Clinical Study to Compare the Efficacy of Betadine, Calcium Alginate and Recombinant Epidermal

“RELEVANCE OF EXTRA CORPOREAL SHOCKWAVE LITHOTRIPSY (ESWL) IN THE ERA OF URETEROSCOPY FOR LOWER THIRD URETERIC STONES”

SQN LDR CR RAKESH

SYNOPSIS FOR REGISTRATION OF SUBJECT FOR DISSERTATION TO

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

KARNATAKA

BANGALORE

IN PARTIAL FULLFILMENT OF REGULATIONS FOR THE AWARD OF

MASTER OF SURGERY IN

GENARAL SURGERY

DEPARMENT OF SURGERY COMMAND HOSPITAL (AIR FROCE), BANGALORE – 560 007

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES KARNATAKA, BANGALORE ANNEXURE – II

______PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION______

1. NAME OF THE CANDIDATE : SQN LDR CR RAKESH PG IN MS – GENERAL SURGERY COMMAND HOSPTAL (AF) BANGALORE – 560 007

2. NAME OF THE INSTITUTION : COMMAND HOSPITAL (AF) BANGALORE- 560 007

3. COURSE OF STUDY AND SUBJECT : MS- GENERAL SURGERY

4. DATE OF ADMISSION TO COURSE : 02 MAY 2008

5. TITLE OF THE TOPIC : “RELEVANCE OF CORPOREAL SHOCKWAVE LITHOTRIPSY (ESWL) IN THE ERA OF URETEROSCOPY FOR LOWER THIRD URETERIC STONES” BRIEF RESUME OF THE INTENDED WORK

1. INTRODUCTION

Urinary calculi are the third most common affliction of the urinary tract, exceeded only by urinary tract infection and pathological condition of the prostate. Advances in the management of urinary stones have led to the early treatment of stones with low morbidity and more effective clearance . Stones do not usually form in the ureter, but drop down from the kidney while they are still small. They tend to increase in size as they remain in the urinary passage. Stones with diameter more than 5 mm are unlikely to pass unaided and have to be removed (1, 2).

Advances in technology have revolutionized the treatment of these ureteric stones. ESWL and ureteroscopy are the two established methods to treat these stones, ESWL being reserved for upper ureteric calculus.

Our hospital caters to a large population of serving soldiers, ex-servicemen and their dependents. A large number of patients present with ureteric stones. Modern ureteroscopes and intracorporeal lithotripsy have good safety profiles with good clearance rates (3). Current data suggests ureteroscopy to be superior to ESWL in terms of efficacy (4). However in the past few years, with better lithotripters, imaging and knowledge of positioning the patient, ESWL is being used more often, with success, in the treatment of lower third ureteric stones too.

This study is aimed at reviewing the use of ESWL with this present knowledge of approach for lower ureteric stones during this period where ureteroscopes have been very successful 2. OBJECTIVES

Ojective of this study is to compare and assess the safety and efficacy of Extracorporeal shock wave lithotripsy vis a via ureteroscopy in the management of lower third ureteric stones. Secondary objective – To look for complications peculiar, if any, specific to ESWL or urteroscopy. 3. REVIEW OF LITERATURE

Chaussy et al. in 1980 were the first to report the clinical application of shock wave lithotripsy in the management of kidney stones, and since then the management of nephrolithiasis has undergone a complete revolution(5). With the development of extracorporeal shockwave lithotripsy, percutaneous and ureteroscopic techniques for the management of urolithiasis, open surgery, which was once the mainstay of stone treatment, is rarely indicated nowadays (6).

The incidence of spontaneous passage of ureteric calculi smaller than 4 mm and 4 to 6 mm, experienced rates of spontaneous passage of 80% and 59%, respectively, and decreases markedly with increase in stone size, with the spontaneous elimination of stones about 6 mm being exceptional and frequently accompanied by complications like recurrent intractable pain, obstruction and infection.(7,8)

Ureteroscopy as a primary treatment modality for distal ureteral calculi is highly effective, with reported success rates in excess of 90% in different reported studies. (9, 10, 11)

The disadvantage of ureteroscopy is that it is an invasive procedure and requires general or regional anaesthesia. Added to this is the fact that it has a 0.5%-10% complications rate. (12, 10) like false passage and ureteral avulsion. The patient requires longer duration of stay in the hospital

ESWL on the other hand may be done without anaesthesia. It is a non-invasive procedure. It may be done as an out patient procedure. Multiple sittings may be done for removal of stones with lesser side effects. However the initial cost of the equipment and its maintenance is high. It is contraindicated in pregnant women. Also the surgical intervention rate after ESWL treatment for ureteric stones in all locations is reported to be 7 %.( 13)

The clearance rate for stones of less than 10 mm size in the lower ureter is around 73.8%, and

42.8% of the patients require more than one treatment session. The ESWL clearance rate for larger stones (11 mm-20 mm) in the lower third of the ureter is 42.8% and 85.7% of the patients require more than one treatment session. Therefore, for stones in the distal one-third of the ureter, as primary therapy, ESWL for stones <10 mm in diameter and ureteroscopy for stones more than 10 mm in diameter is recommended.

