| 1. Objective:1.1 From the Angle of clinical and health economics, evaluate the advantages and disadvantages of traditional laparotomy and laparoscopic surgeryLaparoscopic cholecystectomy is considered the "gold standard" for the treatment of cholelith disease, with widespread promotion and application of laparoscopic technology and traditional laparotomy emerging effectiveness and applicability of minimally invasive surgery is more and more attention. Adopt parallel controlled trial design, this paper compare laparoscopic and open two kinds of operation method for treatment of cholelith disease, medical expenses and health-related quality of life in patients with status(hereinafter referred to as the quality of life), and from the perspective of health economics of cholelith disease patients provided a reference for clinical treatment decisions.1.2 To explore the factors influencing patients life quality and treatment costsAs the change of medical model, medical service concept changes, not only requires treatment interventions can reduce the harm of patients’body and mental shock, and more and more attention to its economy, this article through to under the influence of different factors, analysis of the change of the patient’s survival quality and cost, find the main influencing factors, to develop a healthy lifestyle, and provide reference for reasonable compensation for the costs of health care.2. Methods:2.1 The object of studySelected from January 2014 to October 2014 nanfang hospital,southern medical university diagnosis of gallbladder stone with patients with common bile duct calculi,need to be parallel cholecystectomy and common bile duct exploration,meet the conditions and included in the study patients.Follow-up time is 6 weeks.2.2 Research methods2.2.1 Research toolsDesign health related quality of life questionnaire of cholelith disease patients.Including patients’basic situation,Life style,Gastrointestinal disease Quality of Life Index (GIQLI) and MOS 36-Items Short Form Health Survey (SF-36), Patients with clinical data and cost of health information.GIQLI is specific quality of life scale, dedicated to evaluate the quality of survival in patients with digestive system disease conditions;SF-36 life quality evaluation scale is universality.Choice of two kinds of inventory related research have been shown to have high reliability, validity and reaction degree.2.2.2 Data processing and statistical methodsEpiData3.1 is adopted to establish the database, the design of the questionnaire and double entry check, after confirmed the import SPSS 20.0 statistical software analysis, descriptive statistics method is used to explore the basic conditions of respondents, and the basic condition of the two kinds of scale;GIQLI rating scale and SF-36 scale to compare the Mann-Whiney U test and Wilcoxon test;Surgical results and cost comparison between the two groups using independent sample t test, multiple sets of comparison between using single factor analysis of variance, factors affecting the use multiple stepwise regression analysis;Count data compared with chi-square test;P values for probability, on both sides of the inspection level alpha 0.05.2.2.3 Quality controlThis research selected topic from guangdong science and technology plan projects(number:2012B031800304),from design to sample investigation are carried out in accordance with the project design,to ensure that the entire study scientific nature and rationality.At the beginning of the investigation and study,epidemiological investigation of investigators in system training.Let the investigators focus on the content of the questionnaire, the language expression and the matters needing attention in the process of investigation.In the process of investigation,investigators quantitative score of each items in the inventory, reduce the patients’subjective influence on the evaluation results, and investigator in the problems in the investigation at any time to explain.After investigation,the filtered recycling questionnaire, in order to ensure the quality of the survey data.Eliminating illogical,complete quality is not high, completion rate is lower than 80% of the questionnaires.Epidata3.1 is adopted to establish the database and to double check of the input, to improvethe veracity and reliability of input data.3.Result:3.1 The basic condition of the respondentsIssue 103 questionnaires survey, actually collect 98 valid questionnaires, effective recovery rate was 95.15%.Included in the statistical analysis of 98 cases of patients,OC group of 47 cases,LC group for 51 cases;51 cases of male,47 cases of female;Investigation of the age range of 18 to 65.3.2 Demographic dataTwo groups of patients in the groups at baseline data analysis of the age, gender, level of education, health care situation and live data statistical analysis, two groups of patients into groups has no statistical significance(P>0.05);Two groups of patients with BMI OC group is (21.97±2.19) kg/m2,LC group is (23.60±3.62) kg/m2, no statistical significance (P>0.05),comparable.3.3 Clinical dataOpen group of laparoscopic group significantly longer than the average operation time, incision length laparotomy group leader in laparoscopic group, group is higher than the average blood loss laparotomy laparoscopic group, the difference had statistical significance (P<0.05);Sick time after laparoscopic group is shorter than laparotomy group, the difference was statistically significant (P<0.05);And the difference of two groups on the average such confinement has no statistical significance (P>0.05).4.Survey analysis of the quality of life and its influencing factors4.1 Evaluation of open and laparoscopic group GIQLI survival quality analysisOpen and laparoscopic group before each dimension score,after 2 weeks,6 weeks after operation GIQLI measurement self-conscious symptom scores, there was no sta tistically significant difference (P>0.05);2 weeks postoperatively,laparoscopic group s cored higher than laparotomy group GIQLI score,score (108.04±10.07; 100.38±11.12), the body physiological function (13.30±4.69;11.00±2.31), psychological emotional st ate (17.77±3.61;16.63±2.36),the condition of special disease score(36.46±3.17;33.13 ±5.88), the difference was statistically significant(P<0.05);Six weeks after laparoscop ic group GIQLI scale score(117.98±8.36), and social activities(14.59±3.32), the condi tion of special disease score(37.93±2.51) is significantly higher than laparotomy grou p (114.22±8.07;12.75±2.29;36.09±2.31),the difference was statistically significant (P <0.05).4.2 Evaluation of open and laparoscopic group GIQLI postoperative and preoperative quality of lifeLaparotomy and laparoscopic group 2 weeks,6 weeks after surgery compared wi th preoperative social activity grading,there were no statistically significant difference (P>0.05).After two weeks of laparotomy group self-conscious symptom scores(27.00 ±4.44),the difference was statistically significant (P<0.05);6 weeks after surgery GIQ LI scale total score(114.22±8.07), self-conscious symptom (29.13±2.94), the body ph ysiological function(17.63±4.13), psychological emotional state score(18.63±2.63)wa s higher, the difference had statistical significance (P< 0.05). After two weeks of the 1 aparoscopic group and self-conscious symptom scores before surgery is improved(28. 