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COMPARATIVE EVALUATION OF C-REACTIVE PROTEIN AND TOTAL LEUCOCYTE COUNT IN CONVENTIONAL LAPAROSCOPIC CHOLECYSTECTOMY AND SINGLE INCISION LAPAROSCOPIC CHOLECYSTECTOMY

THESIS SUBMITTED TO THE HIMACHAL PRADESH UNIVERSITY, SHIMLA FOR THE DEGREE OF M.S. (GENERAL SURGERY)

2011-2014

SUBMITTED BY: DR. MUKESH KUMAR

DEPARTMENT OF SURGERY INDIRA GANDHI MEDICAL COLLEGE SHIMLA (H.P.) -171001.

CERTIFICATE OF SUPERVISORS

This is to certify that the work incorporated in this thesis entitled “Comparative Evaluation of C-Reactive Protein and Total Leucocyte Count in Laparoscopic

Cholecystectomy

and

Single

Incision

Laparoscopic

Cholecystectomy’’ has been carried out by Dr.Mukesh Kumar under our direct supervision and guidance in the department of Surgery, Indira Gandhi Medical College, Shimla. The data incorporated in this thesis is genuine and work has been carried out by the candidate himself.

……………………….

_____________________ Dr. R.S.JHOBTA Associate Professor Department of Surgery I.G. Medical College ,shimla (SUPERVISOR)

.............................

SUPERVISOR

.......…………………..

Dr.D.K.VERMA

Dr. SAROJ JASWAL

Professor

Prof.and Head

Department of Surgery

Department of Biochemistry

IGMC,Shimla

IGMC,Shimla

(CO-SUPERVISOR )

(CO-SUPERVISOR)

AKNOWLEDGEMENTS

It is my proud privilege and pleasure to acknowledge with deep sense of gratitude and devotion, the keen personal interest , affectionate encouragement and invaluable guidance rendered to me by my ingenious and revered teacher and supervisor Dr. R.S.Jhobta, Assoc. Professor, Department of Surgery, IGMC, Shimla. His scholastic approach, sympathetic attitude and constructive criticism have gone a long way in the completion of this thesis.

Words cannot express my veracious thanks and deep gratitude to my esteemed and learned guide and co supervisors Dr. D.K.Verma, Professor, Department of Surgery, and Dr.Saroj Jaswal Prof. and Head Department of Biochemistry, IGMC, Shimla, for the keen interest, invaluable suggestions rendered to me from time to time during the completion of this project.

I take this opportunity to thank with deep sense of regard and gratitude Dr. K.S. Jaswal, Professor and Head, Department of Surgery, IGMC, Shimla, for his keen interest, sincere advice and continuous inspiration given to me during the course of this study.

I am also very thankful to Dr. Anil Malhotra , Professor, Department of Surgery, IGMC, Shimla, for his sincere advice and inspiration given to me during the completion of this thesis.

I am deeply indebted to Dr. Arun Gupta, Professor, Department of Surgery, IGMC, Shimla, for his constant source of inspiration course of this study.

during the

I shall be failing in my duty if I do not express my deep gratitude to Dr.Ashok Kaundal, Assistant Professor, Department of Surgery, for his incessant encouragement and excellent guidance throughout the course of the study.

I would also like to thank Dr. U. K. Chandel, Dr. Bhavesh Devkaran, Dr. Puneet Mahajan, Associate Professors and Dr. Sanjeev Gupta , Dr. Dhruv Sharma ,Dr. Ved Sharma, Dr. Jagdish Gupta , Dr.Gopal, Dr.Prikshit and Dr.Arun Chauhan Assistant Professors Department of Surgery for their much needed help, advice and guidance.

Words cannot adequately express the deep sense of gratitude I owe to Dr. Rajan Sood, Dr . Abdhesh and Dr.Rajesh Chopra ,Registrars, Department of Surgery.

I would like to thank my seniors Dr. vikas, Dr. Shirish, Dr. Rahul Mrigpuri, Dr. Rajesh Sharma, Dr. Alok Panday and Dr. Uma Sharma for their help during the making of this thesis.

I would also like to thank my colleagues Dr. Amit, Dr. Abhishek Thakur, Dr. Gian Chand, Dr. Rajesh Chauhan, Dr. Navneet, Dr. Varun and Dr. Raj Kumar and my juniors Dr. Subhash, Dr.Sanjay, Dr. Kapil Negi, Dr. Pawan, Dr. Namit, Dr. Bhavya Thakur, Dr. Rohit Dadwal, Dr. Surender, Dr. Dinesh, Dr. Karan and Dr. Kulbhushan for their help in the making of this thesis.

I bow my head to my father Sh.Chunni Lal and mother Smt. Begi Devi in respect and affection who always inspired me to work hard and boosted my morale. I thank my wife Dr. Neha Gangwar from core of my heart who have stood by me all the time, helped me and provided me with support in so many

ways. I thank my younger brother Mr.Virender who gave me courage to face most distressful situations whenever I happen to experience them. I could not have done my thesis without their inspiration and help.

Last but not the least I want to thank all my patients who have given me such an opportunity to learn. I thank them with all my heart and express my heartfelt gratitude.

……………………. Dr. Mukesh Kumar

TABLE OF CONTENTS

SR.NO. 1. 2. 3. 4. 5. 6. 7. 8. 9. 10.

DESCRIPITION Introduction Review of Literature Aims and Objectives Material and Methods Obervations Discussion Summary Conclusion Bibliography Annexure a) Proforma b) Informed Consent c) Key to Master Chart d) Master Chart

PAGE NO. 1-2 3-18 21 22-23 33-34 40-44 50-54 54-56 57-59 60-65 I-III IV VI VII

ABBREVIATIONS

SILC

= single incision laparoscopic cholecystectomy

cLC

=conventional laparoscopic cholecystectomy

DOS

= duration of surgery

Min

= minute

CRP

=C-reactive protein

TLC

=total leucocyte count

LOS

=length of stay

LESS

=laparo-endoscopic single site surgery

S.NO.

=serial number

BMI

=body mass index

INTRODUCTION

Over the last 20 years, conventional laparoscopic cholecystectomy (cLC) as less invasive method, has replaced open cholecystectomy in the treatment of patients with symptomatic gallstone disease. In recent years, a search for even more minimally invasive approaches has led to innovative techniques of single incision laparoscopic surgery (SILS) and natural orifice transluminal endoscopic surgery (NOTES). While substantial drawbacks of NOTES technique including technical challenges and scarcity of instrumentation, have limited its adoption so far1 the SILS has met more favorable acceptance in surgical community. Its feasibility and safety have been proved in a number of surgical procedures including cholecystectomy 2, 3. Compared to conventional LC which is performed via three or four abdominal ports, the single incision laparoscopic cholecystectomy (SILC) is performed using only one infra umbilical entry into the abdominal cavity. The first SILS procedures were done with several ports placed next to each other through a single skin incision but with multiple fascial perforations 4, 5

. Recent development of multichannel port devices allows entry into the

abdominal cavity through a single fascial incision. Diminishing the number of ports to only one seems attractive due to its potential to reduce wound related complications, to decrease postoperative pain and to improve cosmetic outcome. Surgery, “controlled deliberate injury”, for purpose of therapy, induces a series of biochemical and hormonal responses in the body, that include alteration in the expression of acute phase reactants C–reactive protein (CRP) and total leucocyte count (TLC). In general, the magnitude of changes in CRP is apparently taken as proportional to the extent of overall surgical insult 7 .

Recent evidence indicates that trauma induced stress hormone responses are insufficient to explain the broad spectrum of post injury defects, particularly in relation to immune system. Stress of injury leads to production of cytokines and acute phase proteins, which initiates increase in the levels of “Stress” hormones, loss of muscle proteins, greater vascular permeability and changes in white blood cell count. Some of these responses are homeostatic defense mechanism but others such as catabolic state are thought to be deleterious. Magnitude of metabolic response to surgical trauma, is proportional to degree of injury and reduction of excess trauma by “Laparoscopic Techniques” might therefore diminish the response. Generation of acute-phase proteins is well recognized response to tissue injury. CRP is a key marker of acute phase protein and provides dependable screening test, for acute phase reactants6. Post operative rise in CRP and TLC have been reported by many researchers, whereas other workers have found no significant difference in CRP levels between conventional LC(cLC) and SILC7. Since the introduction of conventional laparoscopic cholecystectomy (cLC) and SILC in our institution,we have been seeing how easily and rapidly patients recover from surgery. An effort was made in the present study to comparatively evaluate the pattern and magnitude of metabolic response to injury by assessing role of CRP and TLC as stress markers in conventional laparoscopic cholecystectomy and SILC.

REVIEW OF LITERATURE

Most of the progress in the diagnosis and treatment of biliary tract diseases has been made in the last 150 years. However, gallstones and their sequelae, which cause most of the clinical problems are not a malady of just the modern times. The earliest reported gallstones date back to 21 st Egyptian dynasty (1085-945 B.C.) having been discovered in the gallbladder of the mummy of a priestess of Amen. Persian, Abu Bakr Mohd. Ibn Zakairya Razi described gall stones in an ox in the year 900 BC8,9. According to Gordon-Taylor, the first clinical description of gall stone disease was recorded in 4 th century BC8,10. Greek physician Alexander Trallianus described the concretions within bile ducts in 5th century which was nothing but the gall stones8. In 1341, Gentile da Aligno demonstrated human gall stones as one of the findings at autopsy during the public dissection 8 Andreas Vesalius gave the accurate description of human gall stones concluding that they represented a disease and described some of their complications 8. In 1546, Vesalius demonstrated eighteen calculi in the gall bladder of famous advocate who died after brief illness8,11,12. Marcelles Donatus undertook a systemic collection of data on human gall stones in 1586 and observed that gall stones may appear in vomitus or stool8,10. Thomas Syndenham of England has been erroneously credited with discovery of gall stone disease. He considered biliary colic as a symptom of hysteria8,13. CONVENTIONAL LAPAROSCOPIC CHOLECYSTECTOMY The laparoscopy had its beginning in the early eighteenth century. Bozzini in 1805, viewed the urinary bladder for stones and neoplasms using a reflecting mirror, candle and a double lumen uretheral cannula14,15.

Endoscopic methods remained crude for most of the 19th century. Stein of Frankfurt developed an instrument called “photo endoscope”, consisting of a reflecting mirror, a light source and a urethral cannula. A versatile endoscope was developed by Desormeauxin in 186514,16. He incorporated a kerosene lamp, a chimney vent and a mirror in the endoscope to visualize the urinary bladder, cervix and uterus. The endoscopy became practical in the year 1890 when Germans improved the optical system14. Three years after, Edison invented the light bulb, DeRoche invented the incandescent cystoscope14. Nitz in 1887 developed an operating cystoscope that had a prizmatic lens system and a channel through which urethral probes could be inserted. 20 years later after the cholecystectomy was performed by Langenbuch in Berlin in 1882; Kelling pioneered diagnostic laparoscopy in dogs using a cystoscope17,18. Jacobeus of Stockholm is credited with the first laparoscopy in humans in 191117,19. The early pioneers introduced their trocars and cystoscopes directly into the peritoneal cavity prior to the insufflation. Goetz in 1918 and later on Veress in 1938, developed an insufflation needle for the safe introduction of gas in the abdominal cavity17,,20. By the 1930’s, CO2 was in use for pneumoperitoneum and spring loaded needle designed by Veress for therapeutic pneumothorax was modified for safe introduction of gas into abdomen20. Fevers in 1933 was first to recommend CO2 as insufflation gas to create pneumoperitoneum. He had his experience with 50 cases in which he used gas from air, oxygen and carbon dioxide16. Kurt and Semm in 1950

created a device for controlled CO2 insufflation with an adjustable pressure limit. Prior to this air was introduced into abdominal cavity by means of a syringe17. The best gas for insufflation at present is carbon dioxide (CO2). It is 200 times as diffusible as O2 and threrfore more rapidly cleared by lungs. Lindemann showed that cardiac arrythmias and haemodynamic disturbances occurred with direct intravascular CO2 insufflation at a rate of greater than 150 ml/min21,22. In 1966, Hopkins incorporated rod shaped lenses as

light

transmitters. This markedly improved the resolution and contrast 17. In this system the role of glass and air are reversed in such a manner that optical system consist of air lenses and long glass spaces. Gynaecologists in Europe began to use laparoscopy regularly for diagnosis and tubal diathermy in the 1960’s. In 1978, Frimberg in Europe performed laparosopic cholecystectomy in pigs. Philipe Mauret drawing an experience with gynaecological operations and appendicectomy is credited with having performed first laparoscopic cholecystectomy in humans in 1987

incidently in the same

sitting while he was performing a laparoscopic gynaecological procedure on a patient23. Hans Frost, with German manufacturing company WISAP, made “Galloscope,” a unique instrument complete with optics, instrument channels, a light conductor, and valves that could maintain pneumoperitoneum when the instrument was in place. Mühe introduced the Galloscope on September 12, 1985 during a planned cholecystectomy. He obtained pneumoperitoneum with a Veress needle and introduced the Galloscope at the patient's umbilicus. He introduced a

Weck-Reynolds pistol grip hemoclip applier and scissors either through channels in the Galloscope or through small portholes in her lower abdomen in order to dissect the gallbladder. Then, in the course of roughly 2 hours, Dr. Mühe performed cLC24,25. He postulated that introducing the scope at the costal margin would eliminate the need for pneumoperitoneum and optic guidance. Initially, Mühe removed the pneumoperitoneum from the procedure and developed what he referred to as “gasless LC.” Of the 94 LCs in Mühe's initial series, the first 6 were done in a “traditional” laparoscopic fashion with pneumoperitoneum and working ports

and the remaining 88 were performed by LC without

pneumoperitoneum and/or without optical guidance.25,26,27. Mühe first presented his experience at the Congress of the German Surgical Society (GSS) in April 1986. His presentation was met with skepticism and ridicule. Mühe's procedure was described as “Mickey Mouse surgery” while others remarked “small brain - small incision.”24

CRP (C REACTIVE PROTIEN) C-reactive protein was originally discovered by Tillett and Francis in 1930 as a substance in the serum of patients with acute inflammation that reacted with the C polysaccharide of pneumococcus . Initially it was thought that CRP might be a pathogenic secretion as it was elevated in people with a variety of illnesses including cancer. Discovery of hepatic synthesis and secretion of CRP closed that debate. It is thought to bind to phosphocholine, thus initiating recognition and phagocytosis of damaged cells. CRP (Acute phase reactant) is an unspecific marker of inflammation regardless of the inflammatory stimuli.28,29. Despite this fact CRP determination is a well established laboratory test for the diagnosis and

monitoring of different inflammatory processes such as discrimination between bacterial and viral infections,29,30 identifications of postoperative complications, diagnosis and grading of other inflammatory diseases, determination of therapeutic approaches and monitoring the effect of treatment. CRP is used mainly as a marker of inflammation. Apart from liver failure, there are a few known factors that interfere with CRP production. Measuring of CRP levels can help to assess disease progression and treatment outcome.31. In

healthy

young

volunteer

blood

donors

the

median

concentration of CRP is 0.8 mg/lt but following an acute phase stimulus value may increase to more than 500 mg/lt . Plasma CRP is produced only by hepatocytes although other sites of local CRP synthesis and possibly secretion have been suggested. De novo hepatic synthesis starts very rapidly after a single stimulus, serum concentration rising above 5 mg/lt by about 6 hrs and peaking around 48 hrs. The plasma half life of CRP is about 19 hrs and is constant under all conditions of health and disease so that the sole determinant of circulating CRP concentration is the synthesis rate, which thus directly reflects the intensity of the pathological process stimulating CRP production. When the stimulus for increased production completely ceases, the circulating CRP concentration falls rapidly. Subjects in the general population tend to have stable CRP concentration characteristics for each individual, apart from occasional spikes presumably related to minor or subclinical infection, inflammation or trauma. The magnitude of the metabolic response to surgical trauma is proportional to the degree of injury.31,32. Avery et al characterized CRP as a protein which required Calcium ions for it to react with polysaccharide C and introduced the term acute phase to refer to serum from acutely ill patients suffering from infectious disease and containing CRP.

Semi quantitative assays of CRP were used for many years to provide an objective index of the acute phase response and of the disease activity in rheumatological and other conditions. Within the past few years there has been a resurgence of interest in the chemical structure and functions of CRP. Injury or inflammation of the human body results in increased concentrations of certain serum proteins, known as acute-phase reactant proteins (APRP). The main influence on the concentration of APRP during the postoperative period depends on the degree of tissue damage and the inflammatory reaction associated with the repair and regeneration processes 33

which act to restore the integrity of the injured tissue

. There is a direct

positive correlation between the concentrations of APRP, especially C-reactive protein (CRP) and the severity of inflammation 34,35. CRP is a major component of the acute-phase response36. CRP is very consistent in response and is therefore reactant

the most satisfactory single screening test for an "acute phase" 34

. CRP is a component of normal serum

37

dramatically than any other protein after surgical trauma

which rises more 38,39

. CRP begins to

rise 4-12 h postoperatively, reaches the peak level after 24-72 h and returns to normal after 2 weeks 38,40,41,42.

CRP in cLC Amount of visceral trauma, manipulation and dissection is often not taken into account during different surgical techniques and emphasis is laid mainly on parietal tissue trauma. Although it may significantly influence surgical stress, LC is mainly considered to be a safer procedure than OC in terms of metabolic, hormonal and immunological changes. Several investigators have examined how laparoscopic surgery affects the acute phase response by measuring CRP. CRP has been found to be reduced in laparoscopic procedures compared to more radical laparotomy. The

alteration of CRP was noted to be 20 folds after OC, but only 5 folds after LC. Many investigators have therefore tried to find the ways of reducing the metabolic response to surgeries43.

TLC (Total Leucocyte Count) There are normally 4,000-11,000 WBC/ lt of human blood. Of these, the granulocytes (polymorphonuclear leucocytes) are the most numerous. Young granulocytes have horse shoe shaped nuclei that become multilobed as the cell grows older. Most of these contain neutrophillic granules (neutrophils) but a few contains granules that stain with acidic dyes (eosinophils) and some have basophillic granules (basophils). Other two cell types found normally in peripheral blood are lymphocytes, which have large round nuclei with scanty cytoplasm

and monocytes which have abundant agranular cytoplasm with

kidney shaped nuclei. Acting together, these cells provide the body with powerful defense against tumors and viral, bacterial and parasitic infections.

TLC in cLC Immunosuppression is an established consequence of surgical stress and injury. This has been defined not only in terms of cytokine but perhaps more importantly in the cellular components of the systemic immune response. Several recent studies have examined how laparoscopic surgery affects various cellular components of the immune system44,45. Laparoscopic

surgery

may

attenuate

the

cellular

immunosuppression created by the stress of surgery. A number of studies have evaluated this in terms of TLC. Some have demonstrated a significant increase in overall peripheral leucocyte numbers in open cholecystectomy but not in patients with LC.46.

SINGLE INCISION LAPAROSCOPIC CHOLECYSTECTOMY (SILC) Single-port laparoscopy is not new. It had been around for more than 30 years. The gynaecologists were doing tubal ligation with a singlepuncture laparoscope since the late 70s.47,48 .This technique works well for gynaecological surgery as the uterus can be manipulated from below. First laparoscopic cholecystectomy by single incision was performed by Navarra et al49 in1997 with the removal of gall bladder through a single periumbilical skin incision .He originally described a technique using transabdominal sutures to suspend the gallbladder during

single incision

laparoscopic cholecystectomy. Romanelli et al50 performed the SILC with the newer devices called triport system.They were among the first surgeons to perform lap cholecystectomy through these devices .They also compared cholecystectomy through these devices . Bresadola et al51 in1999 compared the transumbilical technique of

laparoscopic

cholecystectomy

(2port)

with

standard

laparoscopic

cholecystectomy on 40 patients.He concluded that once the learning curve has been completed, transumbilical cholecystectomy is possible without some of difficulties associated with standard laparoscopic cholecystectomy. Piskun G and Rajpal S.52 in year 1999 studied transumbilical laparoscopic cholecystectomy (2 port) utilizing no incision outside the umbilicus. They also used two transabdominal stay suture to avoid abdominal incision. They concluded that this method result in better cosmesis and may reduce post operative wound complication. Cuesta et al

53

in year 2007 studied the single incision

transumbilical laparoscopic cholecystectomy on 10 female patients with mean

age of 36yrs and mean body mass index (BMI) 23 using two umbilical ports. He used 1mm kirschner wire through subcostal line to pull the gall bladder during dissection. He concluded that in a specific group of patient SILC improve the cosmetic results and reduce operative trauma. Romanelli et al50 performed the SILC with the newer devices called triport system. They were among the first surgeons to perform lap cholecystectomy through these devices .They also compared their results with conventional laparoscopic cholecystectomy with special emphasis on post operative pain in SILC. Rao et al54 also performed SILC using newer tri-port system called R-port on 20 patients in 2007.He concluded that SILC is cosmetically better than the conventional laparoscopic cholecystectomy. Hodgett et al55 compared the LESS (laparo-endoscopic single site ) surgey with conventional laparoscopic surgery on various aspects like operation time ,blood loss, intraoperative complications etc. on 29 patients in year 2008.They concluded that LESS surgey can be done within same time period as taken by conventional laparoscopic cholecystectomy with better cosmetic results. Li Ping CAO et al56 carried out SILC on 36 cases with conventional laparoscopic instruments from 2008 to 2010 and compared it with conventional laparoscopic cholecystectomy. They concluded that SILC with common laparoscopic instruments was safe and feasible .It may need more time to complete the operation in early period .It is an ideal alternative to LC. Scott R Philipp et al57 performed SILC on 29 patients and compared it with 21 patients who underwent traditional LC.They concluded that SILC using conventional laparoscpic instruments is an effective alternative to

standard 4 port LC in selected patients. Development of a standardized technique and additional experience is needed for more consistent success. Noam Shussman et al58 perfomed SILC using modified technique in 31patients.They used endo retractors to retract the gall bladder .They concluded that single incision LC is a technically challenging surgical approach. Increased operative times are expected at the beginning of each surgeon’s learning curve. To overcome the technical obstacles and to perform single port cholecystectomy with safety similar to that for standard LC, dedicated tools for this surgical approach are needed. With such tools, SILS is a safe and feasible approach for cholecystectomy. Deepraj Bhandarkar et al59 attempted SILC in 110 patients between 2009-2010 and completed in 105.They used conventional laparoscopic instruments for this. They described step wise details of how to perform SILC. They concluded that SILC has a relatively short learning curve and is reproducible.SILC has some benefits over LC but still more studies will be needed to accept it as a replacement of LC. Homero Rivas et al60 had performed SlLC i n large series o f patients .They concluded that Single-incision laparoscopic cholecystectomy is safe feasible and quite reproducible i n experienced hands. The outcomes seem comparable with those f o r conventional laparoscopic technique with similar minimal morbidity and no mortality in their series. The operating times are reasonable and can be lessened to times comparable with those for the conventional laparoscopic approach especially when basic concepts regarding the challenges of this technique are better understood and solutions being implemented. A. Karashmalakov e t al61 had performed S I L C in 52 patients at Trakia University Hospital, Stara Zagora, Bulgaria. They concluded that

SILC can safely replace the LC .Main advantage of SILC over LC was the cosmesis, leaving almost invisible scar within the umbilicus. Brittney L. Culp et al

62

had done a comparative study between

SILC and conventional LC .They concluded that post operative hospital stay is significantly less in the patients who had undergone SILC as compared to conventional LC, while operative time is more due to technical difficulties in SILC. Acute-phase proteins and inflammatory cytokines mediate measurable responses to surgical trauma, which are proportional to the extent of tissue injury and correlate with post-operative outcome. McGregor et al in 2011 concluded that there are no statistically significant differences found between SILC and cLC for interleukin-6 and Creactive protein levels, length of stay( LOS) and duration of surgery(DOS). There was also no correlation between systemic stress response and operative parameters7. There were no intra-operative complications. SILC appears to be a safe and feasible technique with potential advantages of cosmesis, reduced incisional pain and well-being recommending its use. Data indicates no difference in systemic stress and morbidity between SILC and cLC .

AIMS AND OBJECTIVES

1. To measure the levels of C-Reactive protein and Total Leucocyte Count in patients undergoing conventional laparoscopic cholecystectomy(cLC) and Single incision laparoscopic cholecystectomy(SILC) .

2

To study the role of and do the comparative evaluation of the levels of CReactive Protein and Total Leucocyte Count in patients of conventional laparoscopic

cholecystectomy

cholecystectomy.

and

Single

incision

laparoscopic

MATERIAL AND METHODS

The present prospective study

included ultrasonographically

proved 50 patients of symptomatic cholelithiasis and were posted for elective cholecystectomy. These patients were admitted in Surgical Wards of Indira Gandhi Medical College, Shimla .SILC were

performed on 25 (50% of

patients) and cLC were conducted in rest of 25 (50%) patients. The patients were

selected

randomly.

investigations were

Relevant

history,

clinical

examination

and

recorded as per performa attached (annexure 1). The

consent of all these patients were taken as per consent form (annexure 2). All the patients were

subjected to same general anesthesia, antibiotics,

perioperative analgesics and intravenous fluids. SILC was done by infra umblical incision and cLC was done by three /four Trocar Technique.

INCLUSION CRITERIA :

All patients with ultrasonographically proved symptomatic cholelithiasis , fit for general anaesthesia were included in the study.

Patients having following conditions have been excluded from the study.

1. Acute Cholecystitis /Pancreatitis. 2 Choledocholithiasis 3 Jaundice / Hypoproteinemia/Malignancy 4 History of Allergy , Taking Steroids and Chemotherapy 5 Patients on Oral Contraceptive Pills/Pregnancy 6 Patients requiring peri-operative blood transfusion. 7 Conversion of cLC to OC.

8 Intra operative injury to adjacent organs/structures. 9 Patients developing peri-operative complications.

Serial measurements of TLC and CRP were done by sampling blood which was collected as mentioned below:-

1. Baseline Sample- Pre-operatively after overnight fasting. 2. At the time of completion of surgery with in 6 Hours. 3. 1st Post Operative day. 4. 2nd post operative day. Data collected was analyzed statistically by using paired ‘t’ test.

C-REACTIVE PROTEIN ESTIMATION

3 ml of clotted blood sample was taken. The concentration of CRP was measured by NYCOCARD CRP SINGLE TEST KIT AND USING NYCOCARD READER II (AXIS– SHIELD, Norway ). MATERIAL TD (Test Device)

:

Plastic device containing a membrane coated with monoclonal anti-CRP antibodies.

R-1 (Dilution Liquid)

:

(0.4 ml) Borate buffer (pH 9.0) and detergents.

R2 (conjugate)

:

(1 x 3.5 ml) Solution

containing

monoclonal

anti-CRP

antibodies with ultra small gold particles. R3 (Working Solution)

:

( 1 x 3.0 ml) Phosphate buffered NaCl solution (pH 7.4) and detergents

C+ (Control Positive)

:

(1 x 05 ml)

Serum of human origin with added purified CRP Capillary tubes

:

5 ml end to end glass capillaries

Pipette (5 ml) and pipette tips Capillary tube holder Nycocard Reader II

Test Procedure

1.

5 L capillary was filled with patient sample or C+ (Control Positive), and the capillary was dropped into the tube with R1(Dilution Liquid). The tube was closed and mixed well for 10 seconds.

2.

50 L diluted sample or dilute C+ (Control Positive) was applied to the TD (Test Device). The sample was allowed to soak into the membrane (approx. 30 second).

3. One drop R/2 Conjugate was allowed to the TD (Test Device). The reagent was allowed to soak into the membrane (approx. 30 seconds).

4. R3 (Washing Solution) was allowed to the TD (Test Device). The reagent was allowed to soak into the membrane (approx. 20 second).

5. The result was read within 45 minutes using the NycoCard READER II following the READER II user instruction manual.

TOTAL LEUCOCYTE COUNT ESTIMATION

TLC was measured by AUTOMATED HEMATOLOGY CELL COUNTER (MELET SCHLOESING LABORATORIES OSNY-FRANCE)  A collecting tube with anticoagulant EDTA K3 (violet or blue cap) was filled upto 2/3rd with the blood sample.  Blood and anticoagulant were mixed thoroughly by inverting the tube 10 times .  Appropriate bank was selected i.e. male adult /female adult/child .After selecting appropriate bank that particular bank was saved.  The MS9 was ready to run the sample. Following procedures were followed. o Cap was taken off the tube o The tube was placed in the holder by choosing the correct adaptor for the volume of the sample tube(red, blue, white or green) o The analysis was started automatically by pressing << ALT>>C. o The tube was taken out after the end of the analysis. o The result was automatically displayed once the counting was done.

CONVENTIONAL LAPAROSCOPIC CHOLECYSTECTOMY

First of all, the patient was asked to pass urine before entering operation theatre. With patient in supine position, general anesthesia was given. Cleaning and draping was done in the standard fashion. The patient was placed in reverse Trendelenberg position of 30 degree while rotating the table to left by

15 degree. This maneuver allowed the duodenum and colon to fall away from the liver edge. The operating surgeon stood to the patient's left, the camera operator to the surgeon's left and the assistant on the patient's right. The video monitor was placed on the patient's right at the level of the shoulder, to give an unobstructed view for the surgeon and camera assistant. The Veress needle was inserted through a stab incision in the infra-umbilical region, almost perpendicular to the abdominal wall with a slight angle towards the pelvis. Saline drop test was done for checking correct placement of Veress needle. (Saline drops were injected into peritoneal cavity. When no aspirate was returned, it checked the correct placement of Veress needle) Pneumoperitoneum was created using this Veress needle through which CO2 was insufflated into peritoneal cavity to a pressure of 13mm of Hg.10mm incision was made for 10mm trocar at the site of stab incision in the infra-umbilical region. The trocar was inserted towards the pelvis at an angle of about 80 degree to the anterior abdominal wall. Laparoscope was introduced through the umbilical port and a complete examination of abdominal cavity was performed. The second trocar was placed under direct laparoscopic vision in the midline between the xiphoid and the umbilicus through a 10mm incision, ensuring that its entry into abdominal cavity was on the right side of the falciform ligament. Also the trocar was directed towards the gall bladder, so that there was no need to reposition it continuously throughout the procedure. Two 5mm ports were placed, one in the subcostal region, in the midclavicular line for the atraumatic grasper for the left hand of the surgeon

and another at the level of umbilicus along anterior axillary line for the assistant’s rachet ( with lock ) grasper, by 5mm stab incisions. With the laparoscope through the umbilical port, a rachet grasper was introduced through the lateral 5mm trocar to grasp the fundus of the gall bladder. The assistant applied traction upward and backward to establish optimal exposure. Another atraumatic grasper was introduced through the midclavicular port. When the anatomy was evident, the grasper was used to catch Hartmann’s pouch and apply the necessary traction. Working with both hands , the surgeon took the grasper that holded Hartmann’s pouch in his or her left hand and applied upward and lateral traction to identify the structures in the cholecystoduodenal ligament and the common bile duct. A 5 or 10mm instrument, generally an atraumatic Maryland curved dissector was introduced through the subxiphoid port with the right hand and blunt dissection was started in the cholecystoduodenal ligament, which was simple when there was no intense acute or chronic inflammation. This dissection allowed identification of the cystic duct, bile duct and cystic artery. Once the junctions of the cystic duct to the gallbladder and to the bile duct were identified and the right peritoneal attachment of the gallbladder dissected out, traction was applied to Hartmann’s pouch to the right side of the patient and slightly upwards to enable dissection of the left peritoneal attachment. At this point care was taken to avoid injury to the small arteries that accompany the cystic lymph node located near the cystic artery bifurcation. In case of haemorrhage, the Monopolar Electrocautry or harmonic scalpel was used.

Once all the structures were clearly identified then the cystic duct and artery were divided. To perform this, two staples were placed in the cystic duct, using clip applicator, one proximal to the main duct and the other as close as possible to the gallbladder to prevent spillage. Two staples were placed distally and one proximally on the cystic artery and both structures were divided with metzenbaum scissors. To dissect and release the gallbladder from the rest of the hepatic bed, a hook or spatula connected to the monopolar Electrocautry device was used, with the irrigation and aspiration at the same time. Dissection was performed ensuring careful haemostasis while the graspers in the fundus and Hartman’s pouch were used to give a good exposure. Before removing the gallbladder completely, a careful examination of the hepatic bed was performed to verify haemostasis and the bleeding points were cauterized. Drains were left as a routine in most of the cases, introduced by most lateral 5mm port. The gall bladder was extracted by subxiphoid port by claw forceps. All incisions of 10mm were sutured with vicryl (port closure 35mm) to avoid herniations and post operative complications.

SINGLE INCISION LAPAROSCOPIC CHOLECYSTECTOMY:

Equipment and Instruments: We used conventional laparoscopic instruments and equipment for performing SILC. We used 5mm laparoscope for performing the procedure. A sharp image that allows clear distinction between tissue planes and tissue textures is essential for safe dissection.

