RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA



RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA

BANGALORE

ANNEXURE – II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

| | | |

| |Name of the candidate & |Dr. VEERABHADRA R., |

|1. |Address (In block letters) |DEPT. OF SURGERY, |

| | |M.R. MEDICAL COLLEGE, |

| | |GULBARGA-585105 |

| | | |

| |Permanent address |S/o Mr. RADHAKRISHNA, |

| | |No. 607, 4th CROSS, |

| | |BASAVANAGUDI, |

| | |SHIVAMOGGA-577201. |

| | | |

|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 |“EVALUATION OF HYPERBILIRUBINEMIA AS A NEW DIAGNOSTIC MARKER FOR ACUTE |

| | |APPENDICITIS AND ITS ROLE IN THE PREDICTION OF APPENDICULAR PERFORATION” |

| | |

|6. |Brief resume of the intended work |

| | | |

| |6.1 |Need for the study: |

| | | |

| | |Acute Appendicitis is the most common general surgical emergency, and early surgical intervention improves outcomes1. |

| | |Despite the increased use of ultrasonography, computed tomography scanning and laparoscopy, the rate of misdiagnosis of|

| | |appendicitis has remained constant (15.3%), as has the rate of appendiceal perforation.2 In an age accustomed to early |

| | |and accurate preoperative diagnosis, acute appendicitis remains an enigmatic challenge and a reminder of the art of |

| | |surgical diagnosis.3 |

| | |Thus a new marker for acute appendicitis would be welcomed. |

| | |Elevated Serum Bilirubin level will help in the early and accurate diagnosis of Acute appendicitis and in predicting |

| | |its serious complications, most importantly the perforation. |

| | |Thus the need for the study is to conclude whether the Serum Bilirubin can be considered as a new laboratory marker to |

| | |aid in the diagnosis of Acute appendicitis and if so, does it have the predictive capacity to warn us about |

| | |Appendicular perforation. |

| | | |

| |6.2 |Review of literature |

| | | |

| | |The first appendicectomy was performed by Claudius Amyand, Surgeon to Westminster and St. George’s Hospitals and |

| | |Sergeant Surgeon to George II, on a boy of 11 years of age in 1736.4 |

| | | |

| | |In 1886, Reginald Fitz of Boston correctly identified the appendix as the primary cause of right lower quadrant |

| | |inflammation. He coined the term APPENDICITIS and recommended early surgical treatment of the disease.1 |

| | | |

| | |The inflamed Appendix results in the clinical syndrome known as Acute appendicitis.3 |

| | | |

| | |Appendicitis is relatively rare in infants and becomes increasingly common in childhood.3 It’s most frequently seen in |

| | |patients in their second through fourth decades of life, with a mean age of 31.3 years and a median age of 22 years. |

| | |There is a slight male:female predominance (1.2 to 1.3:1).2 |

| | | |

| | |Obstruction of the lumen is believed to be the major cause of acute appendicitis.1 Fecaliths are found in 40% of cases |

| | |of simple Acute appendicitis, 65% cases of gangrenous appendicitis without rupture and 90% cases of gangrenous |

| | |appendicitis with rupture.2 Less common causes are hypertrophy of lymphoid tissue, inspissated barium from previous |

| | |x-ray studies, tumours, vegetable and fruit seeds, and intestinal parasites.2 |

| | | |

| | |The bacterial population of normal appendix is similar to that of the normal colon. The principal organisms seen in |

| | |normal appendix, acute appendicitis and in perforated appendicitis are Escherichia Coli and Bacteroids fragilis. |

| | |However a wide variety of facultative and anaerobic bacteria and mycobacteria may be present.2-9-10 |

| | | |

| | |The appendix perforates about 48 hours after the onset of Acute appendicitis. It has been suggested that delay in |

| | |presentation is responsible for the majority of perforated appendices. Overall rate of perforation is 25.8%. Children |

| | |65 years of age have highest rates of perforation. Appendicular perforation occurs most |

| | |frequently distal to the point of luminal obstruction along the antimesenteric border.2 |

| | | |

| | |The study on the association of hyperbilirubinemia with Appendicitis is being carried out recently and there are only a|

| | |few studies in this regard. It was hypothesized that an association exists between the presence of hyperbilirubinemia |

| | |and appendicitis and its complications5. |

| | | |

| | |The Patho-physiology (in brief) behind the elevation of Serum Bilirubin in Acute Appendicitis5-6-11. |

| | | |

| | | |

| | |Acute Appendicitis |

| | | |

| | |A non specific host immune response |

| | |leading to oedema, increased intraluminal pressure |

| | |and ischemic necrosis of mucosa causing gangrene and perforation |

| | |↓ |

| | |Transmigration/translocation of bacteria/toxins/cytokines |

| | |Either by direction invasion or through portal vein |

| | |↓ |

| | |endotoxemia / bacteremia |

| | |↓ |

| | |Invasion of Bacteria into the hepatic parenchyma |

| | |interferes with the physiology of excretion of bile |

| | |↓ |

| | |Hyperbilirubinemia |

| | | |

| | | |

| | |A retrospective study conducted in Department of General & Visceral Surgery, Academic Teaching Hospital of the Ruhr |

