PG Thesis Protocol Review Performa

To be filled by the PG Student

1. Name of the Candidate : Dr. Shubham Gupta Batch: 2021

2. Department : Surgery
3. Name of the Guide : Dr. (Prof.) Sanjay Pandey, MBBS, MS SURGERY
Professor, Dept. of Surgery, 9897084770
4. Co-guide/s : Dr. Anurag Tomer M.B.B.S., M.S. SURGERY
Assistant Professor, Department of Surgery

Dr. Shakul Prakash Kaushik MBBS, M.S. SURGERY,

DrNB Urology, Assistant Professor, Department of Surgery

Dr. Sachin Agrawal MBBS, M.D. RADIOLOGY

Associate Professor, Department of Radio Diagnosis

Dr. Ravi Pratap Singh MBBS, MD BIOCHEMISTRY

Associate Professor, Department of Biochemistry

5. Thesis Title : EVALUATION OF TYPES OF URINARY STONE BY

CONVENTIONAL RADIOLOGICAL AND BIOCHEMICAL
METHOD AND BIOCHEMICAL STONE ANALYSIS IN A
TERTIARY CARE CENTRE
6. Research Question : Whether we can predict the type of stone on the basis
of conventional radiological and biochemical tests in
comparison to FTIR stone analysis?

(Please attach the budget for the project)

(For Office Use)

F - Feasibility: ..........................................................................................................................
...................................................................................................................................................
I –Interesting: ..........................................................................................................................
..................................................................................................................................................
N- Novelty: ..........................................................................................................................
..................................................................................................................................................
E- Ethical: ................................................................................................................................
..................................................................................................................................................
R- Relevance: ..........................................................................................................................
..................................................................................................................................................

7. Methodology

1
 a. Clarity of Study Design
i. Design

ii. Method & Duration of Data Collection

iii. Instruments/Assays

b. Clarity of Statistical Analysis

i. Sample Size -

ii. Data Assessment

8. Funding

a. Total Budget:
b. Applicable for funding: (Yes/No)
c. Funding options recommended:

9. Summary:

Decision:

Accepted Needs revision Rejected

Signature of Members:

Signature of Chairperson SRC:

Expected Budget of Thesis

2
S. No Description Expected Number Total
expenditure
1. Laboratory / Radiology
Investigation (Routine)
CBC 160 200 32000
KFT 600 200 120000
URINE R/M 50 200 10000
IVP 1410 200 282000
2. Laboratory/ Radiology
special investigation (if
any)
NCCT KUB 1320 200 264000

STONE ANALYSIS 1050 200 210000

3. Stationary, typing & 20 200 4000

printing charges of
dissertation
4. Research article 11000
publication charges.

5. Total 9,33,000

PROTOCOL FOR THESIS FOR MASTER OF SURGERY (MS)

3
 IN GENERAL SURGERY

N.S.C.B. SUBHARTI MEDICAL COLLEGE

SWAMI VIVEKANAND SUBHARTI UNIVERSITY, MEERUT

PROPOSED TITLE OF THESIS

EVALUATION OF TYPES OF URINARY STONE BY CONVENTIONAL

RADIOLOGICAL AND BIOCHEMICAL METHOD AND
BIOCHEMICAL STONE ANALYSIS IN A TERTIARY CARE CENTRE

DR. SHUBHAM GUPTA

DEPARTMENT OF GENERAL SURGERY
SUBHARTI MEDICAL COLLEGE,
SWAMI VIVEKANAND SUBHARTI UNIVERSITY,
MEERUT
2021-2024

4
PROTOCOL OF PROPOSED THESIS TOPIC FOR MASTER OF
SURGERY DEPARTMENT OF GENERAL SURGERY SWAMI
VIVEKANAND SUBHARTI UNIVERSITY, MEERUT

Proposed title of thesis

EVALUATION OF TYPES OF URINARY STONE BY CONVENTIONAL

RADIOLOGICAL AND BIOCHEMICAL METHOD AND
BIOCHEMICAL STONE ANALYSIS IN A TERTIARY CARE CENTRE

GUIDE

DR.(Prof.) SANJAY PANDEY

M.B.B.S., M.S. SURGERY
Professor
Department of Surgery
Subharti Medical College, Meerut.

