1 - Rajiv Gandhi University of Health Sciences



RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

KARNATAKA, BANGALORE

ANNEXURE - II

PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

|1. Name of the candidate : and address |Dr.SUBASH K G Room|

| |No.112, PG and Intern Hostel for Men, Near Old Exhibition Building, |

| |MMC & RI, Mysore- 570021 |

|2. Name of the institution : |MYSORE MEDICAL COLLEGE AND RESEARCH INSTITUTE, MYSORE. |

|3. Course of study and : Subject |M.S. GENERAL SURGERY |

|4. Date of admission to : course |09/04/2009 |

|5. Title of topic : |“A CLINICAL STUDY TO DETERMINE PREDICTIVE FACTORS FOR DIFFICULT |

| |LAPAROSCOPIC CHOLECYSTECTOMY” |

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|6. BRIEF RESUME OF THE INTENDED WORK : |

|6.1 NEED FOR THE STUDY: |

|Cholelithiasis is a common ailment and affects about 10 to 15% of general population. |

|Laparoscopic cholecystectomy is one of the most common surgeries performed and has replaced open cholecystectomy. Since the |

|introduction of laparoscopic cholecystectomy, the number of cholecystectomy perform in the United States has increased from 5 Lakh |

|per year to 7 Lakh per year.8 |

|Since the conversion rate from laparoscopic cholecystectomy to open cholecystectomy is 1.5 to 19%, there is a need to evaluate |

|various factors responsible for difficult laparoscopic cholecystectomy. |

|Hence in this dissertation, study is done to evaluate the predictive factors responsible for difficult laparoscopic cholecystectomy.|

|6.2 REVIEW OF LITERATURE |

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|Cholelithiasis is the most common biliary pathology. Gall stones are present in 10-15% of the general population and asymptomatic in|

|the majority >80% - |

|Approximately 1-2% of asymptomatic patients will develop symptoms requiring cholecystectorny per years, making cholecystectomy one |

|of the most common operations performed by general surgeries.1 |

|Cholethiasis is rare in the first two decades. Incidence gradually increases after 21 years and reaches peak in 5th and 6th decade |

|Women are more affected than men in the ratio of 4:1.2 |

|Female sex, obesity, pregnancy, fatty foods, crohn’s disease, terminal ileal resection, gastric surgery, hereditary sperocytosis, |

|sickle cell disease and thalasemia are associated with an increased risk for developing gall stones.3 Only first degree relative of|

|patients with gallstones and obesity (defined as body mass index >30 kg/m2) have been identified as strong risk factors for |

|development of symptomatic gall stone disease.4 |

|About 80% are cholesterol stones, containing more than 50% of crystalline cholesterol monohydrate. The remainder are composed |

|predominantly of bilirubin calcium salts and are designated pigmented stones.5 |

|Classic symptoms presenting the majority of patients include stabbing (colicky) pain in the right upper quadrant radiating to the |

|back and to the shoulder. Although it is often taught that this pain occurs after the patient eats a fatty meal, the pain pattern is|

|not always so predictable. Frequently the pain occurs in the middle of the night, usually between the hours of 12 am and 3 am. |

|After wakening the patient. the pain generally lasts for a few minutes to a few hours. Usually the pain passes with in an hour and |

|the patient returns to sleep. Frequently the pain is associated with nausea and vomiting but a rarely accompanied by Jaundice, fever|

|or chills, unless acute cholecystitis or cholangitis is present. Once symptomatic, patients tend to have recurring symptoms, usually|

|repeated episodes of biliary colic.7 |

|Nonspecific gastrointestinal symptoms develop in 10 to 30% of patients and 5 to 10% of patients develop classic biliary symptoms. 17|

|Ultrasound of the abdomen is an extremely useful and accurate method for identifying gallstones and pathologic changes in the |

|gallbladder consistent with acute cholecystitis.8 Ultrasound of abdomen has a high specificity of >98% and sensitivity of >95% in |

