RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE KARNATAKA

ANNEXURE-2

PROFORMA OF REGISTRATION OF SUBJECT FOR DISSERTATION

1. Name of the candidate and address / Dr. Raghavendra Rao S
Postgraduate in General Surgery
Bowring And Lady Curzon Hospital,
BMC & RI, Bangalore
2. Name of Institution / Bangalore medical college and Research Institute, Bangalore
3. Course of study and subject / M.S in General Surgery
4. Date of admission to the course / 2nd May 2009
5. Title of the topic / A study of etiological factors and biochemical analysis of gallstones

6. Brief resume of intended work:

6.1: Need for the study:

Gallstones have become a common surgical disorder. About one third of the patients land up in complications. Hence early diagnosis and treatment is required. In this study we are emphasising on the etiological causes and biochemical analysis of gall stones and correlating the findings.

6.2: Review of literature:

About 75% of the gallstones are composed predominantly of cholesterol and are called cholesterol stones and about 25% are pigment stones1. However a more recent study from Germany has reported a greater incidence of cholesterol stones2.

Pigment stones are of 2 types - brown and black. The etiology of brown and black stones is entirely different.3

The composition of any gallstone includes the following moieties - cholesterol, other sterols, phospholipids and bile acids.

Cholesterol is solubilised in bile due to the presence of micelles and phospholipids. Phospholipids are responsible for carrying one third of the biliary cholesterol.3,4

The cause of cholesterol stones is cholesterol supersaturation in bile.5They contain more than 70% of cholesterol by weight. Causes include obesity, multiparity and use of oral contraceptives. It is well known that fertile females are more prone to develop gallstones.

The cause of black pigment stones is supersaturation of calcium bilirubinate, phosphate and carbonate. The cause can be either chronic hemolysis or cirrhosis.1,8

Brown pigment stones can develop in the gallbladder or the bile ducts. The cause is secondary infection due to bile stasis8.Parasites are the usual cause of stasis in Asian population whereas strictures or stones are the cause of bile stasis in Western population. These stones contain bacterial cell bodies along with bile salts8.

Appearance: Cholesterol stones solitary, mulberry shaped, soft and faceted. Black pigment stones are small, brittle, black and sometimes spiculated. Brown stones are less than 1 cm, brownish yellow, soft, and mushy7,8

6.3: Objectives:

1. To study the biochemical analysis of gallstones.

2. To study the etiological factors behind each type of gallstone

7. Materials and methods:

7.1: Source of data:

Patients from Bowring and Lady Curzon hospital and Victoria hospital which are attached to Bangalore Medical College & Research institute, Bangalore selected during the period from Nov 2009 to November 2011 to a minimum of 30 cases.

7.2: Method of collection of data:

Data collected from the patient admitted from the OPD by history, clinical examination and laboratory investigations.

A) Inclusion criteria:

Gallstones subjected to biochemical analysis are obtained from patients undergoing open or laparoscopic cholecystectomy, bile duct exploration or endoscopic retrograde cholangiopancreatography

B) Exclusion criteria:

1. Patients below the age of 18 years

2. Patients who are on other modality of treatment other than surgery.

C) Sample size - 30

D) Sample design - purposive sampling

E) Study design - prospective study

F) Study period 2009-11.

G) Statistical analysis:

Data will be expressed using descriptive statistics using rates, ratios and means.

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

1. It does not require any intervention on animals.

2. Investigations are to be done on patients with their consent:

a)  Complete haemogram

b)  Liver function test

c)  Lipid profile

d)  FBS, PPBS, blood urea nitrogen and Serum creatinine

e)  USG abdomen

f)  ERCP and MRCP

7.4 Has ethical clearance been obtained from your institution in case of 7.4?

Yes

8. List of references:

1. Lawrence W Way. MD, The Biliary Tract, Current Surgical Diagnosis and Treatment McGraw Hill 12th Ed 2006 pp1088-95

2. Schafmayer C, Hartleb J, Tepel J et al Predictors of gallstone composition in 1025 symptomatic gallstones from Northern Germany BMC Gastroenterol. 2006 Nov 22;6:36.

3. Strasberg SM: The pathogenesis of cholesterol gallstones a review. J Gastrointest Surg 2:109, 1998. [PMID: 9925435]

John G Hunter, MD, Margret Oddsdttir, M.D. The Gallbladder and Extrahepatic Biliary system, Schwartz’s Principles of Surgery 8th Ed 2007 pp987-995

4. van Erpecum Biliary lipids, water and cholesterol gallstones Biol cell 2005 97(11) 815-22

5. Klein AS, Lillemoe KD, Yeo CJ, et al: Liver, biliary tract, and pancreas, in O'Leary JP(ed): Physiologic Basis of Surgery. Baltimore: Williams & Wilkins, 1996, p 441.

6. Stewart L, Oesterle AL, Erdan I, et al: Pathogenesis of pigment gallstones in Western societies: The central role of bacteria. J Gastrointest Surg 6:891, 2002. [PMID: 12504229]

7. Sheila Sherlock , Sheila Sherlock (Dame) And James Dooley Diseases of the liver and Biliary System Lippincott 2002 pp602-604

8. Hunter J G, Oddsdattir M The gallbladder and extrahepatic biliary system Scwartz Principles of surgery 8th Ed McGraw Hill pp 1055-58

9. Michael J Zinner, Stanley W Ashley Maingot’s abdominal operations McGraw Hill 2007 11th Ed pp560-568

9. Signature of the candidate:

Dr. Raghavendra Rao S, PG in General Surgery, Bowring and Lady Curzon hospital, BMC&RI, Bangalore.

10. Remarks of guide:

Gallstones have become more and more commonly encountered in surgical practice. The study of the etiological factors will go a long way in preventing the problem. Hence a sincere effort has been made to study the factors and its relation to biochemical nature of stones. Hence I recommend this study.

11. Name and designation (in block letters):

11.1: Guide:

Dr. SURESH CHANDU H C

ASST. PROFESSOR OF SURGERY

BMC&RI, BANGALORE

Signature and seal:

Head of department:

Dr. SHIVASWAMY B. S

PROFESSOR AND HEAD OF DEPARTMENT OF SURGERY

BMC&RI, BANGALORE

Signature and seal:

11.3 Co-guide: None

12. Remarks of the Director and Dean:

12.1: Signature and seal: