Rajivgandhi University of Health Sciences, Karnataka, Bangalore

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA, BANGALORE

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1. Name of the candidate and Address : D.P.MADHAN SWAMY DOOR No. Q-6 , SURVEY OF INDIA QUARTERS , KORAMANGALA 2ND BLOCK , BANGALORE-560034

2. Name of the Institution : Kempegowda Institute Of Medical Sciences & Research Centre,Banglore 3. Course of Study and Subject : M.S. (GENERAL SURGERY)

4. Date of admission to course : 01/06/13

5.Title of the Topic : Impacted Calculus at the neck of gall bladder -laparoscopic management

6. BRIEF RESUME OF THE INTENDED WORK:  We intend to conduct this prospective study at the department of surgery , KIMS hospital and research centre , Bangalore from November 2013 to October 2015 a period of 2 years including follow up. All inpatients admitted to the department of surgery will be screened and patients will be included into the study by means of purposive sampling .  Upon admission and enrollment into the study all patient characteristics will be recorded including their age , sex, socio economic status and demography .  A detailed history , findings of physical examination and relevant laboratory and radiological investigations or interventions performed will be recorded in a performa  Informed consent will be taken by the patient and/or his attenders after explaining the need and the type of surgical intervention planned under a

1 suitable type of anaesthesia as determined by the operative team  The operative and histopathology findings will also be entered into the proforma  The patients will be followed up for the development of any complications during and after the their hospital stay.

6.1 NEED FOR THE STUDY:  Cholelithiasis is one of the most common diseases of the biliary tract  Laparoscopic cholecystectomy(LC) is the gold standard in its management .  However, calculus impacted at the neck or cystic duct of the gall bladder is relatively uncommon  Further these can cause mechanical obstruction of the common bile duct (CBD) there by causing mechanical jaundice , a condition termed Mirizzi syndrome  This rare complication may occur in about 0.05-0.7% of patients who have gall stones  Additionally there may be cholecystobiliary fistula formation  Laparoscopic cholecystectomy becomes challenging in such conditions  Accurate preoperative diagnosis of the condition is difficult and is of great importance for the surgeon as it is associated with increased incidence or risk of bile duct injury and demands more complex surgical techniques with a risk of development of strictures post operatively  Further , unrecognized cholecystobiliary or cholecystoenteric fistula resulting from stone penetration leads to serious postoperative complications , which can be avoided if the condition is properly recognized  USG (Ultrasonography) and CT (Computerized Tomography scan) or MRI (Magnetic Resonance Imaging)are now widely used as primary methods in preoperative evaluation of this condition

6.2 REVIEW OF LITERATURE:

2 Introduction -Gallstones extremely common, approximately 10% of the adult population affected -Twice as commonly in females as in males -Prevalence peaking in the sixth and seventh decade -Majority of gallstones remain asymptomatic for life -Only 20-30% of all patients ever develop symptoms -risk of a patient with asymptomatic gallstones developing biliary-related symptoms is estimated at 1-2% per year -risk of 0.1% per year of developing severe complications such as gallbladder perforation or empyema -cholecystectomy is the treatment of choice for symptomatic gallstones -70-80% of patients undergo elective cholecystectomy for chronic cholecystitis or biliary colic or USG evidence of gall stones. -Only 10-30% of patients undergo cholecystectomy due to complications of acute cholecystitis -The most common clinical presentation is acute cholecystitis, which occurs in 90-95% of cases -Jaundice is rare in both acute and chronic cholecystitis -when present, should suggest the presence of choledocholithiasis, secondary cholangitis, or partial obstruction of the common duct -Acute cholecystitis GB may be palpable , chronic cholecystitis GB never palpable “courvosier’s law”.

