A PROSPECTIVE RANDOMIZED TRIAL COMPARING OUTCOMES …

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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.

Transcript of A PROSPECTIVE RANDOMIZED TRIAL COMPARING OUTCOMES …

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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.