| | |University, Bochum, Germany found elevated bilirubin in all patients in the range of 0.1 – 4.3 mg/dl, while patients |

| | |with Appendiceal perforation had Bilirubin in the range of 4.0 – 4.3 mg/dl7. |

| | | |

| | | |

| | |Study conducted by Dept. of Surgery, Nepalgunj Teaching Hospital, Nepalgunj, Nepal found elevated Total Serum Bilirubin|

| | |(TSB) in 87% of cases. The mean of elevated serum Bilirubin was 2.26mg/dl and in patients with gangrenous or perforated|

| | |appendix; elevation of TSB was found to be much higher8. |

| | | |

| | |A retrospective study done in USC Medical Center, Los Angeles found elevated Bilirubin levels in 38% of cases and |

| | |patients with Gangrene/perforation were significantly more likely to have Hyperbilirubinemia than those with Acute |

| | |Appendicitis. The odds of appendiceal perforation are three times higher (odds ratio 2.6) for patients with |

| | |Hyperbilirubinemia compared to those with normal Bilirubin levels5. |

| | | |

| | |Another study conducted by Dept. of Surgery, Nepalgunj Teaching Hospital, Nepalgunj, Nepal found hyperbilirubinemia in |

| | |86.6% of the patients of acute appendicitis. The range of Hyperbilirubinemia ranged from 1.2mg – 8.4mg/dl with mixed |

| | |type (Direct and Indirect) of Serum Bilirubin6. |

| | | |

|7 |6.3 |Objectives of the study |

| | | |

| | |To study the relationship between hyperbilirubinemia and acute appendicitis and to evaluate its credibility as a |

| | |diagnostic marker for acute appendicitis. |

| | | |

| | |To evaluate whether elevated Bilirubin levels have a predictive potential for the diagnosis of Appendicular |

| | |perforation. |

| | |

|7. |Material and Methods |

| | | |

| |7.1 |Source of Data: |

| | | |

| | |All patients admitted with clinical diagnosis of “Acute Appendicitis” or “Appendicular Perforation” 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. |

| | |The primary data for this study would be the blood investigations of the patients. |

| | | |

| |7.2 |Methods of collection of data (including sampling procedure, if any) |

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| | |Study Design: Cross-sectional Study |

| | | |

| | |Sample Size: 100 |

| | | |

| | |Calculated as per the below applied formulae: |

| | | |

| | |n = Z2 × p × q |

| | |d2 |

| | | |

| | |where, n: sample size |

| | |Z: if 1.96 ~ 2 (taking confidence as 95%) |

| | |p: prevalence (prevalence is taken as 50% as exact prevalence is not known) |

| | |q: is 100 – p i.e. 50% |

| | |d: absolute error which is 10% |

| | | |

| | |Timeline of the Study: 12 months from DEC 2010 to NOV 2011 |

| | | |

| | |Methodology: |

| | |The following tests would be carried out for patients diagnosed as ‘Acute Appendicitis’ or ‘Appendicular Perforation’ |

| | |under General Surgery care and admitted to HKE’s BASAVESHWAR Hospital, Gulbarga. |

| | |Routine blood investigations (i.e. complete blood count, platelet count, reticulocyte count etc.) |

| | |Peripheral smear to rule out hemolytic anemia. |

| | |Serum Bilirubin (Total & Direct bilirubin) |

| | |Liver Enzymes, which include - |

| | |SGPT (Alanine transaminase) |

| | |SGOT (Aspartate transaminase) |

| | |ALP (Alkaline phosphatase) |

| | |Seropositivity for HbsAg |

| | |Urine examination (routine & microscopy) |

| | | |

| | |The serum bilirubin & Liver Enzymes would be carried out using the Auto Analyser machine available in the hospital. |

| | | |

| | |HbsAg would be tested by ELISA / Spot technique using HEPALISA© or HEPACARD© kit. |

| | | |

| | |The results would be grouped as ‘Normal’ or ‘Raised’ as per the below reference levels: |

| | | |

| | |Reference Range of Serum Bilirubin and Liver Enzymes2 |

| | |Test |

| | |Normal Range |

| | | |

| | |Serum Bilirubin |

| | |Total |

| | |Direct |

| | | |

| | |0.3 - 1.0 mg/dl |

| | |0.1 – 0.3 mg/dl |

| | | |

| | |Liver Enzymes |

| | |SGPT |

| | |SGOT |

| | |ALP |

| | | |

| | |0 – 35 U/L |

| | |0 – 35 U/L |

| | |30 – 120 U/L |

| | | |

| | | |

| | | |

| | |The sensitivity and Specificity of Serum bilirubin in the diagnosis of acute appendicitis would be determined. |

| | | |

| | |Inclusion Criteria: |

| | |All patients diagnosed as acute appendicitis clinically on admission. |

| | |All patients diagnosed as appendicular perforation clinically on admission |

| | |For both these groups (i and ii), only patients with histopathological report suggestive of appendicitis would be |