CO- GUIDE
DR. ANURAG TOMER
M.B.B.S., M.S. SURGERY
Assistant Professor
Department of Surgery

DR. SHAKUL PRAKASH KAUSHIK

M.B.B.S., M.S. SURGERY, DrNB UROLOGY
Assistant Professor
Department of Surgery

5
 Dr. SACHIN AGRAWAL
MBBS, M.D. RADIOLOGY
Associate Professor
Department Of Radio Diagnosis

DR. RAVI PRATAP SINGH

MBBS, M.D. BIOCHEMISTRY
Associate Professor
Department Of Biochemistry

6
To,
The Dean

N.S.C.B. SUBHARTI MEDICAL COLLEGE

Swami Vivekanand Subharti University,

Meerut

Through: Proper Channel

Sir,

I humbly submit the following particulars for registration of my Thesis for MS in General
surgery examination of S.V.S.U. to be held in March/April 2024

1. FIRST NAME – SHUBHAM

2. SURNAME – GUPTA

3. YEAR OF GRADUATION – 2019

4. COLLEGE AND UNIVERSITY FROM WHICH GRADUATED – HARBIN MEDICAL

UNIVERSITY, HARBIN, HEILONGJIANG, P.R. CHINA

5. PROPOSED TITLE OF THESIS – EVALUATION OF TYPES OF URINARY STONE

BY CONVENTIONAL RADIOLOGICAL AND BIOCHEMICAL METHOD AND
BIOCHEMICAL STONE ANALYSIS IN A TERTIARY CARE CENTRE

6. DEPARTMENT UNDER WHICH SUBJECT OF THESIS FALLS- DEPARTMENT OF

GENERAL SURGERY.

PLACE: Meerut ....................................

(Signature of candidate)

7
 RECOMMENDATION OF HEAD OF DEPARTMENT

Recommended that the subject is suitable for thesis for MS in General Surgery
and can be registered as such.

Dr. SHASHANK MISHRA

M.S. (General Surgery) FMAS, FIAGES, FCLS, FAIS

Professor and Head Department of General Surgery

Subharti Medical College Meerut

8
 CONTENTS
1.INTRODUCTION : 11

2.AIMS AND OBJECTIVES : 13

3.REVIEW OF LITERATURE : 14

4.MATERIAL AND METHODS : 20

5.BIBLIOGRAPHY : 22

6.WORKING PROFORMA : 24

7.CONSENT FORM : 26

9
 PROFORMA FOR REGISTRATION OF THESIS

FOR M.S. (GENERAL SURGERY) – 2021 SUBHARTI UNIVERSITY, MEERUT

(U.P.)

NAME OF THE CANDIDATE: Dr. SHUBHAM GUPTA

DEPARTMENT: GENERAL SURGERY

TITLE OF DISSERTATION: EVALUATION OF TYPES OF URINARY STONE BY

CONVENTIONAL RADIOLOGICAL AND BIOCHEMICAL METHOD AND
BIOCHEMICAL STONE ANALYSIS IN A TERTIARY CARE CENTRE

PLACE: Meerut ....................................

(Signature of candidate)

10
 INTRODUCTION

Stones that develop in the urinary tract (known as nephrolithiasis or urolithiasis) form when
the urine becomes excessively supersaturated with respect to a mineral, leading to crystal
formation, growth, aggregation and retention within the kidneys. Globally, approximately
80% of kidney stones are composed of calcium oxalate (CaOx) mixed with calcium
phosphate (CaP). Stones composed of uric acid, struvite and cystine are also common and
account for approximately 9%, 10% and 1% of stones, respectively. Urine can also become
supersaturated with certain relatively insoluble drugs or their metabolites, leading to
crystallization in the renal collecting ducts (iatrogenic stones)1.

Stone formation is a common disease, with an estimated 5-year recurrence rate of up to

50%. The prevalence of stones has been consistently increasing over the past 50 years and
further increases are expected owing to changing lifestyle, dietary habits and global warming.
Obesity, diabetes, hypertension and metabolic syndrome are considered risk factors for stone
formation; conversely, stone formers are at risk of hypertension, chronic kidney disease
(CKD) and end-stage renal disease (ESRD)1.

