Rajiv Gandhi University of Health Sciences s150

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES BENGALURU, KARNATAKA

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1 Name of the candidate and DR. B. N. VINOD KUMAR address (in block letters) Vydehi Institute of Medical Sciences & Research Centre, #82 EPIP Area, Nallurahalli, Whitefield, Bangalore- 560066

2 Name of the Institution Vydehi Institute of Medical Sciences & Research Centre

3 Course of the study and M.S.Degree in GENERAL SURGERY subject

4 Date of admission to course 6th June,2013 5 Title of the topic :

A comparative study between Open cholecystectomy and Laparoscopic Cholecystectomy with or without placement of a drain.

6 Brief resume of the intended work

6.1 Need for the study: Gall stones cccurrence is one of the commonest disease processes treated by general surgeon. Open cholecystectomy which had been performed unchallenged for over a century now faces challenge with advent of laparoscopic cholecystectomy. The advent of laparoscopic surgery with its accompanying smaller incisions,less pain and shorter hospitalization.(1) Patient acceptance,preference,and demand for laparoscopic cholecystectomy is logical since this procedure gives less pain,need for less medication,shorter hospitalization,early retun to normal work and activity. Laparoscopic cholecystectomy further offers long term benefit of negligible incidence of wound infection,incisional hernia,nerve entrapment and post operative adhesions. The serum alkaline phosphatase is particularly elevated in cholestasis and liver disease or biliary obstruction.(1, 2) ERCP usefulness lies in its ability to dignose and treat diseases of biliary tree.(1) Drains may be placed at the time of cholecystectomy to know post operative biliary leakage and haemorrhage. So,we will study both the techniques and their standing in present scenario with background of experience in open cholecystectomy.

6.2 Review of literature:

In 1882 Carl Langenbuch performed the first successful open cholecystectomy,enunciating a principle that the gall bladder need to be removed not because it contains stones,but because it forms them. Over the years cholecystectomy has been the gold standard in the treatment gallbladder diseases. Despite the efficacy of open cholecystectomy , there was always a search for other less invasive options. In 1985 philipe mouret from France performed first laparoscopic cholecystectomy. Following the advent of laparoscopic surgery,surgeons have performed increased number of laparoscopic cholecystectomies.[2] 1. Vikas Guptha, Nisar Chowdari, Nazir Ahmad Wani, Sameer Naqash, in their study on Lap V/S open cholecystectomy over a period of 8 years concluded that LC & OC are comparable procedure for the treatment of gall stone disease in terms of complication, although hospital stay and time taken to return to work were less in LC group. Study demonstrate that LC is essentially a safe procedure with low morbidity and mortality rate.[3] 2. Dr. Kunal Solanki , Dr. Hiren Parmar, Dr. Vikram Gohil , Dr Samir Shah conducted a study on 100 patients with a diagnosis of calculus cholecystitis that underwent Cholecystectomy, concluded that Laparoscopic cholecystectomy is a considerable advancement in the treatment of gall bladder disease .technically the dissection of the cystic artery and cystic duct is very precise and bleeding is easily controlled with less per operative blood loss.LC is associated with less chances of wound infection and there is no risk of wound dehiscence. The antibiotic usage in LC comparatively lesser than that of OC. The amount of analgesic requirement is less in LC. LC patients tolerate oral feeds earlier and are mobilized faster. The duration of hospital stay is less and patients can be discharged quickly from hospital.[4] 3. M.Iqbal.ZEAMS,Afzal anees MS,Nazmul IMD they studied on comparison of Metabolic and inflammatory stress response after LC & OC concluded that metabolic and inflammatory stress response of the body are higher after OC as compared to LC, because body faces more trauma in OC.[5] 4. Keus F conducted a prospective study between laparoscopic and open cholecystectomy shows that Laparoscopic cholecystectomy is associated with significantly shorter hospital stay and a quicker convalescence compared with classical open cholecystectomy. Result confirms the Exiting preference for the laparoscopic cholecystectomy over open cholecystectomy.[6] 5. P.K. Chowbey, A Sharma, R.Khullar, V Mann, M Baijal & A Vashistha conducted study on laparoscopic subtotal cholecystectomy concluded that laparoscopic subtotal cholecystectomy is safe, feasible, effective and help to prevent conversion to open surgery in carefully selected patients with difficult cholecystectomies.[7] 6. Ravi mohan SM conducted a study on pulmonary function after LC and OC concluded that impairment in pulmonary function after LC was less marked than after OC.[8] 7. Placement of drains becomes a part of operation for long period of time.Hospital stay was long in drain group patients than in group without drain.[9] 8. Alkaline Phosphatase is raised in acute calculous cholecystitis and Common bile duct stone(CBD) stone, raise in serum level of this enzyme in acute cholecystitis implies stone in CBD is not well studied.[10] 9. Endoscopic retrograde cholangiopancreatography is a technique that combines the use of endoscopy and fluoroscopy to diagnose and treat certain problems of the biliary or pancreatic ductal systems. ERCP is used primarily to diagnose and treat conditions of the bile ducts and main pancreatic duct, including gallstones, inflammatory strictures, leaks (from trauma and surgery), and cancer.(11]

6.3 Objectives of the study: 1. To compare the outcome of laparoscopic and open cholecystectomy. 2. To compare the outcome of procedure with or without placement of a drain. 3.To study clinical correlation of raised Alkaline phosphatase and ERCP findings in patients with calculous cholecystitis with cbd stone.