Position of the patient, team and equipment: The patient was positioned supine on the operating table with the legs split apart and strapped firmly to the leg boards. Both arms of the patient were placed on arm boards at an angle less than 90º to the torso. The surgeon stood on the left side of the patient, with the assistant opposite to him during the placement of the first port. For rest of the procedure, the surgeon stood between the legs and the camera person stood to his right (near the left leg of the patient). The monitor trolley was placed above the patient's right arm. The diathermy pedal was placed near the surgeon's left foot and all tubes and cables were fixed such that they do not interfere with the camera person. Placement of ports: We had given an infraumbilical curved incision. The umbilicus was everted and held with two-toothed forceps in a cephalic and caudal position prior to making an incision of length 2-2.5 cm. This was deepened through the fat and the flaps were undermined to expose the fascia over a distance of 2-2.5 cm. The left edge of the skin incision was retracted and a fascial stab incision was made. A Veress needle was introduced through this incision and after confirmation of its intraperitoneal position; CO2 pneumoperitoneum was induced and maintained at 12 mm Hg. In the initial cases a 10 mm port was inserted at the incision line and the two five mm ports were placed 0.5 cm inferiorly and laterally on either side through the same skin incision. A grasper introduced through the right lateral port was used for fundal traction. The dissector introduced through the left lateral port was used to dissect the fine Calot’s triangle. The instrument port and the telescope port were crossed by a chopstick method to avoid “sword fighting’’ and clashing of instruments in the abdomen. At this stage, the patient's position was changed to an antiTrendelenberg one with a left-sided tilt which helped in the better exposure of the Calot’s triangle. Later we used only two ports one five mm port for five mm

camera and another was ten mm working port through which laparoscope, needle holder, grasper and extractor were introduced at the various steps of SILC procedure. Placement of traction sutures : This was the key step of the SILC i.e. "puppeteer"12 technique, in which traction sutures were used to hold gall bladder. At the beginning of the procedure, a grasper or a dissector was used to move the omentum away from the right upper quadrant so as to obtain a view of the fundus of the gallbladder. Flimsy omental adhesions, if present, were teased off at this stage. We used a strand of 1-0 vicryl on a 60-mm straight needle for placing the traction sutures. The needle was introduced laterally through one of the intercostal spaces above the level of the costal margin on right side. A laparoscopic needle holder brought the needle into the peritoneal cavity and placed it on the omentum. The needle was then regrasped at its midpoint, a bite of the fundus of the gallbladder was taken and the needle was driven out through the same intercostal space. The needle was retrieved using an open needle holder and the suture was pulled out leaving two ends of 5-6 cm. The suture was divided and a haemostat was applied to both ends close to the skin, resulting in elevation of the gallbladder fundus. Another traction suture was taken in which the needle was introduced from the epigastric region just below the xiphi sternum .This needle was passed through the Hartmann’s pouch with the help of needle holder and then taken out from lateral abdominal wall. Both ends were held with hemostats. This helped in lifting the Hartmann’s area and helped in better dissection. Dissection of the Calot's triangle: The posterior peritoneum was divided to free the Hartmann's pouch. This was followed by further dissection of the anterior and posterior peritoneal leaves overlying the Calot's triangle with the help of a hook and/or a

Maryland dissector. The cystic artery and the cystic duct were skeletonised - the endpoint of this dissection was obtaining a "critical view". Control of the cystic artery: The two windows in the Calot's triangle were dissected more widely than during an conventional LC so as to safely observe the tips of the instruments controlling the artery and the duct. We had clipped the cystic artery with a 10-mm reusable clip applicator. Subsequently, the cystic artery was divided. Control of the cystic duct: If the cystic duct appeared narrow, it was clipped thrice with 10mm clips and divided. If the duct appeared wide, we preferred to pass a No. 1 polyglactin suture around it, exteriorize the same and fashioned an extracorporeal Meltzer’s knot. This knot was then snugged down onto the cystic duct with the help of a metal knot-pusher. The duct was divided between two extra corporeally tied ligatures. If there was a suspicion of an impacted stone in the cystic duct, it was controlled on the gallbladder side, divided partially to allow the stone to be milked out, and then the stump was ligated using extracorporeal knotting. A 10-mm port was used for introducing a spoon forceps for the retrieval of stones from cystic duct or those that may spill from the gallbladder if it was perforated during dissection. The divided ends of the cystic artery and duct were carefully inspected to confirm their secure closure. Dissection of the gallbladder: Alternating medial and lateral rotation of the gallbladder using the ends of the suture placed on Hartmann's pouch was done to dissect the gallbladder from the liver bed using a diathermy hook. Prior to the final detachment of the gallbladder, meticulous haemostasis in the liver bed was ensured and the subhepatic space lavaged with saline. The fundal traction suture

was

loosened

and

the

gallbladder

was

freed

from

the

liver.

Specimen extraction: Gall bladder was then held at neck with the grasper and extracted through the umbilical 10 mm port. Closure of the incision: Careful closure of the fascial incision was done to prevent formation of port-site hernia. The edges of the fascial incision were identified, grasped and elevated using fine Kocher's forceps. We closed the rectus sheath using vicryl no.1 suture. The fascia and the skin were infiltrated with a local anaesthetic and the skin was closed using sutures.

Postoperative course: The postoperative care was identical to that of patients undergoing standard laparoscopic cholecystectomy. Intravenous analgesics and anti-emetics were administered for the duration of hospital stay. Patients were allowed to ambulate and take liquids after 6-8 hours of surgery. Findings were recorded as per Performa attached.

NYCO CARD READER WITH REAGENTS KIT

REAGENTS KIT

AUTOMATED HEMATOLOGY CELL COUNTER

INFRAUMBLICAL INCISION

INSTRUMENTS INCISION

INSERTION

THROUGH

INFRAUMBLICAL

PUPPETEER TECHNIQUE

DISSECTION OF CALOT’S TRIANGLE

SPECIMEN EXTRACTION

WOUND AFTER SKIN CLOSURE

PATIENT POST OPERATIVELY

CONVENTIONAL LAPAROSCOPIC CHOLECYSTECTOMY

OBSERVATIONS

The present study was conducted in the Department of Surgery, IGMC, Shimla over a period of 1 year from 1st July, 2012 to 30th June, 2013 on 50 patients who were admitted for elective cholecystectomy. These patients were alternatively divided into two groups of 25 patients each. Group ‘A’ included patients in whom SILC was done and Group ‘B’ included patients who underwent cLC. Detailed history was taken, thorough clinical examination was done and appropriate investigations were carried out in each case which were recorded in the Performa attached. The following observations were made:

1:- AGE DISTRIBUTION IN SINGLE INCISION AND CONVENTIONAL LAPAROSCOPIC CHOLECYSTECTOMY GROUP:The age of patients in the present study ranged from 15 to 58 years. In SILC group, the age ranged from 15 to 58 years and the mean age was 30.88±9.248 (standard deviation ) years, whereas in cLC group, the age ranged from 15 to 54 years and the mean age was 35.20±9.923 (standard deviation) years. Patients were grouped as : below 30 years,30-45 years and more than 45 years .Majority of patients were in between 30-45 years and were 56% and 68% in SILC and cLC groups respectively . The youngest patient in SILC group was 15years of age, whereas in cLC group, youngest patient was

of 16 years (see master

charts). The p value for age of patients between SILC and cLC groups was 0.095 . (Table 1a,1b and figure 1a,1b ) .

Table no 1a :- GROUP STATISTICS (AGE) Group

N

Age SILC cLC

Mean

Std. Deviation

Std. Error Mean

25

30.88

9.248

0.850

25

35.32

9.923

0.980

FIGURE 1a :-

40 35 30 no.of pts

25

mean 20

std .deviation

15

std error of mean

10 5 0 SILC

c LC

Table no 1b :- Age Distribution

Age (years) <30 30-45 >45

SILC No. of patients (n=25) 10 14 1

%age 40 56 4

Clc No. of patients (n=25) 5 17 3

%age 20 68 12

pvalue= .095, (p >0.05 - insignificant). FIGURE 1b :70 60 50 40

<30

30

30-45

20

>45

10 0 No. of patients

%age

No. of patients

SILC

%age cLC

2:- SEX DISTRIBUTION:-

Out of 50 patients, 43 patients (86%) were female and 7 patients (14%) were male. In the SILC group 24 patients (96%) were female and only 1 patient (4%) was male, whereas in the cLC 19 patients (76%) were females and 6 patients (24%) were males. (Table 2, Figure 2)

Table no 2 :- Sex Distribution

Sex Male Female

SILC (n=25) 1 24

Clc %age 4 96

p value= 1.00 ( p >0.05- insignificant )

(n=25) 6 19

%age 24 76

FIGURE 2:100 90 80 70 60 50 40 30 20 10 0

Male Female

(n=25)

%age SILC

(n=25)

%age cLC

3:-BASAL METABOLIC INDEX (BMI) :The BMI ranged from 18 to 3O kg/m2 with mean BMI of 21.08 whereas it was 21.04 and 21.88 in the SILC and cLC groups respectively. The p value is0.20 which is statistically insignificant. (Table 3, figure 3)

Table no 3 :- BASAL METABOLIC INDEX (BMI) :2

BMI(Kg/M ) 18-20 21-23 24-26 27-29 30-32 MEAN

SILC No. of patients (n=25) 16 9 0 0 0 21.04

p value= .20 ( p >0.05- insignificant )

%age 64 36 0 0 0

c LC No. of patients (n=25) 2 15 6 1 1 21.88

%age 8 60 24 4 4

FIGURE 3:16 14 12 10 8 6 4

SILC c LC

2 0

4:- COMPARISON OF DURATION OF SURGERY (DOS):-

Only one (4%) patient of SILC group was operated during the time interval of 20-39 minutes while in cLC group 13(52%) were operated during the similar time interval. During 40-59 minutes of time interval 16(64%) patients in SILC group had undergone surgery while in cLC group 12(48%) patients were operated in this time interval. In 60-79 minutes of time duration 8 (32%) of the patients were operated in SILC group while the entire patient in cLC group had been operated before this time interval. The mean time for the duration of surgery was 53.32 min in SILC group and in cLC group mean operating time was 39.40min, with p value 0.001 ,showing that the operating time in the SILC group was significantly high as compared to the cLC group. (table 4, figure 4)

Table 4:- COMPARISON OF DURATION OF SURGERY (DOS):Time

SILC GROUP

(in minutes)

No. of patients

cLC GROUP

%Age

No. of patients

(n =25)

%Age

(n =25)

20-39

1

4

13

52

40-59

16

64

12

48

60-79

8

32

0

0

53.32

MEAN

35.20

p value= <.001 (p <0.05- significant). FIGURE 4 :-

70 60 50 40 30

20-39

20

40-59

10

60-79

0 No. of patients

%Age

No. of patients

%Age

SILC GROUP cLC GROUP

5:- COMPARASION OF TLC ( BASE LINE) The pre operative TLC of these patients ranged from 4.78 m/mm3 to 9.56 m/mm3. In the SILC group, pre operative TLC ranged from 4.10 m/mm3 to 8.80 m/mm3 and the mean was 6.286±1.147 m/mm3(standard deviation) . In the cLC group, pre operative TLC ranged from 4.38 m/mm3 to 9.36 m/mm3 and the mean was 6.654±1.569 m/mm3(standard deviation). The p value for pre operative TLC between OC and LC groups was 0.349. (Tables 5. figures 5) Table 5:- COMPARASION OF TLC ( BASE LINE) TLC (in m/mm)

SILC GROUP No. of patients

%Age

(n =25)

cLC GROUP No. of patients

%Age

(n =25)

4.00-7.90

24

96

19

76

8.00-11.00

1

4

6

24

>11.00

0

0

0

0

MEAN

6.286

p value= 0.349, which is insignificant.

6.654

FIGURE 5:100 90 80 70 60 50 40 30 20 10 0

4.00-7.90 8.00-11.00 >11.00

No. of patients

%Age

No. of patients

%Age

SILC GROUP cLC GROUP

6 :- COMPARASION OF TLC (WITH IN 6 HOURS

TLC with in 6 hours ranged from 4.2 m/mm3 to 11.63 m/mm3 . In the SILC group, mean was 7.106±2.361 m/mm3(standard deviation). In the cLC group, TLC ranged from 2.2 m/mm3 to 12.00 m/mm3 and the mean was 9.991±14.547 m/mm3(standard deviation) .The p value for TLC between SILC and cLC groups was 0.333. (Table 6 and figure 6 ).

