RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA

BANGALORE

ANNEXURE – II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1. /

Name of the candidate &

Address (In block letters) / Dr. NAGARAJ MALLADAD
DEPT. OF SURGERY,
M.R. MEDICAL COLLEGE,
GULBARGA-585105
Permanent address / S/O DR S.C MALLADAD
MALLADAD NURSING HOME LAXMESHWAR 582116
DIST GADAG.KARNATAKA
2. /

Name of the Institution

/ H.K.E.SOCIETY’S
MAHADEVAPPA RAMPURE
MEDICAL COLLEGE,
GULBARGA – 585105.
3. /

Course of study and subject

/ M.S. (GENERAL SURGERY)
4. /

Date of admission to course

/ 31st May 2012
5. /

Title of the topic

/ “CLINICAL STUDY AND RECENT SURGICAL MANAGEMENT OF VESICAL CALCULUS”
6. / Brief resume of the intended work
6.1 / Need for the study:
Until the 20th centuries bladder stones were a prevalent disorder among poor children and adolescent. Because of improved diet, especially in increased protein carbohydrate ratio, primary vesicle calculi are rare1.
But Evidence shows that the incidence of urinary stone disease has been increasing continually in the past decades 2
The major incidence of urinary lithiasis was bladder stones in children. As nations increased productivity and moved into industrial age, average income and food quality improved. These events resulted in disappearance of endemic bladder stone disease from previously affected population3.
Bladder stone disease in children almost disappeared from European countries 50 to 60 years ago; It still is endemic in some of developing countries. Due to lack of health awareness, health infrastructure and research facilities, the incidence of bladder calculi continues to be high and is a major health problem in India.
Although new and effective therapeutic methods to treat urolithiasis have been introduced recently, urinary stones continue to occupy an important place in everyday urological practice4
In this context, the study will be performed to known the clinical presentation and management of vesicle calculus.
6.2 /

Review of literature

Bladder stones have occurred in humans since early times. Twenty three centuries ago Hippocrates cautioned that “to cut through the bladder is lethal.”5
Incidence of stone disease is also found in Sushruta Samhita. The estimate date of these works in 600 BC to 600AC Sushruta attributed the cause of calculi to four entities i.e..phlegm, bile, air, or semen and gave the following description of presentation. When air and phlegm mixed, a small stone is formed. This grows towards the bladder outlet and hinders the outflow of urine. The tortured patient then grinds his teeth, presses on his abdomen and rubs his penis. Urine, flatus and faces are passed with severe pains. In such cases, the stone is black, rough, irregular and covered with spikes like the maneleacadamba flower.
Bladder calculi account for 5% of urinary calculi, it is classified as migrated from upper urinary tract, primary idiopathic, or secondary calculi.6
Bladder calculi are rarely formed spontaneously. There must be an inciting event namely bladder outlet obstruction or infection to promote the stone formation.7
The process of stone formation depends on factors like urinary volume, concentrations of calcium, phosphate, oxalate, sodium, and uric acid ions, and natural calculus inhibitors, and the urinary pH 8.
Most bladder calculi are seen in men compared to women at 8:1 ratio. Stones analysis frequently reveals ammonium urate, uric acid or calcium oxalate stones. A solitary bladder stone is the rule, but these are numerous stones in 25% to 30% of patients.9,10
Frequency is the earliest symptom and sensation of incomplete bladder emptying. Pain is most often found in patients with speculated oxalate calculus. Hematuria is due to stone abrading the vascular trigon.
Interruption of urinary stream is due to the stone blocking the internal meatus. Urinary infection is a common presenting symptom.1
Examination of the urine reveals microscopic haematuria, pus or crystals that are typical of calculus. In most patients stone is visible on ultrasound or on plain radiogram Imaging of whole urinary tract should be undertaken to exclude an upper tract stone1.
CT is superior to USG in detection of calculi in cases of lower tract reconstruction
Cystoscopy is the most accurate examination to document to presence of bladder calculus9
The majority of bladder calculi are treated endoscopically, but treatment may vary from chemolysis to open surgery. Bladder calculi may be surgically treated by shock wave lithotripsy, cystolitholapaxy, cystolithotripsy with mechanical, electrohydraulic, ultrasonic, or laser energy sources; percutaneous cystolithotomy; and open cystolithotomy. The approach is influenced by the patient's anatomy and comorbidities; stone size, location, and composition; previous stone treatment; and risks and complications. In addition to removal of the calculi, treatment should address predisposing factors such as bladder outlet obstruction, urinary stasis, infection, and foreign bodies to minimize recurrence.9
6.3 /

Objectives of the study

1.  To study etiopathogenesis of vesicle calculi
2.  To study different clinical presentation of vesicle calculi
3.  To study recent surgical management.
7. / Material and Methods
7.1 / Source of Data:
All patients admitted with clinical diagnosis of “vesicle calculus” under General Surgery care in HKE’S Basaveshwar Teaching and General Hospital, Gulbarga will be taken as Subjects for this study.
After taking the proposed Informed Consent, data will be collected using the questionnaire / proforma.
The primary data for this study would be the history, clinical examination, KUB x ray, USG abdomen of the patients.
7.2 /