|diagnosing cholelithiasis.9 In addition to identifying gallstones, ultrasound can also detail signs of cholecystitis such as |

|thickening of the gall bladder wall, pericholecystic fluid, and impacted stone in the neck of the gallbladder.8 Dilation of the |

|extrahepatic (>10 mm) or intrahepatic (>4mm) bileducts suggests biliary obstruction.8 |

|First described in 1882 by langenbuch, open cholecystectomy has been the |

|Primary treatment of gallstone disease for most of the past century. 10 |

|In 1985, the first documented laparoscopic cholecystectomy was performed by Erich Muhe in Germany in 1985. 18 In 1987, Phillipe |

|Mouret, perform the first laparoscopic cholecystectomy in Lyons, France using vido technique. 18 |

|In 1992, the National Institutes of Health (NIH) consensus development conference stated that laparoscopic cholecystectomy “provides|

|a safe and effective treatment for most patients with symptomatic gallstone.11 |

|The advantages of 1aparoscopic cholecystectomy over open cholecystectomy were immediately appreciated: earlier return of bowel |

|functions, less postoperative pain, informed cosmesis, shorter length of hospital stay, earlier return to full activity, and |

|decreased overall cost.12,13,14 |

|Conversion rate in Laparoscopic cholecystectomy is still 1.5 to 19%. Significant independent predictive factors for conversion of |

|laparoscopic cholecystectomy to open cholecystectomy are male gender, previous abdominal surgeries, acute cholecystitis thickened |

|gallbladder wall on preoperative ultrasonography of abdomen and suspicion of common bile duct stones.15 |

|Laparoscopic surgery is associated with better preservation of immune function and a reduction of the inflammatory response compared|

|with open surgery. The rate of post operative infections seems to be significantly lower.16 |

| |

|OBJECTIVES OF THE STUDY |

|To determine the predictive factors for difficult laparoscopic cholecystectomy. |

|To study the clinical presentation of cholelithiasis. |

|To study the complications of cholelithiasis. |

|To study the surgical mode of management. |

| |

|7. MATERIALS AND METHODS |

| |

|7.1 SOURCE OF DATA |

|Cases admitted as in patient in various surgical wards in K.R. Hospital, Mysore with signs and symptoms of cholelithiasis |

|/cholecystitis who are clinically evaluated and confirmed by USG. |

| |

|7.2 METHOD OF COLLECTION OF DATA |

|A Performa for study of all consecutive patients of cholelithiasis admitted from November 2009 to July 2011 will be used - with |

|presentation clinical findings, duration, investigations, predictive factors for difficult laparoscopic cholecystecty. A minimum of |

|50 laparoscopic cholecystectomy will be studied during the period. |

|The patients confirmed by USG examination will be evaluated with following factors age, sex, h/o previous hospita1isation, DM, BMI, |

|Wt(kg) /ht(m2 ), abdominal scar- whether infraumbilical or supraumbilifcal, Palpable gallbladder, and sonographic findings-wall |

|thickness, pericholecystic collection, impacted stone, post ERCP status.15 |

|Following evaluation the patient will be subjected to laparoscopic cholecystectomy and time taken, biliary / stone spillage, injury |

|to duct / artery or conversion will be noted.19 |

|INCLUSION CRITERIA |

|The patients aged between 16 to 60 years presenting symptoms and signs of |

|Cholelithiasis / cholecystitis and diagnosed by USG examination in various surgical wards of K.R. Hospital, Mysore. |

|EXCLUSION CRITERIA |

|Patients below 15 years. age. |

|Patients with CBD calcu1us, raised ALP, dilated CBD, where CBD |

|exploration was needed. |

|Patients with features of obstructive jaundice. |

|Patients refusing surgery. |

|Patients not willing for laparoscopic cholecystectomy. |

|7.3 INVESTIGATION |

|a. Routine investigation |

|Hb, BT, CT, TC, Blood Urea, Serum Creatinine, RBS, FBS and PPBS for diabetic patients. ECG in all leads. Urine analysis (Albumin, |

