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xohaib
Re: pl help me
Synopsis in easy words is an outline of the research activities you are going to undertake and No you cannot put in a discussion section in there to validate your results with established findings and vice versa, Remember its a sketch of whats going to be done, not what already has been done.
zain
Re: pl help me
Synopsis is basically a submission of the programme of your study which demands Why, When, Where, and How you want to do. As far as I have checked, in the end there must be a heading of Discussion (under How) which compares your study results with those of the national and international literature. Furthermore it is better if the references are of last 5 years.
Anyone else may point out some other points.
i_arbani@y
pl help me
SYNOPSIS
TITLE: PNEUMATIC LITHOTRIPSY FOR MANAGEMENT OF URETERIC CALCULI.
INTRODUCTION:
Various methods have been used for the removal of ureteric calculi. The advent of extra- corporeal shock wave lithotripsy (ESWL) in the early 1980s and ultra thin ureteroscopes in the early 1990s have revolutionized the management of ureteric calculi. 1-2
Due to frequent changes in the treatment options for the removal of ureteric calculi, open surgical stone extraction is almost non-existent nowadays, comprising only 0.5% of all cases of ureteric calculi 3. The success rate of in-situ ESWL of upper ureteric stones is approximately 84%. With location problems and impacted stones in the middle ureter and small stone in the lower ureter, the success rate is even lower and ranges between 58% and 72%4respectively.Due to the high rate (38%) of re-treatment sessions in ESWL, ureteroscopy has become the method of choice for the quickest way of rendering patients stones-free.5
Various forms of energy for intracorporeal lithotripsy including electro hydraulic, ultrasonic, laser and pneumatic energy have been used for breaking stones; pneumatic lithotripsy has been found the most effective, safe and economical mode of treatment. 6-7
The Swiss lithoclast was developed in, Lausanne, Switzerland in 1989. It fragments the stones by oscillary movements of metal probe against the stone like the jack-hammer and clinical results of its use in fragmenting urinary stones were published in the early 1990s. 8- 10. Thereafter it has been used widely all over the world 11-16.
OBJECTIVE: “To determine the efficacy of Swiss Lithoclast in the management of
Ureteric Calculi and complications encountered in lithotripsy”
OPERATIONAL DEFINITIONS:
Efficacy: Efficacy will be measured in terms of clearance of stones, that will be confirmed by x-ray KUB and if needed IVP.
Complications
Complications of this procedure will be measured by following criteria;
1. Failure of fragmentation of stone
2. Migration of stone proximally in ureter during procedure.
3. Haematuria
4. Ureteric perforation
5. Fever
6. Septicemia
7. Post operative pain
Pneumatic Lithotripter: used in this study will be the EMS( Electro Medical Services) Swiss pneumatic lithoclast.
HYPOTHESIS:
I hypothesize that pneumatic lithotripsy is a safe, simple and effective procedure with less complication for treatment of all types of ureteric calculi.
MATERIALS AND METHODS:
Study Design: Prospective Observational study.
Setting: Nephro-Urology Department, Chandka Medical College Hospital Larkana.
Duration of Study: Minimum 06 months after approval of synopsis.
Sample Size: 60 Patients of ureteric stones.
Sample Technique: Non-probability purposive
SAMPLE SELECTION:
Inclusion Criteria:
1. Patients with evidence of ureteric stone on Ultrasound KUB/ X-ray KUB/IVP/Ante grade pyelography/ Retro grade pyelography presenting in the emergency or in the out patient Department.
2. Patient of either sex, above the age of fifteen years.
3. Patient with single ureteric stone(unilaterally/bilaterally)
4. Patient having negative urine culture.
Exclusion Criteria:
1. Those who have stone size > 2cm (20mm)
2. Those who require intervention urgently because of suspicion of pyonephrosis on effected side, compromised renal functions (azotemia)
3. After procedure, a patient who last the follow-up.
4. Patient having single kidney with ureteric stone >1cm located at upper/mid
Ureter.
DATA COLLECTION PROCEDURE
All patients in the study will be evaluated by History taking, Physical examination and Laboratory investigation. Investigation which will be done in all cases including; urine examination, complete blood count, blood urea, serum creatinine, serum calcium, serum uric acid, urine culture X-ray Abdomen and pelvis, U/S KUB and post procedure stone analysis.
Intravenous pyelography, Ante grade pyelography and retrograde pyelography were done when indicated to document size and location of stone.
All those patients whose urine culture is negative will be proceeded for procedure.
Purpose, procedure, risks and benefits will be planned and finally informed consent and written consent will be taken.
Pneumatic lithotripsy procedure will be performed in single sitting (session), time taken will be between20-40 minutes, mode of fragmenting stones will be single/multi.
Hospital stay of patient after procedure will be noted.
After the procedure all the patients in this study will be followed up to 3 months. If any patient lost the follow-up he/she will not be included in study.
Treatment out come will be defined as complete clearance of stone that will be confirmed by comparing the previous x-ray KUB films with current one.
DATA ANALYSIS PROCEDURE:
Data will be analyzed by SPSS version 10.0.
Descriptive statistics will be used for numerical data to calculate mean and standard deviation (SD) for age of patient, location of stone in ureter, mode of fragmenting stone, time taken for procedure and duration of hospital stay in days.
Frequency will be calculated for gender of the patients, size of stone in mm, site of calculus in ureter, number of complication listed (Failure of fragmentation of stone, Migration of stone proximally in ureter during procedure, Haematuria, Ureteric perforation, Fever, Septicemia, Post operative pain) etc.