Methods of collection of data (including sampling procedure, if any)

Sample Size: 50
Timeline of the Study: 18 months from DEC 2012 to JUNE 2014
Methodology: Collection of data is from the clinical history ,physical examination, relevant investigation and imaging modalities
The following tests will be carried out for patients diagnosed as ‘Vesicle calculi’ under General Surgery care and admitted to HKE’s BASAVESHWAR Hospital, Gulbarga.
I.  Urine examination-mid stream sample of urine will be collected for analysis for routine, albumin, sugar, microscopy and culture and sensitivity.
II.  Routine blood investigation.
III.  Radiological investigations.
1.Plain x ray KUB
2. Ultrasonograpic evaluation and 3. Intravenous urography.
After considering the above findings a clinical diagnosis will be arrived at during the preoperative period, patients will be given treatment for correction of anaemia, and vitaminosis and malnutrition.
Appropriate antibiotics will be given according to urine culture and sensitivity report. Options of management will be explained to the patient and the possibility of intra-operative conversion to other modality of management from endourology procedure to open surgery will also be explained.
Endourological treatment via transurethral, percutaneous routes, open cystolithotomy and ESWL will be the options of management.
The stones removed will be subjected for chemical analysis.
Inclusion criteria: Only cases presenting with stones in urinary bladder will be included in present study.
Exclusion criteria: Cases presenting with stones in urethra, ureter and kidneys will be excluded in the present study.
7.3 /

Does the study require any investigation or intervention to be conducted on patients or other humans or animals? If so please describe briefly.

1.  Routine haematological investigation
2.  KUB x-ray
3.  Urine routine
4.  Ultra sonography abdomen and pelvis
5.  Intravenous urography
6.  Cystoscopy
7.4 / Has ethical clearance been obtained from your institution in case of 7.3?
YES. Ethical clearance has been obtained from “Ethical Clearance Committee” of the institution for the study. It is in the form of signature from Head of Dept. Surgery and Dean of M R Medical college Gulbarga.
8. / List of References
1.  David E Neal, .The Urinary bladder in Norman s Willaiams. Christopher J.K Bulstrode. P.Ronan O’connell, Bailey and Love’s short Pratise of surgery. 25th edition Edward Arnold Publishers Ltd, London 2008; 1313-1342
2.  Tanagho EA, McAninch JW. Smith's General Urology, 15th ed. New York, McGraw-Hill. 2000, pp 699-736.
3.  Walsh Reitk, Vaughan Wein, Campbell’s urology 8th Ed, Saunders publication Pennsylvania.2004 vol.4:3291-3292:3384-3386.
4.  Stamatiou KN, Karanasion VI, Lacrois RE, Kavouras NG, Papadimitriou VT, Chlopsios C, Lebren F, Sofras F. Prevalence of urolithiasis in rural Thebes, Greece. The International Electronic Journal of Rural and Remote Health Research, Education, Practice and Policy 2006; 6: 1-7.
5.  San D Grhab jr.James F Glenn Chrles B Brendler, Willey Carson. Leonard Gomella et al. Glen’s urologic surgery,5th ed. William and Wilkins usa 1988,978-983
6.  Bradley F Schwartz, Marshall L Shaller. The vesical calculus. Uro Clin North Am, 2000 May; 272:301-311:333-346
7.  Papatsoris AG, Varkarakis I, Dellis A, et al. Bladder lithiasis: from open surgery to lithotripsy. Urol Res. 2006 Jun; 34(3): 163-7.
8.  Mandel N. Mechanism of stone formation. Semin Nephrol 1996; 16:364-374.
9.  Marshall L. Stoller MD. Urinary stone disease in Emil A. Tanagho Jack W McAninch Smith’s general urology 17th edition. The Mcgraw Hill Companies 2008, page no 246-275
10.  Khai-linh V. HO MD Joseph W. Segura, editors Wein. Kavoussi. Novick. Partin and Peters. Campbell’s -Walsh urology 9th edition, Saunders publication Pennsylvania, chapter 84 lower urinary tract calculi .2006 page 2663-2674
9. /

Signature of Candidate

10. /

Remarks of Guide

/ Topic deserves consideration for dissertation study
11. / Name & Designation of (in block letters)

11.1 Guide

/ Dr. R ANIL M.S {GEN. SURG},FRCS
PROFESSOR,
DEPT. OF SURGERY,
M.R.MEDICAL COLLEGE, GULBARGA.

11.2 Signature

11.3 Co-guide (If any)

/ None

11.4 Signature

/ -

11.5 Head of the Department

/ Dr. S.A.HALKAI M.S {GENERAL SURGERY}
PROFESSOR & HEAD,
DEPT. OF SURGERY,
M.R.MEDICAL COLLEGE, GULBARGA.

11.6 Signature

12. /

12.1 Remarks of the Chairman and Principal

12.2 Signature