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Erschienen in: Surgical Endoscopy 3/2017

Open Access 15.07.2016

Health economic analysis of costs of laparoscopic and open surgery for rectal cancer within a randomized trial (COLOR II)

verfasst von: Jacob Gehrman, Ingela Björholt, Eva Angenete, John Andersson, Jaap Bonjer, Eva Haglind

Erschienen in: Surgical Endoscopy | Ausgabe 3/2017

Abstract

Background

Previous studies regarding the comparative costs of laparoscopic and open surgery for rectal cancer provide ambiguous conclusions, and there are no large randomized trials or long-term follow-up.

Methods

A prospective cost-minimization analysis was carried out by using data of clinical resource use from the randomized controlled trial COLOR II. Some data needed for the health economic evaluation were not collected in the clinical trial; therefore, a retrospective data collection was made for COLOR II-patients operated at the largest participating Swedish hospital (n = 105). Sick leave information was provided by the Swedish social insurance agency. Unit costs were collected from Swedish sources. The primary outcome was the difference in mean cost between laparoscopic and open surgery.

Results

The COLOR II-trial enrolled 1044 rectal cancer patients randomized between laparoscopic and open surgery 2:1. At the 3-year follow-up data for the clinical variables used in the analysis were available for 74–89 % of patients. Laparoscopic surgery costs the health care sector more than the open technique, both at 28 days ($1910, 95 % CI 677–3143) and 3 years ($3854, 95 % CI 1527–6182) after surgery. There were, however, no differences in long-term costs to society between laparoscopic and open surgery ($684, 95 % CI −5799 to 7166).

Conclusions

Though the study found short- and long-term cost differences for the healthcare sector, there was no difference in regard to the long-term societal perspective. Future research is suggested to investigate the effects of sick leave costs using material from a greater number of patients.

Background

Several smaller series and one large randomized trial, the COLOR (COlorectal cancer Laparoscopic or Open Resection) II-trial [1], have shown that laparoscopic surgery for rectal cancer has short-term benefits and is safe in comparison to open surgery. The short-term outcomes of the COLOR II-trial found that the laparoscopic group had less blood loss and a shorter hospital stay, but longer operating room time [2]. The analysis of the primary endpoint showed no difference with regard to loco-regional recurrence rates. There was no statistically significant difference in 3-year survival between the surgical procedures [3]. The study continues to monitor the disease-free and overall survival rates 5 years after surgery. The short-term outcomes of the ACOSOG Z6051 [4] and ALaCaRT [5] randomized clinical trials of laparoscopic and open rectal cancer resections failed to establish non-inferiority in terms of the pathological and adequate surgical resection outcomes. These trials have, however, used other endpoints, both are short-term and the group sizes are such that clinically relevant long-term oncological results cannot be ascertained.
Uncertainties remain regarding the relative costs of laparoscopic and open rectal cancer surgery. Several studies performed alongside randomized trials comparing the costs of laparoscopic and open surgery for rectal cancer have had short time perspectives [69] or have not included the cost of sick leave [810]; the results are difficult to interpret from a societal viewpoint.
The aim of the present study was to evaluate the cost of laparoscopic versus open resection for rectal cancer from both the healthcare and the societal perspective, based on the randomized COLOR II-trial. The health economic method employed was a cost-minimization analysis (see health economic methodology). The costs were assessed at 28 days (short-term analysis) and 3 years (long-term analysis). The hypothesis was that laparoscopic surgery would be more costly when assessed at 28 days after the primary operation but not at 3 years.

Materials and methods

The COLOR II-trial

The COLOR II-trial provided the clinical data for the present cost study [11]. The study was designed as a non-inferiority trial undertaken at thirty hospitals in eight countries (Belgium, Canada, Denmark, Germany, the Netherlands, Spain, Sweden and South Korea) between January 2004 and May 2010 [11]. The patients were randomized on a 2:1 basis, 699 patients in the laparoscopic resection group and 345 in the open resection group. The trial was stratified by center, location of tumor and radiotherapy prior to surgery [2, 11]. During the course of the trial, clinical record forms (CRF) were administered, one each for the pre-, intra- and postoperative stages (up to 28 days after the operation) and one CRF per year up to 5 years after the index surgery. In case of complications, reoperations or recurrences an additional CRF was completed. At the primary endpoint data were available for 771 patients (74 %) regarding loco-regional recurrence and for 903 patients (87 %) concerning overall survival [3]. The institutional review board at each participating center approved the trial. All patients provided informed consent in writing.

