Hernia DOI 10.1007/s10029-016-1480-z
ORIGINAL ARTICLE
The economic burden of incisional ventral hernia repair: a multicentric cost analysis J-F Gillion1 • D. Sanders2 • M. Miserez3 • F. Muysoms4
Received: 27 September 2015 / Accepted: 17 February 2016 Ó Springer-Verlag France 2016
Abstract Purpose A systematic review of literature led us to take note that little was known about the costs of incisional ventral hernia repair (IVHR). Methods Therefore we wanted to assess the actual costs of IVHR. The total costs are the sum of direct (hospital costs) and indirect (sick leave) costs. The direct costs were retrieved from a multi-centric cost analysis done among a large panel of 51 French public hospitals, involving 3239 IVHR. One hundred and thirty-two unitary expenditure items were thoroughly evaluated by the accountants of a specialized public agency (ATIH) dedicated to investigate the costs of the French Health Care system. The indirect costs (costs of the post-operative inability to work and loss of profit due to the disruption in the ongoing work) were estimated from the data the Hernia Club registry, involving 790 patients, and over a large panel of different Collective Agreements. Results The mean total cost for an IVHR in France in 2011 was estimated to be 6451€, ranging from 4731€ for unemployed patients to 10,107€ for employed patients The data of the present study were presented by J-F Gillion during the 36th Annual Congress of the European Hernia Society in Edinburgh on 31 May 2014. & J-F Gillion [email protected] 1
Unite´ de Chirurgie Visce´rale et Digestive, Hoˆpital Prive´ d’Antony, Antony, France
2
Department of Surgery, Derriford Hospital, Plymouth, UK
3
Department of Abdominal Surgery, University Hospitals, KU Leuven, Leuven, Belgium
4
Department of Abdominal Surgery, AZ Maria Middelares, Ghent, Belgium
whose indirect costs (5376€) were slightly higher than the direct costs. Conclusion Reducing the incidence of incisional hernia after abdominal surgery with 5 % for instance by implementation of the European Hernia Society Guidelines on closure of abdominal wall incisions, or maybe even by use of prophylactic mesh augmentation in high risk patients could result in a national cost savings of 4 million Euros. Keywords Incisional hernia Prevention Cost analysis Health economics Mesh augmentation
Introduction Incisional hernias are a frequent complication of abdominal surgery and some patient variables including obesity, postoperative surgical site infections and the presence of abdominal aortic aneurysm have been identified as risk factors [1–3]. The surgical technique and material to close abdominal wall incisions are also of utmost importance to avoid a high frequency of incisional hernias [4, 5]. The European Hernia Society has recently developed and published guidelines on the closure of abdominal wall incisions [6]. As part of this initiative, the Guidelines Development Group ‘‘The Bonham Group’’ has tried to determine the economic burden related to the treatment of an incisional hernia according to previously published recommendations [7]. Apart from the known negative impact of an incisional hernia on the patients’ quality of life and body image, patients with an incisional hernia are at risk of potential serious complications [8]. The repair of incisional hernia has direct costs and indirect costs. Estimation of the costs related to the treatment of incisional hernias can reflect the socio-economic gain to be made by
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optimizing abdominal wall closure technique and reduction of the incidence of incisional ventral hernia. The magnitude on a national level of the costs related to incisional hernias has been reported for Sweden, where about 2000 incisional hernias are repaired annually with a direct cost approximately 170 million Swedish Krona (SEK) (±18 million Euro). The direct and indirect costs for an incisional hernia have been calculated to be 86,257 SEK (±9112€) [9]. In a nationwide study for the United State (US) an estimated 348,000 ventral hernia repairs were performed in 2006 with a direct cost for inpatient procedures of 15,899 US dollar (±13,000€) and for outpatient procedures 3873 US dollar (±3168€) [10]. This amounts to a total cost of ventral hernia repair for the US in 2006 of 3.2 billion US dollar (±2.6 billion Euro). The objective of this study was to perform a review of the literature on the costs related to incisional hernia repair and to make an estimate of the direct and indirect costs for incisional hernia repair in France using nationwide data.
Materials and methods A systematic review of the literature was performed on 25 February 2014 in Pubmed, Medline and EmBase, limited to Human data with the search terms: ‘‘Incisional hernia OR ventral hernia AND health planning/economics/cost and cost analysis/vital statistics/demography/population characteristics/quality adjusted life years/health burden’’. The Prisma flow diagram of the records found is shown in Fig. 1. The results [9–16] are displayed in Table 1. The cost of an incisional hernia repair is the sum of direct costs and indirect costs [10]. The direct costs comprise all consumption of resources resulting from the treatment. The indirect costs are those related to the outpatient care during the sick leave, but mainly related to the inability to work, such as the costs of a substitute, the loss of productivity, and the costs of the daily allowance.
such cost analysis serve as a basis to determine the amount of money to be reimbursed to the hospitals for each GHM. The reimbursement of every GHM is not calculated for every patient, it is a package, annually updated. It has to be noted that the reimbursed prices may be different from the actual costs, especially if the National Health Policy targets to promote certain healthcare priorities and therefore adjusts the tariff to make the procedure more attractive to healthcare providers. The ATIH data are actual observed costs, written in the general ledger. Among these ATIH data, we extracted those concerning Incisional Ventral Hernia Repair in adults, gathered in five GHM (Table 2). One of them is dedicated to day-care surgery (06C24J), the four others concern the inpatients, classified into four levels of severity (06C241, 06C242, 06C243, 06C244). Patients are grouped into four levels to determine the complexity of their care and hence the costs involved. Levels 1–4 are calculated using a National Health Care System (National Security Fund) software named ‘groupeur’, taking into account the severity of the co-morbidities, the associated intra-hospital events (such as pulmonary embolism, cardiac failure), the length of stay out of the target. Not many surgical items are taken into account, such as: complications related to a previous mesh, bowel necrosis, or a bacteriologically proven deep infection. For instance, this financial classification does not take into account whether the procedure is done laparoscopically or through an open approach, even though it probably carries some financial implications. The list of the relevant items is annually updated. Clinical conditions, which do not have any impact on finance, are removed from the list at the annual review. In the ATIH multi-centric study, every observed unitary piece of expenditure was detailed by specialized accountants, classified into 132 sub-groups of expenditure, and 6 chapters (medical expenses, technical-medical expenses, management, direct charges, structural expenses) registered and averaged for each GHM (Table 3).
Direct costs Calculations based on the ATIH data Analysis of the ATIH data In our study the direct costs were estimated from a cost analysis [17] performed in 2011 among 51 public French hospitals by the Agence Technique de l’ Information sur l’ Hospitalisation (ATIH). The ATIH (www.atih.sante.fr) is a public agency dedicated to investigate the costs of the French Health Care system, especially the intra-hospital costs of various diseases, classified in more than 3000 GHM (Groupes Homoge`nes de Malades = Homogeneous groups of patients), the French version of the DRG (Diagnosis-Related Groups). The actual costs, observed in
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We wanted to calculate the average direct cost regardless of the level of severity: The average cost for each GHM was then weighted according to the prevalence of the corresponding GHM (Table 3) resulting in a ‘‘weighted average of the direct cost for an average incisional hernia repair’’. Indirect costs The sick leave and the inability to work (including the hospital stay) were estimated using data extracted from the
Hernia Fig. 1 Prisma flow diagram
prospective registry on abdominal wall hernias from the ‘‘Club Hernie’’. This is a collaborative registry of nearly 50 French surgeons with a specific interest in abdominal wall surgery. Each participant accepts and signs the charter of quality stating that ‘‘all input must be registered consecutive, unselected, exhaustive and in real time’’. The participants allow peer review control of the original medical chart of randomly selected patients. Follow-up is obtained by a clinical research assistant, independent from the individual participants and blinded for the surgical procedure. Consecutive patients with an IVH operated between September 30th, 2011 and August 31st, 2014, were used for the estimation of the indirect cost. Data on hospital stay and postoperative absence from work were extracted from the database to determine the estimated average duration of inability to work (Table 4).
The average cost of inability to work and loss of productivity, were estimated, firstly from the mean wages in France in 2011 (Table 5), published by the National Institute of Statistics (INSEE), and secondly using a table taking into account the most frequent Collective Agreement among the myriad of the different French social public and private contracts (Table 6).
Results Systematic review The results of our systematic review are shown in the Prisma flow diagram in Fig. 1. Initially 402 records were identified, after removal of duplicates and non-relevant
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1. Relative risk reduction 0.016 with S:W C 4 2. Cost reduction SEK 686 3. Saving per patient of SEK116 4. Estimated nationwide saving of SEK2, 107,140 (2000) per year Economic Low 884 Consecutive patients undergoing evaluation incisional hernia repairs
1. Shorter stay with lap 2. Longer op time with lap 3. Higher supply costs with lap (US$6396 vs US$664) 4. Higher 30 days hospital encounters with lap (15 vs 13 %) Economic Low N/A Theoretical patients with incisional evaluation hernia. Placed into decision analysis model
Effect size
Effect size
[14]
[13]
[12]
1. 154, 278 ventral hernia repairs in US in 2006 2. Cost per operation US$15,899 3. Total cost US$3.2billion 4. US$32 million dollar reduction in cost for every 1 % decrease in incisional hernias Economic Moderate 861 Consecutive patients 1988-1992 having evaluation midline laparotomy
Effect size
Patients from healthcare cost and utilization project
Cost saving of 6034 SEK with mesh repair Economic Very low N/A evaluation
Effect size [10]
[11]
Effect size
Patient characteristics
Economic Moderate 691 Matched evaluation from RCT 1. Cost reduction with small stitches 1339 SEK per patient 2. Direct costs of incisional hernia repair 59909 SEK and indirect costs 26348 SEK Economic Low 44 Consecutive patients evaluation
Number of patients
[9]
Level of evidence GRADE
Study type
Reference citation
Summary of evidence table for ‘‘the cost of incisional hernia repair’’
Table 1 Summary of findings table
Open mesh repair
Laparoscopic incisional hernia repair
Suture length to wound length ratio C4
Inpatient ventral hernia repair
Mesh repair
Small stitch closure (n = 321)
Intervention
Open suture repair
Open incisional hernia repair
Suture length to wound length ratio \4
None
Suture repair
Large stitch closure (n = 370)
Comparison
N/A
30 days
1 year
5 years
[1 year
5 years
Length of follow-up
1. Costs (US $ = US Dollar) 2. Cost effectiveness
1. Operative time 2. Cost (US $ = US Dollar) 3. Length of stay 4. 30 days postoperative hospital encounters
1. Incisional hernia rate 2. Costs (SEK = Swedish Krona)
1. Total number of repairs 2. Mean costs (US $ = US Dollar)
Cost direct and indirect (SEK = Swedish Krona)
Cost direct and indirect (SEK = Swedish Krona)
Outcome measure (currency)
Educational Grant Olympus
Not stated
None
Not stated
Not stated
University Grant
Source of funding
Hernia
None N/A N/A N/A
Not stated Mean 1 year N/A
Costs (US $ = US Dollar)
Length of follow-up
Source of funding
records, eight records remained for qualitative evaluation. The Summary of Findings of the systematic review is shown in Table 1. Significant heterogeneity in time periods and the different currencies of the studies make it impossible to perform quantitative evaluation. Direct cost of IVHR in our study
Comparison
Outcome measure (currency)
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In this multi-centric study the direct costs were studied among 3239 patients treated in 51 French public hospitals. The average direct costs for incisional hernia repair are shown in Table 3. They were, respectively, 3497€, 4652€, 8402€, 16,367€ for the level 1, level 2, level 3 and level 4 GHM and 2041€ for day-case incisional hernia repair. Each of these five average costs was then weighted according to the prevalence of the related GHM resulting in the weighted average direct cost of a mean incisional hernia repair, which is 4731€.
N/A
N/A
[16] Effect size
Effect size
[15]
1. Total cost of suture repair US$16,355 2. Total cost of mesh repair US$16,947 3. Incremental costs to prevent one recurrence with mesh US$1878 Economic Moderate 1008 All surgical patients undergoing an evaluation operation 1. Median hospital costs if no complication: US$4487 2. Median hospital costs if minor complications occurred: US$14,094 3. Median hospital cost if major complications occurred: US$28,536 Review Very low N/A Incisional hernias Mesh incisional hernia is more cost effective than suture repair Effect size
Level of evidence GRADE
Number of patients
Patient characteristics Study type Reference citation
Summary of evidence table for ‘‘the cost of incisional hernia repair’’
Table 1 continued
Intervention
Indirect cost of incisional hernia repair in our study From 30 September 2011 till 31 August 2014, 10,529 patients were registered in the Hernia Club Registries, including 7851 patients operated on for groin hernias and 2678 patients for ventral hernias, including 991 patients operated on for incisional ventral hernias. Sick leave, hospital stay and nature of employment were properly recorded in 790 of these 991 patients (Table 4). One-third of our patients were employed. The hospital stay was 2.6 days for employed and 3.7 days when including unemployed patients. The mean sick leave duration for employed patients, including the hospital stay was 29.6 (range 0–90) days. The mean monthly wages for employees in France in 2011, retrieved from the National Institute of Statistics are reported Table 5. The average monthly wages were as follows: Net wages: 2130€, Gross wages: 2830, Total wages 4671€, corresponding to weekly Net wages of 492€, Gross wages of 654€ and Total wages of 1078€. The differences between these different wages are explained in Table 5. The estimation of the value of one-week sick leave among the most frequent French collective agreements for this mean wages is reported in Table 6. The value of a weekly sick leave for employed widely ranged across these collective agreements from 359 to 1977€. The weighted mean value of a weekly sick leave for employed was estimated at 1271€ (Table 6). Therefore the average sick leave cost for our employed patients was 5376€ (1271€ per week/7 9 29.6) while the values ranged from 1518€ (359/7 9 29.6) to 8360€ (1977/ 7 9 29.6) [Tables 4, 6].
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Hernia Table 2 The five IVHR-GHM (Homogeneous groups of patients for Incisional Ventral Hernia repairs) GHM
Description
Relevant comorbidities or risk factors
Relevant associated intra-hospital events
Hospital stay \ or [ to the target
06C241
IVHR [ 17 years, level 1
0
0
0
Level calculated using the French National Health Care computerized device ‘groupeur’ taking into account severity and combinations of items annually updated according to their financial relevance
06C242
IVHR [ 17 years, level 2
06C243
IVHR [ 17 years, level 3
06C244
IVHR [ 17 years, level 4
06C24J
IVHR [ 17 years, D case
Low risk
0
0
Levels are calculated using the National Health Care computerized device (‘groupeur’) taking into account severity and combinations of the comorbidities, the associated intra-hospital events (such as pulmonary embolism, cardiac failure), the length of stay out of the target; Not many surgical items are taken into account such as complications related to a previous mesh, bowel necrosis, or a bacteriologically proven deep infection. For instance, this classification does not take into account whether the procedure is done laparoscopically or through an open approach These items are annually updated. If one of these items does not have any financial relevance, it is withdrawn from the list IVH incisional ventral hernia repair, y year, D case day case surgery
Table 3 Prevalence and observed direct costs of the five IVHR-GHM in the ATIH multicentric study, and calculation of the weighted average direct cost of an average IVHR GHM
Description
Prevalence Cases
%
Costsa
Weightingb
€
€9 %
06C241
IVHR [ 17 years, level 1
1.285
39.7
3497
1388
06C242
IVHR [ 17 years, level 2
1.516
46.8
4652
2177
06C243 06C244
IVHR [ 17 years, level 3 IVHR [ 17 years, level 4
221 105
6.8 3.2
8402 16,367
571 524
06C24J
IVHR [ 17 years, D case
112
3.5
2041
3.239
100
71 4731€
a
Observed costs per case
b
Each cost was weighted according to the prevalence of the corresponding GHM
Weighted average
Weighted average of the direct cost of an average IVHR
Table 4 Average sick leave duration, in IVHR registered in the Hernia Club registry Occupation (item available for 790 patients)
Average hospital stay (days, range)
Employed
Unemployed
Employed
Total
Average sick leave including the hospital stay (days, range) Employed
251
539
2.6
3.7
29.6
32 %
68 %
(0–11)
(0–29)
(0–90)
Total cost of incisional hernia repair in our study (Table 7) For employed persons the global average cost (direct ? indirect costs) in 2011 of an incisional hernia repair in France was estimated at 10,107€. For these employed patients, the indirect costs were higher than the direct costs. Some of our patients, mainly unemployed and/or elderly, probably spent their recovery in convalescent home, but we could not evaluate these costs due to the lack
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of indication concerning the rate, the duration, and the prices. For unemployed we took into account the direct costs, because of the difficulty to evaluate in Euros the impact of surgery on their daily life. Finally the average total costs of IHR, regardless to the employment was 4731 9 68 ? 10,107 9 32 % = 6451€. In other words: ‘‘the average total cost for an average incisional hernia repair in an average patient’’ in France in 2011 was estimated to be 6451€.