Table 6 :- COMPARASION OF TLC (WITH IN 6 HOURS) TLC

SILC GROUP

cLC GROUP

(in m/mm)

No. of patients

%Age

No. of patients

(n =25)

%Age

(n =25)

4.00-7.90

19

76

19

76

8.00-11.00

4

16

5

20

>11.00

2

8

1

4

7.106

MEAN

9.991

p value =0.333 ,which is insignificant.

FIGURE 6:-

80 70 60 50 4.00-7.90

40

8.00-11.00

30

>11.00 20 10 0 No. of patients

%Age

SILC GROUP

No. of patients

%Age

cLC GROUP

7 :- COMPARASION OF TLC (WITH IN 24 HOURS) TLC on 1st post operative day (24 hours after surgery) of these patients ranged from 4.4 m/mm3 to 12.2 m/mm3. In the SILC group, mean was 7.554±3.196 m/mm3(standard deviation) .In the cLC group, the mean was 7.122±2.351 m/mm3(standard deviation) . Number of patients were 25 in each group .Majority of patients had TLC between 4.00 -7.90m/mm3 . .i.e. 56 % and 64% in SILC and cLC group respectively .The p value for TLC on 1st post operative day between SILC and cLC groups was 0.589.(Table 7 and figure 7 ).

Table 7 :- COMPARASION OF TLC (WITH IN 24 HOURS) TLC (in m/mm)

SILC GROUP No. of patients

%Age

(n =25)

cLC GROUP No. of patients

%Age

(n =25)

4.00-7.90

15

56

16

64

8.00-11.00

9

36

8

32

>11.00

2

8

1

4

MEAN

7.554

p value = 0.589 ,which is insignificant.

7.122

Figure 7:70 60 50 40

4.00-7.90

30

8.00-11.00

20

>11.00

10 0

No. of patients

%Age

SILC GROUP

No. of patients

%Age

cLC GROUP

8 :- COMPARASION OF TLC (WITH IN 48 HOURS) TLC on 2nd post operative day (48 hours after surgery) of these patients ranged from 4.3 m/mm3 to 12.8 m/mm3 . In the SILC group, mean was 8.923±2.165 m/mm3(standard deviation). In the cLC group, mean was 7.339±2.776 m/mm3 (standard deviation). Number of patients were 25 in each group .Majority of patients had TLC between 4.00 -7.90m/mm3 . .i.e. 52 % in cLC group. In SILC group,majority of patients had TLC between 8.00 -11.00m/mm3 . .i.e. 52 %.The p value for TLC on 2nd post operative day between SILC and cLC groups was 0.029. (Table 8 figure 8).

Table 8 :- COMPARASION OF TLC (WITH IN 48 HOURS) TLC

SILC GROUP

(in m/mm)3

No. of patients

cLC GROUP

%Age

No. of patients

(n =25)

%Age

(n =25)

4.00-7.90

8

32

13

52

8.00-11.00

13

52

11

44

>11.00

4

16

1

4

8.923

MEAN

7.339

p value= 0.029, which is insignificant.

FIGURE 8 :60

50

40 4.00-7.90

30

8.00-11.00 20

>11.00

10

0 No. of patients

%Age

SILC GROUP

No. of patients

%Age

cLC GROUP

9 :-COMPARASION OF CRP (BASELINE) The pre operative CRP of these patients ranged from 2 mg% to 5 mg%. In the SILC group, pre operative CRP was < 5 mg% . In the cLC group, pre operative CRP was also < 5 mg% .The p value for pre operative CRP between SILC and cLC groups was insignificant. Table 9 :-COMPARASION OF CRP (BASELINE) CRP

SILC GROUP

(in mg/dl)

No. of patients

cLC GROUP

%Age

No. of patients

(n =25)

%Age

(n =25)

<5

25

100

25

100

6- 10

0

0

0

0

>10

0

0

0

0

p value in 1.00 , insignificant. FIGURE 9 :-

100 90 80 70 60 50 40 30 20 10 0

<5 .6-10. >10 No. of patients

%Age

No. of patients

%Age

SILC GROUP cLC GROUP

10 :- COMPARASION OF CRP (WITH IN 6 HOURS) CRP with in 6 hours ranged from 5 mg% to 48 mg% .In the SILC group, CRP mean was 22.98±17.55 mg%(standard deviation ). In the cLC group, CRP mean was 20.58±22.6 mg%(standard deviation). Number of patients were 25 in each group .Majority of patients had CRP value below 5 mg% i.e. 80 % and 60% in SILC and cLC group respectively. The p value for CRP between SILC and cLC groups was 0.854. (Table 10 and figure 10) .

Table 10 :- COMPARASION OF CRP (WITH IN 6 HOURS) CRP (in mg/dl)

SILC GROUP No. of patients

%Age

(n =25)

cLC GROUP No. of patients

%Age

(n =25)

<5

20

80

15

60

6- 10

01

4

2

8

11- 20

03

12

2

8

>20

01

4

6

24

MEAN

22.98

p value =0.854, which is insignificant.

20.58

FIGURE 10 :-

80 70 60

SILC GROUP No. of patients

50

SILC GROUP %Age

40 30

cLC GROUP No. of patients

20

cLC GROUP %Age

10

0 <5

.6-10

.11-20

>20

11 :- COMPARASION OF CRP (WITH IN 24 HOURS) CRP on 1st post operative day (24 hours after surgery) of these patients ranged from 5 mg% to 120 mg% . In the SILC group, CRP mean was 47.10±33.28 mg% (standard deviation ). In the cLC group, CRP mean was 45.40±28.54 mg%(standard deviation ). Number of patients were 25 in each group .Majority of patients had CRP value more than 20 mg% i.e. 60 % and 76% in SILC and cLC group respectively.

The p value for CRP at 1st post

operative day (24 hours after surgery) between SILC and cLC groups was 0.854. (Table 11 and figure 11). Table 11 :- COMPARASION OF CRP (WITH IN 24 HOURS) CRP (in mg/dl)

SILC GROUP No. of patients

%Age

cLC GROUP No. of patients

%Age

(n =25)

(n =25)

<5

3

12

2

8

6- 10

2

8

0

0

11- 20

5

20

4

16

>20

15

19

76

60 47.10

MEAN

45.40

p value =0.854 ,which is insignificant.

FIGURE 11 :80 70 60

SILC GROUP No. of patients

50

SILC GROUP %Age

40 cLC GROUP No. of patients

30

cLC GROUP %Age

20

10 0 <5

06-Oct

Nov-20

>20

12 :- COMPARASION OF CRP (WITH IN 48 HOURS) CRP on 2nd post operative day (48 hours after surgery) of these patients ranged from 6.2 mg% to 120 mg% . In the SILC group, CRP mean was 61.98±37.06 mg%. In the cLC group, CRP mean was 65.08±39.6 mg%. Number of patients were 25 in each group .Majority of patients had CRP value more than 20 mg% in each group i.e. 80 % in both SILC and cLC group. The p value for CRP at 2nd post operative day between SILC and cLC groups was 0.781 .(Table 12 and Figure 12). Table 12 :- COMPARASION OF CRP (WITH IN 48 HOURS) CRP (in mg/dl)

SILC GROUP No. of patients

%Age

(n =25)

cLC GROUP No. of patients

%Age

(n =25)

<5

1

4

1

4

6- 10

1

4

2

8

11- 20

3

12

2

8

>20

20

20

80

MEAN

80 61.98

p value = 0.781, which is insignificant.

65.08

FIGURE 12 :-

80 70 60 No. of patients

50

%Age

40

No. of patients

30

%Age

20 10 0 <5

06- .10

.11-20

>20

Group Statistics N

Age

BMI

DOS

TLC1

Mean

Std. Deviation

Std. Error Mean

SILC

25

30.88

9.2480

0.850

cLC

25

35.20

9.923

0.980

SILC

25

21.04

2.111

.422

cLC

25

21.88

2.505

.501

SILC

25

53.32

8.924

1.785

cLC

25

39.40

7.263

1.453

SILC

25

6286.64

1147.485

229.497

cLC

25

6654.72

1569.302

313.860

TLC2

TLC3

TLC4

CRP1

CRP2

CRP3

CRP4

SILC

25

7106.72

2361.017

472.203

cLC

25

9991.56

14547.668

2909.534

SILC

25

7554.72

3196.590

639.318

cLC

25

7122.44

2351.837

470.367

SILC

25

8923.64

2165.719

433.144

cLC

25

7339.08

2776.619

555.324

0.000.

0.000.

0.000.

25

SILC cLC

25

0.000.

0.000.

0.000.

SILC

4

22.98

17.558

8.779

cLC

10

20.58

22.662

7.166

SILC

23

47.10

33.285

6.940

cLC

22

45.40

28.545

6.086

SILC

24

61.98

37.062

7.565

cLC

24

65.08

39.640

8.091

Independent Samples Test Levene's Test for Equality of Variances

F

Age

Equal variances assumed

Sig.

3.649

t-test for Equality of Means

t

.062

Df

-2.757

48

Equal variances not assumed

BMI

Equal variances assumed

.369

.546

Equal variances not assumed

DOS

Equal variances assumed

.822

.369

Equal variances not assumed

TLC1

Equal variances assumed

4.842

.033

Equal variances not assumed

TLC2

Equal variances assumed

2.502

.120

Equal variances not assumed

TLC3

Equal variances assumed

.445

.508

Equal variances not assumed

TLC4

Equal variances assumed

2.082

.156

Equal variances not assumed

CRP2

Equal variances assumed

.102

.755

Equal variances not assumed

CRP3

Equal variances assumed

.858

.360

Equal variances not assumed

CRP4

Equal variances assumed

.122

.728

Equal variances not assumed

Independent Samples Test t-test for Equality of Means

-2.757

45.203

-1.282

48

-1.282

46.658

6.049

48

6.049

46.098

-.947

48

-.947

43.958

-.979

48

-.979

25.263

.545

48

.545

44.095

2.250

48

2.250

45.313

.188

12

.211

7.256

.184

43

.185

42.509

-.280

46

-.280

45.794

Sig. (2-tailed) Std. Error p-value

Age

BMI

DOS

TLC1

TLC2

TLC3

TLC4

CRP2

CRP3

CRP4

Mean Difference

Difference

Equal variances assumed

.008

-8.320

3.018

Equal variances not assumed

.008

-8.320

3.018

Equal variances assumed

.206

-.840

.655

Equal variances not assumed

.206

-.840

.655

Equal variances assumed

.000

13.920

2.301

Equal variances not assumed

.000

13.920

2.301

Equal variances assumed

.349

-368.080

388.815

Equal variances not assumed

.349

-368.080

388.815

Equal variances assumed

.333

-2884.840

2947.603

Equal variances not assumed

.337

-2884.840

2947.603

Equal variances assumed

.589

432.280

793.708

Equal variances not assumed

.589

432.280

793.708

Equal variances assumed

.029

1584.560

704.271

Equal variances not assumed

.029

1584.560

704.271

Equal variances assumed

.854

2.395

12.720

Equal variances not assumed

.838

2.395

11.332

Equal variances assumed

.854

1.709

9.263

Equal variances not assumed

.854

1.709

9.231

Equal variances assumed

.781

-3.104

11.077

Equal variances not assumed

.781

-3.104

11.077

DISCUSSION Laparoscopic cholecystectomy (three or four trocars) is known to be a gold standard for cholecystectomy63,64. As a result of development of new surgical technique and highly sophisticated technologies, surgical approach to gallbladder has tendency to become less invasive by reducing number and size of operative ports and instruments

63,65,66

; with intention of less postoperative

pain, shorter hospitalization time and better cosmetic results. Single-incision laparoscopic (SILC) cholecystecomy is a step toward these objectives, because it cannot be overstated that every incision and trocar placement poses a risk of bleeding, organ damage and incisional hernia. 66,67. CRP and TLC are well known systemic stress factors. In order to understand more about the impact of stress factors like C- reactive protein and total leucocyte count during the surgery and after the surgery, study was conducted in IGMC,shimla. In this study 25 patients who underwent cLC were compared with 25 patients who underwent SILC. The patients in reference to variables such as age, height, weight or BMI were similar in the two different groups of cLC and SILC . The aim of this

study was to compare single incision

laparoscopic cholecystectomy with 4 port laparoscopic cholecystectomy in terms of preoperative and post operative CRP and TLC at different time intervals and to look for any significant difference between these two groups.

