` RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA BANGALORE
ANNEXURE – II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
Name of the candidate & Dr. DASARI NARESH, 1. Address (In block letters) DEPT. OF SURGERY, M.R. MEDICAL COLLEGE, GULBARGA-585105.
Permanent address S/o Dr D.V. GIDDAIAH, PLOT No. 47, H/No. 87/639, Near AMMA HOSPITAL, GAFOOR NAGAR, KURNOOL-518002. ANDHRA PRADESH.
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 MAY 2010
5. Title of the topic “ CLINICO-PATHOLOGICAL STUDY AND MANAGEMENT OF BILIARY STONES”
6. Brief resume of the intended work
6.1 Need for the study: Biliary calculi is one of the most common problems affecting the digestive tract and autopsy reports have shown a prevalence of Gall stones from 11 to 36%.1,2
Incidence of biliary calculus disease varies widely throughout the world which may be related to environmental & dietary considerations.3 It also varies with age. About 20-25% patients above 60 years with symptomatic biliary calculus disease have shown stone in the CBD as well as in the Gall bladder.4
Symptomatic biliary stone disease may progress to complications such as acute cholecystitis, choledocholithiasis with or without cholangitis, gall stone pancreatitis, cholecysto-choledochal fistula, cholecysto-enteric fistula leading to gall stone ileus.5
Diagnostic methods for the imagining diagnosis of biliarystone disease have been proliferating rapidly in recent years and the choice can be dewildering.6
One can only anticipate that well designed analyses will help clarify and define the most appropriate & cost effective treatment for biliary stone disease as it affects such as significant percentage of the population throughout the world.
Hence the need for study on biliarystone disease is to provide an indication of the prevalence of the disease and also to furnish information on clinical presentation,pathological picture and various modes of management on biliarystone in basaveshwar hospital,gulbarrga.
6. Review of literature 2
The first biliary tract operation is credited to John Stough Bobb of Indianapolis in 1867.6
In 1882, Karl Langenbuch, a noted German surgeon, performed the first successful cholecystectomy.3
Choledochotomy with stone extraction was first performed in 1889 associated with high mortality led to the use of chelecysto-jejunostomy for biliary obstruction.3
In 1891, choledocho-duodenostomy was initially attempted for an impacted common duct stone by Oskar Sprenger in Germany.6
Idea of medically treating stone in the biliary tract is probably ascribed J.W.W. Thudichum who wrote in 1863 “Physician became Naturally anxious to discover some remedy by which these concretions in the biliary channels might be chemically dissolved.”
Cholecystocholangiography had been performed by percutaneous puncture of the gallbladder in 1921 by Burckhardt & Muller.6
Diagnosis of biliary stones was improved considerably by the development of Oral cholecystography by Graham and Cole in 1924.3
Operative cholangiography was introduced by Mirrizi in 1937 in argentina. Pathogenesis of biliary stones is certainly multifactorial.3 Nucleation of cholesterol monohydrate crystals from multilamellar vesicles is a crucial step in the formation of cholesterol stones. Deconjugation of bilirubin deglucuronide by bacterial beta- glucuronidase forms pigment stones, most common in bile duct.7
Biliary colic begins quite suddenly and may persist with severe intensity for 30 minutes to 5 hours after a fatty meal, which subsides gradually or rapidly.8
Biliary calculi may also lead to acute cholecystitis in 5-10% cases further leading to ischemia and necrosis of the gall bladder wall.9
Natural history of biliary stones is as follows:
The main indication of cholecystectomy is symptomatic gallstones, which may be combined with common bile duct exploration to remove further stones.10
The management of patients with a high suspicion of or proven choledocholithiasisis is dependent on local resources and expertise.
7 6. Objectives of the study 3
1. To evaluate age, sex, incidence, most common etio-pathological factors for biliary calculi.
2. To illustrate varying clinical presentation and study various modes of management adopted in our institution.
3. To analyse biochemical types of stones prevalent in Gulbarga.
7 Material and Methods .
7. Source of Data: 1
All patients admitted with clinical diagnosis of “Biliary calculi” under General Surgery care in HKE’S Basaveshwar Teaching and General Hospital, Gulbarga would be taken as Subjects for this study.
After taking the proposed Informed Consent, data would be collected using the questionnaire / proforma.