|Sugar, Microscopy), LFT. |

|b. Special investigation USG abdomen |

|USG Abdomen |

|CT Scan abdomen |

|Oral cholecystogrpahy If necessary |

|Intravenous cholecystogrpahy |

|7.4 DOES THE STUDY REQUIRE ANY INVESTIGATION / INTERVENTION TO BE CARRIED OUT ON ANIMALS/ IF SO, DESCRIBE BRIEFLY - No. |

|7.5 HAS ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR INSTITUTION? |

|YES (copy enclosed) |

| |

|8. LIST OF REFERENCES |

|1. Kurin Conlon. Gallbladder and bile ducts 25th edition. Chatper 63 in Bailey and Love’s short practice of Surgery, Norman S. |

|Williams, Christopher J.K. Bulstrode, P. Ronan O’Connell. p. 1119-1120. |

|2. Das S. Biliary system. Chapter 46 in: A concise textbook of surgery, Das S. (ed). 4th edition. Calcutta (India), Sumanth Das |

|2006 p. 904-938. |

|3. Bellows CF, Berger DH, Crass RA. Management of gallstones. AM Fam Physician 2005; 72: 637-642, 2005 |

|4. Nakeeb A, Comuzzie A G, Martin L. et al. Gallstones : Genetics versus environment. Ann Surg 2002; 235: 843-849. |

|5. James M. Crawford, M.D., Ph.D., Live,r and Biliary tract, chapter 18 in Robbins and cotran pathologic basis of disease, Vinay |

|Kumar, Abdul K. Abbas, Nelson Fausto, 7th edition p. 877-939. |

|6. John G Hunter and Sarah K. Thompson. Laparoscopic cholecystectorny, intraoperative cholangiography, and common bile duct |

|exploration; chapter 98; mastery of surgery: Josef E. Fischer and Kirby I. Bland: p. 1116-1128. |

|7. Glasgow RE, Cho M. Hutter MM. et al: The spectrum and cost of complicated gallstone disease in California. Arch Surg 2000; 135: |

|1021-1025. |

|8. Ravi S. Chari,MD and Shinul A. Shah,MD. Biliary system, Chapter 54 Sabiston textbook of surgery, Volume 2, 18th edition, Courtney|

|M. Town Send, R. Laniel Beauchamp, B. Mark Evers, Kenneth.L. Mattox, p. 1547-1588. |

|9. Trowbridge RL, Putkouski NK, Shojania KG. Dose this patient have acute cholecystitis? JAMA 2003; 289: 80-86, 2003. |

|10. Beal JM. Historical perspective of gallstone disease. Surg Gvnecol Obstet 1984;158: 181-189. |

|11. Conference,NC. Gallstones and laproscopic cholecystectomy. JAMA 1992; 269: 1018-1024. |

|12. Barkun J S, Barkun A N. Sampalis J S, et al. Randomized controlled trial of laproscopic versus mini-cholecystectomv. Lancet |

|1992: 340: 1116-1119. |

|13. Bass EB, Pitt HA. Lillenore KD. Cost effectiveness of laproscopic cholecystectomy versus open cholecystectomy. Am J Surg 1993; |

|165: 466-471. |

|14. Soper N, Barteau J, Clayman R, et al. Laproscopic versus standard open cholecystectomy : Comparison of early results. Surg |

|Gynecol Obstet 1992; 174:114-118. |

|15. Kama NA, Doganay M, Dolapa M. Reis E, Atli M, et a!. Risk factors resulting in conversion of la~oscopic cholecystectomy to open |

|cholecystectorny. surgical endoscopy, Springer New York ;V15: 965-968. |

|16. Boni L, et al. Infective complication of laproscopic surgery. Surg Infect (Larchmt), 2006; 7 suppl 2 : S 109-11. |

|17. Gertsch P. The technique of cliolecysiectoiny. Chapter 35. In : Surgery of the liver and biliary tract. Blumgart LH and Fong Y. |

