Human Reproduction vol.11 no.2 pp.287-29O, 1996 Financial impact in the Italian Health Service of laparoscopic versus laparotomic surgery for the treatment of ovarian cysts CBuUetti1-3, R-SeracchioU1, V.Polli1, AAlbonetti1, S.Rossi1, L.Barbieri2, A.Callegaro2 and CFlamigni 1 'Unit of Special Pelvic Surgery, Operative Laparoscopy and Hysteroscopy, 1st Institute of Obstetrics and Gynecology, University of Bologna; Members of the the Special Group (GIS) for Operative Laparoscopy and Hysterosalpingoscopy of the Italian Society of Fertility and Sterility and Reproductive Medicine (SIFES-MR), 2Health Care Administration of the Azienda S.Orsola Malpighi, S.Orsola-Malpighi General Hospital, Via Massarenti, 13 40138 Bologna, Italy ^ o whom correspondence should be addressed To assess the cost of two procedures for the removal of ovarian cysts, 200 pre-menopausal women were recruited for the surgical removal of ovarian cysts by laparoscopy (n = 100) and laparotomy (n = 100) according to casecontrol criteria. Patients operated by laparoscopy (mean age ± SD 32.22 ± 9.98 years) and laparotomy (mean age ± SD 29.57 ± 6.62 years) for ovarian cysts (mean diameters ± SD 4.98 ± 3.62 and 4.83 ± 2.78 cm) had a post-surgical hospital stay of 3.12 ± 0.41 and 7.25 ± 1.08 days (P < 0.001) respectively. The total rate of complications occurring in patients operated by laparoscopy was 9 versus 53% (P < 0.001) of those operated by laparotomy; body temperature >38°C was recorded in 52/100 of patients operated by laparotomy versus 6/100 of those operated by laparoscopy. The mean cost for each pure surgical treatment performed by laparoscopy was US $498.17 versus US $642.47 when it was performed by laparotomy (P < 0.001). The laparoscopic surgical approach is more expensive in the first 36 operations, thereafter becoming cheaper. The mean of the entire overall expenditure was US $1142.08 and US $2138.72 for laparoscopy and laparotomy (P < 0.001) respectively. The entire expenditure for laparoscopy is higher than laparotomy only until eight operations. In conclusion, laparoscopy versus laparotomy has resulted in a saving of US $14 4293 for 100 operations while the saving on entire costs was US $99 664.8. Key words: financial costs/health care administration/operative laparoscopy/ovarian cysts Introduction Administrative costs have been found to be one of the fastest growing components of hospital budgets. In future, research should not only determine the effect of these increases on the quality of patient care but also carefully evaluate the low costs/high quality of medical/surgical procedures. In addition to this world-wide phenomenon, the Italian health system is © European Society for Human Reproduction and Embryology moving from a pure 'free of charge' social service without financial restrictions to a budget-administered system because of the enormous national internal debt (~2 000 000 trillion Italian lira). Over the last 15 years, operative laparoscopy has gained increasing acceptance alongside the evidence that more and more practitioners are becoming trained in this field. Although the first attempt at endoscopy is attributed to Philip Bozzini of Italy in 1805, using a tube and a candle (Nezhat et ah, 1992), the main promotion of laparoscopy in gynaecology was by Steptoe (1969) in the UK and by French gynaecologists who reported the first human tubal fulguration in 1962. Other pioneers of operative laparoscopy were Victor Gomel in the US, Kurt Semm in Germany, Bruhat, Manhes and Dubuisson in France, and Cittadini in Italy. The benefits of substituting laparoscopy for laparotomy or the vaginal route include decreased trauma (Semm et ah, 1987), shorter recovery period (Nezhat C. et ah, 1986, Baggish M. 1989), shorter hospitalization (Nezhat et ah, 1986), less disability (Baggish, 1989), and financial savings for patients and the health care system (Levine et ah, 1985; Goodman et ah, 1989). The present study was undertaken to evaluate the financial impact of operative laparoscopy in comparison with the classical laparotomic approach in the Italian health care system. The weights of all financial parameters on the entire expenditure were considered. Materials and methods The financial cost of the surgical treatment of 200 pre-menopausal women having ovarian cysts was analysed. The women were divided by the method of surgical removal: the abdominal route (n = 100) and by operative laparoscopy (n = 100). The study was designed as a case-control study based on number of previous operations, serum concentration of CA125 <35 IU/ml and ovarian cyst size. Ultrasonography was performed before surgery to exclude a presumptive diagnosis of ovarian cancer. Complications of the two procedures included body temperature >38°C, haemoglobin <8.5 g/100 ml, infiltration of the abdominal sutures, dysuria, reduction in blood platelet count All costs were calculated on the basis of 100 operations per study group. Statistical analysis was performed by using Student's unpaired f-test and MacNemar's test The cost for a day's hospitalization in this study was US $206.4, which included medical staff, nurses, administrative staff, direct costs (employers other than doctors and nurses, consumptions, upkeep of the medical centre, standard hospital equipment excluding the operating room), specific medical and/or technical services Qaboratories, other medical consultations and tests), structural costs including the medical care and supervision, administration, maintenance, kitchen, building and permanent structures, cleaning and laundry services, hospital security and consumer service. 