Urologists are able to determine the chemical composition of retrieved stones only post-
operatively using crystallography (e.g., infrared spectroscopy). Knowledge of stone
composition prior to treatment can help guide optimal management. Firm stones, such as
cystine and calcium oxalate monohydrate, are less likely to be successfully fragmented via
extracorporeal shock-wave lithotripsy (ESWL), instead necessitating invasive endourological
treatment such as ureterorenoscopy or percutaneous nephrolithotomy (PCNL). Uric acid
stones can be dissolved medically with urinary alkalinization therapy, such as oral potassium
citrate solution & allopurinol. Patients with familial metabolic stone diseases may also
benefit from medical therapy; for example, captopril in patients with cystinuria 2.

The three most common techniques for stone analysis are in vitro x-ray diffraction, infrared
spectroscopy, and polarization microscopy. In addition to being costly and time consuming
and not being easily available, these methods have a major disadvantage in that the chemical
analysis of the stones is performed only after the stones are extracted. Thus, they offer no
benefit during preoperative treatment planning. Nonenhanced computed tomography (CT) of
the abdomen and pelvis is currently the reference-standard examination for the diagnosis and

11
evaluation of urinary stones, and it is widely used owing to its safety and reported high
sensitivity (96%)3.

A sensitive preoperative test or series of tests that can predict the composition of the urinary
stones accurately is highly desirable. Hence the present study will be conducted to evaluate
types of urinary stone by conventional radiological method and biochemical method and
biochemical stone analysis in a tertiary care centre. If radiological/biochemical tests or their
combination i.e. IVP, NCCT KUB, Urine R/M and it’s physical appearance – can predict the
chemical composition of the stone then we will be able to bypass the need of the more
expensive post-operative biochemical stone analysis test.

12
 AIMS AND OBJECTIVES

Primary Aim

1. To find out whether prediction of the chemical composition of the urinary stones by
pre-operative Urine R/M, IVP, NCCT scan of KUB region, and physical appearance,
can be done in co-relation with stone analysis by FTIR spectroscopic method.

Secondary Aim

2. To study the clinical profile i.e., presenting complains, location, shape, size etc. of
urinary stones presenting in our tertiary care centre.
3. To calculate the individual prediction scores of different modalities for prediction of
chemical composition of stone.

13
 REVIEW OF LITERATURE

Sudhamsu Koirala9 in 2014 conducted a study on significance of analysing chemical

composition of renal stones. Renal stones were analysed using simple qualitative biochemical

tests.The stones were checked for presence of calcium, magnesium, ammonium, oxalate,

phosphate, uric acid, cystine and carbonate. Results showed that calcium was present in

97.8%, ammonium was present in 98.9%, phosphate was present in 25.2%, uric acid was

present in 17.8%, magnesium was present in 10.5%, carbonate was present in 2.1% and

cystine was not present in any of the stones. Most of the stones were composed of mixture of

two or more than two of the above mentioned elements. Authors concluded most stones are

mixture of more than two cations and anions. Studies on larger test samples and if possible in

correlation with routine examination of urine and urinary electrolyte excretion in a 24 hr

urine sample would further aid in efforts aimed at preventing stone recurrence.

Sudip Das Gupta et al10 in 2015 conducted a study on chemical composition of urinary tract

stones: experience in a medical college hospital, in Dhaka. A cross sectional hospital based

study was conducted among 140 patients from October 2011 to September 2014 in SSMC &

MH. The study included all patients of either gender and all ages who were diagnosed to have

urinary tract stones and were managed in their hospital. Chemical analysis of stones were

performed on stones, fragments, gravel’s passed spontaneously, or retrieved from

endourological intervention or after ESWL or open surgery. Results were reviewed and

analyzed with the help of SPSS17. Result showed that out of 140 patients about one third

(31.4%) were female and two thirds were (68.6%) male. Most of the patients belong to age

group 40-50 years. Mean age of the patients was 43.74 years with standard deviation of 10.28

years. 20% of the patients have recurrent stones. By the type of symptoms all of the patients

had loin or back pain. One third of the patients had (36.7%) calcium oxalet stones, more than

one fourth of respondents (27.1%) had mixed stones and 12.9% had magnesium, ammonium

14
phosphate stones. Calcium containing stones were the most (60%). Authors concluded that

calcium containing stones constitute the most common variety of urinary tract calculi in the

local population.