However there is a paucity of Indian Data in this regard, and this study is aimed at comparing the efficacy of ESWL vis a vie Ureteroscopy for treatment of lower third ureteric stones in Indian population. 4. RESEARCH METHODOLOGY

4.1 Inclusion criteria

All patients with symptomatic distal ureteric stones presenting to our hospital

from Oct 2008 to Dec 2010 will be included in the study. Only those with normal renal

function with stones of sizes 5 to 14 mm will be included. A minimum of thirty patients

would be included in the study for each of the procedures. Total patients would be sixty.

We shall consider lower third ureteric stones as those stones seen from below the

Sacroiliac joint upto the uretero-vesicular junction as seen on IVU

4.3 Methods of collection of data

All patients presenting to the hospital will symptoms of ureteric colic/calculi will

be evaluated. Of theem a total of sixty successive patients who on evaluation have lower

third ureteric stones of 5mm and above will be included in this study

Ureteric colic

Evaluate for urolithiasis

Positive for lower third ureteric stones

Exclusion criteria All patients will be covered with antibiotics(ciprofloxacin for 3 days) first dose

being given prior to procedure. All patients will be covered with Inj Amikacin at the time

of procedure. Antibiotics will be changed if necessary in event of complications.

Choice of stenting in particular case will be left to to discretion of the treating

surgeon

4.4 Exclusion criteria

1. Pregnant women.

2. Calculi less than 4 mm

3. Patient presenting with features of urinary tract infection / urosepsis

4. Patients with deranged renal function ( Serum creatinine > 1.8 mg/dl)

5. Patients with bilateral ureteric calculi

6. Patients with radiolucent calculi

7. Patients below 18 yrs of age

8. Patients with bleeding disorders

PROCEDURE AND RESULTS

4.5 Does the study require any investigations or investigations to be conducted on

patients or other humans? If so describe briefly.

1. Hb, TLC, DLC

2. Urine routine, microscopy, culture and antibiotic sensitivity. 3. Blood sugar level

4. Blood urea and Serum creatinine

5. X-ray KUB and USG KUB

6. NCCT ( in selective cases)

5. ANALYSIS

All relevant data will be maintained on a Performa, and data will be tabulated on a spread sheet for statistical evaluation using univalent and multivalent analyses

P value of 0.05 or less will be considered significant

REFRENCES

(1) Segura JW, Preminger GM, Assimos DG, et al. Ureteral Stones

Clinical Guidelines Panel summary report on the management of

ureteral calculi. The American Urological Association. J Urol 1997;

158: 1915-21.

(2) Ehreth JT, Drach GW, Arnett ML, et al. Extracorporeal shock wave

lithotripsy: multicenter study of kidney and upper ureter versus

middle and lower ureter treatments. J Urol 1994; 152: 1379-85.

(3) Farsi HM, Mosli HA, Alzimaity M, et al. In situ extracorporeal

shock wave lithotripsy for primary ureteric calculi. Urology 1994;

43: 776-81. (4) Lam JS, Greene TD, Gupta M. Treatment of proximal ureteral

calculi: Holmium:YAG laser ureterolithotripsy versus extracorporeal

shock wave lithotripsy. J Urol 2002; 167: 1972-6.

(5) PARKER Brian D. ; FREDERICK Robert W. ; REILLY T. Philip ;

LOWRY Patrick S. ; BIRD Erin T. Efficiency and cost of treating

proximal ureteral stones Urology ISSN 0090-4295 2004, vol. 64,

(6) Menon M, Parulkar BG, Drach GW urinary lithiasis: etiology,

diagnosis and medical management IN Walsh PC, et al.,eds.

Campbell’s urology7th edition

(7) ANDREW J PORTIS, M.D., and CHANDRU P SUNDARAM,

M.D. Am Fam Physician 2001;63:1329-38.)

(8) Hubner WA, Irby P, Stoller ML. Natural history and current

concepts for the treatment of small ureteral calculi. Eur Urol

1993;24:172-6.

