Rajiv Gandhi University of Health Sciences, Bangalore, Karnataka s45

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA ANNEXURE – IIPROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION1. Name of the Candidate and DR.YADALA.HARSHAVARDHAN Address S/O Y.SUDHAKAR 5-1-15, PRAKASH NAGAR, (in block letters) STONEHOUSE PET, NELLORE-524002 ANDHRAPRADESH2. Name of the Institution J.J.M. MEDICAL COLLEGE, DAVANGERE-577004.3. Course of Study and Subject POST GRADUATE - MEDICAL M.S. IN GENERAL SURGERY4. Date of admission to Course 05-06-2013 5. Title of the Topic LAPAROSCOPIC VERSUS MINI- LAPAROTOMY CHOLECYSTECTOMY : A PROSPECTIVE STUDY6. BRIEF RESUME OF INTENDED WORK6.1 Need for study:Gallstones are the most common biliary pathology affecting females predominantly all over the world. The vast majority of gallstones are asymptomatic, often being identified at the time of abdominal imaging for other reasons or during laparotomy.Conventional or open cholecystectomy has been the gold standard treatment for gall stones for many years. During the 1980s and in the early 1990s, it was shown that the conventional large sub costal incision in cholecystectomy could be replaced by a much smaller incision, giving a shorter convalescence.1Gastro-intestinal surgery has undergone a revolution in the recent years by the introduction of laparoscopic techniques.The advantages of laparoscopic cholecystectomy(LC) cited are the avoidance of large incision, shortened hospital stay and earlier return to work.2Laparoscopic cholecystectomy also has advantage of less analgesic intake, smoother postoperative course than conventional cholecystectomy.Laparoscopic cholecystectomy requires lengthy training and knowledge of materials and technological equipment, which carries a high economic cost. Also, the need to create pneumoperitonium with carbon dioxide present anesthesia management challenges particularly in elderly patients with heart lung diseases. Despite the increasing interest in the minimally invasive technique of laparoscopic surgery, the role of new technique has been questioned in the management of gall bladder diseases by small incisions.Mini-laparotomy cholecystectomy(MC) has been suggested as alternative procedure performed through a 5-6 cm transverse/oblique right subcostal incision and uses standard operating techniques.3 Technical advantage of mini-laparotomy are absence of intra abdominal hypertension, carbon dioxide in abdominal cavity and use of conventional laparotomy instruments which are very relevant in developing country like ours. Thus, aim of this study is to observe and compare, laparoscopic and mini- laparotomy cholecystectomy in terms of operating time, duration of hospital stay, time to return to work, intra and post operative complications, post operative use of analgesics, so as to see if mini-laparotomy cholecystectomy can become viable alternative to laparoscopic cholecystectomy.6.2 Review of Literature:Gall stones and their sequel which cause most of the maladies date back to 1085-945 BC having been discovered in the mummy of Priestess of Amen.  The first open cholecystectomy was performed by Carl Johann Augustus Langenbuch on July 15, 1882 according to theory that the gallbladder needed to be removed not because it had stones, but because it was “sick”. 3 In 1985, Erich Muhe in Germany performed the first laparoscopic cholecystectomy.3 Merrill 4described the procedure of mini-cholecystectomy and termed it as minimal trauma cholecystectomy. In 1991, Tehemton Udwadia performed the first laparoscopic cholecystectomy in India. A randamized clinical trial at pemex Regional Hospital in Salamanca, Guanajuato, Mexico from Jan to Dec 2009 showed, Mean operative time was 79.02 min for mini-laparotomy and 86.04 min for laparoscopic cholecystectomy. Average hospital stay was 2.75 days for mini-laparotomy and 2.02 days for laparoscopic cholecystectomy. Complications of mini- laparotomy were demonstrated in 6.6% patients and laparoscopic cholecystectomy 16.3% patients.3  A prospective, randomized, single blind, multicentre trial by Ros, from 1997 to 1999, on 1705 cholecystectomies of which 724 entered trail and 362 were randomized to each procedure. Median operating times were 100 and 85 min for laproscopic cholecystectomy and mini-laprotomy cholecystectomy respectively. Median