Francisco R. Spivacow et al5 in 2016 conducted a study on kidney stones: composition,

frequency and relation to metabolic diagnosis. In a subset of 715 patients, we performed an

ambulatory metabolic protocol with diagnostic purposes. From the total sample 79% of

stones were made of calcium salts (oxalate and phosphate), followed by uric acid stones in

16.5%, calcium salts and uric acid in 2%, other salts in 1.9% and cystine in 0.6%. Male to

female ratio was almost three times higher in calcium salts and other types of stones, reaching

a marked male predominance in uric acid stones, M/F 18.8 /1.0. The major risk factors for

calcium stones are idiopathic hypercalciuria, followed by unduly acidic urine pH and

hyperuricosuria. In uric acid stones unduly acidic urine pH and less commonly

hyperuricosuria are the most frequent biochemical diagnosis. Their results show that analysis

of kidney stones composition and the corresponding metabolic diagnosis may provide a

scientific basis for the best management and prevention of kidney stone formation, as well as

it may help us to study the mechanisms of urine stone formation.

Colin J. McCarthy et al7 in 2016 conducted a study on radiology of renal stone disease.

Nephrolithiasis is a common cause of abdominal pain and will affect approximately 1 in 10

people in their lifetime. In the past two decades, there have been several technological

advances that have changed the imaging approach to stone diagnosis and follow-up. We

present a review of the current imaging evaluation for renal stone disease, and outline how

new technology has helped with diagnosis and management.

Selçuk Sarıkaya et al4 in 2020 conducted a cross-sectional single-center experience on

analysis of urinary stone types’ distribution in Turkey according to the geographical regions

15
where patients were born and live. The patients who were treated for urinary system stone

disease in our hospital between January 2011 and March 2019 were included in the study.

Stone samples were collected by endoscopic stone surgery methods or shock wave

lithotripsy. Stone analyses were made with manual chemical analysis methods. Stone types

and distribution were recorded according to geographical regions of Turkey. Results showed

that a total of 706 patients who were treated for urolithiasis were included in the study.

Calcium oxalate (CO) stones were at the highest rates for both genders [127 (68.6%) and 359

(68.9%), for females and males, respectively]. There were no statistically significant

differences in terms of stone types between genders (p=0.323). There were statistically

significant more CO (297), uric acid (17), mixed stones (78) in the Anatolian (central) region

than the other regions according to the geographical region where patients were born

(p<0.001, for each). Additionally, there were significantly more calcium phosphate stone

formers (25) in the Anatolian region according to the geographical region where patients

lived (p<0.001). Authors concluded that CO is the most common stone type in Turkey

independently of where patients were born or where patients live. Higher prevalence rates of

stone disease and CO stones were seen in Central Anatolia. Both geographic origin and

dietary habits affect the incidence of urinary system stone disease.

Pratima Shah et al6 in 2020 conducted a study on urinary calculi: a microbiological and

biochemical analysis at a tertiary care hospital in eastern Nepal. A total of 88 cases of

urolithiasis admitted for elective stone removal at Department of surgery, B.P. Koirala

Institute of Health Sciences (BPKIHS), were enrolled. Preoperative urine culture and

postoperative stone culture were performed. Isolation, identification, and AST were done by

the standard microbiological technique. Further qualitative biochemical analysis of stones

was also attempted. Result showed that among 88 stone formers recruited, culture of urine,

whole stone, and nidus yielded the growth of bacteria 44, 32, and 30, respectively. Bacteria

16
isolated from urine culture correlated with those from stone matrices with a sensitivity of

90%, specificity of 79.69%, PPV of 63.64%, and NPV of 95.45%. Escherichia coli (46.7%)

was the most common bacteria followed by Klebsiella pneumoniae (16.7%) and Proteus

mirabilis (13.3%) from urine and stone cultures. Almost all the uropathogens isolated were

susceptible to commonly used antibiotics. Calcium oxalate (84.1%) was common

biochemical constituent found in stone formers followed by calcium oxalate + phosphate

(8%). Authors concluded that the association of microorganism isolated from urine and nidus

culture was significant that can predict the source of infective stone; however, in some cases,

microorganisms and the antimicrobial susceptibility pattern from urine and nidus were

different. %is study emphasizes the use of appropriate antimicrobial agents to prevent the

regrowth of residual stones and minimize the risk of infectious complications after surgical

removal of stones.