287 C.BuUetti et aL Generical surgical instruments Table I. Distribution of histological features of ovarian cysts according to whether they were operated by laparoscopical or laparotomic procedure Surgical staff Number of women with ovarian cysts of different histological type Surgical technique used Serous Laparoscopy Laparotomy 38 20 Mucous Dermoid Endometriotic 20 47 53 Direct costs Throwaway material Structural costs The examinations requested for general anaesthesia were not included in the present evaluation because they were performed in advance and were exactly the same for both study groups. Preparation for the operations was also the same for both study groups and they were included in the amount of money requested for a day of hospital ization. The cost of pure surgical treatments included instruments and equipment (for laparoscopy) or instruments (for laparotomy) plus consumer products and personnel (one anaesthesiologist, two surgeons, two nurses, one technician) of the operating room. The functional lifespan of equipment for laparoscopy is 6.5 years, while that for laparoscopy instruments is 3 years; for general surgical instruments mainly required for laparotomy and partly for laparoscopy the equivalent duration was 8 years. All calculations were made on the basis of spreading the cost of these instruments/equipment over their expected durability in years. Calculations were also made by converting Italian lira into US dollars according to the Associazione Giomalistica Italiana for 20 February, 1995 at 03:45 p.m. (when $1000 « 1599 Italian lira). Values were reported as mean ± SD. Specific services [-, Surgical instruments for laparoscopy Generical surgical instruments Throwaway material Medical and administrative staff Structural costs Results The mean ages of the two groups of patients were not different (32.22 ± 9.98 and 29.57 ± 6.62 years respectively). The histological diagnosis of the ovarian cysts are shown in Table I according to the type of operation. The mean diameter of the ovarian cysts operated by laparoscopy (4.98 ± 3.62 cm) did not differ from those operated by laparotomy (4.83 ± 2.78 cm). The mean duration of hospital stay after surgical treatment for the two groups of study was 3.12 ± 0.41 days for laparoscopy and 7.25 ± 1.08 days for laparotomy (P < 0.001); the mean total duration of hospital stay including 1 day of preparation for the surgical procedure was 4.74 ± 0.94 and 8.39 ± 1.20 respectively (P < 0.001). Post-surgical complications occurred in 53% of the laparotomy operations (52 cases with fever, two cases with haemoglobin <8.5 g/ 100 ml, one with infiltration of the abdominal sutures, two with dysuria, one with reduction in blood platelet number) compared with 9% of the laparoscopic operations (six cases with fever, two cases with haemoglobin <8.5 g/100 ml, one case with infiltration of the abdominal sutures, one case with dysuria) (P < 0.001). The mean cost for each pure surgical treatment in the 100 operations was calculated as $498.17 and $642.47 for the laparoscopic and laparatomic techniques (P < 0.001). The mean cost for the hospital stay alone was $643.90 and $1496.25 for laparoscopy and laparotomy respectively (P < 0.001). The mean total cost of each operation performed by laparoscopy was $1142.08 while that of each one performed by laparotomy 288 Medical and administrative staff Specific efforts Figure 1. Pie chart showing the distribution of the various costs associated with cyst removal by laparotomy (a) or laparoscopy (b). The diagrams clearly show that the major cost is the hospital stay which includes the direct costs, medical and administrative staff, specific efforts and structural costs. The percentage of the purely surgical expenses for the laparoscopic procedure does not appear significantly higher than that for the laparotomic procedure when 100 operations arc performed. was $2138.72 (P < 0.001). The total cost for pure surgery on 100 operations by the laparotomical route was $64 247.72, while that for the same number of operations by laparoscopy was $49 817.92. The total costs for hospitalization were $149 625 for patients operated by laparotomy compared with $64 390 for those operated by laparoscopy (P < 0.001). The entire cost for 100 patients operated by laparotomy was $213 872.72 versus $114 207.92 for those operated by laparoscopy (P < 0.001). Figure 1 shows how the costs were distributed in the two groups. The direct cost for laparotomy was 33.59 versus 27.07% for laparoscopy; medical staff, nurses, and administrative staff correspond to 18.89 and 15.23% of the total charge for a single patient undergoing surgical laparotomy and laparoscopy respectively; specific medical and/or technical services accounted for 4.89 and 3.94% of the costs of laparotomy and laparoscopy and structural costs were 12.59 and 10.15% respectively. The proportion of costs accounted for by throwaway material, surgical staff and instruments was similar for the two procedures, as shown in Figure 1. Instruments and Financial impact of laparoscopic surgery LAPABO3COPY LAPAROSCOPY LAPAROTOMY LAPAROTOMr 100 25 BO 75 Number of caMt LAPAROSCOPY LAPAROSCOPY LAPAROTOMY LAPAROTOMY Kumb«f of cas*s Number ol cas«* Figure 2. Total costs of pure surgical treatment of 200 ovarian cysts as a function of number of operations performed by laparoscopical (n = 100) versus laparotomic (n = 100) procedure. The costs became lower for laparoscopy after 36 operations had been performed (a). Extrapolation of the graph up to 500 operations for ovarian cysts shows that the total cost was less by using the laparoscopic instead of the laparotomic, and the saving amounted to $76 041.22 (b). Figure 3. Total cost of surgery and hospital stay for 200 cases of ovarian cysts removed by laparoscopic (n = 100) versus laparotomic (n = 100) procedures related to the number of operations. The costs became lower for laparoscopy after eight operations had been performed (a). Extrapolation of the graph up to 500 operations for ovarian cysts shows that the entire cost was less by using the laparoscopic instead of laparotomic procedure and after 500 operations the saving was calculated as $603 341.22 (b). was the reduced length of hospital stay in connection with laparoscopy. equipment for laparoscopy accounted for 2.83 and 5.32% of the total expense of the laparoscopic operations (Figure 1). Figure 2 shows the curves relating to the total cost of the entire procedures to the number of operations performed for surgical removal of ovarian cysts as performed both by laparoscopy and laparotomy. Figure 3 shows the corresponding curves but including the hospital stay. In Figures 2a and 3a the curves were drawn from data for 100 versus 100 cases and then in Figures 2b and 3b the data were extrapolated up to 500 cases. The intersection point occurred at 36 and eight operations in Figures 2a and 3a respectively, illustrating the different balance of costs when hospital stay was included. The separation between the extrapolated curves from 100 to 500 operations gradually increased, suggesting a cumulative saving of $99 664.80, $207 279.80, $314 894.80, $422 509.80 and $530 124.80 for operative laparoscopy in 100, 200, 300, 400 and 500 ovarian cyst cases respectively (P < 0.001). The increase of the crude saving continued after this number (data not shown). The major contribution to these savings Discussion The safety and efficacy of the laparoscopic surgical procedure was previously demonstrated to be at least comparable to that of laparotomy (Albini et al., 1994). Benefits of this procedure have frequently been reported in recent literature by convincing studies (Deckardt et al, 1994). The laparoscopic surgery was demonstrated to be more cost-effective than laparotomy for the treatment of ectopic pregnancy (Maruri and Azziz, 1993). A matched case study was performed comparing the financial impact of substituting laparoscopy for laparotomy; laparoscopy was less costly for the patient and more profitable for the hospital (Davison et al., 1993). The present study clearly demonstrated both the shorter hospitalization and the lower cost of the laparoscopic versus laparotomic procedure in a European country when the number of procedures per year is higher than eight The post-surgical complications recorded by laparoscopy 289 CBuUettl et aL were significantly lower than those recorded by laparotomy, especially concerning the most frequent complication reported for the laparotomic procedure, i.e. a transient body temperature >38°C. These results should only be considered in the context of the Italian Health Community and specifically for the area of Bologna, where the S.Orsola General Hospital is one of the biggest in Europe (>2500 beds). The contribution of administrative costs to the entire cost was not separately defined because it is part of the direct costs which include other expenses (see above). The direct costs represent the highest percentage contribution to the total (27.1% for laparoscopy versus 33.6% for laparotomy), although it is not possible to compare them directly with that of other medical communities such as the USA (corresponding average 25%). The administrative costs are similar in countries with high and low rates of enrolment in health maintenance organizations (Woolhandler et al, 1993). In the recent past the Italian Health System has mainly focused on health care as a social non-profit making and free of charge service. Recently the system was changed to a partial-charge service and the contribution by the citizen for each health service is increasing. In the past, hospital administrations received payment for their annual debts from the National Health Care Service because of the social context in which they operated. The purpose of the hospital therefore justified payment of its debts. Currently, however, the hospital administration must work within their budget and are no longer allowed to accrue debts. Calculation of the cost for each procedure thus became necessary both to curb the continuous large increases in health care expenses and to identify the most profitable procedures in terms of cost/benefit balance. Other clinical treatments have also been recently evaluated; a costeffectiveness analysis of natural versus stimulated cycles in in-vitro fertilization (TVT) programmes was carried out with interesting results by Daya et al. (1995). The removal of ovarian cysts represents one of the most common gynaecological operations. The main procedure used until a few years ago was laparotomy, and it is still widely used in Italy. Subsequently, laparoscopy was introduced for the surgical treatment of adnexal masses, including ovarian cysts, and these are considered one of the most appropriate indications for operative laparoscopy (Nezhat et al, 1992). The routine time for hospitalization in our institution for laparoscopy and laparotomy is longer than that for the same operations in other institutions (Albini et al., 1994). Thus in our study, the expense of both laparoscopic and laparotomic approaches may be over-estimated; adopting a shorter hospital stay should reduce the cost of the entire procedure for both surgical approaches. The saving achieved by the laparoscopic versus laparotomic procedure purely for surgical treatment of ovarian cysts is significant and consistent for a programme which includes more than 36 operations. By extrapolating from data of this study, we can calculate that a hospital that performs 200, 300, 400 or 500 operations per year would save $207 279.80, $314 894.80, $422 509.80 and $530 124.80 respectively; greater savings could be achieved by including other types of laparoscopic operations such as myomectomy, ectopic 290 pregnancy, adhesiolysis, etc. When the total costs of the two procedures are compared, the curves intersect after only eight operations (Figure 3a), thus indicating the financial advantage of laparoscopy over laparotomy even for small institutions in which only small programmes of operative laparoscopy are performed. In conclusion, in the present health care system in Italy, the laparoscopic procedure may provide a modern, safe and less expensive approach than laparotomy for the surgical removal of ovarian cysts. In addition, the surgical training programme in our school of medicine is the same for the laparotomic and the laparoscopic approach to the surgical removal of ovarian cysts. It is the time taken to perform at least 25 operations for the removal of ovarian cysts, assisted by an expert surgeon. An additional future comparison in the evaluation of health care administration of medical/surgical procedures is the comparison of costs for the same type of operation performed in different hospitals. It will be necessary also to establish a cost/ benefit value comparable between hospitals of the same health care organization, as well as the specific value of institutions (expressed as scores of intrinsic value of doctors and quality of the institutional organization). Acknowledgements This study was supported by The Italian National Council of Research, grant no. 940840. References Albini, S.M., Benadiva, C.A., Haveriy, K. and Luciano, A.A. (1994) Management of benign ovarian cystic teratomas: laparoscopy compared with laparotomy. J. Am. Assoe. GynecoL Laparosc, 1, 219—222. Baggish, M. (1989) Telescope and stab: the new wave surgery. J. Gynecol. Surg., 5, 131. Davison, J.M., Park, W. and Penney, L.L. (1993) Comparative study of operative laparoscopy versus laparotomy: analysis of the financial impact. J. Reprod Med., 5, 358-360. Deckardt, R., Saks, M. and Graeff, H. (1994) Comparison of minimally invasive surgery and laparotomy in the treatment of adnexal masses. J. Am. Assoc. Gynecol. Laparosc., 1, 333-338. Goodman, M.O., Jhons, D.A. and Levine, R.L. (1989) Report of the study group: advanced operative laparoscopy (pelviscopy). J. Gynecol. Surg., 5, 353. Levine, R.L. (1985) Economic impact of pelviscopic surgery. J. Reprod Med., 30, 655. 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