1. AGE DISTRIBUTION IN SINGLE INCISION AND 4PORT LAPAROSCOPIC CHOLECYSTECTOMY GROUP:The age of patients included in the study ranged from 15 years to 58 years. The mean age was 30.8 years in the SILC and 35.40 years in cLC group respectively,which is statistically insignificant(p value=.095).

Rasic Zaraco et al 201068, in his study conducted to compare SILC and cLC also has shown no significant age differerence. 2. SEX DISTRIBUTION:In the present study 86% of the total patients were females and 14 % were males (Table 2, Figure 2). There was 1 male (4%) and 24 females (96%) in the SILC and 6 males (24%) and 19 females (76%) in the cLC group. The study of H. Rivas et al60 in which 80 women (85%) and 15 men (15%) were included in SILC group and female to male ratio was 16:3. The study conducted by Roland Raakow et al69 had included 142 women (65%) and 78 (35%) men. Of all the above cited studies it has been supported the fact that gall stones are more common in females. 3. BASAL METABOLIC INDEX (BMI):The BMI ranged from 18 to 3O kg/m2 . Mean was 21.04 in the SILC and 21.88 in the cLC group respectively. The p value was >0.206 which was statistically insignificant. (table3,figure3). The BMI in the study of Asakuma et al70 was 22+-2kg/m2 in both SILC and 4 port LC group. Study conducted by Dragon schwartz et al71 , in 2010 have shown no significant difference in BMI in SILC and cLC.

4. COMPARISON OF DURATION OF SURGERY (DOS):Only 1 (4%) patient of SILC group was operated during the time interval of 20-39 min while in 4port LC group 13 (52%) were operated during the similar time interval. During 40-59 min of time interval 16(64%) patients in SILC group had undergone surgery while in 4port LC group 12(48%) patients were operated in this time interval. In 60-79 min of time duration 8(32%) of the

patients were operated in SILC group while all the patient in 4port LC group had been operated before this time interval. The mean time for the duration of surgery was 53.32min in SILC group and in 4port LC group mean operating time was 39.40min, showing that the mean operating time in the SILC group was significantly high as compare to the 4port LC group. P value= <.oo1 (p <0.05- significant). The study conducted by Evangelos C. Tsimoyiannis et al 72 had found Mean operative time 37.3 ± 9.16 min in 4 port LC and 49.65 ± 9.02min in SILC. Thus, the results of the present study are similar to that reported above in the manner that total duration of surgery in SILC group is more than that in the cLC group. Zaraco et al 201068, in his study conducted to compare SILC and cLC also has shown no significant differerence in terms of duration of surgery .It was 46 min in SILC and 43 min in cLC

5. PRE OPERATIVE TLC The mean pre operative TLC in the SILC group, the mean was 6.286±1.147 m/mm3 whereas in the cLC group, the mean pre operative TLC was 6.654±1.569 m/mm3. The result was comparable in both the groups (p = 0.395). which is insignificant . Wright VJ et al73 also compared systemic stress response in the form of TLC pre and post operatively and found no significant difference between SILC and cLC. 6. TLC WITH IN 6 HOURS:TLC with in 6 hours ranged from 4.2 m/mm3 to 11.63 m/mm3. In the SILC group, mean was 7.106±2.361 m/mm3. In the cLC group, TLC ranged

from 2.2 m/mm3 to 12.00 m/mm3 and the mean was 9.991±14.54 m/mm3. The p value for TLC between SILC and cLC groups was 0.333. (Table 6 and figure 6). Darzi et al 201174 also compared systemic stress response in the form of TLC pre and post operatively and found no significant difference between SILC and cLC. 7.COMPARASION OF TLC (WITH IN 24 HOURS) TLC on 1st post operative day (24 hours after surgery) of these patients ranged from 4.4 m/mm3 to 12.2 m/mm3. In the SILC group, mean was 7.554±3.196 m/mm3. In the cLC group, the mean was 7.122±2.351 m/mm3. The p value for TLC on 1st post operative day between SILC and cLC groups was 0.589. (Table 7 and figure 7 ). As shown by p value there is no significant difference between both groups.

8. COMPARASION OF TLC (WITH IN 48 HOURS)

TLC on 2nd post operative day (48 hours after surgery) of these patients ranged from 4.3 m/mm3 to 12.8 m/mm3. In the SILC group, mean was 8.923±2.165 m/mm3. In the cLC group, mean was 7.339±2.776 m/mm3. The p value for TLC on 2nd post operative day between SILC and cLC groups was 0.029. (Table 8 figure 8). pvalue= 0.290, which is insignificant. Same finding was supported by McGregor et al ,2011 in his study7.

9 .COMPARASION OF CRP (BASELINE) The pre operative CRP of these patients ranged from 2 mg% to 5 mg%. In the SILC group, pre operative CRP was ,< 5 mg% . In the cLC group, pre operative CRP was also < 5 mg% . As all values were < 5 mg% , so p value for pre operative CRP between SILC and cLC groups was insignificant.

10. COMPARASION OF CRP (WITH IN 6 HOURS)

CRP with in 6 hours ranged from 5 mg% to 48 mg% .In the SILC group, CRP mean was 22.9±17.55 mg%. In the cLC group, CRP mean was 20.58±22.6 mg%. The p value for CRP between SILC and cLC groups was 0.854. (Table 10 and figure 10) . McGregor et al 20117, measured CRP,TLC and IL-6 after gall bladder removal in both groups i.e. SILC and cLC and found no significant difference in both these groups.

11. COMPARASION OF CRP (WITH IN 24 HOURS) CRP on 1st post operative day (24 hours after surgery) of these patients ranged from 5 mg% to 120 mg% . In the SILC group, CRP mean was 47.10±33.23 mg%.

In the cLC group, CRP mean was

45.40±28.54 mg%. The p value for CRP at 1st post operative day (24 hours after surgery) between SILC and cLC groups was 0.854. (Table 11 and figure 11). Froghi et al (2011)75 reported that serum IL-6, TNF-α, CRP and TLC levels were not significantly different in the SILC and 4PLC groups at baseline and at six , 24 hours and 48 hours after surgery (p>0.05 for all).

12 . COMPARASION OF CRP (WITH IN 48 HOURS)

CRP on 2nd post operative day (48 hours after surgery) of these patients ranged from 6.2 mg% to 120 mg% . In the SILC group, CRP mean was 61.98±37.06 mg%. In the cLC group, CRP mean was 65.08±39.6 mg%. The p value for CRP at 2nd post operative day between SILC and cLC groups was 0.781 .(Table 12 and Figure 12). Two studies compared the surgical stress response in SILC and 4PLC patients by measuring biochemical stress markers including IL-6, TNF-α, CRP and TLC, six and 24 hours after surgery (Froghi et al 2011; McGregor et al 2011). Froghi et al (2011) reported that serum IL-6, TNF-α, CRP and TLC levels were not significantly different in the SILC and 4PLC groups at baseline and at six and 24 hours after surgery75 . Similarly, McGregor et al (2011)7 reported that serum IL-6 and CRP levels were not significantly different in the SILC and 4PLC groups at baseline and at 6 ,24 and 48 hours after surgery (p>0.05 for all).

SUMMARY The present study was carried out in the Department of Surgery, IGMC, Shimla over a period of 12 months from 1st July 2012 to 30th June 2013 on 50 patients who were admitted with clinical diagnosis of symptomatic cholelithiasis. The following observations were made:1):-

The age of patients included in the study ranged from 15 years to 58 years with mean age of 39.45years . The mean age was 30.8 years in the SILC and 35.40 years in cLC group respectively,which is statistically insignificant(p value=.095).

2):-

In the present study 86% of the total patients were females and 14 % were males. There was 1 male (4%) and 24 females (96%) in the SILC and 6 males (24%) and 19 females (76%) in the cLC group. The data shows that cholelithiasis is more common among females.

3):-

The BMI ranged from 18 to 3O kg/m2 with mean BMI of 21.44 It was 21.04 in the SILC and 21.88 in the cLC group respectively. The p value is >0.206 which is statistically insignificant.

4):-

The total duration of surgery was more in the SILC group as compared to cLC group .The mean time for the duration of surgery was 53.40min in SILC group and in 4port LC group mean operating time was 39.80min, showing that the mean operating time in the SILC group was significantly high as compared to the 4port LC group. P value= <.oo1 (p <0.05significant).

5):-

As expected, the preoperative levels of the TLC and CRP were comparable in the two groups.

6.):-

Mean of TLC with in 6 hours ,in SILC group was 7.106±2.361 m/mm3 whereas in the cLC group, mean was 9.991±14.54 m/mm3. The p value for TLC between SILC and cLC groups was 0.333.

7):-

TLC on 1st post operative day (24 hours after surgery) of these patients ranged from 4.4 m/mm3 to 12.2 m/mm3. In the SILC group, mean was 7.554±3.196 m/mm3. In the cLC group, the mean was 7.122±2.351 m/mm3. The p value for TLC on 1st post operative day between SILC and cLC groups was 0.589. As shown by p value there is no significant difference between both groups.

8):-

TLC on 2nd post operative day (48 hours after surgery) of these patients ranged from 4.3 m/mm3 to 12.8 m/mm3. In the SILC group, mean was 8.923±2.165 m/mm3. In the cLC group, mean was 7.339±2.776 m/mm3. The p value for TLC on 2nd post operative day between SILC and cLC groups was 0.029.

9) :-

The pre operative CRP in both groups were <5 mg% , so p value for pre operative CRP between SILC and cLC groups was insignificant.

10):-

CRP with in 6 hours ranged from 5 mg% to 48 mg% .In the SILC group, CRP mean was 22.9±17.55 mg%. In the cLC group, CRP mean was 20.58±22.6 mg%. The p value for CRP between SILC and cLC groups was 0.854.

11):-

CRP on 1st post operative day (24 hours after surgery) of these patients ranged from 5 mg% to 120 mg% . In the SILC group, CRP mean was 47.19±33.28 mg%. In the cLC group, CRP mean was 45.40±28.54 mg%. The p value for CRP at 1st post operative day (24 hours after surgery) between SILC and cLC groups was 0.854.

12):-

CRP on 2nd post operative day (48 hours after surgery) of these patients ranged from 6.2 mg% to 120 mg% . In the SILC group, CRP mean was 61.98±37.06 mg%. In the cLC group, CRP mean was 65.08±39.6 mg%.

The p value for CRP at 2nd post operative day between SILC and cLC groups was 0.781.