Waliul Islam et al8 in 2021 conducted a study on spectrum of chemical analysis of 150

consecutive upper urinary tract stones with critical analysis in respect of demographic and

geographical distribution. 150 patients of upper tract urolithiasis were prospectively selected

during the study period. Chemical composition was analyzed by FTIR spectroscopy. A

subgroup study based on the patient's age, sex and geographical origin was done. For

subgroup analysis patients were divided into two age groups; group A (5-18 years, 14

patients) and group B (>18 years, 136 patients). The geographical origin of the patients was

recorded according to the administrative division. Results showed that male were

predominant in all age groups with ratio of 2.49:1. Most of the patients were from Rangpur

(28.67%) and Mymensingh (20.67) division. Mixed composition stones were much more

common than pure one (75.99% vs 24.01%). Overall, combination of calcium oxalate

monohydrate with dehydrate was the most common composition (56.67%). Calcium oxalate

was the predominant chemical composition in 82% of stones, followed by struvite in 9.33%,

17
apatite in 4.67%, uric acid in 3.33% and cystine in 0.67%. The proportion of calcium oxalate

stone was increasing while that of struvite, uric acid, and cystine stone was decreasing with

age. But stone composition did not show any significant difference on geographical

distribution. Authors concluded that calcium oxalate is the most common composition of

urinary stones in all age groups. Mixed stones are more common than pure ones. The

incidence of calcium oxalate stone increases while that of struvite, uric acid, and cystine

stone decreases with age.

Pushpa Durgawale et al11 in 2010 conducted a study on Chemical analysis of stones and its

significance in urolithiasis, The study included one hundred and twenty five uroliths obtained

by surgical intervention of Urolithiasis patients, clinically and radiographically diagnosed at

Krishna Hospital and research centre Karad a South-West region of Maharashtra (India),

during a period of 2006-2008.The data of Urolithiasis cases was collected with the help of

structured questionnaire proforma. The stones obtained from Surgery department to clinical

Biochemistry laboratory were washed with distilled water to remove the debris, dried

completely and weighed. The stones were cut and crushed, the powdered form was

qualitatively analyzed for their chemical composition adopting standard methods [13] using

chemicals of Analytical reagent grade. Results showed that High percentage of urolithiasis

was reported in males than females of age group between 31-60 years. When the uroliths

were grouped according to their locations in the urinary tract, the result of analysis showed a

high incidence of stones in ureter followed in the order by bladder, urethra and kidney. All

the analyzed uroliths were of heterogenous mixed type, each was chemically different.

Jonathan Cloutier et al12 in 2014 conducted a study on Kidney stone analysis Chemical and

physical methods are both used for analysis. The manuscript provides a review on analytic

methods and review all the information that should be included into an appropriate morpho-

18
constitutional analysis. It can supply an excellent summarization of the stone morphology and

give the opportunity to find specific metabolic disorders and different lithogenic process into

the same stone. Here, specific chemical types with their different crystalline phases are

shown in connection with their different etiologies involved.

19
 MATERIALS AND METHOD

Study site: Department of General Surgery, N.S.C.B Subharti Medical College, Meerut

Study design: Prospective study

Study duration: December 2022 to 2024

Sample size: 200

The study will be a prospective study on urogenital stones presenting to department of

Surgery at Chhatrapati Shivaji Subharti, Hospital during the period from December 2022 to
2024.

Definitions

a. Pure stones in our study will be defined as stone composed of ≥90% of the reported
composition.

b. Mixed stones: made up of more than one composition, but none of the compositions
was ≥90% of the total.

c. The stone component will be considered as predominant one if it exceeded 50% of the
total composition of the calculus.8

INCLUSION CRITERIA

1. All patients irrespective of age or gender clinically presented with urinary stones,

where the stones will be managed surgically, and a sample of the stone can be

obtained.

EXCLUSION CRITERIA:

1. Patients with Contraindication for radiation exposure of radiological tests.

2. Patients with multiple stones where the final stone samples cannot be separated from each

other.

20
Method

1) Written and informed consent to be taken along with providing the patient
information sheet.

2) History and clinical examination of the patient will be done on the available format.

3) The test as per the protocol i.e., Urine R/M, IVP, NCCT KUB, CBC, KFT(including
Uric Acid) and Stone analysis will be performed of all patients.

4) The patient will be operated as per the need and consent of the patient.

5) The visual characteristic of the stone will be recorded.

6) The sample of stone obtained will be sent for the biochemical analysis

FTIR Method :

1. All stones removed during surgery will be placed on a wire mesh and air dried,

transferred to a plastic envelope, bearing a sample number.

