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International Journal for Quality in Health Care 2004 16(6):473-482; doi:10.1093/intqhc/mzh077
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International Journal for Quality in Health Care vol. 16 no. 6 © International Society for Quality in Health Care and Oxford University Press 2004; all rights reserved

Cholecystectomy: costs and health-related quality of life: a comparison of two techniques

Erik Nilsson1, Axel Ros2, Mikael Rahmqvist3, Karin Bäckman3 and Per Carlsson3

Departments of Surgery at 1 Motala Hospital, Motala, 2 Ryhov County Hospital, Jönköping, 3 Centre for Medical Technology Assessment, Linköping University, Linköping, Sweden

Background. Outcomes of previous health economic evaluations comparing minilaparotomy cholecystectomy and laparoscopic cholecystectomy have been inconsistent.

Objective. To compare costs for minilaparotomy cholecystectomy and laparoscopic cholecystectomy and to study changes in quality of life induced by these operations.

Design. Single-blind, randomized controlled trial, run from 1 March 1997 to 30 April 1999.

Setting. One university hospital and four non-university hospitals in Sweden.

Main measures. Cost and perceived health estimation according to the global quality of life instrument EuroQol-5D.

Results. Of 1719 cholecystectomy patients at five centres, 724 entered the trial and were treated with minilaparotomy cholecystectomy or laparoscopic cholecystectomy, 362 in each group. Total health care costs were less for minilaparotomy cholecystectomy than for laparoscopic cholecystectomy (median values US$2428 for minilaparotomy cholecystectomy versus US$2613 or US$3006 for laparoscopic cholecystectomy with 100 operations per year and reusable trocars or 50 operations per year and disposable trocars, respectively). There was no significant difference in total costs (including costs due to loss of production) between minilaparotomy cholecystectomy and laparoscopic cholecystectomy with 100 operations per year and reusable trocars in laparoscopic cholecystectomy (US$3731 versus US$3649, respectively). However, in calculations assuming 50 operations per year and disposable trocars in laparoscopic cholecystectomy, this technique was more expensive than minilaparotomy cholecystectomy (US$4042 versus US$3731). Health-related quality of life was slightly but significantly lower for the minilaparotomy cholecystectomy group 1 week after surgery. One month and 1 year postoperatively no difference between the randomized groups was found.

Conclusion. Total costs did not differ between minilaparotomy cholecystectomy and laparoscopic cholecystectomy with high-volume surgery and disposable trocars, whereas laparoscopic cholecystectomy was more expensive with fewer operations and disposable trocars. The gain in health-related quality of life with laparoscopic cholecystectomy compared with minilaparotomy cholecystectomy was small and of limited duration.

Keywords: cholecystectomy, health care costs, quality of life

Address reprint requests to Erik Nilsson, Department of Surgery, Umeå University Hospital, SE-90185 Umeå, Sweden. E-mail: Erik.Nilsson{at}lio.se

Accepted for publication July 21, 2004.


Gallbladder disease is the most costly of all digestive disorders requiring hospitalization, and cholecystectomy is the most common abdominal operation undertaken, with 500 000 operations annually in the USA [1]. Gallstones are often asymptomatic, increasing in prevalence with age. At 60 years of age ~30% of women and ~15% of men in European populations have gallstones [2].

When laparoscopic cholecystectomy was introduced it rapidly became the method of choice for gallbladder surgery. It was concluded that laparoscopic cholecystectomy could be performed at a treatment cost that was equal to or slightly less than that of open cholecystectomy, and with substantial cost savings to the patient and society due to the reduced loss of time from work [3]. However, the cost of laparoscopic cholecystectomy and small-incision open cholecystectomy or minilaparotomy cholecystectomy, has been compared in only four randomized controlled trials with divergent results [47]. The external validity of outcome, i.e. the extent to which conclusions could be generalized to the entire population [8,9], was not analysed in these studies.

We have previously reported results from a prospective, randomized controlled, single-blind trial of laparoscopic cholecystectomy and minilaparotomy cholecystectomy [10]. The present analysis was undertaken in order to compare costs and quality of life changes for the two surgical alternatives.


    Methods
 Top
 Methods
 Results
 Discussion
 Acknowledgements
 References
 
Study design
All patients having cholecystectomy at four non-university hospitals in the South-East Health Care Region and one university centre, Karolinska Hospital in Stockholm, were prospectively registered with the exception of cholecystectomies done as adjunct to other abdominal operations such as pancreatic resection, hepatic resection or operation for aortic aneurysm. Trainees were encouraged to participate in surgery under supervision as is routine practice. Patients were eligible to participate in the randomized controlled trial comparing minilaparotomy cholecystectomy and laparoscopic cholecystectomy according to exclusion and inclusion criteria [10]. Approval of the ethics committee was obtained for the study.

Surgical procedures
Laparoscopic cholecystectomy was performed according to routines at participating units. Minilaparotomy cholecystectomy was defined as cholecystectomy performed through a laparotomy <8 cm long. The experience of the operating surgeon and the assistant was recorded and dichotomized into two groups, ≤25 operations or >25 operations with the technique used.

Recruitment of patients, randomization, blinding, sample size calculation, control panel and rules stopping the randomized trial, surgical procedures, data collection and processing
Details have been given in a previous report [10], where 1705 patients were recognized during the inclusion period. By scrutiny of medical records another 14 non-randomized patients were identified; 726 patients were randomized. Of the remaining 724 patients used for the statistical analysis, 362 were randomized to each group. Randomization was carried out at each hospital in blocks of 18 using a ‘sealed envelope’ technique. Blinding was achieved by using identical opaque dressings for wounds and port sites regardless of surgical procedure. Sample size was determined according to Campbell et al. [11]. With a significance level of 5% and 95% power, 325 patients in each group would detect a true difference between means greater than one-third of a standard deviation of normally distributed data. For binary data a true difference of ≥10% between the two groups would be detected with a power of at least 80% for all proportions below 30%. This was considered adequate for all clinically relevant questions except technique-related injuries of bile ducts.

Primary endpoints
Data on direct and indirect costs and health-related quality of life according to EuroQol-5D [12] were collected for patients included in the randomized trial. The EuroQol-5D questionnaire consists of five questions with three response alternatives concerning patient mobility, self-care, activity, pain/discomfort and mood. Patients are also asked to compare their current health with their perceived health over the previous 12 months and to estimate their general well-being on a VAS scale from 0 to 100 where 0 indicates worst possible and 100 maximum well-being.

Follow-up
Randomized patients were asked to complete EuroQol-5D [12] questionnaires preoperatively, and at 1 week, 1 month and 1 year postoperatively. Hospital stay, as defined in this study, included readmission starting within 30 days of surgery. Reoperations within 30 days were recorded prospectively and checked with hospital records. Information concerning deaths within 1 year of surgery was obtained from Statistics Sweden [13].

Cost calculations
The study has a societal perspective and takes into account all relevant direct and indirect costs during the follow-up period from surgery until 3 months afterwards. Information about costs for particular hospital services included in the study protocol was collected from four of the participating hospitals in the study (Norrköping, Jönköping, Motala and Kalmar). There is no standardized system for calculating costs for services in hospitals or in primary care in Sweden. For some cost items of relevance to our study accurate information was only available at one or two of the participating hospitals. For key items a separate costing study was considered necessary.

Costs for minilaparotomy cholecystectomy and laparoscopic cholecystectomy are based on detailed calculations from one hospital (Ryhov County Hospital in Jönköping). The laparoscopic instruments were for this calculation (and in reality), purchased in 1991–1992 and used for 10 years. We based the calculation on the actual capital outlay in 1998 prices (US$ 53 000). According to Drummond et al. [9] (p. 70) the annual sum was estimated by dividing US$53 000 by an annuity factor of 8.532 (3% and 10 years), which gave an annual capital cost of US$6211. The annual cost was then divided by the average number of laparoscopic procedures at the hospital during 1 year in order to get the capital cost per procedure.

Costs for actual surgery were based on recently performed, detailed calculations of all costs for facilities and staff excluding surgeons at the central theatre complex, Vrinnevi County Hospital, Norrköping. The cost of $13.70 per operation minute was reduced by 5% to $13.02 per minute as disposables and laparoscopic instruments were calculated separately. The cost for surgeons was calculated from the average weighted monthly salary for different categories of surgeon in Sweden. The total annual cost including social benefits was estimated to be $82980. We estimated that each surgeon works 200 days per year. Effective operating time for a surgeon during an operation day is ~6 hours, yielding a cost per minute of $1.2. The number of surgeons present during the gallbladder operation varied for both laparoscopic cholecystectomy and minilaparotomy cholecystectomy between study centres. We found 1.5 surgeons per operation to be a reasonable estimate. This gives an overall cost per minute at the operating theatre of US$15.

Indirect costs due to loss of production were calculated based on an annual average income for males of US$28 206 and for females of US$20 053. The annual income was divided by 230 working days and multiplied by 1.69 to include social benefits and other costs for the employer. With these presumptions, cost per day off work was US$207 for men and US$148 for women. Table 1 gives costs for relevant items per patient in the randomized trial. Costs in SEK were converted into US dollars by taking the average exchange rate in 1999: US$1 = 8.243 SEK.


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Table 1 Costs per patient for relevant items in randomized trial

 

As the cost of laparoscopic instruments is a key issue, alternative calculations were made with two different assumptions. In the basic case the number of laparoscopic operations per year was set to 100 and reusable trocars were assumed to be used. In an alternative calculation 50 operations per year and disposable trocars were assumed.

Statistical analysis
The distribution of quantitative variables in the randomized groups was compared by using the Kolmogorov–Smirnov non-parametric test. Cost data were analysed according to the intention-to-treat principle and differences between groups were tested by using the Mann–Whitney U test. Differences between groups with respect to EuroQol-5D data, were examined with the chi-square test. The data were analysed by the statistical package SPSS.


    Results
 Top
 Methods
 Results
 Discussion
 Acknowledgements
 References
 
Figure 1 shows allocation of all patients operated for gallstone disease during the inclusion period. The randomized groups were well matched except for the proportion of acute to elective procedures, previous history of jaundice and pancreatitis, and body mass index (see Table 2). The experience of surgeons was significantly less with minilaparotomy cholecystectomy than with laparoscopic cholecystectomy, 59% of surgeons in the minilaparotomy cholecystectomy group having done ≤25 operations with this technique as compared with 23% in the laparoscopic cholecystectomy group (P < 0.01).



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Figure 1 Flow scheme for patients operated for gallstone disease during the inclusion period.

 

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Table 2 Patients in randomized controlled trial comparing laparoscopic cholecystectomy (LC) and minilaparotomy cholecystectomy (MC)

 

EuroQol-5D health state data shown in Table 3 demonstrated small but statistically significant (P < 0.001) differences between the two randomized groups 1 week postoperatively, with decreased mobility, level of self-care and main activity, as well as increased pain score in minilaparotomy cholecystectomy patients. No differences in mood (anxiety or depression) could be detected at any time after surgery. One week after surgery fewer patients in the minilaparotomy cholecystectomy group considered their health improved or unchanged with respect to the previous 12 months, 78% versus 85% (P = 0.04) (Table 4). These differences had all disappeared 1 month after surgery. With respect to general well-being as defined by the VAS scale there was no significant difference between the two groups at any time after operation (see Table 5). Compared with preoperative values both groups were significantly improved 1 month and 1 year postoperatively (P < 0.001 for both minilaparotomy cholecystectomy and laparoscopic cholecystectomy, 1 month and 1 year postoperatively).