hospital stay was 2 days in each group and time for return to normal recreational activities were shorter after laparoscopic than mini-laparotomy cholecystectomy.1  A retrospective study in AHEPA university hospital over period of 6 years on 1276 patients showed median operating time was significantly short in mini- laprotomy than in laproscopy(46 min vs 61 min), hospital stay was longer for mini than laproscopic (2.7 days vs 2.5 days).5 A randamized trial by F.P.McGINN, on 310 patients showed, median operating time for laproscopic cholecystectomy was 24 min longer than for mini- laparotomy. Post operative opiates administration was reduced in laproscopic than mini-laparotomy cholecystectomy but not the number of NSAIDS. Rate of conversions to open cholecystectomy was 13% in laproscopic cholecystectomy. Conversion of mini-laparotomy cholecystectomy to conventional open cholecystectomy was 4% .6 A prospective, randamized, single centre observational study on 44 patients in each group showed, there was no significance regarding post operative day on which patients commenced eating and dosage of analgesics used during surgery and in recovery room. Time to resume normal activity was significantly shorter in laproscopic than mini-laparotomy cholycystectomy.7 In prospective randomized study by Harju.J in 60 patients with non complicated symptomatic gall stones as day-care surgery, successes rate was 66% for mini- laparotomy and 55% for laparoscopic cholecystectomy. But there was no difference between two procedures in operation time, perioperative bleeding, conversion to conventional open cholecystectomy, length of stay. Three patients developed superficial infection (two with mini-laparotomy and one with laparoscopic )8 A meta analysis by Purkayastha et al of nine randamized studies show that no difference in the patients surgical outcome or quality of life after mini-laparotomy or laparoscopic cholecystectomy.8 McDermott et al compared their first 50 consecutive patients treated by laparoscopic cholecystectomy with their first 55 consecutive patients treated with mini-laparotomy cholecystectomy. They found that Minilaparotomy was a mean of 24 minutes faster than thelaparoscopic technique(mean time 85 min) and postoperative stay was similar in both groups.9 6.3 Objectives of Study1. To analyze the outcome of two minimally invasive techniques i.e. laparoscopic and mini-laparotomy cholecystectomy in terms of a) Operating time period. b) Duration of Hospital stay. c) Time to return to normal activity d) Intra operative complications like Bile leak, Vascular injury, common Bile duct injury, abdominal organs injuries (liver, intestines) e) Post operative complications like wound infection, Thrombo embolism, cardiac and pulmonary and urinary tract infections. f) Requirement of post operative analgesics.7. MATERIAL AND METHODS:7.1 Source of data: All proven cases of symptomatic gall stones, acute cholecystitis and chronic cholecystitis admitted in surgical wards of Chigateri general hospital and Bapuji hospital affiliated to JJM Medical College, Davanagere during the period of October 2013 to October 2015.7.2 Method of collection of data:All consecutive proven cases of symptomatic gallstones, acute cholecystitis and chronic cholecystitis who required cholecystectomy were randomly subjected to either mini-laparotomy cholecystectomy by 5-6 cm right subcostal oblique/transverse incision or standard 4 port laparoscopic cholecystectomy. Following inclusion and exclusion criteria will be used to select the cases for study. Inclusion criteria:1. All patients admitted with symptomatic gall bladder stones, acute or chronic cholecystitis as ultra sound diagnosis and who are fit for general anesthesia in the age group between 18 to 65 years. 