Hernia Table 5 Wages in France in 2011 (INSEE)
Net wagesa (€)
Gross wagesb (€)
Senior manager
3988
5385
Intermediate professions
2182
2910
Employees
1554
2049
Workers
1635
2137
Average
2130
2830
Total wagesc Monthly (€)
Total wagesd Weekly (€)
4671
1078€e
INSEE National Institute of Statistics and Economic Studies (www.insee.fr/) a
Net wages: take home wages after payment of the compulsory social contributions (employer and employee’s parts) and before payment of the direct taxes
b Gross wages (Net 9 1.329): wages paid to the employee minus the compulsory employer’s part of social contributions c Total wages (Net 9 2.195 or Gross 9 1.65): net wages ? employee’s and employer’s compulsory social contributions = the real employee’s wages = the actual cost of the employee for his employer d
Weekly wages = Monthly wages/4.33 An average monthly gross wages of 2830€ is equivalent to weekly net wages of 492€, gross wages of 654€, total wages of 1,078€ e
Table 6 Estimation of the value of 1 week sick leave among the most frequent French Collective Agreements for the average gross wages of 2830€ Collective agreement (CA)
Sickness, benefita, (SB) % of wages
Waiting periodb, before SB
Income, supplementc, up to 100 %
Substituted
Profit loss (%)e
Valuef, (€)
3 days
No
No
15
359
Private sector
Prevalence (%)g
Weighted, valueh (€)
80
Income supplement, not included in CA
50 % 50 %
3 days
No
Yes
20
1196
8
96
Income supplement, included in CA
50 %
3 days
Yes
No
15
947
16
152
50 %
3 days
Yes
Yes
20
1896
16
303
50 %
Assumed, by employer
Yes
No
15
1028
16
164
50 %
Assumed, by employer
Yes
Yes
20
1977
16
316
Public sector
8
29
20 100 %
0 day
–
No
15
505
10
51
100 %
0 day
–
Yes
20
1603
10
160
Weighted average value of a weekly, sick leavei
1271
Note it is almost the double of the gross wage and 2 times and a half more than the net wage CA collective agreement The Sickness Benefit, or Daily Allowance, is directly paid to the employee by the National Social Security Insurance (Se´curite´ Sociale), usually after a waiting period of 3 days, except in Public sector, or if it is assumed by the employer a
b
During their sickness, the public employers are given 100 % of their wages, the private employees are given 50 % of their wages
c
Some private employees are given income supplement up to 100 % wages depending on their contracts
d
The cost of a substitute is comparable with the total wage of the substituted (1078€)
e
Due to the work disruption a profit loss of 15–20 % is generally estimated
f
Value of a one-week sick leave taking into account the former items
g
Estimated prevalence of each collective agreement
h
Weighted value (value 9 prevalence)
i
Weighted average value of a weekly sick leave (1271€) for a weekly gross wage of 654€
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Hernia Table 7 Total (direct and indirect) costs of IVHR for employed and unemployed patients Employment
%
Average direct, costs (€)
Average indirect, costs (€)
Average, total cost
Average sick leave Cost per week Unemployed
68
4731
–
Employed
32
4731
1271
Irrespective, of employment
(0.68 9 4731) ? (0.32 9 10,107) =
a
Cost Per day
Duration (days)
Total cost –
4731€
182
29.6
5376a
10,107€ 6451€
(1271/7) 9 29.6
Key results The mean total cost for an incisional hernia repair in France in 2011 was estimated to be 6451€, ranging from 4731€ for unemployed patients to 10,107€ for employed patients whose indirect costs were slightly higher than the direct costs. The average direct cost was 4731€, but direct costs widely ranged from 3497€ for level 1 to 16,367€ for level 4 of severity (Tables 2, 3). The mean cost of a day-case IVHR was 2041. The average indirect cost for employed patients was 5376€ (Table 7), but the indirect costs spread across a wide range of 1518€–8360€ (Tables 4, 6).
Poulouse et al. reporting on the cost of ventral hernia repair (including both primary ventral and incisional hernias), the direct cost for inpatient procedures was 15,899 US dollar (±13,000€) and for outpatient procedures 3873 US dollar (±3168€) [10]. Overall we can conclude that most authors see an important cost saving in the prevention of incisional hernias. Significant heterogeneity in time periods and the different currencies of the studies, made it is not possible to perform quantitative evaluation. Therefore we wanted to assess the actual costs of IVHR. Financial study
Discussion Systematic review The summary of findings of the systematic review is shown in Table 1. Three records were from the Sundsvall Hospital in Sweden [9, 11, 12]. In their most recent publication the overall mean cost for an incisional hernia repair was 86,257 SEK (±9060€), with a direct cost of 59,909 SEK (±6294€) and an indirect cost of 26,348 SEK (±2768€) [9]. They estimated that by adopting the technique of small bites during closure of a midline laparotomy, the anticipated reduction of incisional hernias results in a cost reduction for each patient of 1339 SEK (±141€). Four other studies reported data from the United States and one record is a recent review on the topic [10, 13–16]. Dimick et al. showed that the incidence of postoperative complications in surgical procedures, including hernia surgery, increases the costs related to the procedure significantly [15]: after adjusting for differences in patient characteristics, major complications were associated with an increase of $11,626 (95 % CI $9419 to $13,832; p \ 0.001). Bower et al. concluded that mesh repair of incisional hernias is more cost effective than suture repair, because of the significant higher need for subsequent repair of recurrent incisional hernia [16]. In the most recent study by
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In this multi-centric cost analysis, the mean total cost for an incisional hernia repair in France in 2011 was estimated to be 6451€, ranging from 4731€ for unemployed patients (68 % of patients) to 10,107€ for employed patients (32 % of patients) whose indirect costs were slightly higher than the direct costs. The average direct cost was 4731€, but direct costs widely ranged from 3497€ for level 1 to 16,367€ for level 4 of severity (Tables 2, 3). The mean cost of a day-case IVHR was 2041. The average indirect cost for employed patients was 5376€ (Table 7) but the indirect costs spread across a wide range of 1518€ to 8360€ (Tables 4, 6). Around 13.000 incisional hernia repairs are performed in France each year. The global yearly cost for incisional hernia repair in France can be estimated to be almost 84 million Euros, with a direct cost of 62 million Euros. In this study the costs were calculated for public hospitals. In France, 50–55 % of surgery is performed in private hospitals. From data of the ATIH we know that the direct costs are 25–50 % lower in private hospitals [17] even after reintegration of the medical fees, not included in the private hospital costs. Therefore the direct overall cost in France (private and public) are probably closer to 45 million Euros. Nevertheless, reducing the incidence of incisional hernia repair after abdominal surgery by 5 % (13.000 9 5 % = 650) would result in a yearly national cost savings (direct
Hernia
and indirect cost) of approximately 4 million Euros (6451 9 650 = 4193,150€). Implementation of the recently published European Hernia Society guidelines on the closure of abdominal wall incisions [6], thus hold a good potential not only to avoid postoperative morbidity related to incisional hernias, but also to a significant cost saving from avoiding subsequent incisional hernia repair operations. Prevention of incisional hernias in patients at high risk for this complication with a primary mesh augmentation is currently being studied in several studies and the evidence on the efficacy and the safety of this approach is increasing rapidly [6, 18, 19]. The resulting decrease in incisional hernias will undoubtedly compensate for the additional cost for a primary mesh augmentation in mesh material and operative time in highrisk patients. Strengths of this study This study is the first published multi-centric cost analysis of both direct and indirect costs of IVHR. It was done among a large panel of 51 French public hospitals, including 3239 patients for the direct costs evaluation and 790 patients for the indirect costs evaluation. The hospital costs were retrieved from a thorough analysis of 132 unitary expenditure items done by the accountants of a specialized public agency (ATIH) dedicated to investigate the costs of the French Health Care system. Moreover, the ATIH data consist in observed costs (written in the general ledger) and not reimbursed prices, which may differ from actual costs especially if the national health policy targets to promote some priorities and changes in the sanitary behaviours. The pathology studied (IVHR) is homogeneous and did not include primary ventral hernias, which are very different in terms of pathology, hospital stay, postoperative complications, recurrence rate [20] and finally in terms of costs. Furthermore this study estimates the costs of the postoperative inability to work and loss of profit due to the disruption in the on-going work over a large panel of different Collective Agreements. Limitations The ATIH cost analysis dates back from 2011. Such a wide cost analysis is not organized each year. Fortunately, due to a very low inflation rate over this period these costs are still valid today. The ATIH analysis does not address the indirect costs, which were evaluated from the patients registered in the Hernia Club Registry. These two populations may slightly differ. For instance more laparoscopic repairs could have
been performed in the CH cohort, and more level 4 cases could be treated in the ATIH cohort. The difference, if it exists, may have a slight impact because the relative financial weight of the level 4 is not prominent (Table 3). The indirect costs, mainly for unemployed patients, are probably slightly underestimated: Unemployed and elderly patients may have spent some of their recovery in convalescent homes, for which costs could not be evaluated. Furthermore the Quality of Life is not a financial variable, so we could not evaluate in unemployed patients the cost of the daily life impairment during the sick leave. The costs of a redo surgery in case of recurrent IVHR, the costs of further medical care and work gaps in case of complications such as chronic pain were also not taken into account. It would have been helpful to split the cost analysis between open and laparoscopic repairs. Unfortunately due to the lack of specific GHM (DRG) in this financial and not medical ATIH study we could not assess the specific costs of the laparoscopic repairs. This becomes more relevant as laparoscopic techniques continue to improve and more complex cases are being done in this fashion. This will have a direct effect on the direct cost of the procedure as laparoscopic consumables are more costly and the length of the procedure may be longer. This may be offset by the fact that laparoscopic procedures generally have a shorter length of stay and a quicker return to work. Moreover it is really difficult to briefly explain what the four levels of hernia repair are and how they differ. Levels are calculated using the National Health Care computerized device (groupeur) taking into account severity and combinations of the co-morbidities, the associated intra-hospital events (such as pulmonary embolism, cardiac failure), the length of stay out of the target; Not many surgical items are taken into account such as complications related to a previous mesh, bowel necrosis, or a bacteriologically proven deep infection. These items are annually updated and move: If one of these items has not got any financial relevance, it is withdrawn from the list. Therefore it is really difficult to briefly explain what these four levels are. We have used the best available data at our disposal to estimate the different components of the direct and indirect costs. Although we think the samples are representative they might not reflect the overall population of French patients undergoing incisional hernia repair, such as independent professionals, farmers, artisans, liberal professions whose social systems are different from those of employees. The economic evaluations are, a priori, difficult to extrapolate to other countries, because of variations in healthcare systems and financing, the changes in currencies and the inflation over time. Nevertheless the costs identified in the current study are very similar to those found in
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Sweden (9, 11–12). Therefore these costs seem representative for the cost of IVHR in Europe. In the United States direct costs (16), are significantly higher than those reported in this study.
Conclusion Our study shows that next to a considerable direct cost, also the indirect costs of incisional hernia repair have to be accounted for when calculating the potential benefit of preventive measures to decrease the rate of incisional hernias after abdominal wall incisions. Upcoming evidence on the efficacy and safety of mesh augmentation during closure of abdominal wall incisions in the prevention of incisional hernias shows an important potential to decrease the costs related to subsequent incisional hernia repair. Acknowledgments The authors would like to acknowledge the Bonham Group and Hernia Club members (see appendix) and Guy Gravet (GG), a specialized accountant, for helping them in the estimation of the indirect costs. Compliance with ethical standards Conflict of interests None for this work: As President of the Hernia-Club and Organiser of the Mesh Congress, JFG has financial partnerships with a number of companies. However, he received no personal funding for this study. The Hernia-Club is an independent scientific institution whose objective is to assess the use of different procedures and prostheses for hernia repair. It therefore has relationships with a number of companies with an interest in independent evaluation of their products.
Appendix A: Members of the Bonham Group * F.E. Muysoms Head of the Department of Abdominal Surgery, AZ Maria Middelares, Ghent, Belgium * J-F. Gillion Unite´ de Chirurgie Visce´rale et Digestive, Hoˆpital Prive´ d’Antony, France * D.L. Sanders Department of Surgery, Derriford Hospital, Plymouth, United Kingdom * M. Miserez Department of Abdominal Surgery, University Hospitals, KU Leuven, Belgium * S.A. Antoniou 1,2 1 Center for Minimally Invasive Surgery, Neuwerk Hospital, Mo¨nchengladbach, Germany 2 Department of General Surgery, University Hospital of Heraklion, University of Crete, Greece * K. Bury
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Department of Cardiac and Vascular Surgery, Medical University of Gdansk, Poland * G. Campanelli University of Insubria, General and day surgery, Center of research and high specialization for abdominal wall pathology and hernia repair, Istituto Clinico Sant’ Ambrogio, Milano, Italy * J. Conze UM Herniacentre, Munich and Department of General, Visceral and Transplantation Surgery, University Hospital of the RWTH Aachen, Aachen, Germany * D. Cuccurullo Department of General and Laparoscopic Surgery, Monaldi Hospital, Azienda Ospedaliera dei Colli, Naples, Italy *A.C. de Beaux Department of General Surgery, The Royal Infirmary of Edinburgh, Edinburgh, United Kingdom * E.B. Deerenberg Department of Sugery, Erasmus MC University Medical Center Rotterdam, Rotterdam, the Netherlands * B. East Department of Surgery, Second Faculty of Medicine, Charles University in Prague, Czech Republic * R.H. Fortelny Chief of the Hernia Center, Department of General, Visceral and Oncological Surgery, Wilhelminenspital, Vienna, Austria * N.A. Henriksen Digestive Disease Center, Bispebjerg Hospital and Department of Gastroenterology, Hvidovre Hospital, Copenhagen, Denmark * L. Israelsson Department of Surgery and Perioperative science, Umea˚ University, Umea˚, Sweden * A. Jairam Department of Sugery, Erasmus MC University Medical Center Rotterdam, Rotterdam, the Netherlands * A. Ja¨nes Head of Upper GI and Trauma Surgery, Department of Surgery, Sundsvall Hospital, Sundsvall, Sweden * J. Jeekel Department of Neurosciences, Erasmus MC University Medical Center Rotterdam, Rotterdam, the Netherlands * M. Lo´pez-Cano Abdominal Wall Surgery Unit, Hospital Universitario Vall d’Hebro´n. Universidad Auto´noma de Barcelona, Barcelona, Spain * S. Morales-Conde Chief of the Unit of Innovation in Minimally Invasive Surgery, University Hospital Virgen del Rocı´o, Seville, Spain * M.P. Simons
Hernia
Department of Surgery, Onze Lieve Vrouw Gasthuis, Amsterdam, The Netherlands * M. S´mietan´ski Department of General and Vascular Surgery, Ceynowa Hospital in Wejherowo, Poland * L. Venclauskas Lithuanian University of Health Sciences, Department of Surgery, Kaunas, Lithuania * F. Berrevoet Department of General and Hepatobiliary Surgery and Liver Transplantation Service, University Hospital Ghent, Belgium
Appendix B: Members of the Hernia Club Ain J-F: Polyclinique Val de Saone, Macon, France Beck M: Clinique Ambroise Pare´, Thionville, France Barrat C: Hoˆpital Universitaire Jean Verdier, Bondy, France Berney C: Bankstown-Lidcombe Hospital, Sydney, Australia Berrot J-L: Groupe Hospitalier Paris St Joseph, Paris, France Binot D: MCO Coˆte d’Opale, Boulogne sur Mer, France Blazquez D: Clinique Jeanne d’Arc, Paris, France Bonan A: Hoˆpital Prive´ d’Antony, Antony, France Cas O: Centre Me´dico Chirurgical–Fondation WALLERSTEIN, Are`s, France Dabrowski A: Clinique de Saint Omer, Saint Omer, France Champault-Fezais A: Groupe Hospitalier Paris St Joseph, Paris, France Chastan P: Bordeaux, France Cardin J-L: Polyclinique du Maine, Laval, France Chollet J-M: Hoˆpital Prive´ d’Antony, Antony, France Cossa J-P: CMC Bizet, Paris, France Durou J: Clinique de Villeneuve d’Ascq, Villeneuve d’Ascq, France Dugue T: Clinique de Saint Omer, Saint Omer, France Faure J-P: CHRU Poitiers, Poitiers, France Framery D: CMC de la Baie de Morlaix, Morlaix, France Fromont G: Clinique de Bois Bernard, Bois Bernard, France Gainant A: CHRU Limoges, Limoges, France Gauduchon L: CHRU Amiens, France Gillion J-F: Hoˆpital Prive´ d’Antony, Antony, France Jacquin C: CH du Prado, Marseille, France Jurczak F: Clinique Mutualiste, Saint Nazaire, France Khalil H: CHRU Rouen, Rouen, France Lacroix A: CH de Auch, Auch, France Ledaguenel P: Clinique Tivoli, Bordeaux, France
Lepe`re M: Clinique Saint Charles, La Roche-sur-Yon, France Letoux N: Clinique Jeanne d’Arc, Paris, France Loriau J: Groupe Hospitalier Paris St Joseph, Paris Magne E: Clinique Tivoli, Bordeaux, France Ngo P: Hoˆpital Ame´ricain, Neuilly, France Paterne D: Clinique Tivoli, Bordeaux, France Pavis d’Escurac X: Strasbourg, France Renard Y: CHRU Reims, Reims, France Soler M: Polyclinique Saint Jean, Cagnes-sur-Mer, France Rignier P: Polyclinique des Bleuets. Reims Roos S: Clinique Claude Bernard, Albi, France Thillois J-M: Hoˆpital Prive´ d’Antony, Antony, France Tiry P: Clinique de Saint Omer, Saint Omer, France Zaranis C: Clinique de la Rochelle, La Rochelle, France
References 1. Ho¨er J, Lawong G, Klinge U, Schumpelick V (2002) Factors influencing the development of incisional hernia. A retrospective study of 2983 laparotomy patients over a period of 10 years. Chirurg 73:474–480 2. Antoniou GA, Georgiadis GS, Antoniou SA, Granderath FA, Giannoukas AD, Lazarides MK (2011) Abdominal aortic aneurysm and abdominal wall hernia as manifestations of a connective tissue disorder. J Vasc Surg 54:1175–1181 3. Henriksen NA, Helgstrand F, Vogt KC, Jorgensen LN, Bisgaard T (2013) Risk factors for incisional hernia repair after aortic reconstructive surgery in a nationwide study. J Vasc Surg 57:1524–1530 4. Diener MK, Voss S, Jensen K, Buchler MW, Seiler CM (2010) Elective midline laparotomy closure: the inline systematic review and meta-analysis. Ann Surg 251:843–856 5. Meijer EJ, Timmermans L, Jeekel J, Lange JF, Muysoms FE (2013) The principles of abdominal wound closure. Acta Chir Belg 113:239–244 6. Muysoms FE, Antoniou SA, Bury K, Campanelli G, Conze J, Cuccurullo D, de Beaux AC, Deerenberg EB, East B, Fortelny RH, Gillion J-F, Henriksen NA, Israelsson L, Jairam A, Ja¨nes A, Jeekel J, Lo´pez-Cano M, Miserez M, Morales-Conde S, Sanders DL, Simons MP, S´mietan´ski M, Venclauskas L, Berrevoet F (2015) European Hernia Society guidelines on the closure of abdominal wall incisions. Hernia 19(1):1–24. doi:10.1007/ s10029-014-1342-5 Epub 2015 Jan 25 7. Siegel JE, Weinstein MC, Russell LB, Gold MR (1996) Recommendations for reporting cost-effectiveness analyses. Panel on cost-effectiveness in health and medicine. JAMA 276:1339–1341 8. van Ramshorst GH, Eker HH, Hop WC, Jeekel J, Lange JF (2012) Impact of incisional hernia on health-related quality of life and body image: a prospective cohort study. Am J Surg 204:144–150 9. Millbourn D, Wimo A, Israelsson LA (2014) Cost analysis of the use of small stitches when closing midline abdominal incisions. Hernia 18:775–780 10. Poulose BK, Shelton J, Phillips S, Moore D, Nealon W, Penson D, Beck W, Holzman MD (2012) Epidemiology and cost of ventral hernia repair: making the case for hernia research. Hernia 16:179–183
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Hernia 11. Israelsson LA, Jonsson L, Wimo A (2003) Cost analysis of incisional hernia repair by suture or mesh. Hernia 7:114–117 12. Israelsson LA, Wimo A (2000) Cost minimisation analysis of change in closure technique of midline incisions. Eur J Surg 166:642–646 13. Earle D, Seymour N, Fellinger E, Perez A (2006) Laparoscopic versus open incisional hernia repair: a single-institution analysis of hospital resource utilization for 884 consecutive cases. Surg Endosc 20:71–75 14. Finan KR, Kilgore ML, Hawn MT (2009) Open suture versus mesh repair of primary incisional hernias: a cost-utility analysis. Hernia 13:173–182 15. Dimick JB, Chen SL, Taheri PA, Henderson WG, Khuri SF, Campbell DA (2004) Hospital costs associated with surgical complications: a report from the private-sector National Surgical Quality Improvement Program. J Am Coll Surg 199:531–537 16. Bower C, Roth JS (2013) Economics of abdominal wall reconstruction. Surg Clin North Am 93:1241–1253