2. All specimens will be first washed carefully with distilled water and dried.

3. After noting the morphological features such as color, shape, etc., stones will be cut

with a clean, sterile knife and one quarter will be ground with mortar and pestle into a

fine homogeneous powder which will then be stored into a sample tube used for FTIR

analysis.

4. Spectroscopy results will be recorded.

7) Statistical comparison will be done of the results obtained by conventional methods

with the results of biochemical analysis, to see whether a correlation can be made
between the result of different test modalities to the type of stone

21
 REFRENCES

1. Saeed R. Khan1, Margaret S. Pearle2, William G. Robertson3,4, Giovanni Gambaro5,

Benjamin K. Canales1, Steeve Doizi6, Olivier Traxer6, and Hans-Göran Tiselius7,
Kidney stones Nat Rev Dis Primers. Author manuscript; available in PMC 2017
November 14.
2. Chaytor RJ, Rajbabu K, Jones PA, McKnight L. Determining the composition of
urinary tract calculi using stone-targeted dual-energy CT:evaluation of a low-dose
scanning protocol in a clinical environment. Br J Radiol 2016; 89: 20160408.
3. Guy Hidas, MD, Ruth Eliahou, MD, Mordechai Duvdevani, MD, Phillipe Coulon,
PhD, Laurent Lemaitre, MD, Ofer N. Gofrit, MD, PhD, Dov Pode, MD, Jacob Sosna,
MD, Determination of Renal Stone Composition with Dual-Energy CT: In Vivo
Analysis and Comparison with X-ray Diffraction, Radiology: Volume 257: Number 2
—November 2010.
4. Analysis of urinary stone types’ distribution in Turkey according to the geographical
regions where patients were born and live: A cross-sectional single-center experience,
Selçuk Sarıkaya1, Çiğdem Yücel2, Nejdet Karşıyakalı3, Erdim Sertoğlu2, Engin
Kaya1, Turgay Ebiloğlu1, Selahattin Bedir1, Taner Özgürtaş2, Gulhane Med J
2020;62:163-9
5. Kidney stones: composition, frequency and relation to metabolic diagnosis, francisco
r. Spivacow, elisa e. Del valle, ernesto lores, paula g. Rey, medicina (buenos aires)
2016; 76: 343-348
6. Urinary Calculi: A Microbiological and Biochemical Analysis at a Tertiary Care
Hospital in Eastern Nepal, Pratima Shah ,1 Ratna Baral,1 C. S. Agrawal,2 Madhab
Lamsal,3 Dharanidhar Baral,4 and Basudha Khanal1, Hindawi, International Journal
of Microbiology, Volume 2020, Article ID 8880403, 9 pages
7. Radiology of renal stone disease, Colin J. McCarthy a, Vinit Baliyan a, Hamed
Kordbacheh a, Zafar Sajjad b, Dushyant Sahani a, Avinash Kambadakone a, *
International Journal of Surgery 36 (2016) 638e646
8. Spectrum of chemical analysis of 150 consecutive upper urinary tract stones with
critical analysis in respect of demographic and geographical distribution, Waliul
Islam1*, Fazal Naser2, Mahmood Hasan3, Mohammed Mizanur Rahman4, Mizanur
Rahman2, Shohrab Hossain5, International Surgery Journal 2021, Jun;8(6):1694-1698

22
9. Significance of analysing chemical composition of renal stones, Koirala S1, Journal
of Pathology of Nepal (2014) Vol. 4, 560 -564
10. Chemical composition of urinary tract stones: experience in a medical college hospital, in
dhaka, sudip das gupta1, manzoor-ul-mahbub1, afroza ghani2, mohammed mizanur rahman1,
md. Zahurul haque, uro make 18(1) 2015, bangladesh j. Urol. 2015; 18(1): 8-11
11. Biomedical Research 2010; 21 (3): 305-210, Chemical analysis of stones and its
significance in urolithiasis, Pushpa Durgawale, Anissa Shariff, Anup Hendre, Sangita
Patil, Ajit Sontakke, Department of Biochemistry, Krishna Institute of Medical
Sciences and Research Centre, Karad, India
12. Jonathan Cloutier · Luca Villa · Olivier Traxer ·Michel Daudon, Kidney stone
analysis, World J Urol (2015) 33:157–169.