While Wilcoxon sign test will be applied to compare the P value for proportion of all qualitative variables like [gender of the patients, size of stone in mm, site of calculus in ureter, number of complication listed (Failure of fragmentation of stone, Migration of stone proximally in ureter during procedure, Haematuria, Ureteric perforation, Fever, Septicemia, Post operative pain) etc].
95% confidence interval will also be estimated.
P value of < 0.05 will be considered as significance.
REFERENCES
1. Holden D, Rao PN. Ureteral stones. The results of primary in situ extracorporeal
shock-wave lithotripsy. J Urol 1989; 142: 37-39
2. Marberger M, Hofbauer J, Turk C, Albrecht W. Minimally invasive therapy of
ureteric calculi. Min Invas Ther 1992; 1: 159-67
3. Stenzl A, Seibold J, Peschel R, Hobisch A, Anetschek G, Bartsch G. Pneumatic
lithotripsy with an optional suction device (Lithovac) for treatment of ureteral stones. Jap J Endourol & ESWL 1996; 9: 59-62
4. Hofbauer J, Hobarth K, Marberger M. Lithoclast: New and inexpensive mode of
intracorporeal lithotripsy. J Endourol 1992; 6: 429-32
5. Hofbauer J, Tuerk C, Hobarth K, Hasun R, Marberger M. ESWL in situ or
ureteroscopy for ureteric stones? World J Urol 1993; 11: 54-58
6. Naqvi SAA, Khaliq M, Zafar MN, Rizvi SAH. Treatment of ureteric stones:
Comparison of laser and pneumatic lithotripsy. Br J Urol 1994; 74: 694-98
7. Hofbauer J, Hobarth K, Marberger M. Electrohydraulic versus pneumatic
Disintegration in the treatment of ureteral stones: a randomized, prospective trial. J Urol 1995; 153: 623-25
8. Wisard M, Jichlinski P, Languetin J-M, Favre R, von Niederhausern W. Premiere
Evaluation clinique du lithoclaste CHUV an energie balistique. Helv Chir Acta 1991; 58: 319-21.
9 Denstedt JD, Eberwein PM, Singh RJ. The Swiss lithoclast: a new device for
Intracorporeal lithotripsy. J Urol 1992; 148: 1088-90
10. Schulze H, Haupt G, Piergiovanni M, Wisard M, von Niederhausern W, Senge T.
The Swiss lithoclast: a new device for endoscopic stone disintegration. J Urol 1993; 149:15-18
11. Wadhwa SN, Hemal AK, Sharma RK. Intracorporeal lithotripsy with the Swiss
Lithoclast. Br J Urol 1994; 74: 699-702
12. Seong SJ, Ji-Hwan H, Kyu SL. A comparison of holmium: YAG laser with lithoclast
Lithotripsy in ureteral calculi fragmentation. Int Jr of Urol 2005; 12:544-7.
13. Kamran T. Pneumatic lithotripsy for the management of ureteric calculi. JCPSP 2003; 13: 101-3.
14. Mohseni MG, Arasteh S, Alizadeh F. Preventing retrograde stone displacement during pneumatic lithotripsy for ureteral calculi using lido Cain jelly. Urology 2006; 68: 505-7.
15. Schock J, Barsky RI, Pietras JR: Urolithiasis update: Clinical experience with the Swiss lithoclast. J Am Osteopath Assoc 2000; 101: 437-40.
16. Zheng W, Denstedt JD: Intra corporeal lithotripsy: update on technology. Urol Clin North Am 2000; 27: 301-13.
PNEUMATIC LITHOTRIPSY FOR MANAGEMENT OF URETERIC CALCULI
PROFORMA
I. DEMOGRAPHY:
Name: ________________________________ Reg# ____________Date:_____________
Age: _________________ Sex: ________________Occupation: ____________________
II. CLINICAL HISTORY:
III. EXAMINATION FINDINGS
IV. INVESTIGATIONS;
V. PROCEDURE
PNEUMATIC LITHOTRIPSY DONE:
Ureteric Side Stone Site at Ureter Calculus size
Upper Mid Lower
Right ureter
Left ureter
Procedure Details;
Procedure Criteria
Mode of Fragmenting Stone(single)
Mode of Fragmenting Stone (multi)
Mean Treatment Time in (Min)
VI. PER OPERATIVE COMPLICATIONS
1. Migration of stone proximally in ureter during procedure. Yes [ ] No [ ]
2. Failure of fragmentation of stone Yes [ ] No [ ]
3. Ureteric Perforation Yes [ ] No [ ]
VII. ANY FURTHER INTERVENTION REQUIRED:
Yes [ ] No [ ]
If yes, specify Procedure Name __________________________
VIII. HOSPITAL STAY AFTER PROCEDURE
01 Day [ ] 02 Days [ ] 03 Days [ ]
IX. ANY POST OPERATIVE COMPLICATION:
1. Haematuria Yes [ ] No [ ]
2. Fever Yes [ ] No [ ]
3. Post op: tenderness Yes [ ] No [ ]
4. Urosepsis Yes [ ] No [ ]
X. FOLLOW UP X-RAYS:
1st post operative day Complete clearance of stone Yes [ ] No [ ]
After 02 weeks Complete clearance of stone Yes [ ] No [ ]
After 03 months Complete clearance of stone Yes [ ] No [ ]