CONCLUSION Recent developments in laparoscopic surgery have led to single incision laparoscopic surgery

technique, in which instead of several ports placed

throughout the abdomen only one entry site into the abdominal cavity is used. Moreover, with fewer abdominal incisions it seems justified to expect reduced wound related complications and less postoperative pain as well as better patient satisfaction with cosmetic outcome. In this study 50 patients were taken and they had all variables similar i.e age, BMI as shown in the study. As SILC is comparatively newer technique in the world of minimal asses surgery and it has its learning curve , so SILC took longer operative time than the cLC . We can say that as the experience increases with the SILC procedure the operative time will decrease . Moreover,in this study, SILC was done with conventional instruments which are used for cLC. In this study,no significant statistical difference were found in systemic stress factors i.e. CRP and TLC pre and post operatively in either of groups (SILC and cLC). Hence based on the comparative evidence presented in this study, SILC appears to be as safe , effective and feasible technique and good alternative to cLC with potential advantages of cosmesis. The costs associated with SILC and cLC procedures appear similar. Ultimately, the decision as to whether to perform SILC or traditional/conventional LC will be dependent on the preferences of individual surgeons and patients.

BIBLIOGRAPHY

01. Tomikawa M, Xu H, Hashizume M: Current status and prerequisites for natural orifice translumenal endoscopic surgery (NOTES). Surg Today 2010;40:909–916 02. Ahmed K, Wang TT, Patel VM et al: The role of single-incision laparoscopic surgery in abdominal and pelvic surgery: a systematic review. Surg Endosc 2011;25:378–396 03 . Antoniou SA, Pointner R, Granderath FA: Single-incision laparoscopic cholecystectomy: a systematic review. Surg Endosc 2011;25:367–377 04. Podolsky ER, Rottman SJ, Poblete H et al: Single Port Access cholecystectomy : a completely transumbilical approach.J Laparoendosc Adv Surg Tech A 2009;19:219–222 05. Roberts KE, Solomon D, Duffy AJ et al: Single-incision laparoscopic cholecystectomy: a surgeon’s initial experience with 56 consecutive cases and a review of the literature. J Gastrointest Surg 2010;14:506–510 6.

Crokson RA,Payne CJ,Ratcliffe AP,Soothill JF(1966).Screening test for an acute phase reactant,Clin Chimica Acta 14:435-441.

7.

McGregor CG,Sodergren MH,Aslanyan A,Wright VJ,Purkayastha S,Darzi A,Paraskeva P.Evaluating systemic stress response in laparoscopic cholecystectomy.J Gastrointest Surg.2011 Apr;15(4):614-22.

8.

Beal JM, Illinois. Historical perspective of gallstone disease. The Surgeon Libirary. Surg Gynae Obstet 1984;158:181-189.

9.

Thidichum JL. A treatise of gallstones. London : J Churchill and Sons 1863

10.

Taylor G. On gall stones and their sufferers. Br J Surg 1937;25:241-51

11. Glenn F, Grafe WR. Historical events in biliary tract surgery. The archives of surgery 1966; 93: 848-852 12.

Glenn F. Biliary tract disease since antiquity. Bull N Y Acad Med. 1971;47:329-50

13.

Graham EA, Cole WH, Copher GH, Moore S. Diseases of gall bladder and bile ducts,Philadelphia: Lea and Febiger 1928;12:142-4

14.

Marlow J. History of laproscopy, optics, fibreoptics and instrumentation. Clinical obstetrics and gynaecology 1976; 19: 261-275

15.

Bozzini P, Lichtelter. Erfindung zur Anschung Innerer Theile and Krankhelton nebst abbildung. J Pract Aresenykunde 1896; 24:107.

16.

Gunning J. Gynaecological laproscopy. Symposium specialist 1974; 5766.

17.

Stellato TA. History of laproscopic surgery. Surgical clinics of North America 1992; 72: 997- 1002.

18.

Kelling G. Liberoesophagoskopic, gastroskopic and koelloskopic. Munch Med 1991;76:887-1111

19.

Wochonbeher 1901; 42-21. Jacobacus HC. Kuzzeuberschicht uber meine Erfahrungen mitder laprothosakoskopicc.Munech Med Wochenscher 1911; 57- 2017

20.

Veress J. Neues Instrument zur ausfuhrung von Brust- order B auckpunktionen and Pneumotherex behandlung Atsch. Med Wochenschur 1938; 41-1480.

21.

Fittzgibbons RJ, Annibali R, Litka S. Gallbladder and gallstones removal, open versus closed laproscopy and pneumoperitoneum. Am J Surg 1993; 165: 497-504.

22.

Deyo GA. Complications of laproscopic cholecystectomy. Surg Laprose Endosc 1992; 2: 41- 48.

23.

Mauret P. From the first laproscopic to the frontliners of laproscopic surgery: the future perspectives. Dig Surg 1991; 8: 142- 5.

24.

Litynski GS. Erich Mühe and the rejection of laparoscopic cholecystectomy (1985): A surgeon ahead of his time. JSLS. 1998;2:341– 6

25 Mühe E. Laparoskopische cholecystektomie. EndoskopiHeute. 1990;4:2626. 26. Mühe E. Laparoskopische cholezystektomie-Spatergebnisse. Langenbecks Archiv Fur Chirurgie. Supplement. Kongressband. Deutsche Gesellschaft Fur Chirurgie. Kongress.1991:416–23 27. Mühe

E.

Long-term

follow-up

after

laparoscopic

cholecystectomy. Endoscopy.1992;24:754–8 28.CM Colley, A Fleek, AW Goode. Early time course of the acute phase protein response in man. J Clin Pathol 1983;36:203-207. 29.Belfarge S. Plasma protein pattern in the course of acute infectious disease. Acta Med Scand1963;suppl 395. 30.Pepys MB. C-reactive protein, serum amyloid –P-component and serum amyloid A protein in autoimmune disease. In: Holbrow EJ, ed. Clinics in immunology and allergy. London, Philadelphia, New York: WB Saunders 1981; 1:77-101.

31.Cruickshank AM, Fraser WD, Burns HJG, Van Damme J, Shenkin A, Response of serum interleukin-6 in patients undergoing elective surgery of varying severity. Clin Sci 1990; 79: 161-5. 32. Schaver PR, Sirinek KR. The laparoscopic approach reduces the endocrine response to elective cholecystectomy. Am J Surg 1995;61:106-111. 33 Shakespeare PG, Ball AJ, Spurr ED (1989) Serum protein changes after abdominal surgery. Ann Clin Biochem 26: 49-57. 34.Crockson RA, Payne CJ, Ratcliffe AP, Soothill JF (1966) Time sequence of acute phase reactive proteins following surgical trauma. Clin Chimica Acta 14:435-441 35.Thompson D, Milford-Ward A, Whicker JT (1992) The value of acute phase-protein measurements in clinical practice. Ann Clin Biochem 29:123-13 36.Heinrich PC, Castell JV, Andus T. Interleukin 6 and the acute phase response. Biochem J 1990;265: 621-36. 37.Claus DR, Osmand AP, Gewurz H (1976) Radioimmunoassay of human Creactive protein and levels in normal sera. J Lab Clin Med 87:120-128 38.Aronson KF, Ekelund G, Kindmark CO, et al. (1972) Sequential changes of plasma proteins after surgical trauma. Scand J Clin Lab Invest 29:127136 39.Werner M, Odenthal D (1967) Serum protein changes after gastrectomy and a model of acute phase reaction. J Lab Clin Meal 70:302-310 40.Conner JG, Eckersall PD, Douglas TA (1983) Acute phase response in the dog following surgical trauma. Res Vet Sci 45: 107-110

41.Ohzato H, Yoshizaki K, Nishimoto N, et al. (1992) Interleukin-6 as a new indicator of inflammatory status: detection of serum levels of interleukin6 and C-reactive protein after surgery. Surgery 111:201-209 42.Pullicino EA, Carli F, Poole S, et al. (1990) The relationship between the circulating concentrations of Interleukin 6 (IL-6) tumor necrosis factor (TNF) and the acute phase response to elective surgery and accidental injury. Lymph Res 9: 231-238. 43. Jorris J, Cigarini I, Legrand M, et al. Metabolic and respiratory changes after cholecystectomy performed via laparotomy or laparoscopy. Br J Anaesth 1992; 69:341-345. 44.Mealy K, Gallagher H, Barry M, Lennon F, Traynor O, Hyland J. Physiological and metabolic responses to open and laparoscopic cholecystectomy. Br J Surg 1992; 79: 1061-1064. 45.McMohan AJ, O Dwyer PJ, Cruikshank AM et al. Comparison of metabolic responses to laparoscopic and minilaparotomy cholecystectomy. Br J Surg 1993; 80:1255-58. 46.Cho JM, LaPorta AJ, Clark JR, et al. Response of serum cytokines in patients undergoing laparoscopic cholecystectomy. Surg Endosc 1994; 8:1380-138. 47.

Junker H. .Laparoscopic tubal ligation by the single puncture technique (author’s transl). Geburtshilfe Frauenheilkd. 1974; 34:952–5.

48.

Bailer P, Rauskolb R. .Gynaecological laparoscopy (author’s transl). Geburtshilfe Frauenheilkd. 1975; 35:747–53.

49.

Navarra G, Pozza E, Occhionorelli S, et al. One-wound laparoscopic cholecystectomy. Br J Surg .1997; 84:695.

50. Romanelli JR, Mark L, Omotosho PA. Single port laparoscopic cholecystectomy with the TriPort system: A case report. Surg Innov. 2008; 15: 223–8. 51.

Bresadola F, Pasqualucci A, Donini A, Chiarandini P, Anania G, Terrosu G, et al. Elective transumbilical compared with standard laparoscopic cholecystectomy. Eur J Surg.1999; 165:29–34.

52.

Piskun G, Rajpal S. Transumbilical laparoscopic cholecystectomy utilizes no incisions outside the umbilicus. J Laparo endosc Adv Surg Tech A. 1999;9:361–364.

53.

Cuesta MA, Berends F, Veenhof AA. The “invisible cholecystectomy”: A

transumbilical laparoscopic operation

without a scar. Surg Endosc. 2008; 22:1211–3. 54.

Rao PP, Bhagwat SM, Rane A, The feasibility of single port laparoscopic cholecystectomy: a pilot study of 20 cases. HPB .2008; 10: 336–340.

55.

Hodgett

SE,Hernandez

JM,

Morton

CA,

Ross

SB,

et

al.

Laparoendoscopic single site (LESS) cholecystectomy. J Gastrointest Surg. 2009;13: 188–192. 56.

Li-Ping

CAO,Ri-ShengQue,FanZhou,Guo-PingDing,Di-xi

Jing.Transumbilical single port laparoscopic cholecystectomy using traditional laparoscopic instruments:A report of thirty six cases.JZus B 2011;1673-1581. 57.

Scott

RPhillip,Brent

W

Miedema,Klaus

Thaler.single

incision

laparoscopic cholecystectomy using conventional instruments:early experience in comparison with the gold standard.J Am Coll Surg 2009;209:632-637. 58.

Noam Shussman,Avraham Schlager,Ram Elazary,Abed Khalaileh,Andrei Keidar,Mark

Talamini

cholecystectomy:lessons Endosc.2011;25(2):404-407.

et

al.single learned

incision

laparoscopic

for

success.Surg

59.

Deepraj Bhandarkar,Gaurav Mittal,Rasik Shah,Avinash Katara,Tehemton E udwadia.single incision laparoscopic cholecystectomy:how I do it?. J Minim Access Surg. 2011; 7(1): 17–23.

60.

Homero Rivas,Esteban Varel,Daniel Scott.Single incision laparoscopic cholecystectomy: initial evaluation of a large series of patients. Surg Endosc. 2010;24:1403–1412.

61.

