Diseases of the gallbladder are common and costly1.
In a country like India, with its ethnic background and increasing age, theincidence rising is almost a certainty among the obese females with increasingage1,2. The rising epidemic of obesity and the metabolic syndromepredicts an escalation of cholesterol gallstone frequency1,3.Gallstone disease in childhood, once considered rare, has become increasinglyrecognized with similar risk factors as those in adults, particularly obesity.The incidence of Gallbladder cancer is also high, particularly in Indians.Over the past years, there has been substantialdevelopment in cholecystectomy techniques, as well as in the pre- andpost-operative management of patients. The open surgical procedure with a largeincision (OC)4 has been succeeded by small incision opencholecystectomy (SIOC)5, laparoscopic cholecystectomy6, single port laparoscopic cholecystectomy technique7 and roboticcholecystectomy8.
The introduction of laparoscopic cholecystectomyin 1989 further increased the cholecystectomy rate10,11. It is essential to scrutinise such changes insurgical technology in terms of cost and quality of life, to ensure fairdistribution of resources. AlthoughLaparoscopic Cholecystectomy is being done more commonly, there have alwaysbeen questions raised regarding its benefits over Open Cholecystectomy. It hasalso been stated that Open can be preferred as it offers less operation timeand Laparoscopic method gives no benefit in terms of complications12,13. Similar findings were reported in anexpertise-based randomised controlled trial14. Theaim of the present study is to compare Open and Laparoscopic Cholecystectomy concerning costs and quality oflife using the data obtained in this study and to provide data for furthermeta-analysis.
There is sparse literature on thecost-effectiveness of one surgery over other and the quality of lifethereafter. Hence, addressing this research gap will help the surgeon inselecting one operation over other with proper mobilization of availableresources. OBJECTIVES : Primaryobjectives:1. To find out thecost-effectiveness of Open and Laparoscopic Cholecystectomy.
2. To compare the healthrelated quality of life among patients treated with Open and LaparoscopicCholecystectomy. Secondaryobjectives:1. To identify and determinecomplications within the time of discharge, operative time, length of hospitalstay, conversion rate, frequency of ambulatory surgery and readmissions within30 days. METHODOLOGY:StudyDesignAfter the approval of Ethics Committee of myinstitution, I plan to carry out my study as described below.Study Type: Prospective Comparative Study. Study Site: Department of Surgery of a tertiary carehospital, Ahmedabad.
Study Duration: Two months between May 2018 and September 2018.Study Method: Written informed consent of the patientsfulfilling the inclusion and exclusion criteria will be taken. Patients will be followed from the time ofadmission, perioperative period, till the time of discharge. Detailed casereport form is developed to record information on demographic data, admissiondetails, present history findings, past medical history of Diabetes, Hypertensionand to record the pre-operative and post-operative details. Patients withcomplications will be followed till 30 days and all relevant information willbe noted in the case report form. The economic assessment will be conductedfrom a societal perspective, calculating both direct public healthcare costsand indirect costs generated by the loss of productivity (sick leave). Costgenerating posts in health care will be calculated from the time the patientwas admitted for surgery. Health-relatedquality of life will be assessed using questions concerning patient mobility,self-care, usual activities, pain/discomfort and anxiety/depression.
DataAnalysis: Dataentered in an excel sheet will be analyzed by SPSS 16.0 (Statistical Packagefor Social Sciences; IBM, Chicago, USA) software. Statistical comparisonsbetween OC and LC groups will be made with Student’s t testfor categorical variables. Statistical significance is defined as P<0.05.
Interventions: None.StudyPopulationInclusionCriteria:1. All patients admitted forelective cholecystectomies, irrespective of age or gender.2.
Patient willing toParticipate in Study .Exclusioncriteria: 1. Patients with critical illness. 2.
Medically unfit forsurgery.3. Cholecystectomy performedas a part of other Surgery. Sampling All the patients admitted in this hospital forelective cholecystectomy within the Study Duration, satisfying the inclusionand exclusion criteria’s will be included in this study.IMPLICATIONS: A. If this study canestablish significant cost-effectiveness of one operation over other, theoperation can be considered more often for elective cholecystectomy, especiallywhen resources are to be taken care of.
B. Patient satisfaction ofthe surgery can be greatly increased if better health related quality of lifeafter surgery is established.C. When the operation, otherthan the one proved better is selected, proper counseling of the patient shouldbe done, explaining the reasons of choosing the operation, costs that will beincurred, the problems he/she might face and precautions to be taken for thoseproblems.