Preoperative Studies - Plain abdominal x-ray -Radiolucent gallstones can be detected in 10-20% of patients on plain radiographs - Ultrasonography should be the initial study performed if the diagnosis of either acute or chronic cholecystitis is considered -ERCP for all cases which show GB neck calculus on USG - Characteristic ultrasound findings:

-thickened gallbladder wall -acoustical shadowing from stones - biliary sludge or mucosal sloughing may be noted - air in the gallbladder wall -pericholecystic fluid with severe disease - porcelain gallbladder or gallbladder polyps

Surgical Anatomy -Gall bladder : Fundus, body , infundibulum, neck and cystic duct. - Calot’s triangle: -The common hepatic duct medially(c) -cystic duct laterally(L) -cystic artery and inferior surface of 3 liver superiorly(m)

-Exuberant surgical technique and failure to recognize and anatomic variantions involving the insertion of the cystic duct or cystic artery or the confluence of the hepatic ducts is the sources of nearly all biliary injuries. - Normal intra- and extrahepatic biliary anatomy is present in approximately 75 percent of cases. Complications of calculus at GB neck includes : 1)due to impaction muocoele , pyocoele , perforation 2)persistent impaction : mirizzi syndrome 3)due to iatrogenic injury trying to manage the calculus :CBD stricture , CBD necrosis , bile leak due to partial wall necrosis. 4)due to the stump left behind if subtotal cholecystectomy is done : post cholecystectomy syndrome , retained calculus .

Mirizzi syndrome Mirizzi syndrome, has been explained as an inflammatory phenomenon secondary to a pressure ulcer caused by an impacted gallstone at the gallbladder infundibulum. The impacted gallstone together with the inflammatory response, causes first external obstruction of the bile duct, and eventually erodes into the bile duct evolving into a cholecystocholedochal or cholecystohepatic fistula with different degrees of communication between the gallbladder and bile duct

Type 1- Stone impacted at GB neck or infundibulum causing shortening and fibrosis of cystic duct with compression of CBD (classic cholecystectomy) Type 2-cholecystobiliary fistula from erosion of the bile duct wall by a gallstone, the fistula must involve less than one-third of the circumference of the bile duct(subtotal cholecystectomy , leaving a remnant of gallbladder wall measuring about 5 mm around the cholecystobiliary fistula in order to aid in the closure of the destroyed bile duct) Type 3-involving less than two third of CBD (leaving a flap of gallbladder wall measuring at least 1 cm to repair the bile duct) Type 4-cholecystobiliary fistula with complete destruction of the bile duct wall with the gallbladder completely fused to the bile duct forming a single structure with no recognizable dissection planes (Roux-en-Y hepaticojejunostomy) Type 5-(5a)includes a cholecystoenteric fistula without gallstone ileus(treated with division and simple suture with an absorbable material of the bilioenteric fistulae) (5b)includes a cholecystoenteric fistula without gallstone ileus(treat the acute condition first (gallstone ileus), followed by repair of the biliary system at a later date 3 or more months later .

Management strategies : A)Sub total cholecystectomy B)Fundus first technique C)Continued dissection with total cholecystectomy

4 6.3 AIMS AND OBJECTIVES OF THE STUDY:

1)Assess the impact of preoperative and intraoperative diagnosis of impacted stone at the neck of gallbladder on the performance and efficacy of laparoscopic cholecystectomy 2) Determine the incidence, nature and outcome of management of complications of laparoscopic cholecystectomy in these patients 3)Review and compare the findings on surgery with the ultrasonographic, CT and MRI findings in order to asses their usefulness in this condition

7. MATERIAL AND METHODS:

7.1 SOURCE OF DATA : Source – In-patients in the department of surgery KIMS hospital and research center, Bangalore .

7.2 METHOD OF COLLECTION OF DATA

a. Patient data collection and evaluation. • Patient data will be collected from all in-patients at KIMS general, irrespective of their age/gender/ background /socio economic status. The patients will be evaluated and followed up according to protocol.  Detailed history of patient will be entered in proforma.  Clinical examination of patient  Preliminary investigations – Blood routine,biochemical routine urine analysis and LFT (Liver Function Test)  Screening – USG (Ultrasonograpghy)  MRCP (Magnectic Resonance Cholangio Pancreaticography) for patients whose USG shows calculus at GB neck.  Patient will be informed about any surgical procedure and consent will be taken.  Surgery and operation record  Histopathology  Follow up of patients:Patients will be followed up daily until discharge and then once every 3 months for 6 months.