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Table 3 Outome for each dimension of EuroQol-5D, preoperatively and postoperatively 1 week, 1 month and 1 year

A. Mobility

 

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Table 4 The patient’s self-reported health status today compared with that of the previous 12 months

 

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Table 5 Self-estimated well-being according to EuroQol-5D VAS (where 0 is equal to the worst possible and 100 equal to best possible status)

 

Table 6 gives costs of resources used in the minilaparotomy cholecystectomy and in the laparoscopic cholecystectomy groups during first admission and follow-up including readmission and reoperation when applicable. Using non-parametric tests, operation costs as well as total health care costs were higher for LC1 (100 laparoscopic operations per year and reusable trocars) and LC2 (50 laparoscopic operations per year and disposable instruments), whereas indirect costs were higher for minilaparotomy cholecystectomy. When minilaparotomy cholecystectomy was compared with the basic case (LC1) there was no difference in total cost, whereas minilaparotomy cholecystectomy was cheaper than LC2.


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Table 6 Costs for operation, other health care costs, costs due to sick-leave and total costs with laparoscopic cholecystectomy using reusable (LC1) or disposable (LC2) instruments and minilaparotomy cholecystectomy (MC), 1999 US$

 

As the minilaparotomy cholecystectomy group comprised more acute operations than the laparoscopic cholecystectomy group [10] (63 versus 43, P = 0.03) and this might affect cholecystectomy cost, a separate analysis was done with acute operations excluded. Using elective operations only (299 minilaparotomy and 319 laparoscopic cholecystectomies) in this calculation there was no difference in loss of production costs between the two groups (P = 0.09). Also employing these presumptions total cost was lower for minilaparotomy cholecystectomy than for LC2 (P = 0.007), and there was no significant difference in total cost between minilaparotomy cholecystectomy and LC1 (P = 0.93).


    Discussion
 Top
 Methods
 Results
 Discussion
 Acknowledgements
 References
 
One week postoperatively, there were small but statistically significant differences favouring laparoscopic compared with minilaparotomy cholecystectomy in four EuroQol-5D dimensions (mobility, self care, main activity, pain/discomfort) and in ‘self-reported health status today compared with the status the previous 12 months’, whereas patients in the two groups did not differ with respect to ‘mood’ and ‘self-estimated well-being according to the EuroQol-5D VAS’. One month and 1 year postoperatively there were no differences between the two groups in any EuroQol-5D dimension. With high-volume surgery and reusable trocars in laparoscopic cholecystectomy the total costs for the two operations did not differ, with low-volume surgery and disposable trocars minilaparotomy cholecystectomy was cheaper.

The strength of this study is its size, to our knowledge the largest randomized controlled trial on laparoscopic versus open cholecystectomy, carried out in general surgical practice with wide inclusion criteria and with the experience of the surgeons documented. We are aware of two biases in our trial, both disfavouring minilaparotomy cholecystectomy. As expected, the experience of surgeons was significantly less with minilaparotomy cholecystectomy and, by chance, the percentage of acute operations was higher in the minilaparotomy than in the laparoscopic cholecystectomy group. The trial was performed at a time when day-surgery was not practised at any of the participating units. Since the completion of this study, day-surgery has been practised for minilaparotomy cholecystectomy and laparoscopic cholecystectomy at surgical units participating in the trial [14] (Axel Ros, Ryhov County Hospital, Jönköping).

Clearly, in our trial laparoscopic cholecystectomy was more costly for the health care system. Considering also the relevant costs for society outside hospital, the overall cost difference was small. In one early report [4] laparoscopic cholecystectomy was found to be cheaper than minilaparotomy cholecystectomy, whereas in two studies laparoscopic cholecystectomy was found more expensive than minilaparotomy cholecystectomy [5,7]. In none of these studies were costs for sick-leave taken into account. In a cost-minimization analysis Berggren et al. [15] concluded that laparoscopic cholecystectomy was a cost-saving strategy compared with conventional open cholecystectomy if at least 68 patients were operated on annually.