(9) Morse RM, Resnick MI. Ureteral calculi: natural history and

treatment in the era of advanced technology. J Urol 1991;145:263-5,

and Glowacki LS, Beecroft ML, Cook RJ, Pahl D, Churchill DN.

The natural history of asymptomatic urolithiasis. J Urol

1992;147:319-21

(10) Tawfiek ER, Bagley DH. Management of upper urinary tract calculi

with ureteroscopic techniques. Urology 1999;53:25-31. PROTOCOL OF ASSESSMENT OF PATIENTS TREATED WITH URETEROSCOPY/ESWL

Name………………… Age…………. Sex………… Date………..

BRIEF CLINICAL NOTES

PAST HISTORY

INVESTIGATION Hb % TLC DLC

UREA CREATININE

URINE CULTURE

USG SIZE BACKPRESSURE CHANGES

X-ray KUB

SIZE OF STONE

5-10MM

URETEROSCOPY DATE OF OPERATION

RESULT

COMPLICATONS PAIN HAEMATURIA UTI FALSE PASSAGE AVULSION OTHERS

HOSPITAL STAY

ESWL SESSION I II III IV V

DATE SHOCKS

INTENSITY

COMPLICATONS ECCHYMOSIS PAIN HAEMATURIA UTI OTHERS

HOSPITALISATION IF ANY

PATIENT COMPLIANCE

(11) 9. Signature of the candidate :

10. Remarks of the guide : “clinical study to compare the efficacy of ureteroscopy

versus ESWL for upper ureteric calculus” is a feasible

dissertation topic. Clinical materials will be available in this hospital.

11.1 Name and designation of : Wg Cdr Sivaramakrishna the guide Prof (Cl Spl Surgery and Urology) Department of Surgery Command Hospital (AF), Banglore-560 007

11.2 Signature of the guide :

11.3 Co-Guide (if any) : Department of Surgery Command Hospital (AF), Banglore-560 007

11.4 Signature of Co-Guide : 11.5 Head of the Department : Air Cmde P J Vincent,VSM HOD & Consultant Surgery Department of Surgery Command Hospital (AF), Banglore-560 007

11.6 Signature of Head of the : Department

12.1 Remarks of the : Commandant and Principal

12.2 Signature and Designation of : Commandant and Principal

CERTIFICATE OF ACCEPTANCE BY THE GUIDE

I, Wg Cdr (Dr) B Sivaramakrishna, Additional Professor (Cl Spl Surgery and Urology), Command Hospital (AF) Bangalore, hereby certify that I accept Sqn Ldr (Dr) CR Rakesh as candidate of MS (Surgery) course. The title of his dissertation is as follows:-

“ A Clinical Study To Compare The Efficacy Of ESWL Versus Ureteroscopy For Lower Third Ureteric Calculi”.

He will be under my guidance during the entire period of his study and thesis work.

Date : Wg Cdr Sivaramakrishna Addl Prof (Cl Spl Surgery and Urology) Department of Surgery Command Hospital (AF) Banglore-560 007

CERTIFICATE FROM THE HEAD OF THE INSTITUTION

Permission is hereby accorded to the student Sqn Ldr CR Rakesh, to undergo MS

(Surgery) course being conducted as Command Hospital (Air Force) Bangalore affiliated to Rajiv

Gandhi University of Health Sciences commencing from May 2007 under the guidance of Wg Cdr

Sivaramakrishna, Prof (Cl Spl Surgery and Urology), Command Hospital (AF) Bangalore. Date : (COMMANDANT AND PRINCIPAL)

COMMAND HOSPITAL (AIR FORCE)

BANGALORE – 560 007

ETHICAL COMMITTEE CLEARANCE

The committee has examined the scope including the need, objective, method of data collection and human intervention of the following study to be carried out by Sqn Ldr (Dr) CR Rakesh (Gen Surg) student under the guidance of Wg Cdr Sivaramakrishna, Prof (Cl Spl Surgery and Urology), Command Hospital (AF) Bangalore the title of which is:-

“CLINICAL STUDY TO COMPARE THE EFFICACY OF URETEROSCOPY VERSUS ESWL FOR UPPER URETERIC CALCULUS”.”

The committee has no objection for undertaking this study at Command Hospital (Air Force)

Bangalore – 560 007 GS Sandhu, VSM

(Surg Capt (Gp Capt (Gp Capt (Gp Capt

Sr Adv, Prof & HOD Sr Adv, Prof & HOD Sr Adv, Prof & HOD Sr Adv & Prof

Dept of ENT Dept of Pediatrics) Dept of Obst & Gynae) Dept of Medicine)

Vice Principal

COMMAND HOSPITAL, AIR FORCE