RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE KARNATAKA
ANNEXURE II
PrOforma For Registration Of Subjects For Dissertation
1 / Name of the candidate and Address(Block letters) / : / DR PALLA ABHISHEK REDDYM.S. GENERAL SURGERY
MAHADEVAPPA RAMPURE MEDICAL COLLEGE
GULBARGA- 585105
KARNATAKA
Permanent Address / : / S/O P.LAXMIKANTH REDDY
PLOT NO 40,SADASHIVNAGAR OLD JEWARGI ROAD BEHIND WATER TANK,GULBARGA-585102.
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 / : / 01/08/2013
5 / Title of Topic / : / COMPARATIVE STUDY FOR THE TREATMENT OF LOWER THIRD URETERAL CALCULI BETWEEN LASER LITHOTRIPSY AND OTHER LITHOTRIPSIES.
6 / Brief resume of work
6.1 / Need for the study:
Urinary stone disease is very common disease in and around Gulbarga because of high concentration of calcium and minerals in water. The other reason is tobacco chewing which contains high calcium level.Various studies over time have shown urinary stones to be multifactorial .
Stones do not usually form in the ureter ,but drop down from the pelvi –calyceal system while they still small . They tend to increase in sze as they remain in the urinary passage .Most stones ,smaller than 5mm pass spontaneously.However some stones may arrest in the ureter producing complications such as obstruction ,infection ,hematuria and acute renal failure .Therefore urgent relief is to be given to these patients.
The treatment of ureteral stones has undergone a remarkable evolution in the last 15 years .At one time open uretero-lithotomy and blind stone basket manipulation were the mainstay of surgical management ,they have now been superseded by an array of superior maodalites . Among them ureteroscopy(URS) and extracorporeal shock wave lithotripsy(ESWL) are the two most favoured method for the treatment of ureteric stones .
The earlier complications like false passage ,ureteral rupture ; following rigid ureteroscopes was a limiting factor in the treatment of these stones . But with the introduction of flexible and small ureteroscopes ,the complication have reduced considerably with very high clearance rates and patients satisfactions .
ESWL was earlier preferred for the treatment of upper third ureter stones only with limited success in the management of lower third ureteric stones . But with modern lithotripters and better imaging,ESWL is being offered for the management of lower third stones also.
However the management of lower third ureteral stone continues to evoke much controversy .Proponents of ureteroscopy emphasize that it is a simple , straight forward procedure in most hands almost always yielding success .ESWL enthusiasts counter that although stone free rates are not as high as with ureteroscopy ,ESWL is the less invasive procedure with fewer complications and predictable success .
Both are accepted as management modalities for lower third ureteral stones .Patients however prepare the noninvasive modality over invasive modality in the treatment of urolithiasis .
Our hospital is a tertiary referral hospital and we are using in house lithotripters and ureteroscopes for the treatment of ureteric calculi.
6.2 / Review of Literature
In the year 2007,Nasser simtoroosh ,abhas basiri and others studied on laparoscopic management of ureteral calculus out of 123 laproscopic calculus removal in 103 men and 31 women .Indication for the procedure were ESWL or TRANSURETERAL LITHOTOMY failure and large calculus . the mean operative time was 143 +/- 60 minutes . 119 patients (96.7%) became stone free .Minor complications occurred in 14 (11.4%)patients this study concluded the efficacy and safety of laproscopic removal of ureteral calculi in selected group of patients with better cosmetic results and patients satisfaction.1
In the year 2009,medical bulletin with references of STEVE WH CHAN,SHELEY.R.C,ANNA HOLDGATE and others concluded the urological emergencies due to calculi are common clinical conditions that most clinicians of different specialities will encountrer from time to time. Being familiar with this clinical problem can facilitate early diagnosis and referral for specialist care.2
In 2008 .Dr.FRANCIS LEE studied on update on the management of ureteric stones Study shows that efficacy of ESWL on the treatment of ureteric stones is related to stone size and stone location.Stone clearance rates range from 74% for stones <10mm to 43% for those >10mm.clearance rates for stone located at proximal mid and distal ureter are 82%,73% and 74% respectively.Serious complications are rare Ureteroscopy is particularly indicated in cases wen ESWL is technically difficult or contraindicated such as radiolucent tones,stonedensity>750HU,obese,anticoagulation and pregnancy.3