7 Materials and Methods 7.1 Source of data

Patients admitted in Department of General Surgery and Department of Gastrosurgery, Vydehi Institute of Medical Sciences and Research Centre, Bangalore, between January 2014 to june 2015.

7.2 Method of collection of data (including sampling procedure if any) 1) Definition of a study subject: This will be prospective study. Study protocol: 25 patients undergoing laparaoscopic chlaecystectomy and 25 patients undergoing open cholecystectomy will be selected for study. All the patients will be operated under general anaesthesia. A single shot of broad spectrum antibiotic prophylaxis is administered for both the procedures at the time of induction of anaesthesia.

 The method of study consists of . Detail history taking and clinical examination as per the proforma. . Investigations after taking written informed consent. . Patients will be explained about types of surgeries available-open and laparoscopic.  Intraoperatively careful note will be made . time taken for the procedure; . documentation of any complications encountered during the procedure; . if the laparoscopic procedure is converted to open cholecystectomy, the reason for the same  Postoperative period was divided into immediate or in-hospital stay and the follow up period. During the in-hospital stay the following data was collected; . drain removal,if placed. . postoperative hospital stay and . any complication if occurred. 2)Patients of both group will be followed regularly up to 3 months. 3)Note will be made any complications,time taken to return to work and patient satisfaction. Inclusion Criteria

 Adult patients with following presentations will be included in the study :  Acute cholecystitis  Chronic cholecystitis  Cholelithiasis  Empyema gall bladder  Mucocele of gallbladder  Gangrenous gallbladder.

Exclusion criteria

 Patients having any other associated pathology like cardiovascular or pulmonary disease, major bleeding disorders.  Pregnant patients were excluded from the study.  Childrens are excluded in this study.  Patients unfit for general anaesthesia.

Statistics

Analysis will be done using z-test or t-test and chi-square test.

7.3 Does the study require any investigations or interventions to be conducted on patients or other humans or animal? If so, please describe briefly.

The investigations done in the cases selected for the study are :

1. Hb, TLC, DLC,HIV,HBSAG 2. Urine routine, microscopy, culture and antibiotic sensitivity. 3. Blood sugar level 4. Blood urea and Serum creatinine 5. USG Abdomen 6. LFT,RFT,LIPID Profile. 7. ERCP 8. Erect X-ray abdomen,X-ray chest.

7.4 Has ethical clearance been obtained from your institution in case of 7.3 : YES 8 List of References: 1. Courtney M. Townsend, Daniel Beauchamp R, Mark Evers B, Kenneth L, Mattox. Sabiston Textbook of Surgery, Elsevier, 19th ed, ; Pg. 1430,1491,1496.

2. Russell RCG, Norman S. William, Christopher K, Bullstrode. Bailey and Love Short Practice of Surgery, 26th ed, Arnold International ; Pg. 1067.

3. Vikas Guptha, Nisar Chowdari, Nazir Ahmad Wani, Sameer Naqash. Lap V/S Open Cholecystectomy: Prospective study of 800 patients. JK Science. Jan- Mar 2009; Vol 11 No.1.

4. Kunal Solanki , Hiren Parmar, Vikram Gohil , Samir Shah. Comparative Study between Open V/S Laparoscopic Cholecystectomy. NJIRM.jan-mar 2010;Vol.1

5. Iqbal.ZEAMS,Afzal anees MS,Nazmul IMD. Comparision of Metabolic and inflammatory stress response after LC & OC. Internet journal of surgery.2010;volume 22 :number 2.

6. Keus F, de Jong J, Goozen HG,Laarhoven CJHM. Lap V/s Open cholecystectomy for patients with symptomatic cholecystolithiasis. Cochrane Data base systematic Rev. 2006 Oct 18(4) ;Issue 4. Art No. CD006231

7. P.K. Chowbey, A Sharma, R.Khullar, V Mann, M Baijal & A Vashistha. Journal of laparo endoscopy & advanced surgical techniques. Jan 30:2009; Vol 10

8. RaviMohan SM, Kaman L, Jindal R, Singh R, Jindal SK. Postoperative pulmonary function in Lap v/s open Cholecystectomy: comparative study. Indian J Gastroenterology. Jan-Feb 2005 ; Vol 24(1):6-8.

9. Gowda el labban,Emad,Hokkam,Mohammad,Ali saber.Jornal of minimal invasive surgery,vol8(3),jul-sept-2012. 10. Thapa PB, Maharjan DK, Suwal B, Byanjankar B, Singh DR, J Nepal Health Res Counc. 2010 Oct;8(2):78-81

11. Adler DG, Baron TH, Davila RE, Egan J, Hirota WK, Leighton JA, Qureshi W, Rajan E, Zuckerman MJ, Fanelli R, Wheeler-Harbaugh J, Faigel DO; Standards of Practice Committee of American Society for Gastrointestinal Endoscopy. ASGE guideline: the role of ERCP in diseases of the biliary tract and the pancreas.Gastrointest Endosc. 2005 Jul;62(1):1-

9 Signature o f the candidate

10 Remarks of the guide: To evolve the best management protocol in diagnosed cases of cholecystitis

11.1 Name and designation of the Dr. CHALAPATHY. D. V. guide (in block letters) PROFESSOR Guide DEPARTMENT GENERAL SURGERY VYDEHI INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE, BANGALORE.

11.2 Signature

11.3 Head of the Department Dr.RAMESH REDDY PROFESSOR AND HOD DEPARTMENT OF GENERAL SURGERY VYDEHI INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE, BANGALORE. 11.4 Signature 12.1 Remarks of the Principal

12.2 Signature