5 b. Inclusion Criteria: 1. Patients with cholelithiasis , with a stone impacted in the neck of gall bladder - proved either by preoperative investigation or identified intraoperatively 2. Patients with Mirizzi syndrome are also included

c. Exclusion Criteria: 1.Patients in paediatric age group

2.Patients not willing for surgery or those who are not fit for surgey or laparoscopic surgery due to other comorbid conditions 3.Patients with malignancy of the gall bladder

d. Sample size: 50

e. Study design: Prospective study

f. Sample design: Purposive sampling. g. Duration of study: One and half years (inclusive of follow up) Minimum follow up period 6months h. Study place: KIMS Hospital, Bangalore.

7.3 Does the study required any investigations or interventions to be conducted on patients ? If so, please describe briefly. 1.) USG 2.) Routine investigations 3.) MRCP 7.4 Has ethical clearance been obtained from your institution, in case of 7.3. YES

6 9. SIGNATURE OF THE CANDIDATE:

10. REMARKS OF THE GUIDE: The need for an alternative method for management of impacted calculus at the neck of gall bladder, as many cases were converted to open cholecystectomy or injured during the procedure, is being evaluated in the study.

11. NAME AND DESIGNATION OF:

11.1. GUIDE: Dr. Ramesh Reddy Professor and Unit head General Surgery,KIMS

11.2 SIGNATURE:

11.3. HEAD OF THE DEPARTMENT: Prof. Dr.Sudarshan Babu K G HOD-General Surgery,KIMS

11.4. SIGNATURE:

12. REMARKS:

12.1. CHAIRMAN AND PRINCIPAL:

12.2. SIGNATURE:

7 References:

1.Abou-Saif A, Al-Kawas FH. Complications of gallstone disease: Mirizzi syndrome, cholecystocholedochal fistula, and gallstone ileus. Am J Gastroenterol. 2002;97:249–254.

2. Dorrance HR, Lingam MK, Hair A, Oien K, O’Dwyer PJ. Acquired abnormalities of the biliary tract from chronic gallstone disease. J Am Coll Surg. 1999;189:269–273.

3. Sherwinter DA, Subramanian SR, Cummings LS, Malit MF, Fink SL, Macura JM, et al. Cholecystectomy, Laparoscopic: emedicine.

4. Turner MA, Fulcher AS. The cystic duct normal anatomy and disease processes. Radiographics. 2001;21:3–22. 8 5.Reddick EJ, Olsen DO.(1989) Laparoscopic subtotal cholecystectomy. Surg Endosc3:131-133.

6. Beldi G, Glattli A. Laparoscopic subtotal cholecystectomy for severe cholecystitis. Surg Endosc. 2003;17:1437–9.

7. Lawes D, Motson RW. Anatomical orientation and cross-checking: the key to safer laparoscopic cholecystectomy. Br J Surg. 2005;92:663–4

8. Ransom KJ. Laparoscopic management of acute cholecystitis with subtotal cholecystectomy. Am Surg. 1998;64:955–7

9.Mishra MC, Vashishtha S, Tandon R. Bilio-biliary fistula: pre-operative diagnosis and management implications. Surgery. 1990;108:835–9

10. Michalowski K, Bornman PC, Krige JE, Gallaher PJ, Terblanche J. Laparoscopic subtotal cholecystectomy in patients with com- plicated acute cholecystitis or ﬁbrosis. Br J Surg. 1998;85:904–6.

11. 10. Dewar G, Chung SCS, Li AKC. Operative strategy in Mirizzi's syndrome. Surg Gynaecol Obstet.1990;171:157–9.

12. Posta ZG. Unexpected Mirizzi's anatomy: a major hazard to the common bile duct during laparoscopic cholecystectomy. Surg Endosc. 1995;5:412–4.

13.Corlette MB, Bismuth H. Biliobiliary fistula: A trap in the surgery of cholelithiasis. Arch Surg.1975;110:377–83.

From Dr. D.P.Madhan Swamy PG in General surgery KIMS Hospital Banglore

To, THE PRINCIPAL KIMS, BANGLORE 9 Sub: forwarding of synopsis of dissertation topic to the Rajiv Gandhi university of health sciences Bangalore for registration Ref: Through proper channel

Respected sir, With reference of the above subject here in I submit my synopsis for the registration of dissertation topic that is “Impacted Calculus at the neck of gall bladder -laparoscopic management” Hence I request your kind self to forward the same to the Rajiv Gandhi university of health sciences , Bangalore , for registration and do the needful. Thanking you Yours sincerely

(Dr. D.P.Madhan Swamy)