2. Both elective and emergency cases.3. All patients who give informed and written consent for cholecystectomy.Exclusion criteria: 1. Patients who are not fit for general anesthesia and do not give consent.2. Patients with co-morbid conditions like DM, IHD, and HTN.3. CBD stones, GB polyp, GB cancer.4. History of previous abdominal surgeries.5. Liver cirrhosis, pregnancy, obesity (BMI >=35)6. Laparoscopic converted to conventional open laparotomy and mini-laparotomy incision extended beyond 8 cm.A pretested structured proforma will be used to collect information regarding detailed clinical history, examination findings, laboratory investigations, operative details and post operative course of these patients. The patients will be followed up after one week, one month and 6 months after surgery.30 cases will undergo laparoscopic cholecystectomy and 30 cases will undergo mini-laparotomy cholecystectomy.Comparison of outcome will be analysed by following statistical methods as follows,Unpaired ‘t’ test for comparing mean values of two groups and Z test for comparing proportion values of two groups . Duration of study : 2 years from October 2013 to October 2015.7.3 DOES THE STUDY REQUIRE ANY INVESTIGATION/ INTERVENTIONTO BE CONDUCTED ON PATIENT IF SO PLEASE MENTION? YES a) Routine investigations: (tests for fitness for surgery) Complete blood picture and Blood grouping &cross matching. Blood urea, Serum creatinin, Random blood sugar. HIV and HbsAg.  ECG Chest X-Ray Plain X-Ray Abdomen b) Special investigations : Ultra sound Abdomen Liver function tests Coagulation profile7.4 HAS ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR INSTITUTION IN CASE OF 7.3?YesEthical clearance has been obtained from research and dissertation committee/ethical committee of the institution for this study. 8. LIST OF REFERENCES 1) Ros A, Gustafsson L, Krook H, Nordgren CE, Thorell A, Wallin G, and Nilsson E. Laparoscopic cholecystectomy Versus mini-laparotomy Cholecystectomy. A Prospective, randomized, Single-BlindStudy .Ann surg 2001;234(6):741-749.2) Abbasi S A, Haleem A, Tariq G R, Almas D et al, An audit of laparoscopic cholecystectomies performed at PNS Shifa.Pak armed forces med 2003; 53: 51- 58.3) Mendoza JDV, Murillo FJV, and Ojeda AG. Mini-laparotomy vs. laparoscopic cholecystectomy: results of a randamized clinic trial. Cir Cir 2012;80:111-116.4) Merrill JR Minimal trauma cholecystectomy.The American surgeon 188;54(5): 256-261.5) Syrakos T, Antonitsis P, Zacharakis E, Takis A, Manousari A, Bakogiannis K, Efthimiopoulos G, Achoulias I, Trikoupi A, Kiskinis D. Small-incision (mini- laparotomy) versus laparoscopic cholecystectomy: a retrospective study in a university hospital. Langenbecks Arch Surg. 2004 Jun;389(3):172-7.6) Ginn F.P., Miles.A.J.G, Uglow.M, Ozmen.M, Terzi.C.and Humby.M..Randamized trial of laparoscopic cholecystectomy and mini cholecystectomy. Br J Surg 1995; 82:1374-1377.7) Vagenas K, Spyrakopoulos P, Karanikolas M, Sakelaropoulos G, Maroulis I,Karavias D. Mini-laparotomy cholecystectomy verses laparoscopic cholecystectomy: which way to go?.Surg Laparosc EndoscPercutanTech.2006 oct;16(5):321-4.8) Harju.J, Kokki.H, Paakkonen.M, Karjalainen.K, Eskelinen.M.Feasibility of mini- laparotomy verses laparoscopic cholecystectomy for day surgery: a prospective randamized study. Scandinavian journal of surgery 2010;99:132-136.9) Baxter J N, Dwyer P J O. Laparoscopic or mini-laparotomy cholecystectomy?. BMJ feb 1992;304:559-60. 9. Signature of the Candidate10. Remarks of the Guide Laparoscopic surgery has made tremendous progresses in recent years. Laparoscopic cholecystectomy has over taken open cholecystectomy as the treatment of choice for cholelithiasis in developed countries. However due to higher cost involved and lack of adequate surgical training needed in laparoscopic cholecystectomy, open cholecystectomy is still being performed on a very large scale in most part of developing countries including India. Mini- laparotomy cholecystectomy promises to address the issues of cost and early recovery. Hence this study is being conducted to compare a mini laparotomy cholecystectomy and laparoscopic cholecystectomy.11. Name & Designation of (in block letters) Dr. DINESH M. GUNASAGAR. M.S. 11.1 Guide PROFESSOR, DEPARTMENT OF SURGERY, J.J.M. MEDICAL COLLEGE, DAVANGERE - 577004.11.2 Signature11.3 Co-Guide (if any)11.4 Signature11.5 Head of the Department Dr. R.L.CHANDRASEKHAR M.S., PROFESSOR AND H.O.D., DEPARTMENT OF SURGERY, JJM MEDICAL COLLEGE, DAVANGERE - 577004.11.6 Signature 12. 12.1 Remarks of the Chairman& The Principal12. 2 Signature

Rajiv Gandhi University of Health Sciences, Bangalore, Karnataka s45

Details

Download

Copyright

We respect the copyrights and intellectual property rights of all users. All uploaded documents are either original works of the uploader or authorized works of the rightful owners.

Support