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17. https://www.epmsi.atih.sante.fr. Accessed 26 Feb 2016 18. Timmermans L, de Goede B, Eker HH, van Kempen BJ, Jeekel J, Lange JF (2013) Meta-analysis of primary mesh augmentation as prophylactic measure to prevent incisional hernia. Dig Surg 30:401–409 19. Timmermans L, Eker HH, Steyerberg EW, Jairam A, de Jong D, Pierik EG, Lases SS, van der Ham AC, Dawson I, Charbon J, Schuhmacher C, Izbicki JR, Neuhaus P, Knebel P, Fortelny R, Kleinrensink GJ, Jeekel J, Lange JF (2014) Short-term results of a randomized controlled trial comparing primary suture with primary glued mesh augmentation to prevent incisional hernia. Ann Surg. (Epub ahead of print) 20. Ko¨ckerling F, Schug-Paß C, Adolf D, Reinpold W, Stechemesser B (2015) Is pooled data analysis of ventral and incisional hernia repair acceptable? Front Surg 2:15. doi:10.3389/fsurg.2015. 00015 (eCollection 2015)
ORIGINAL ARTICLE
The economic burden of incisional ventral hernia repair: a multicentric cost analysis J-F Gillion1 • D. Sanders2 • M. Miserez3 • F. Muysoms4
Received: 27 September 2015 / Accepted: 17 February 2016 Ó Springer-Verlag France 2016
Abstract Purpose A systematic review of literature led us to take note that little was known about the costs of incisional ventral hernia repair (IVHR). Methods Therefore we wanted to assess the actual costs of IVHR. The total costs are the sum of direct (hospital costs) and indirect (sick leave) costs. The direct costs were retrieved from a multi-centric cost analysis done among a large panel of 51 French public hospitals, involving 3239 IVHR. One hundred and thirty-two unitary expenditure items were thoroughly evaluated by the accountants of a specialized public agency (ATIH) dedicated to investigate the costs of the French Health Care system. The indirect costs (costs of the post-operative inability to work and loss of profit due to the disruption in the ongoing work) were estimated from the data the Hernia Club registry, involving 790 patients, and over a large panel of different Collective Agreements. Results The mean total cost for an IVHR in France in 2011 was estimated to be 6451€, ranging from 4731€ for unemployed patients to 10,107€ for employed patients The data of the present study were presented by J-F Gillion during the 36th Annual Congress of the European Hernia Society in Edinburgh on 31 May 2014. & J-F Gillion [email protected] 1
Unite´ de Chirurgie Visce´rale et Digestive, Hoˆpital Prive´ d’Antony, Antony, France
2
Department of Surgery, Derriford Hospital, Plymouth, UK
3
Department of Abdominal Surgery, University Hospitals, KU Leuven, Leuven, Belgium
4
Department of Abdominal Surgery, AZ Maria Middelares, Ghent, Belgium
whose indirect costs (5376€) were slightly higher than the direct costs. Conclusion Reducing the incidence of incisional hernia after abdominal surgery with 5 % for instance by implementation of the European Hernia Society Guidelines on closure of abdominal wall incisions, or maybe even by use of prophylactic mesh augmentation in high risk patients could result in a national cost savings of 4 million Euros. Keywords Incisional hernia Prevention Cost analysis Health economics Mesh augmentation
Introduction Incisional hernias are a frequent complication of abdominal surgery and some patient variables including obesity, postoperative surgical site infections and the presence of abdominal aortic aneurysm have been identified as risk factors [1–3]. The surgical technique and material to close abdominal wall incisions are also of utmost importance to avoid a high frequency of incisional hernias [4, 5]. The European Hernia Society has recently developed and published guidelines on the closure of abdominal wall incisions [6]. As part of this initiative, the Guidelines Development Group ‘‘The Bonham Group’’ has tried to determine the economic burden related to the treatment of an incisional hernia according to previously published recommendations [7]. Apart from the known negative impact of an incisional hernia on the patients’ quality of life and body image, patients with an incisional hernia are at risk of potential serious complications [8]. The repair of incisional hernia has direct costs and indirect costs. Estimation of the costs related to the treatment of incisional hernias can reflect the socio-economic gain to be made by
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Hernia
optimizing abdominal wall closure technique and reduction of the incidence of incisional ventral hernia. The magnitude on a national level of the costs related to incisional hernias has been reported for Sweden, where about 2000 incisional hernias are repaired annually with a direct cost approximately 170 million Swedish Krona (SEK) (±18 million Euro). The direct and indirect costs for an incisional hernia have been calculated to be 86,257 SEK (±9112€) [9]. In a nationwide study for the United State (US) an estimated 348,000 ventral hernia repairs were performed in 2006 with a direct cost for inpatient procedures of 15,899 US dollar (±13,000€) and for outpatient procedures 3873 US dollar (±3168€) [10]. This amounts to a total cost of ventral hernia repair for the US in 2006 of 3.2 billion US dollar (±2.6 billion Euro). The objective of this study was to perform a review of the literature on the costs related to incisional hernia repair and to make an estimate of the direct and indirect costs for incisional hernia repair in France using nationwide data.
Materials and methods A systematic review of the literature was performed on 25 February 2014 in Pubmed, Medline and EmBase, limited to Human data with the search terms: ‘‘Incisional hernia OR ventral hernia AND health planning/economics/cost and cost analysis/vital statistics/demography/population characteristics/quality adjusted life years/health burden’’. The Prisma flow diagram of the records found is shown in Fig. 1. The results [9–16] are displayed in Table 1. The cost of an incisional hernia repair is the sum of direct costs and indirect costs [10]. The direct costs comprise all consumption of resources resulting from the treatment. The indirect costs are those related to the outpatient care during the sick leave, but mainly related to the inability to work, such as the costs of a substitute, the loss of productivity, and the costs of the daily allowance.
such cost analysis serve as a basis to determine the amount of money to be reimbursed to the hospitals for each GHM. The reimbursement of every GHM is not calculated for every patient, it is a package, annually updated. It has to be noted that the reimbursed prices may be different from the actual costs, especially if the National Health Policy targets to promote certain healthcare priorities and therefore adjusts the tariff to make the procedure more attractive to healthcare providers. The ATIH data are actual observed costs, written in the general ledger. Among these ATIH data, we extracted those concerning Incisional Ventral Hernia Repair in adults, gathered in five GHM (Table 2). One of them is dedicated to day-care surgery (06C24J), the four others concern the inpatients, classified into four levels of severity (06C241, 06C242, 06C243, 06C244). Patients are grouped into four levels to determine the complexity of their care and hence the costs involved. Levels 1–4 are calculated using a National Health Care System (National Security Fund) software named ‘groupeur’, taking into account the severity of the co-morbidities, the associated intra-hospital events (such as pulmonary embolism, cardiac failure), the length of stay out of the target. Not many surgical items are taken into account, such as: complications related to a previous mesh, bowel necrosis, or a bacteriologically proven deep infection. For instance, this financial classification does not take into account whether the procedure is done laparoscopically or through an open approach, even though it probably carries some financial implications. The list of the relevant items is annually updated. Clinical conditions, which do not have any impact on finance, are removed from the list at the annual review. In the ATIH multi-centric study, every observed unitary piece of expenditure was detailed by specialized accountants, classified into 132 sub-groups of expenditure, and 6 chapters (medical expenses, technical-medical expenses, management, direct charges, structural expenses) registered and averaged for each GHM (Table 3).