7. Methods of collection of data (including sampling procedure, if any) 2
Study Design: Prospective Study
Sample Size: 50
Timeline of the Study: 12 months from DEC 2010 to NOV 2011
Methodology:
The laboratory and radiological tests would be carried out for patients diagnosed as “Biliary calculi” under General Surgery care and admitted to HKE’s BASAVESHWAR Hospital, Gulbarga.
Open cholecystectomy, Open CBD exploration with drainage procedure such as T- tube or biliary enteric anastomosis would be performed for gall stone and CBD stone disease respectively. The clinical manifestation; biochemical, radiological and pathological investigations; and intervention procedures would be analysed.
Inclusion Criteria:
1. All patients diagnosed as Biliary stone disease by clinical examination and radiological investigations.
Exclusion Criteria:
1. Patients below the age of 15 years and above 75 years. 2. Asymptomatic biliary stones found accidentally either at laparotomy or during sonography done for some other problem. 3. Patients with hepatobiliary malignancy.
7. Does the study require any investigation or intervention to be conducted on 3 patients or other humans or animals? If so please describe briefly.
Yes, the following blood investigations would be carried out in addition to routine investigations for patients - I. Routine blood investigations (i.e. complete blood count, platelet count, reticulocyte count etc.) II. Urine examination (routine & microscopy) III. Renal profile IV. Serum Electrolytes V. Blood sugar VI. Liver function tests Total & Direct bilirubin SGPT SGOT ALP PT/INR VII. Plain x-ray abdomen- erect posture VIII. Chest x-ray: PA view IX. HBsAg & HIV X. USG- Abdomen & pelvis XI. Bile for bacteriological analysis XII. Stone for biochemical composition XIII. ERCP,MRCP,PTC in selected casses
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. F. Charles Brunicardi et al. SCHWARTZ’S PRINCIPLES OF SURGERY. 9th ed. McGraw Hill; 2010
2. Brett M., Barker D.J. THE WORLD DISTRIBUTION OF GALL STONES. Int. J. Epidemiol. 5: 335; 1976
3. Michael J. Zinner et al. MAINGOT’S ABDOMINAL OPERATIONS. 10th ed. Prentice hall International; 1997
4. Ko C, Lee S.: EPIDEMIOLOGY AND NATURAL HISTORY OF CBD STONES AND PREDICTION OF DISEASE.Gastrointest endosc 56:S 165;2002
5. Brasea A. Berli D. et al. MORPHOLOGICAL AND DEMOGRAPHIC ASSOCIATION OF BILIARY SYMPTOMS IN SUBJECTS WITH GALL STONES. Findings from a population based survey in Rosario,,Argentina. Dig Liver Dis 34: 577; 2002
6. Courtney M. Townsend et al. SABISTON TEXT BOOK OF SURGERY, 18th edition, Philadelphia: Saunders, An Imprint of Elsevier; 2008
7. Norman S. Williams et al. BAILEY AND LOVE’S SHORT PRACTICE OF SURGERY. 25th ed. London: Edward Arnold (Publishers) Ltd; 2008
8. Anthony S. Fauci et al. HARRISON’s PRINCIPLES OF INTERNAL MEDICINE. 17th edition:McGraw Hill; 2008.
9. Strasberg SM: CHOLELITHIASIS AND ACUTE CHOLECYSTITIS .Baillieres clin gastroenterol 11:643,1997.
10. Margaret Farquharson et al. FARQUHARSON’s TEXT BOOK OF OPERATIVE GENERAL SURGERY. 8th edition:Edward Arnold; 2005 9. Signature of Candidate
10. Remarks of Guide
Name & Designation of (in block letters) 11.
Dr. S.R. HARWAL M.S., M.Ch. (PAED SURG), PROFESSOR, 11.1 Guide DEPT. OF SURGERY, M.R.MEDICAL COLLEGE, GULBARGA.
11.2 Signature
11.3 Co-guide (If any) None
11.4 Signature -
Dr. S.A. HALKAI M.S. (GENERAL SURGERY), 11.5 Head of the PROFESSOR & HEAD, Department DEPT. OF. SURGERY, M.R.MEDICAL COLLEGE, GULBARGA.
11.6 Signature 12. 12.1 Remarks of the Chairman and Principal
12.2 Signature