A. Karashmalakov, A. Julianov, H. Stoyanov, Iv. Rachkov, H. Hristov et al. from standard to transumbilical laparoscopic cholecystectomy – learning

curve

and

preliminary

results.

Trakia

Journal

of

Sciences.2010;8:296-298. 62.

Brittney L. Culp, MD.Veronica E. Cedillo, MSN, RN-BC, and David T. Arnold, MD. Single-incision laparoscopic cholecystectomy versus traditional four-port cholecystectomy. Proc (Bayl Univ Med Cent). 2012 October; 25(4): 319–323.

63. Gecco CF ,Tacchino R, Matera CD, Surg Endosc, 2008 Sep25. 64.

Alaz, Velni D, Jerkovi V, Kovai D, Dalmatin L Depolo A, Rai Z, Perko Z, Acta Clin Croat, 35 (1996) 63.

65.

Marescoux J, Dallemagne B, Perreta S, Watteiz A, Mutter D, Coumoros D,Arch Surg, 142 (2007) 823.

66. Zoring C,Emmermann A, Von Waldenfel HA, Mofid H, Endoscopy, 39(2007) 913. 67.

Navarra G, Pozza E, Ochinorollis, Carpoforo P, Doninii, Br J Surg, 84 (1997) 695.

68.

Zaraco R,Veldin D ,Alaz, , Jerkovi V, Kova D , Dalmitin L, Depolo A, Rai Z, Perko , Original scientific paper Coll. Antropol. 34 (2010) 2: 595– 598

69.

Roland Raakow, Dietmar A. Jacob. Single-Incision Cholecystectomy in about 200 Patients. Minimally Invasive Surgery. 2011:1-5.

70.

Asakuma M, Hayashi M, Komeda K, Shimizu T, Hirokawa F,Miyamoto Y, et al. Impact of single-port cholecystectomy on postoperative pain. Br J Surg. 2011; 98: 991–995.

71.

Dragon Schwartz ,Marescoux J, Dallemagne B, Perreta S, Watteiz A, Mutter D, Coll. Antropol. 34 (2010) 2: 578–589.

72.

Tsimoyiannis EC, Tsimogiannis KE, Pappas-Gogos G, et al. Different pain

scores

in

cholecystectomy

single

versus

transumbilical

classic

incision

laparoscopic

laparoscopic

cholecystectomy:

a

randomized controlled trial. Surg Endosc .2010; 24:1842–1848. 73.

Wright VJ,Sodergren MH,Aslanyan A, ,Purkayastha S,Darzi A,Paraskeva P.Evaluating systemic stress response in laparoscopic cholecystectomy.J Gastrointest Surg.2011 Apr;15(4):614-22.

74 . Darzi A,Paraskeva MH,Aslanyan A, ,Purkayastha P.Evaluating systemic stress response in laparoscopic cholecystectomy.J Gastrointest Surg.2011 Apr;15(4):614-22. 75.

Froghi F, Sodergren MK, Wright VJ, Coomber R, Courtney AP, Darzi A, Paraskeva P. Single-Center Experience in Systemic Stress and ShortTerm Morbidity of Single-Incision Cholecystectomy. Surgical Innovation 2011;

PROFORMA 1.

Particulars of the Patient. 

C.R No. :…………………………..............………………



Name :……….………………………....….........………



Age

:………………Sex

…………………...…............ 

Permanent Address ………………………………………...………. …………………………………………………………………...… ….



Date of Admission: …………………….……………………...…....



Date of Operation : ............................................................................



Date of Discharge: ……………………...……….…………………..



Operation (SILC/cLC): ..........................................................................

2.



Consultant/Surgeon :...........................................



Duration of surgery : ........................

Chief Complaints: Onset/Duration/Progression 

Abdominal Pain .................................................................................. ............................................................................................................ ....



Dyspepsia ............................................................................................ ............................................................................................................ ....



Others .................................................................................................. ............................................................................................................ ....

3.

Relevant History  ............................................................................................................ ... ............................................................................................................ .... ............................................................................................................ ....

4.

General Physical Examination

Pallor

Y

N

Pedal Oedema

e s

e s

e s

e s

5.

Y

N

Icterus

Y

N

PR per min

e s

e s

Systemic Examination Per Abdomen

Clubbing BP in mmHg

Y

N

e e s s ____/_____

Chest

Cardiovascular System

CNS

6.a Routine Laboratory Investigations Date

Hb

RBC

ESR

Na

K

Cl

PLT

6.b Laboratory Investigations Blood Sugar Fasting

Random

Urea

Bilirubin Total

Serum Proteins

Conjugated Total

SGOT

Albumin

SGPT

Creatinine

Amylase

Alkaline Phosphatase

7.Radiological Findings:o Chest X-Ray :……………………………………….................. o Ultra Sonography :………………………………………….............. o Others :…………………………………………..............

8. Parameters :Sr. No.

TLC (per mm3)

CRP (mg/lt)

1. Pre-operative value (baseline) 2. After the completion of Surgery (with in 6hour) 3. 1st Post-operative Day (with in 24 hours) 4. 2nd Post-operative Day (with in 48 hours)

Remarks:................................................................................................................. .... ................................................................................................................................ ......

INFORMED CONSENT

I ------------------------------exercising my free power of choice, hereby give my consent to be a subject in the comparative study of single incision laparoscopic Cholecysectomy with conventional laparoscopic Cholecystectomy. I have been informed to my satisfaction by the attending Surgeon, the purpose of study and nature of procedure and drugs to be used. I am also aware of my right to opt out of the study at any time during the course of the procedure without any reason.

.................................................................. Signature/thumb impression of the patient

KEY TO MASTER CHART

Sr.No.

serial number

Min

minute

F

female

M

male

BMI

body mass index

TLC1

total leucocyte count (baseline)

TLC2

total leucocyte count(with in 6 hours)

TLC3

total leucocyte count(with in 24 hours)

TLC4

total leucocyte count(with in 48 hours)

CRP1

c reactive protein (baseline)

CRP2

c reactive protein (with in 6 hours)

CRP3

c reactive protein (with in 24 hours)

CRP4

c reactive protein (with in 48 hours)

MASTER CHART SINGLE INCISION LAPAROSCOPIC CHOLECYSTECTOMY Sr.No.

Name

Age

Sex

(yrs)

BMI

Duratio

(kg/m2)

n of

TLC(m/mm3)

CRP(mg/dl)

TLC1

TLC2

TLC3

TLC4

CRP1

CRP2

CRP3

CRP4

surgery (min) 1.

Bimla bhanu

45

F

20

60

5730

6200

9000

7800

<5

10

5

30

2.

Sumitra

30

F

23

70

6100

6500

6000

7688

<5

<5

<5

11

3.

Jagdish

34

M

24

60

6500

8600

8354

9800

<5

<5

13

24

4.

Neelam

41

F

19

55

6000

5233

5900

5799

<5

<5

9

<5

5.

Hemlata

40

F

22

50

7688

6165

7212

8565

<5

<5

120

89

6.

Anita

21

F

24

40

4621

6477

7488

12870

<5

<5

70

120

7.

Priyanka

22

F

19

45

4100

6700

8800

4800

<5

<5

9.4

10.6

8.

Kanta

27

F

20

45

6200

6879

4700

9000

<5

<5

31.7

10.7

9.

Sarla

58

F

22

35

6500

6900

3800

8900

<5

48.9

18.8

60.6

10.

Rimpy

25

F

22

50

6200

12000

19500

11677

<5

<5

74

88

11.

Seema

35

F

18

70

7499

11890

9800

7900

<5

<5

44

41

12.

Parwati

21

F

23

60

6519

7400

8489

10986

<5

<5

119

120

13.

Sonia

21

F

18

70

4588

6200

4000

4300

<5

<5

44.6

53.7

14.

Nanda

15

F

19

62

7000

6500

6100

6400

<5

<5

85.7

81.8

15.

Babli

32

F

19

55

5700

2000

4789

9807

<5

<5.6

76.9

86.5

16.

Gulshan

41

F

20

50

4470

7599

4199

11000

<5

<5

14

40

17.

Sunaina

28

F

23

48

7989

10879

6879

8766

<5

<5

71.2

47

18.

Neelam

28

F

25

45

5600

4000

4577

8978

<5

<5

52.8

53

19.

Reenu

21

F

22

50

5758

9800

7699

7566

<5

<5

31.5

116

20.

Rekha

30

F

23

50

6588

3342

6578

8765

<5

<5

48

78.6

21.

Hemlata

30

F

18

55

6799

8766

8890

9877

<5

<5

<5

6

22.

Sunita

32

F

22

50

7599

7400

8766

8466

<5

<5

24.8

40

23.

Geeta

34

F

20

58

5788

6600

6588

9806

<5

<5

20

80

24.

Menu

30

F

22

50

8897

7896

10980

12343

<5

16

40

120

25.

Radha

31

F

19

50

6733

5742

9780

11232

<5

17

60

80

MASTER CHART OF cLC

Sr.No.

Name

Age

Sex

(yrs)

BMI

Duration

(kg/m2)

of

TLC(m/mm3)

CRP(mg/dl)

TLC1

TLC2

TLC3

TLC4

CRP1

CRP2

CRP3

CRP4

<5

9.2

15

40

surgery (min) 1. 2.

Nirmla Raj

56

F

20

35

8976

7322

8544

6421

23

F

22

40

5600

6788

4456

6122

<5

39

5.4

10.7

kumari 3.

Priyanka

14

F

23

35

5763

6123

6800

6400

<5

<5

<5

<5

4.

Kanta

44

F

24

30

7123

8722

6400

5432

<5

<5

54

85

5.

Rajo

40

F

18

40

6987

5934

4987

5876

<5

78

120

120

6.

Subhadra

52

F

19

45

7190

9821

7809

8796

<5

6

27

62

7.

Kamlesh

28

M

23

50

4699

7699

6498

4000

<5

<5

<5

21.7

8.

Satya

34

F

22

30

7655

4000

1233

9876

<5

<5

99

85

9.

Mukti

23

F

23

35

8790

4199

2133

1300

<5

<5

43

83

10.

Hira ram

24

M

21

40

7688

9100

4709

3899

<5

<5

49.8

120

11.

Sushil

34

M

22

45

6788

14888

9822

9800

<5

12.7

66

70

Mehta 12.

Usha

32

F

18

55

8890

4800

5300

10438

<5

<5

60.7

120

13.

Harnam

42

M

19

40

6588

5643

7009

877

<5

5.6

70

19

14.

Sari devi

34

F

22

35

6123

7865

8322

6554

<5

<5

34.7

79

15.

Akla

32

F

23

30

7544

78990

6453

8765

<5

<5

12.7

40

16.

Bharmi

28

F

24

40

4532

6579

7860

6700

<5

<5

<3

6

17.

Kali

32

M

19

40

9346

4800

7986

7900

<5

<5

45.8

120

chand 18.

Lata

30

F

18

45

4300

4756

11230

10987

<5

<5

49

80

19.

Anita

33

F

19

45

5000

6978

9876

9870

<5

5.6

64

86.8

20.

Satya

29

F

24

35

5678

8345

7654

8123

<5

<5

56.8

118

21.

Getu

34

F

25

30

5480

6987

9780

10999

<5

,5

17

30

22.

Roshni

26

F

23

50

8450

6540

7800

6577

<5

>5

12

10

23.

Surrender

28

M

26

50

4590

8799

8900

9765

<5

23

46.2

65.6

24.

Maya

24

F

24

30

7800

6456

8700

9877

<5

16.7

30

10

25.

Kavita

32

F

26

35

4788

7655

7800

8123

<5

10

20.6

80.2

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