Direct costs Calculations based on the ATIH data Analysis of the ATIH data In our study the direct costs were estimated from a cost analysis [17] performed in 2011 among 51 public French hospitals by the Agence Technique de l’ Information sur l’ Hospitalisation (ATIH). The ATIH (www.atih.sante.fr) is a public agency dedicated to investigate the costs of the French Health Care system, especially the intra-hospital costs of various diseases, classified in more than 3000 GHM (Groupes Homoge`nes de Malades = Homogeneous groups of patients), the French version of the DRG (Diagnosis-Related Groups). The actual costs, observed in
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We wanted to calculate the average direct cost regardless of the level of severity: The average cost for each GHM was then weighted according to the prevalence of the corresponding GHM (Table 3) resulting in a ‘‘weighted average of the direct cost for an average incisional hernia repair’’. Indirect costs The sick leave and the inability to work (including the hospital stay) were estimated using data extracted from the
Hernia Fig. 1 Prisma flow diagram
prospective registry on abdominal wall hernias from the ‘‘Club Hernie’’. This is a collaborative registry of nearly 50 French surgeons with a specific interest in abdominal wall surgery. Each participant accepts and signs the charter of quality stating that ‘‘all input must be registered consecutive, unselected, exhaustive and in real time’’. The participants allow peer review control of the original medical chart of randomly selected patients. Follow-up is obtained by a clinical research assistant, independent from the individual participants and blinded for the surgical procedure. Consecutive patients with an IVH operated between September 30th, 2011 and August 31st, 2014, were used for the estimation of the indirect cost. Data on hospital stay and postoperative absence from work were extracted from the database to determine the estimated average duration of inability to work (Table 4).
The average cost of inability to work and loss of productivity, were estimated, firstly from the mean wages in France in 2011 (Table 5), published by the National Institute of Statistics (INSEE), and secondly using a table taking into account the most frequent Collective Agreement among the myriad of the different French social public and private contracts (Table 6).
Results Systematic review The results of our systematic review are shown in the Prisma flow diagram in Fig. 1. Initially 402 records were identified, after removal of duplicates and non-relevant
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1. Relative risk reduction 0.016 with S:W C 4 2. Cost reduction SEK 686 3. Saving per patient of SEK116 4. Estimated nationwide saving of SEK2, 107,140 (2000) per year Economic Low 884 Consecutive patients undergoing evaluation incisional hernia repairs
1. Shorter stay with lap 2. Longer op time with lap 3. Higher supply costs with lap (US$6396 vs US$664) 4. Higher 30 days hospital encounters with lap (15 vs 13 %) Economic Low N/A Theoretical patients with incisional evaluation hernia. Placed into decision analysis model
Effect size
Effect size
[14]
[13]
[12]
1. 154, 278 ventral hernia repairs in US in 2006 2. Cost per operation US$15,899 3. Total cost US$3.2billion 4. US$32 million dollar reduction in cost for every 1 % decrease in incisional hernias Economic Moderate 861 Consecutive patients 1988-1992 having evaluation midline laparotomy
Effect size
Patients from healthcare cost and utilization project
Cost saving of 6034 SEK with mesh repair Economic Very low N/A evaluation
Effect size [10]
[11]
Effect size
Patient characteristics
Economic Moderate 691 Matched evaluation from RCT 1. Cost reduction with small stitches 1339 SEK per patient 2. Direct costs of incisional hernia repair 59909 SEK and indirect costs 26348 SEK Economic Low 44 Consecutive patients evaluation
Number of patients
[9]
Level of evidence GRADE
Study type
Reference citation
Summary of evidence table for ‘‘the cost of incisional hernia repair’’
Table 1 Summary of findings table
Open mesh repair
Laparoscopic incisional hernia repair
Suture length to wound length ratio C4
Inpatient ventral hernia repair
Mesh repair
Small stitch closure (n = 321)
Intervention
Open suture repair
Open incisional hernia repair
Suture length to wound length ratio \4
None
Suture repair
Large stitch closure (n = 370)
Comparison
N/A
30 days
1 year
5 years
[1 year
5 years
Length of follow-up
1. Costs (US $ = US Dollar) 2. Cost effectiveness
1. Operative time 2. Cost (US $ = US Dollar) 3. Length of stay 4. 30 days postoperative hospital encounters
1. Incisional hernia rate 2. Costs (SEK = Swedish Krona)
1. Total number of repairs 2. Mean costs (US $ = US Dollar)
Cost direct and indirect (SEK = Swedish Krona)
Cost direct and indirect (SEK = Swedish Krona)
Outcome measure (currency)
Educational Grant Olympus
Not stated
None
Not stated
Not stated
University Grant
Source of funding
Hernia
None N/A N/A N/A
Not stated Mean 1 year N/A
Costs (US $ = US Dollar)
Length of follow-up
Source of funding
records, eight records remained for qualitative evaluation. The Summary of Findings of the systematic review is shown in Table 1. Significant heterogeneity in time periods and the different currencies of the studies make it impossible to perform quantitative evaluation. Direct cost of IVHR in our study
Comparison
Outcome measure (currency)
Hernia
In this multi-centric study the direct costs were studied among 3239 patients treated in 51 French public hospitals. The average direct costs for incisional hernia repair are shown in Table 3. They were, respectively, 3497€, 4652€, 8402€, 16,367€ for the level 1, level 2, level 3 and level 4 GHM and 2041€ for day-case incisional hernia repair. Each of these five average costs was then weighted according to the prevalence of the related GHM resulting in the weighted average direct cost of a mean incisional hernia repair, which is 4731€.
N/A
N/A
[16] Effect size
Effect size
[15]
1. Total cost of suture repair US$16,355 2. Total cost of mesh repair US$16,947 3. Incremental costs to prevent one recurrence with mesh US$1878 Economic Moderate 1008 All surgical patients undergoing an evaluation operation 1. Median hospital costs if no complication: US$4487 2. Median hospital costs if minor complications occurred: US$14,094 3. Median hospital cost if major complications occurred: US$28,536 Review Very low N/A Incisional hernias Mesh incisional hernia is more cost effective than suture repair Effect size
Level of evidence GRADE
Number of patients
Patient characteristics Study type Reference citation
Summary of evidence table for ‘‘the cost of incisional hernia repair’’
Table 1 continued
Intervention
Indirect cost of incisional hernia repair in our study From 30 September 2011 till 31 August 2014, 10,529 patients were registered in the Hernia Club Registries, including 7851 patients operated on for groin hernias and 2678 patients for ventral hernias, including 991 patients operated on for incisional ventral hernias. Sick leave, hospital stay and nature of employment were properly recorded in 790 of these 991 patients (Table 4). One-third of our patients were employed. The hospital stay was 2.6 days for employed and 3.7 days when including unemployed patients. The mean sick leave duration for employed patients, including the hospital stay was 29.6 (range 0–90) days. The mean monthly wages for employees in France in 2011, retrieved from the National Institute of Statistics are reported Table 5. The average monthly wages were as follows: Net wages: 2130€, Gross wages: 2830, Total wages 4671€, corresponding to weekly Net wages of 492€, Gross wages of 654€ and Total wages of 1078€. The differences between these different wages are explained in Table 5. The estimation of the value of one-week sick leave among the most frequent French collective agreements for this mean wages is reported in Table 6. The value of a weekly sick leave for employed widely ranged across these collective agreements from 359 to 1977€. The weighted mean value of a weekly sick leave for employed was estimated at 1271€ (Table 6). Therefore the average sick leave cost for our employed patients was 5376€ (1271€ per week/7 9 29.6) while the values ranged from 1518€ (359/7 9 29.6) to 8360€ (1977/ 7 9 29.6) [Tables 4, 6].
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Hernia Table 2 The five IVHR-GHM (Homogeneous groups of patients for Incisional Ventral Hernia repairs) GHM
Description
Relevant comorbidities or risk factors
Relevant associated intra-hospital events
Hospital stay \ or [ to the target
06C241
IVHR [ 17 years, level 1
0
0
0
Level calculated using the French National Health Care computerized device ‘groupeur’ taking into account severity and combinations of items annually updated according to their financial relevance
06C242
IVHR [ 17 years, level 2
06C243
IVHR [ 17 years, level 3
06C244
IVHR [ 17 years, level 4
06C24J
IVHR [ 17 years, D case
Low risk
0
0
Levels are calculated using the National Health Care computerized device (‘groupeur’) taking into account severity and combinations of the comorbidities, the associated intra-hospital events (such as pulmonary embolism, cardiac failure), the length of stay out of the target; Not many surgical items are taken into account such as complications related to a previous mesh, bowel necrosis, or a bacteriologically proven deep infection. For instance, this classification does not take into account whether the procedure is done laparoscopically or through an open approach These items are annually updated. If one of these items does not have any financial relevance, it is withdrawn from the list IVH incisional ventral hernia repair, y year, D case day case surgery
Table 3 Prevalence and observed direct costs of the five IVHR-GHM in the ATIH multicentric study, and calculation of the weighted average direct cost of an average IVHR GHM
Description
Prevalence Cases
%
Costsa
Weightingb
€
€9 %
06C241
IVHR [ 17 years, level 1
1.285
39.7
3497
1388
06C242
IVHR [ 17 years, level 2
1.516
46.8
4652
2177
06C243 06C244
IVHR [ 17 years, level 3 IVHR [ 17 years, level 4
221 105
6.8 3.2
8402 16,367
571 524
06C24J
IVHR [ 17 years, D case
112
3.5
2041
3.239
100
71 4731€
a
Observed costs per case
b
Each cost was weighted according to the prevalence of the corresponding GHM
Weighted average
Weighted average of the direct cost of an average IVHR
Table 4 Average sick leave duration, in IVHR registered in the Hernia Club registry Occupation (item available for 790 patients)
Average hospital stay (days, range)
Employed
Unemployed
Employed
Total
Average sick leave including the hospital stay (days, range) Employed
251
539
2.6
3.7
29.6
32 %
68 %
(0–11)
(0–29)
(0–90)
Total cost of incisional hernia repair in our study (Table 7) For employed persons the global average cost (direct ? indirect costs) in 2011 of an incisional hernia repair in France was estimated at 10,107€. For these employed patients, the indirect costs were higher than the direct costs. Some of our patients, mainly unemployed and/or elderly, probably spent their recovery in convalescent home, but we could not evaluate these costs due to the lack
123
of indication concerning the rate, the duration, and the prices. For unemployed we took into account the direct costs, because of the difficulty to evaluate in Euros the impact of surgery on their daily life. Finally the average total costs of IHR, regardless to the employment was 4731 9 68 ? 10,107 9 32 % = 6451€. In other words: ‘‘the average total cost for an average incisional hernia repair in an average patient’’ in France in 2011 was estimated to be 6451€.