23
 PROFORMA

1.General particulars

Patient name :

Age :

Sex:

Registration number:

Mobile number :

Address:

Occupation :

2.Presenting complaints

Pain :

Site :

Radiating /non radiating :

Nausea:

Vomiting:

Fever :

H/o LUTS :

Hematuria :

3.Past h/o

4.Family h/o

5.Personal h/o

Dietary habits :

6.General examination

Pulse :

Blood pressure:

Respiratory rate :

7. Systemic examination

24
RS :

CVS :

CNS:

Per abdomen :

8.Local examination

B/L testis

P/R examination

9.Investigations

CBC:

Creatinine:

Electrolytes:

Calcium:

Magnesium:

Uric acid :

Urine RM :

IVP:

NCCT KUB-

Stone location:

Hounsfield units:

Stone analysis :

25
 CONSENT FORM
I ____________ s/d/w of____________, a resident of____________, hereby declare that I
give informed consent to participate in the thesis study titled “EVALUATION OF TYPES
OF URINARY STONE BY CONVENTIONAL RADIOLOGICAL AND BIOCHEMICAL
METHOD AND BIOCHEMICAL STONE ANALYSIS IN A TERTIARY CARE CENTRE”

I give full consent for being enrolled in the above study and I reserve my rights to withdraw

from the study whenever I wish without prejudice of my right to undergo further treatment at

Subharti Medical College, Meerut.

_________________ ____________ ________________________

Name of Subject Date Signature of Subject

We have witnessed that the patient signed the above form in the presence of his/her free will
after fully having understood its contents.

_________________ ______________ ____________________

Name of Witness Date Signature of Witness

__________________ _______________ ____________________

Name of Investigator Date Signature of Investigator

26
 सहमति पत्र

मैं ____________ बेटा/बेटी/पत्नी _________________________, का एक निवासी, इसके द्वारा घोषणा करता हूं कि मैं
थीसिस अध्ययन में भाग लेने के लिए सूचित सहमति देता हूं जिसका शीर्षक है

" EVALUATION OF TYPES OF URINARY STONE BY RADIOLOGICAL METHOD AND

BIOCHEMICAL STONE ANALYSIS IN A TERTIARY CARE CENTRE”

मैं उपरोक्त अध्ययन में नामांकित होने के लिए पूर्ण सहमति देता हूं और सुभारती मेडिकल
कॉलेज, मेरठ में आगे के इलाज के अपने अधिकार के बिना जब भी मैं चाहूं अध्ययन से पीछे
हटने का अधिकार सुरक्षित रखता हूं।

_________________ ____________ ____ ____________________

विषय का नाम दिनांक विषय के

हस्ताक्षर

हमने देखा है कि रोगी ने उपरोक्त फॉर्म की सामग्री को पूरी तरह से समझने के बाद अपनी
स्वतंत्र इच्छा की उपस्थिति में हस्ताक्षर किए हैं।

_________________ ______________ _ __________________

गवाह का नाम दिनांक गवाह के

हस्ताक्षर

__________________ _______________ _ __________________

अन्वेषक का नाम दिनांक

अन्वेषक के हस्ताक्षर

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 ANNEXURE-I
INFORMED CONSENT FORM

Study Title-
" EVALUATION OF TYPES OF URINARY STONE BY RADIOLOGICAL
METHOD AND BIOCHEMICAL STONE ANALYSIS IN A TERTIARY CARE CENTRE”

Subject’s Name:_________________________________________________________

Subject’s Initials:________________________________________________________

Date of Birth/Age:_______________________________________________________

Address:______________________________________________________________

(1) I confirm that I have read and understood the information sheet dated _________ for
the above study and have had the opportunity to ask questions.
[]
(2) I understand that my participation in the study is voluntary and that I am free to
withdraw at any time, without giving my reason, without my medical care and legal
rights being affected. [ ]
(3) I agree not to restrict the use of any data or results that arise from this study provided
such a use is only for scientific purpose(s).
[]
(4) I agree to take part in the above study.
[]

Signature (or thumb impression) of the subject/ legally acceptable representative:

Signatory’s Name:__________ ____________Date : _____/____/_______

Signature of the Investigator:________ ________________________
Study Investigator’s Name:___________ ________________________
Signature of the witness : _______________________________
Name of witness: ______________________Date : ____/___/________
Copy of the patient information sheet and duly filled informed consent form shall be
handed over to the subject or his/her attendant.