|Vol (1) .3rd edition, London W.B. Saunders 2002, p. 697-708. |

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|18. History of minimal access surgery : An article by R.K.Mishra. |

|19. Preoperative prediction of difficult laparoscopic cholecystectomy : a scoring method. Jaskiran .S.Randhawa, |

|Ashwini.K.Pujari. Indian J Surg (July-August 2009) 71 : 198 – 201. |

|20. Art of laparoscopic surgery, textbook and atlas, C.Palanivellu, Foreword: Jacques Perssat, |

|Horacio.J.Asbun.Volume 1; Chapters- Evolution of laparoscopic surgery 3-11 and Laproscopic cholecystectomy 555-585. |

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|9. Signature of the candidate : |

|10. Remarks of the guide : |

|11.Name and designation of (in block | |

|letter) |Dr.DINESH.H.N. Asst. |

|11.1 Guide |Professor, Department of Surgery, Mysore Medical College and |

| |Research Institute, Mysore |

|11.2 Signature of guide: | |

|11.3 Co-Guide (if any) | |

|11.4 Signature of co-guide: | |

|11.5 Head of Department |Prof. Dr. AVADHANI GEETA.K. M.S.(GENERAL SURGERY) |

| |Professor, Department of Surgery, Mysore Medical College and |

| |Research Institute, Mysore |

|11.6 Signature of HOD | |

|12. Remarks | |

|12.1 Remarks of Dean and Director: | |

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|12.2 Signature : | |

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|ETHICAL COMMITTEE CLEARANCE |

|Title of Dissertation |A CLINICAL STUDY TO DETERMINE PREDICTIVE FACTORS FOR DIFFICULT |

| |LAPAROSCOPIC CHOLECYSTECTOMY |

|Name of the candidate |Dr.SUBASH.K.G. |

|Subject |MS (GENERAL SURGERY) |

|Name of the guide |Dr.DINESH.H.N. Asst. Professor,|

| |Department of Surgery, Mysore Medical College and Research |

| |Institute, Mysore |

|Approved/Not approved (If not approved, suggestion) | |

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|MEDICAL SUPERINTENDENT |MEDICAL SUPERINTENDENT |

|K.R.HOSPITAL, MYSORE |CHELUVAMBA HOSPITAL, MYSORE |

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|PROFESSOR AND HOD |PROFESSOR AND HOD |

|DEPARTMENT OF MEDICINE, MYSORE |DEPARTMENT OF SURGERY |

|MEDICAL COLLEGE AND RESEARCH INSTITUTE, MYSORE |MYSORE MEDICAL COLLEGE AND RESEARCH INSTITUTE, MYSORE |

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|MEDICAL SUPERINTENDENT P.K.T.B |LAW EXPERT |

|AND CHEST DISEASES HOSPITAL, MYSORE | |

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|DEAN AND DIRECTOR MYSORE MEDICAL |

|COLLEGE AND RESEARCH INSTITUTE, MYSORE |

From

Dr. K. G. SUBASH

PG in General Surgery

Mysore Medical College & Research Institute

Mysore.

To

The Dean & Director

Mysore Medical College & Research Institute

Mysore.

Through

The Professor & Head

Department of General Surgery

Mysore Medical College & Research Institute

Mysore

Subject: Submission of Synopsis Titled “A CLINICAL SUTDY TO DETERMINE PREDICTIVE FACTORS FOR DIFFICULT LAPAROSCOPIC CHOLECYSTECTOMY’.

Respected Sir,

I am hereby submitting the above titled synopsis (4 Copies) as mentioned above kindly accept my application and do the needful.

Thanking You Yours Faithfully

(Dr. SUBASH K G)

Forwarded to Principle, Mysore Medical College & Research Institute, Mysore for further needful action.

Date: Professor & Head

Place: MYSORE Department of General Surgery

Mysore Medical College & Research Institute

MYSORE

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