In the year 2004,GLENN S.GERBER studied on management of ureteric calculi out of 205 participants.ureteroscopic stone removal may be performed more quickly with less morbidity and shorter recovery time.The case of ureteroscopic stone removal in most cases has led many investigate to explore the avoidance of stent after the procedure.4
.In the year 2007,MARK THOMAS studied on clinical diagnosis a total of 201 references were identified with 17 selected as relevant studies using plane radiograph or IVU as diagnostic standards .The majority of renal stones remain asymptomatic over 3 to 5 years follow up .After a mean follow up 33months(1-61),24(12%)patients with asymptomatic microscopic hematuria and renal calculi on USG required urological management.Prospective structure clinical data was collected on 1333 patients with acute flank pain .Renal colic was diagnosed by abdominal x ray,IVU,Lab,clinical decision for follow up in 59 of 1333 cases.5
.Aboumarzouk OM,kata SG,Keeley FX,McClinton S,Nabi G studied to examine evidence from randomized controlled trials(RCT’S) on the outcomes of ESWL or ureteroscopy in the treatment of ureteric calculi.They studied ESWL and uretroscopy with or without intracorporeal lithotripsy,as the most common interventions used to treat ureteral stones .ESWL treatment is less invasive than ureteroscopy,but has some limitations such as high retreatment rate and is not available in all centres.The authors concluded that compared with ESWL,ureteroscopic removal of ureteral stones achieves a greater stone free state,but with a higher complication rates and longer hospital stay.6
Fong YK, Ho SH,Peh OH,Ng FC,Lim PH,Quek PL,Ng KK studied that ESWL is the treatment modality of choice of many urologists for proximal ureteric calculi in this study they compared the efficacy and safety of ESWL versus ureteroscopy with holmium laser lithotripsy for the treatment of this group of stones.Between may 1999 and October 2000,50 patients had ESWL and another 51 patients underwent ureteroscopy with holmium laser lithotripsy for proximal calculi.They concluded that ureteroscopy with holmium laser lithotripsy was significant better in terms of the mean procedure time(56 min in ESWL;25 min in ureteroscopy;P<0.001) and the month stone free rate(50% in ESWL;80% in ureteroscopy;P=0.001).The 3-month stone free rate was also higher for ureteroscopy(78% in ESWL;90% in ureteroscopy) but this difference was not satistically significant (P=0.09).7
.Lam JS, Greene TD, Gupta M compared the safety and efficacy of ureteroscopy with intracorporeal holmium:YAG laser lithotripsy and ESWL .A total of 67 patients underwent 81 primary procedures,including in situ ESWL with a Doli 50 lithotriptor or ureteroscopy combined with holmium:YAG laser lithotripsy for proximal ureteral calculi.The authors demonstrated that ureteroscopy combined with holmium:YAG laser lithotripsy is an acceptable treatment modality for all proximal ureteral calculi and extended results are achieved for calculi 1cm or larger.Although the stone free rate was better for smaller stones with ureteroscopic laser lithotripsy efficiency quotients were similar.Therefore,ESWL should remain first line therapy for proximal ureteral calculi less than 1cm.because of less morbidity,and a lesser anaesthesia and analgesic requirement.8
Wu CF, Chen CS, Lin WY, Shee JJ, Lin CL, Chen Y, Huang WS. Studied to compare the safety and cost-effectiveness of ureterorenoscopic holmium:yttrium-aluminium-garnet(YAG) laser lithotripsy (URSL) with ESWL for proximal ueteral stones .This investigation assessed 220 patients with upper ureteral stones.Those in the ESWL group were treated on an outpatient basis using the Medispec Econolith 2000 under intravenous sedation. URSL was performed with a 6/7.5F semirigid tapered ureterorenoscope and holmium:YAG laser under spinal anaesthesia on an inpatient basis. A successful outcome was defined as the patient being stone free on radiography 1 month after treatment. The stone size, success rate, postoperative complications, and cost were evaluated in each group.9
.Antonio Correa Lopes Neto, Marcello Mackado Gava, Marco Henrique, Elias de Mathes, Milton Barrelli, Eri Roger Wroclawski Studied to report the experience of treating ureteral calculi by ureteroscopy at the Faculdaude de Medicina do ABC-SP, with an emphasis on the efficacy and safety of the method.A perioperative analysis of 100 ureteroscopes performed from January 2001 to August 2003 in 98 patients with ureteral calculi.The present study demonstrated results comparable with those reported in large seriesin the literature. The high success rates, low morbidity, rapid convalescence and lack of esthetic consequences corroborate the role of ureteroscopy as an attractive alternative for treating ureteral calculi.10
6.3 / Objectives of the study
1.