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 ANNEXURE-II

सूचित सहमति प्रपत्र

अध्ययन शीर्षक: " EVALUATION OF TYPES OF URINARY STONE BY RADIOLOGICAL

METHOD AND BIOCHEMICAL STONE ANALYSIS IN A TERTIARY CARE CENTRE”

संख्या :_____________________________________________________________

विषय का नाम :_____________________________________________________________

विषय के आद्याक्षर :____________________________________________________________

जन्म तिथि आयु / :___________________________________________________________

पता :______________________________________________________________

(1) मैं पुष्टि करता हूं कि मैंने उपरोक्त अध्ययन के लिए _________ के सूचना पत्र को पढ़ और समझ लिया है
और मुझे प्रश्न पूछने का अवसर मिला है। []

(2) मैं समझता हूं कि अध्ययन में मेरी भागीदारी स्वैच्छिक है और मैं बिना कारण बताए मेरी चिकित्सा ,

देखभाल और कानूनी अधिकारों को प्रभावित किए बिना किसी भी समय वापस लेने के लिए स्वतंत्र हूं। , [
]

(3) मैं इस अध्ययन से उत्पन्न होने वाले किसी भी डेटा या परिणामों के उपयोग को प्रतिबंधित नहीं करने
के लिए सहमत हूं बशर्ते ऐसा उपयोग के वल वैज्ञानिक उद्देश्यों के लिए हो।
, []

(4) मैं उपरोक्त अध्ययन में भाग लेने के लिए सहमत हूं। []

विषय कानूनी रूप से स्वीकार्य प्रतिनिधि के हस्ताक्षर या अंगूठे का निशान

/ ( ):

हस्ताक्षरकर्ता का नाम :__________ ____________ दिनांक : _____/____/_______

अन्वेषक के हस्ताक्षर :____________________________________

अध्ययन अन्वेषक का नाम :___________ _________________

गवाह के हस्ताक्षर : _______________________

गवाह का नाम : _____________________ दिनांक : ____/______/________

रोगी सूचना पत्र की प्रति और विधिवत भरा हु आ सूचित सहमति प्रपत्र विषय या उसके परिचारक को
सौंप दिया जाएगा।

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 ANNEXURE-III
PATIENT INFORMATION SHEET
I am entering into a study on informed that participation in this study is completely voluntary
and I can withdraw at any point of time. " EVALUATION OF TYPES OF URINARY STONE
BY RADIOLOGICAL METHOD AND BIOCHEMICAL STONE ANALYSIS IN A
TERTIARY CARE CENTRE” Refusal to participate will not draw any penalty or loss of
benefits to which you are entitled otherwise. The study will be confidential. The ill effects of
the drugs have been explained to me. I acknowledge that I understand the consent from and
my participation is voluntary and give my consent for the use of study data for academic or
research purpose.

Date signature (patient's)

Date signature (researcher's)

Name of the doctor: Shubham Gupta

Designation: (Junior Resident)

Department: SURGERY

Mobile no: 9129556469

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 ANNEXURE-IV

रोगी सूचना पत्र

मैं एक अध्ययन में प्रवेश कर रहा हूं " EVALUATION OF TYPES OF URINARY STONE BY
RADIOLOGICAL METHOD AND BIOCHEMICAL STONE ANALYSIS IN A TERTIARY
CARE CENTRE” मैंने सूचित किया कि इस अध्ययन में भाग लेना पूरी तरह से स्वैच्छिक है और मैं

किसी भी समय वापस ले सकता हूं। भाग लेने से इनकार करने पर कोई जुर्माना या लाभ की हानि नहीं
होगी जिसके आप अन्यथा हकदार हैं। अध्ययन गोपनीय रहेगा।

मुझे दवाओं के दुष्परिणामों के बारे में बताया गया है।

मैं स्वीकार करता हूं कि मैं सहमति को समझता हूं और मेरी भागीदारी स्वैच्छिक है और मैं शैक्षणिक
या शोध उद्देश्य के लिए अध्ययन डेटा के उपयोग के लिए अपनी सहमति देता हूं।

दिनांक हस्ताक्षर (रोगी का)

तिथि हस्ताक्षर (शोधकर्ता)

डॉक्टर का नाम डॉ। शुभम गुप्ता

पद: (जूनियर रेजिडेंट)

विभाग: शल्य चिकित्सा

मोबाइल नंबर 9129556469

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