Hernia Table 5 Wages in France in 2011 (INSEE)
Net wagesa (€)
Gross wagesb (€)
Senior manager
3988
5385
Intermediate professions
2182
2910
Employees
1554
2049
Workers
1635
2137
Average
2130
2830
Total wagesc Monthly (€)
Total wagesd Weekly (€)
4671
1078€e
INSEE National Institute of Statistics and Economic Studies (www.insee.fr/) a
Net wages: take home wages after payment of the compulsory social contributions (employer and employee’s parts) and before payment of the direct taxes
b Gross wages (Net 9 1.329): wages paid to the employee minus the compulsory employer’s part of social contributions c Total wages (Net 9 2.195 or Gross 9 1.65): net wages ? employee’s and employer’s compulsory social contributions = the real employee’s wages = the actual cost of the employee for his employer d
Weekly wages = Monthly wages/4.33 An average monthly gross wages of 2830€ is equivalent to weekly net wages of 492€, gross wages of 654€, total wages of 1,078€ e
Table 6 Estimation of the value of 1 week sick leave among the most frequent French Collective Agreements for the average gross wages of 2830€ Collective agreement (CA)
Sickness, benefita, (SB) % of wages
Waiting periodb, before SB
Income, supplementc, up to 100 %
Substituted
Profit loss (%)e
Valuef, (€)
3 days
No
No
15
359
Private sector
Prevalence (%)g
Weighted, valueh (€)
80
Income supplement, not included in CA
50 % 50 %
3 days
No
Yes
20
1196
8
96
Income supplement, included in CA
50 %
3 days
Yes
No
15
947
16
152
50 %
3 days
Yes
Yes
20
1896
16
303
50 %
Assumed, by employer
Yes
No
15
1028
16
164
50 %
Assumed, by employer
Yes
Yes
20
1977
16
316
Public sector
8
29
20 100 %
0 day
–
No
15
505
10
51
100 %
0 day
–
Yes
20
1603
10
160
Weighted average value of a weekly, sick leavei
1271
Note it is almost the double of the gross wage and 2 times and a half more than the net wage CA collective agreement The Sickness Benefit, or Daily Allowance, is directly paid to the employee by the National Social Security Insurance (Se´curite´ Sociale), usually after a waiting period of 3 days, except in Public sector, or if it is assumed by the employer a
b
During their sickness, the public employers are given 100 % of their wages, the private employees are given 50 % of their wages
c
Some private employees are given income supplement up to 100 % wages depending on their contracts
d
The cost of a substitute is comparable with the total wage of the substituted (1078€)
e
Due to the work disruption a profit loss of 15–20 % is generally estimated
f
Value of a one-week sick leave taking into account the former items
g
Estimated prevalence of each collective agreement
h
Weighted value (value 9 prevalence)
i
Weighted average value of a weekly sick leave (1271€) for a weekly gross wage of 654€
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Hernia Table 7 Total (direct and indirect) costs of IVHR for employed and unemployed patients Employment
%
Average direct, costs (€)
Average indirect, costs (€)
Average, total cost
Average sick leave Cost per week Unemployed
68
4731
–
Employed
32
4731
1271
Irrespective, of employment
(0.68 9 4731) ? (0.32 9 10,107) =
a
Cost Per day
Duration (days)
Total cost –
4731€
182
29.6
5376a
10,107€ 6451€
(1271/7) 9 29.6
Key results The mean total cost for an incisional hernia repair in France in 2011 was estimated to be 6451€, ranging from 4731€ for unemployed patients to 10,107€ for employed patients whose indirect costs were slightly higher than the direct costs. The average direct cost was 4731€, but direct costs widely ranged from 3497€ for level 1 to 16,367€ for level 4 of severity (Tables 2, 3). The mean cost of a day-case IVHR was 2041. The average indirect cost for employed patients was 5376€ (Table 7), but the indirect costs spread across a wide range of 1518€–8360€ (Tables 4, 6).
Poulouse et al. reporting on the cost of ventral hernia repair (including both primary ventral and incisional hernias), the direct cost for inpatient procedures was 15,899 US dollar (±13,000€) and for outpatient procedures 3873 US dollar (±3168€) [10]. Overall we can conclude that most authors see an important cost saving in the prevention of incisional hernias. Significant heterogeneity in time periods and the different currencies of the studies, made it is not possible to perform quantitative evaluation. Therefore we wanted to assess the actual costs of IVHR. Financial study
Discussion Systematic review The summary of findings of the systematic review is shown in Table 1. Three records were from the Sundsvall Hospital in Sweden [9, 11, 12]. In their most recent publication the overall mean cost for an incisional hernia repair was 86,257 SEK (±9060€), with a direct cost of 59,909 SEK (±6294€) and an indirect cost of 26,348 SEK (±2768€) [9]. They estimated that by adopting the technique of small bites during closure of a midline laparotomy, the anticipated reduction of incisional hernias results in a cost reduction for each patient of 1339 SEK (±141€). Four other studies reported data from the United States and one record is a recent review on the topic [10, 13–16]. Dimick et al. showed that the incidence of postoperative complications in surgical procedures, including hernia surgery, increases the costs related to the procedure significantly [15]: after adjusting for differences in patient characteristics, major complications were associated with an increase of $11,626 (95 % CI $9419 to $13,832; p \ 0.001). Bower et al. concluded that mesh repair of incisional hernias is more cost effective than suture repair, because of the significant higher need for subsequent repair of recurrent incisional hernia [16]. In the most recent study by
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In this multi-centric cost analysis, the mean total cost for an incisional hernia repair in France in 2011 was estimated to be 6451€, ranging from 4731€ for unemployed patients (68 % of patients) to 10,107€ for employed patients (32 % of patients) whose indirect costs were slightly higher than the direct costs. The average direct cost was 4731€, but direct costs widely ranged from 3497€ for level 1 to 16,367€ for level 4 of severity (Tables 2, 3). The mean cost of a day-case IVHR was 2041. The average indirect cost for employed patients was 5376€ (Table 7) but the indirect costs spread across a wide range of 1518€ to 8360€ (Tables 4, 6). Around 13.000 incisional hernia repairs are performed in France each year. The global yearly cost for incisional hernia repair in France can be estimated to be almost 84 million Euros, with a direct cost of 62 million Euros. In this study the costs were calculated for public hospitals. In France, 50–55 % of surgery is performed in private hospitals. From data of the ATIH we know that the direct costs are 25–50 % lower in private hospitals [17] even after reintegration of the medical fees, not included in the private hospital costs. Therefore the direct overall cost in France (private and public) are probably closer to 45 million Euros. Nevertheless, reducing the incidence of incisional hernia repair after abdominal surgery by 5 % (13.000 9 5 % = 650) would result in a yearly national cost savings (direct
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and indirect cost) of approximately 4 million Euros (6451 9 650 = 4193,150€). Implementation of the recently published European Hernia Society guidelines on the closure of abdominal wall incisions [6], thus hold a good potential not only to avoid postoperative morbidity related to incisional hernias, but also to a significant cost saving from avoiding subsequent incisional hernia repair operations. Prevention of incisional hernias in patients at high risk for this complication with a primary mesh augmentation is currently being studied in several studies and the evidence on the efficacy and the safety of this approach is increasing rapidly [6, 18, 19]. The resulting decrease in incisional hernias will undoubtedly compensate for the additional cost for a primary mesh augmentation in mesh material and operative time in highrisk patients. Strengths of this study This study is the first published multi-centric cost analysis of both direct and indirect costs of IVHR. It was done among a large panel of 51 French public hospitals, including 3239 patients for the direct costs evaluation and 790 patients for the indirect costs evaluation. The hospital costs were retrieved from a thorough analysis of 132 unitary expenditure items done by the accountants of a specialized public agency (ATIH) dedicated to investigate the costs of the French Health Care system. Moreover, the ATIH data consist in observed costs (written in the general ledger) and not reimbursed prices, which may differ from actual costs especially if the national health policy targets to promote some priorities and changes in the sanitary behaviours. The pathology studied (IVHR) is homogeneous and did not include primary ventral hernias, which are very different in terms of pathology, hospital stay, postoperative complications, recurrence rate [20] and finally in terms of costs. Furthermore this study estimates the costs of the postoperative inability to work and loss of profit due to the disruption in the on-going work over a large panel of different Collective Agreements. Limitations The ATIH cost analysis dates back from 2011. Such a wide cost analysis is not organized each year. Fortunately, due to a very low inflation rate over this period these costs are still valid today. The ATIH analysis does not address the indirect costs, which were evaluated from the patients registered in the Hernia Club Registry. These two populations may slightly differ. For instance more laparoscopic repairs could have
been performed in the CH cohort, and more level 4 cases could be treated in the ATIH cohort. The difference, if it exists, may have a slight impact because the relative financial weight of the level 4 is not prominent (Table 3). The indirect costs, mainly for unemployed patients, are probably slightly underestimated: Unemployed and elderly patients may have spent some of their recovery in convalescent homes, for which costs could not be evaluated. Furthermore the Quality of Life is not a financial variable, so we could not evaluate in unemployed patients the cost of the daily life impairment during the sick leave. The costs of a redo surgery in case of recurrent IVHR, the costs of further medical care and work gaps in case of complications such as chronic pain were also not taken into account. It would have been helpful to split the cost analysis between open and laparoscopic repairs. Unfortunately due to the lack of specific GHM (DRG) in this financial and not medical ATIH study we could not assess the specific costs of the laparoscopic repairs. This becomes more relevant as laparoscopic techniques continue to improve and more complex cases are being done in this fashion. This will have a direct effect on the direct cost of the procedure as laparoscopic consumables are more costly and the length of the procedure may be longer. This may be offset by the fact that laparoscopic procedures generally have a shorter length of stay and a quicker return to work. Moreover it is really difficult to briefly explain what the four levels of hernia repair are and how they differ. Levels are calculated using the National Health Care computerized device (groupeur) taking into account severity and combinations of the co-morbidities, the associated intra-hospital events (such as pulmonary embolism, cardiac failure), the length of stay out of the target; Not many surgical items are taken into account such as complications related to a previous mesh, bowel necrosis, or a bacteriologically proven deep infection. These items are annually updated and move: If one of these items has not got any financial relevance, it is withdrawn from the list. Therefore it is really difficult to briefly explain what these four levels are. We have used the best available data at our disposal to estimate the different components of the direct and indirect costs. Although we think the samples are representative they might not reflect the overall population of French patients undergoing incisional hernia repair, such as independent professionals, farmers, artisans, liberal professions whose social systems are different from those of employees. The economic evaluations are, a priori, difficult to extrapolate to other countries, because of variations in healthcare systems and financing, the changes in currencies and the inflation over time. Nevertheless the costs identified in the current study are very similar to those found in
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Sweden (9, 11–12). Therefore these costs seem representative for the cost of IVHR in Europe. In the United States direct costs (16), are significantly higher than those reported in this study.