2. / To compare and to asses the safety and efficacy of laser lithotripsy versus other lithotripsies in the management of lower third ureteral calculi.
To look for complications and clinical outcome which are specific to laser lithotripsy and other lithotripsy.
7. / Materials and Methods
7.1 / Source of Data;
The study will be done on patients presenting with features suggestive of lower third ureteral calculi attending the OPD or admitted in various wards of Basaveshwar teaching & General Hospital, Gulbarga attached to M.R. Medical College, Gulbarga.
The source of data for this study will be patients referred to the Department of Surgery, basaveshwara teaching and general hospital gulbarga for treatment of lower third ureteral calculi. This consists of a study of 50 patients from September 2013 to march 2015
INCLUSION CRITERIA
1. Stones of sizes - 5 to 15 mm
2. Normal renal function
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
9. Obstructive Calculus
7.2 / Methods of collection of data
The study will be conducted on a minimum of 50 sample patients (by random sampling technique 50 samples are selected) features suggestive of lower third ureteral calculi who are referred to the department of radiodiagnosis, Basaveshwar teaching & General Hospital, Gulbarga attached to M.R. Medical college, Gulbarga during the period of November 2013 to August 2015. But the scope for increasing the number of cases depending on the availability of patients within the study period.
7.3 / Does the study require any investigation or intervention to be conducted on patients or other humans or animals’ 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.Intravenous urography(IVU)
7.NCCT(In selected cases)
7.4 / Has Ethical clearance been obtained from your institution in case of 7.3?Yes, ethical clearance has been taken from our institution for this study.
8 / List of References
1. Parivar F,Low RK, Stoller ML. The influence of diet on urinary stone disease. J Urol1996;155:432-440.
2. Dr. Francis Lee. Updated on the management of uretenic stones 2008. May Vol 13 No 511-12.
3. Glenn S. Gerber Management of ureteral calculi 2004 June Vol 18 No : 5
4. Mark Thomas clinical diagnosis of Kidney Stones Nephrology 2007. January 12 S1 – S3. Journal on intensive medical management of ureteric calculi 1998. Urology Vol 56 issue 4 :575 – 578.
5. Aboumarzouk OM, Kata SG, Keeley FX, McClinton S, Nabi G.Department of urology, East of Scotland Deanery, Aberdeen, UK.Cochrane Database Syst Rev.2012 May 16;5:CD006029.doi: 10.1002/14651858.CD006029.
6. Fong YK, Ho SH, Peh OH, Ng FC, Lim PH, Quek PL, Ng KK. Department of Urology, Changi General Hospital, Singapore. Ann Acad Med Singapore.2004 Jan;33(1):80-3.
7. Lam JS, Greene TD, Gupta M. Department of Urology, New York-Presbyterian Hospital, Columbia University College of Physicians and Surgeons,New York,USA. J Urol. 2002 May;167(5);1972-6.
8. Wu CF, Chen CS, Lin WY, Shee JJ, Lin CL, Chen Y, Huang WS. Division of Urology,Department of Surgery, Chang Gung Memorial Hospital, Chia-Yi, Taiwan, Republic of china. Urology. 2005 Jun;65(6):1075-9.
9. Antonio Correa Lopes Neto, Marcello Mackado Gava, Mario Henrique, Elias de Mathes, Milton Barrelli, Eri Roger Wroclawski.
10. Einstein.2004;2(1):28-32.
9 / Signature of candidate
10 / Remarks of Guide / Efficiency of management of stone in respect to all lithotripsy machines.
11 / 11.1 Name and Designation of Guide. [In block letters]. / Dr.R.ANIL
MS(General Surgery)
Professor
Department of Surgery
M.R Medical College, Gulbarga.
11.2 Signature of Guide
11.3 Co-Guide / -
11.4 Signature of Co-Guide / -
11.5 Head of the Department / DR.MALLIKARJUN .V. NISTY
MS
PROFESSOR AND HOD
DEPATMENT OF GENERAL SURGERY
M.R.MEDICAL COLLEGE ,GULBARGA.
11.6 Signature
12 / 12.1 Remarks of the Chairman and Principal.
12.2 Signature