noticeable when the stone size is in between
1.5-2 cms, having greater complications with PCNL procedure.
Table 6: Comparison between ESWL and PCNL w.r.t Complications (1.5-2 cms).
Complications * Procedurew.r.t 1.5-2 cm Procedure
Total ESWL PCNL
Complications
NIL
Count 23a 16b 39
% within
Complications 59.0% 41.0% 100.0%
% within Procedure 95.8% 64.0% 79.6%
% of Total 46.9% 32.7% 79.6%
CD Grade
1
Count 0a 8b 8
% within
Complications 0.0% 100.0% 100.0%
% within Procedure 0.0% 32.0% 16.3%
% of Total 0.0% 16.3% 16.3%
CD
Grade 2
Count 1a 1a 2
% within
Complications 50.0% 50.0% 100.0%
% within Procedure 4.2% 4.0% 4.1%
% of Total 2.0% 2.0% 4.1%
Total
Count 24 25 49
% within
Complications 49.0% 51.0% 100.0%
% within Procedure 100.0% 100.0% 100.0%
% of Total 49.0% 51.0% 100.0%
Each subscript letter denotes a subset of Procedure categories whose column proportions do
not differ significantly from each other at the .05 level.
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Further, comparison is also carried out for hospital stay (in days) between PCNL and ESWL.
It is observed that the average hospital stay differ significantly (p-value<0.05). From the
summary statistics, the average duration of hospital stay is comparatively high in PCNL (3.88
equivalent about 4 days) than that of ESWL(1.6 equivalent to 2 days ). Similar comparison is
done for 1-1.5 cms and 1.5-2 cms. This resulted in an significant outcome and the average
duration of hospital stay is tend to be more for PCNL procedure than ESWL. This means that
the patients who have undergone the PCNL procedure meets longer stay than those with
ESWL. The following are the summary highlights of the study.
Better results with respect to stone free rates is observed with PCNL than ESWL in over
all, 1-1.5 cms and 1.5-2 cms.
However, complications and duration of hospital stay is also at higher levels with PCNL
than ESWL.
Under 1-1.5 cms of stone size both PCNL and ESWL have similar proportion of
complications, where in it differed at 1.5-2 cms stone size.
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Procedure N Mean Std. Deviation t-test (p-value)
Hospital Stay
In Days
ESWL 50 1.60 .948 13.559(0.000*)
PCNL 50 3.88 .718
T-Test
Group Statistics
Procedure
w.r.t 1-1.5 cm N Mean Std. Deviation t-test (p-value)
Hospital Stay
In Days
ESWL 24 1.67 .816 9.697 (0.000*)
PCNL 22 3.86 .710
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T-Test
Procedure
w.r.t 1.5-2 cm N Mean Std. Deviation t-test (p-value)
Hospital Stay
In Days
ESWL 26 1.54 1.067 9.491(0.000*)
PCNL 28 3.89 .737
CONCLUSIONS
Stones in the urinary tract are a common medical problem in the general population. At
present, the great expansion in minimally invasive techniques has led to the decrease in open
surgery. Extracorporeal shock wave lithotripsy (ESWL) has been introduced as an alternative
approach to open surgery which disintegrates stones in the kidney and upper urinary tract
through the use of shock waves. Because of the limitations with the success rate in ESWL,
other minimally invasive modalities for kidney stones such as percutaneous nephrolithotomy
(PCNL) have come in to practice.[5-8]
The success of treatment significantly greater in the PCNL compared to the ESWL group.
Re‐treatment and use of auxiliary procedures was higher in ESWL group compared to
PCNL.[8,9,10]
The efficiency was higher for PCNL than ESWL. Duration of treatment and
hospital stay were significantly shorter in the ESWL group.[5-10]
Overall more complications
were reported with PCNL which is inherent with the invasiveness of the procedure.
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REFERENCES
1. Sorokin I et al. Epidemiology of stone disease across the world. World J Urol. 2017 Sep;
35(9): 1301-1320.
2. Justin B. Ziemba, Brian R. Matlaga. Epidemiology and economics of nephrolithiasis.
Investig Clin Urol 2017; 58: 299-306.
3. Galvin DJ, Pearle MS. The contemporary management of renal and ureteric calculi. BJU
Int 2006; 6: 1283-8.
4. Srisubat A, Potisat S, Lojanapiwat B, Setthawong V, Laopaiboon M. Extracorporeal
shock wave lithotripsy (ESWL) versus percutaneous nephrolithotomy (PCNL) or
retrograde intrarenal surgery (RIRS) for kidney stones. Cochrane Database Syst Rev
2009; 4.
5. Albala DM, Assimos DG, Clayman RV, Denstedt JD, Grasso M, Gutierrez‐Aceves J, et
al. Lower pole I: a prospective randomized trial of extracorporeal shock wave lithotripsy
and percutaneous nephrostolithotomy for lower pole nephrolithiasis‐initial results. Journal
of Urology 2001; 166(6): 2072‐80.
6. Carlsson P, Kinn AC, Tiselius HG, Ohlsen H, Rahmqvist M. Cost effectiveness of
extracorporeal shock wave lithotripsy and percutaneous nephrolithotomy for
medium‐sized kidney stones. A randomised clinical trial. Scandinavian Journal of
Urology & Nephrology 1992; 26(3): 257‐63.
7. Menon M. Cost effectiveness of extracorporeal shock wave lithotripsy and percutaneous
nephrolithotomy for medium‐sized kidney stones: a randomised clinical trial. Journal of
Urology 1993; 150(2 Pt 1): 565.
8. Deem S, Davalos J, Defade B, Martinez F. Percutaneous nephrolithotomy versus
extracorporeal shockwave lithotripsy for moderate sized kidney stones [abstract]. Journal
of Urology 2010; 183(4 Suppl 1): e702‐3.
9. Deem S, De‐Fade B, Modak A, Emmett M, Martinez F, Davalos J. Percutaneous
nephrolithotomy versus extracorporeal shock wave lithotripsy for moderate sized kidney
stones. Urology 2011; 78: 739‐43.
10. Pearle MS, Lingeman JE, Leveillee R, Kuo R, Preminger GM, Nadler RB, et al.
Prospective, randomized trial comparing shock wave lithotripsy and ureteroscopy for
lower pole caliceal calculi 1 cm or less. Journal of Urology 2005; 173(6): 2005‐9.