Conclusion Our study shows that next to a considerable direct cost, also the indirect costs of incisional hernia repair have to be accounted for when calculating the potential benefit of preventive measures to decrease the rate of incisional hernias after abdominal wall incisions. Upcoming evidence on the efficacy and safety of mesh augmentation during closure of abdominal wall incisions in the prevention of incisional hernias shows an important potential to decrease the costs related to subsequent incisional hernia repair. Acknowledgments The authors would like to acknowledge the Bonham Group and Hernia Club members (see appendix) and Guy Gravet (GG), a specialized accountant, for helping them in the estimation of the indirect costs. Compliance with ethical standards Conflict of interests None for this work: As President of the Hernia-Club and Organiser of the Mesh Congress, JFG has financial partnerships with a number of companies. However, he received no personal funding for this study. The Hernia-Club is an independent scientific institution whose objective is to assess the use of different procedures and prostheses for hernia repair. It therefore has relationships with a number of companies with an interest in independent evaluation of their products.
Appendix A: Members of the Bonham Group * F.E. Muysoms Head of the Department of Abdominal Surgery, AZ Maria Middelares, Ghent, Belgium * J-F. Gillion Unite´ de Chirurgie Visce´rale et Digestive, Hoˆpital Prive´ d’Antony, France * D.L. Sanders Department of Surgery, Derriford Hospital, Plymouth, United Kingdom * M. Miserez Department of Abdominal Surgery, University Hospitals, KU Leuven, Belgium * S.A. Antoniou 1,2 1 Center for Minimally Invasive Surgery, Neuwerk Hospital, Mo¨nchengladbach, Germany 2 Department of General Surgery, University Hospital of Heraklion, University of Crete, Greece * K. Bury
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Department of Cardiac and Vascular Surgery, Medical University of Gdansk, Poland * G. Campanelli University of Insubria, General and day surgery, Center of research and high specialization for abdominal wall pathology and hernia repair, Istituto Clinico Sant’ Ambrogio, Milano, Italy * J. Conze UM Herniacentre, Munich and Department of General, Visceral and Transplantation Surgery, University Hospital of the RWTH Aachen, Aachen, Germany * D. Cuccurullo Department of General and Laparoscopic Surgery, Monaldi Hospital, Azienda Ospedaliera dei Colli, Naples, Italy *A.C. de Beaux Department of General Surgery, The Royal Infirmary of Edinburgh, Edinburgh, United Kingdom * E.B. Deerenberg Department of Sugery, Erasmus MC University Medical Center Rotterdam, Rotterdam, the Netherlands * B. East Department of Surgery, Second Faculty of Medicine, Charles University in Prague, Czech Republic * R.H. Fortelny Chief of the Hernia Center, Department of General, Visceral and Oncological Surgery, Wilhelminenspital, Vienna, Austria * N.A. Henriksen Digestive Disease Center, Bispebjerg Hospital and Department of Gastroenterology, Hvidovre Hospital, Copenhagen, Denmark * L. Israelsson Department of Surgery and Perioperative science, Umea˚ University, Umea˚, Sweden * A. Jairam Department of Sugery, Erasmus MC University Medical Center Rotterdam, Rotterdam, the Netherlands * A. Ja¨nes Head of Upper GI and Trauma Surgery, Department of Surgery, Sundsvall Hospital, Sundsvall, Sweden * J. Jeekel Department of Neurosciences, Erasmus MC University Medical Center Rotterdam, Rotterdam, the Netherlands * M. Lo´pez-Cano Abdominal Wall Surgery Unit, Hospital Universitario Vall d’Hebro´n. Universidad Auto´noma de Barcelona, Barcelona, Spain * S. Morales-Conde Chief of the Unit of Innovation in Minimally Invasive Surgery, University Hospital Virgen del Rocı´o, Seville, Spain * M.P. Simons
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Department of Surgery, Onze Lieve Vrouw Gasthuis, Amsterdam, The Netherlands * M. S´mietan´ski Department of General and Vascular Surgery, Ceynowa Hospital in Wejherowo, Poland * L. Venclauskas Lithuanian University of Health Sciences, Department of Surgery, Kaunas, Lithuania * F. Berrevoet Department of General and Hepatobiliary Surgery and Liver Transplantation Service, University Hospital Ghent, Belgium
Appendix B: Members of the Hernia Club Ain J-F: Polyclinique Val de Saone, Macon, France Beck M: Clinique Ambroise Pare´, Thionville, France Barrat C: Hoˆpital Universitaire Jean Verdier, Bondy, France Berney C: Bankstown-Lidcombe Hospital, Sydney, Australia Berrot J-L: Groupe Hospitalier Paris St Joseph, Paris, France Binot D: MCO Coˆte d’Opale, Boulogne sur Mer, France Blazquez D: Clinique Jeanne d’Arc, Paris, France Bonan A: Hoˆpital Prive´ d’Antony, Antony, France Cas O: Centre Me´dico Chirurgical–Fondation WALLERSTEIN, Are`s, France Dabrowski A: Clinique de Saint Omer, Saint Omer, France Champault-Fezais A: Groupe Hospitalier Paris St Joseph, Paris, France Chastan P: Bordeaux, France Cardin J-L: Polyclinique du Maine, Laval, France Chollet J-M: Hoˆpital Prive´ d’Antony, Antony, France Cossa J-P: CMC Bizet, Paris, France Durou J: Clinique de Villeneuve d’Ascq, Villeneuve d’Ascq, France Dugue T: Clinique de Saint Omer, Saint Omer, France Faure J-P: CHRU Poitiers, Poitiers, France Framery D: CMC de la Baie de Morlaix, Morlaix, France Fromont G: Clinique de Bois Bernard, Bois Bernard, France Gainant A: CHRU Limoges, Limoges, France Gauduchon L: CHRU Amiens, France Gillion J-F: Hoˆpital Prive´ d’Antony, Antony, France Jacquin C: CH du Prado, Marseille, France Jurczak F: Clinique Mutualiste, Saint Nazaire, France Khalil H: CHRU Rouen, Rouen, France Lacroix A: CH de Auch, Auch, France Ledaguenel P: Clinique Tivoli, Bordeaux, France
Lepe`re M: Clinique Saint Charles, La Roche-sur-Yon, France Letoux N: Clinique Jeanne d’Arc, Paris, France Loriau J: Groupe Hospitalier Paris St Joseph, Paris Magne E: Clinique Tivoli, Bordeaux, France Ngo P: Hoˆpital Ame´ricain, Neuilly, France Paterne D: Clinique Tivoli, Bordeaux, France Pavis d’Escurac X: Strasbourg, France Renard Y: CHRU Reims, Reims, France Soler M: Polyclinique Saint Jean, Cagnes-sur-Mer, France Rignier P: Polyclinique des Bleuets. Reims Roos S: Clinique Claude Bernard, Albi, France Thillois J-M: Hoˆpital Prive´ d’Antony, Antony, France Tiry P: Clinique de Saint Omer, Saint Omer, France Zaranis C: Clinique de la Rochelle, La Rochelle, France
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