| | |included. |

| | | |

| | |Exclusion Criteria: |

| | |All patients documented to have a past history of |

| | |Jaundice or Liver disease |

| | |Chronic alcoholism (i.e. intake of alcohol of >40g/day for Men and >20g/day in Women for 10 years12) |

| | |Hemolytic disease |

| | |Acquired or Congenital biliary disease. |

| | |All patients with positive HBsAg |

| | |All patients with cholelithiasis |

| | |All patients with Cancer of hepato-biliary system |

| | | |

| |7.3 |Does the study require any investigation or intervention to be conducted on 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 - |

| | |Routine blood investigations (i.e. complete blood count, platelet count, reticulocyte count etc.) |

| | |Peripheral smear to rule out hemolytic anemia. |

| | |Serum Bilirubin (Total & Direct bilirubin) |

| | |Liver Enzymes, which include - |

| | |SGPT (Alanine transaminase) |

| | |SGOT (Aspartate transaminase) |

| | |ALP (Alkaline phosphatase) |

| | |Seropositivity for HbsAg |

| | |Urine examination (routine & microscopy) |

| | | |

| |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 |

| | | |

| | |Courtney M. Townsend et al. SABISTON TEXT BOOK OF SURGERY, 18th edition, Philadelphia: Saunders, An Imprint of |

| | |Elsevier; 2008 |

| | |F. Charles Brunicardi et al. SCHWARTZ’S PRINCIPLES OF SURGERY. 9th ed. McGraw Hill; 2010 |

| | |Norman S. Williams et al. BAILEY AND LOVE’S SHORT PRACTICE OF SURGERY. 25th ed. London: Edward Arnold (Publishers) Ltd;|

| | |2008 |

| | |Michael J. Zinner et al. MAINGOT’S ABDOMINAL OPERATIONS. 10th ed. Prentice hall International; 1997 |

| | |Joaquin J. Estrada et al. HYPERBILIRUBINEMIA IN APPENDICITIS: A NEW PREDICATOR OF PERFORATION. Journal of |

| | |Gastrointestinal Surgery (2007) 11: 714 – 718 |

| | |Khan S. EVALUATION OF HYPERBILIRUBINEMIA IN ACUTE INFLAMMATION OF APPENDIX: A PROSPECTIVE STUDY 0F 45 CASES. Kathmandu |

| | |University Medical Journal (2006); Vol. 4 : No. 3:281-28 9 |

| | |Sand M, Bechara G. et al. DIAGNOSTIC VALUE OF HYPERBILIRUBINEMIA AS A PREDICTIVE FACTOR FOR APPENDICEAL PERFORATION IN |

| | |ACUTE APPENDICITIS. Department of General and Visceral Surgery, Academic Teaching Hospital of the Ruhr Hospital, |

| | |Bochum, Germany. The American Journal of Surgery (2009); Vol. 198: No. 2: 193 – 198. |

| | |Khan S. ELEVATED SERUM BILIRUBIN IN ACUTE APPENDICITIS: A NEW DIAGNOSTIC TOOL. Kathmandu University Medical Journal |

| | |(2008); Vol. 6: No. 2: 161 – 165. |

| | |Robert S. Bennion et al. THE BACTERIOLOGY OF GANGRENOUS AND PERFORATED APPENDICITIS-REVISITED. From the Departments of |

| | |Surgery, Olive View Medical Center and UCLA School of Medicine, Los Angeles. Ann. Surgery (1990); Vol. 211: No. 2: |

| | |165-171. |

| | |Wan Y. Lau et al. THE BACTERIOLOGY AND SEPTIC COMPLICATION OF PATIENTS WITH APPENDICITIS. From the Government Surgical |

| | |Unit and Department of Microbiology, University of Hong Kong. Ann. Surgery (1984); Vol. 200: No. 5: 576-581. |

| | |A. Eley et al. JAUNDICE IN SEVERE INFECTIONS. British Medical Journal (1965), 2, 75-77 |

| | |Anthony S. Fauci et al. HARRISON’s PRINCIPLES OF INTERNAL MEDICINE. 17th edition:McGraw Hill; 2008. |

| |Signature of Candidate | |

|9. | | |

| | | |

| | |Topic deserves consideration for dissertation study |

|10. |Remarks of Guide | |

| | | |

| |Name & Designation of (in block letters) |

| | |

|11. | |

| |11.1 Guide | |

| | |Dr. S.M. PATIL M.S {GEN. SURG}, |

| | |PROFESSOR, |

| | |DEPT. OF SURGERY, |

| | |M.R.MEDICAL COLLEGE, GULBARGA. |

| | | |

| |11.2 Signature | |

| | | |

| | | |

| | | |

| | |None |

| |11.3 Co-guide (If any) | |

| | | |

| | |- |

| |11.4 Signature | |

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| |11.5 Head of the Department | |

| | |Dr. S.A.HALKAI M.S {GENERAL SURGERY} |

| | |PROFESSOR & HEAD, |

| | |DEPT. OF. SURGERY, |

| | |M.R.MEDICAL COLLEGE, GULBARGA. |

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| |11.6 Signature | |

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|12. |12.1 Remarks of the Chairman and Principal| |

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| |12.2 Signature | |

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