One week postoperatively laparoscopic cholecystectomy patients perceived slightly better health than minilaparotomy cholecystectomy patients, but 1 month after surgery no difference could be detected. This is consistent with previously reported health indicators from our trial [10]. Thus, time to normal activity was 6 versus 8 days and sick-leave 10 versus 14 days for laparoscopic cholecystectomy and laparoscopic cholecystectomy, respectively. The lower level of surgical experience with minilaparotomy cholecystectomy than with laparoscopic cholecystectomy might have contributed to this discrepancy, and in an efficacy study this difference is likely to be smaller than observed in our trial. However, in hernia surgery convalescence has also been found to be slightly smoother after laparoscopic compared with open surgery [16].

The use of endoscopic retrograde cholangiopancreatography (ERCP) is not a confounder in this study since it was not used in preoperative programmes. Five per cent of all patients underwent ERCP with no significant difference between patients in the two randomized groups. This is in contrast to a much higher incidence of ERCP following the introduction of LC demonstrated in epidemiological studies from Scotland and Australia [17,18].

The present study has demonstrated that differences in health outcomes and costs between minilaparotomy cholecystectomy and laparoscopic cholecystectomy are small. Even in the laparoscopic era, open surgery has remained an option for a proportion of patients with gallstone disease. We must therefore consider the extra cost of a dual learning curve when open and laparoscopic operations are used in parallel. A programme based upon minilaparotomy cholecystectomy alone has been found to be compatible with low hospital costs and a high proportion being day-case surgery, in a decentralized health care system [19]. Laparoscopic cholecystectomy must have a low (single figure) incidence of conversion in order to be competitive [20]. To overcome this, centralization of laparoscopic cholecystectomy to high-volume surgical centres has been suggested [18]. The present study was not designed to study infrequent serious hazards of gallbladder surgery, known to occur less frequently in open than in laparoscopic cholecystectomy [21,22] but this factor should also be considered when choosing between alternative gallstone treatment strategies.

To continue the evaluation of health gain and costs of gallstone treatment in defined populations, a register comprising all surgical and endoscopic treatment modalities should be valuable, as discussed previously [2,10,23]. Such a register has provided important information in the field of groin hernia surgery [2426].


    Acknowledgements
 Top
 Methods
 Results
 Discussion
 Acknowledgements
 References
 
The authors thank surgeons at participating centres for their co-operation during the course of this study, in particular Hans Krook (Vrinnevi Hospital, Norrköping), Carl-Eric Nordgren (County Hospital, Kalmar), and Göran Wallin and Anders Thorell (Karolinska Hospital, Stockholm). Excellent help was provided by late secretary Gunnel Nordberg and statistician Lennart Gustafsson. We also thank Dr Gunnar Enlund for generously making cost data from the Vrinnevi County Hospital available for this study. The study was supported by a grant from the Health Research Council of South-East Sweden.


    References
 Top
 Methods
 Results
 Discussion
 Acknowledgements
 References
 

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  10. Ros A, Gustafsson L, Krook H et al. Laparoscopic cholecystectomy versus mini-laparotomy cholecystectomy. A prospective, randomized, single-blind study. Ann Surg 2001; 234: 741–749.[CrossRef][ISI][Medline]

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  13. Swedish Vital Statistics, 2001: http://www.scb.se Accessed.

  14. Krementsova J, Nilsson E. Open cholecystectomy for all patients (in Swedish). [Abstract] Svensk Kirurgi 2003; 61: 210.

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  24. Bay-Nielsen M, Kehlet H, Strand L et al. Quality assessment of 26 304 herniorrhaphies in Denmark: a prospective nationwide study. Lancet 2001; 358: 1124–1128.[CrossRef][ISI][Medline]

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