84±3.44), the difference was statistically significant (P< 0.05);In 6 weeks after surger y GIQLI scale total score (117.98±8.36), self-conscious symptom(29.34±3.04),the bo dy physiological function(18.90±4.56),psychological emotional state(19.23±2.58) the condition of special disease score (37.93±2.51) was higher, the differences were statistically significant (P<0.05).4.3 Evaluation of open and laparoscopic group SF-36 survival quality analysisLaparotomy and laparoscopic group before each dimension score comparison, there were no statistically significant difference(P>0.05), comparable;2 weeks postoperatively, SF-36 total score between the two groups and the physical dimension, physiological function, body pain score, the laparoscopic group scored higher, the difference was statistically significant(P<0.05);6 weeks postoperatively, SF-36 scale and the psychological dimension in the dimension, physiological function, body pain, emotional functions score comparison, laparoscopic group scored higher, and the difference was statistically significant(P<0.05).4.4 Evaluation of open and laparoscopic group SF-36 postoperative and preoperative survival quality comparison and analysisTwo groups of preoperative and postoperative compared to 2 weeks,6 weeks after operation, physical function, social function, there were no statistically significant difference(P>0.05);After two weekly intra-articular dimensions of laparotomy group, physiological function, emotional function score compared with the preoperative score decreased, the difference was statistically significant(P<0.05), after 6 weeks of SF-36 total score and physical dimensions, body pain, general health than before, the difference was statistically significant(P<0.05);After two weeks of laparoscopic group compared with preoperative, physical dimensions, physiological function, body pain, emotional functions difference was statistically significant(P<0.05), six weeks after SF-36 total score and the physical dimension, psychological dimension, body pain, general health, energy, and mental health score higher compared before treatment, the difference was statistically significant(P<0.05).4.5 Quality influence factors analysisThe possible influencing factors of cholelith disease patients survival quality single factor analysis, results from different gender, place of residence, level of education, stay up late status, exercise, and three tenors symptoms will affect cholelith disease patient’s quality of life.5. Direct medical costs5.1 The direct medical costs and its influencing factorsThrough hospital fees out patients in hospital information system clearing fees, the direct expenses including expenses for medicine, examination, treatment, surgery, tests, medical and other expenses etc., to analyze its constituent ratio in the total cost respectively, the results showed:laparotomy group parts cost proportion Western medicine(50.82%),examination(0.27%),treatment(24.63%),surgery(17.94%),assay(4. 48%), medical(1.49%), and other fees(0.37%);Laparoscopic group distribution Western medicine(41.22%),examination(0.24%),treatment(23.03%), surgery(24.88%), assay(8.54%), medical(1.87%), and other fees(0.22%).By independent samples t test, the results suggest Western medicine between the two groups, treatment, operation, daily room as well as the total cost exists significant difference (P<0.05), among them, Western medicine, operation and treatment is the main component of average per capita hospitalization cost.5.2. Influence factorsDirect medical costs of different groups on the single factor analysis of the results of operation method, level of education, postoperative sick time and smoking status and other factors affect the direct medical costs of the operation, the differences were statistically significant(P<0.05);Influence factors against doing multiple stepwise regression analysis, the result shows that different ways of operation status, level of education and smoking are the main factors influencing the operation cost directly, among them, the choice of operation method the biggest impact on cost.6. cost-utility analysisCompared to two of Ben utility value, the average total cost and the average net utility computing.OC group of direct cost is 42365.95±8409.17 yuan, the indirect costs was 5335.39±2637.12 yuan, the total cost was 48613.35±5209.20yuan,GIQLI and SF-36 measurement to obtain the net utility (△u) values are:1.23、1.16, and cost effectiveness can be measured values were 39523.05 and 41908.06;Direct costs of LC group was 24425.53±9293.19 yuan, the indirect costs of 3867.53±1661.59 yuan, the total cost was 29 854.34±1289.12 yuan, GIQLI, SF-36 measurement to obtain the net utility(△u)values are:0.94、0.90,measured cost utility value of 31759.94, 31759.94.Laparoscopic Cost-Utility thewire(CUR)group were superior to laparotomy.Sensitivity analysis:to eliminate the difference was not statistically significant indirect costs, with both scale for measuring the net utility (Au) mean 95% CI of upper and lower limits of a sensitivity analysis on observation point, laparoscopic of Ben utility value is still better than the open group, no affect the outcome.7.Conclusion7.1 Gallbladder surgery compared with Open cholecystectomy,laparoscopic cholecystectomy is a cost-utility ratio more optimal operation scheme for the treatment of cholelith disease.7.2 The influence of surgical treatment for the patients quality of life, the two groups of patients after surgery 2 weeks QOL decreased,6 weeks after surgery, and gradually improve the quality of survival;During laparoscopic patients quality of life than laparotomy group patients.7.3 This study suggests different gender, place of residence, level of education, stay up late status, exercise, and with three tenors(high blood pressure, high cholesterol, high blood sugar) affect cholelith disease patients quality of life.7.4 Cholelith disease patients and health care costs in the form of main proportion of Western medicine fees, operation and treatment fees, multiple stepwise regression analysis results indicate that the operation method, level of education and smoking situation for the main influence factors of direct costs. |
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