Health economic methodology

Health economic evaluations such as cost-effectiveness analysis are based on the incremental cost for an incremental unit of a clinically relevant outcome (mortality or morbidity) or a QALY (quality-adjusted life-years) as a measure of treatment or program effectiveness [12]. Survival and health-related quality of life [13, 14] were not statistically different in COLOR II (N.B. non-inferiority trial), and consequently a cost-minimization rather than a cost-effectiveness analysis was appropriate for the analysis [15]. This method implies a comparison of the costs for treatment alternatives that achieve a common outcome to an equal degree [12]. The rationale for the included cost components in the present study is outlined in more detail in Björholt et al. [16]
The cost analysis comprises the health care and the societal perspective, where the latter adds the cost of sick leave to the direct healthcare cost. The study period was set from inclusion into the clinical trial up to 3 years postoperatively, including the short- and long-term clinical endpoints of the COLOR II-study. Censoring and missing data can cause bias in economic studies conducted alongside clinical trials [17]. In this trial, the return rate of clinical record forms was high and it was assumed from a clinical perspective that censored patients and patients with missing data would not differ from non-censored patients and patients with complete data in the aspects affecting cost. One-way sensitivity analysis was employed to challenge the impact of variables sensitive to censoring mechanisms and missing data, i.e., reoperation, stoma care and sick leave. The analysis shows how the difference in mean cost between the surgical techniques is affected by changes (±30 %) in cost per variable for each procedure.

Data collection

Resource use

Data on resource use were collected prospectively through CRF’s in the COLOR II-trial. Details of the use of resources that were needed for this study, but had not been collected within the trial (basic laparoscopic equipment, surgical instruments, anesthesia time and time in recovery room), were determined using other sources.
The basic equipment required for laparoscopic surgery, as well as the type and quantity of instruments required for laparoscopic and open surgery, was determined by conclusions drawn from the health economic evaluation of laparoscopic versus open colon cancer resection within the framework of the randomized trial COLOR [18] and in collaboration with senior surgeons. Data regarding duration of anesthesia and time in the recovery room were collected from the records of COLOR II-patients operated on at the Sahlgrenska University Hospital in Sweden (n = 105). The factor between time in anesthesia and skin-to-skin time was established for the Sahlgrenska patients and applied on all COLOR II-patients. The average time in the recovery room for COLOR II-patients operated on at Sahlgrenska University Hospital was extrapolated to all study participants.
Sick leave was retrieved from the Swedish Social Insurance Agency for Swedish COLOR II-patients, and the observed average number of days on sick leave per surgical technique was calculated. To be able to analyze the total cost at the patient level, the average number of sick leave days per surgical technique observed in the Swedish cohort was applied to the non-Swedish COLOR II-population using random selection. It was ascertained that the proportion of patients on sick leave in the Swedish cohort, and the non-Swedish COLOR II-populations was the same.

Unit costs

Unit costs for basic equipment and surgical instruments were obtained from regional procurement records in Region Västra Götaland, Sweden. The cost per minute in the operating room, time in anesthesia and time in the recovery room were derived from the health economic evaluation of laparoscopic versus open surgery in the COLOR trial [18]. The unit costs for consumables related to stoma care were obtained from pharmacy retail prices in Sweden. The Swedish cost per patient database contains cost data for approximately 70 % of inpatient care in Sweden. The unit cost per type of reoperation in this study was estimated by taking the average cost for the matching procedure in the cost per patient database. Therefore, the cost per reoperation was based on a larger sample which reduced the potential variability in resource use of these rare and costly events. It was assumed that the type of reoperation was unrelated to the original surgical technique, as no significant differences in complications or re-operations were found in the COLOR II-study [2].
The cost of sick leave was calculated by using the average monthly wage (provided by Statistics Sweden) with addition of the social security and supplementary pension fees. All prices were inflation adjusted for 2013 SEK using the consumer price index provided by Statistics Sweden. Costs were converted from SEK to the average value of the US dollar in 2013 ($1 = 6.51 SEK).

Statistical methods

The distribution of cost data is non-negative and right skewed due to the low number of patients incurring particularly high costs, a common phenomenon in studies involving resource items with high unit costs such as hospital care, reoperations and sick leave. The average cost will consequently be higher than the cost of the average patient, but it is still meaningful as it enables the calculation of the total cost of treating all patients with the new therapy [17]. Due, however, to the central limit theorem statistical inference based on the normality assumption regarding average cost is valid despite the skewed distribution. A non-parametric bootstrap was included as a robustness check of the results [19].

Results

For the health economic study, 699 patients in the laparoscopic group and 345 in the open group were available for analysis (Fig. 1). Information relevant for the short-term outcomes of the study was available for between 98 and 100 % of the patients. Concerning the long-term analysis data were available for 74–89 % of the patients. The baseline clinical characteristics (Table 1) were not significantly different between laparoscopic and open resection. The resource use and the corresponding unit costs associated with each treatment are shown in Tables 2 and 3, respectively. Table 4 displays the mean cost per resource use category and treatment, and Table 5 shows the difference in means and the main outcome of the study. The bootstrap method did not affect the p value for any of the results in Table 5, but the confidence intervals became narrower.
Table 1
Baseline clinical characteristics and pathology
Characteristics
Laparoscopic surgery (n = 699)
Open surgery (n = 345)
Gender, no. (%)
 Male
448/699 (64)
211/345 (61)
 Female
251/699 (36)
134/345 (39)
Age, mean (SD), years
66.8 (10.5)
65.8 (10.9)
American Society of Anesthesiologists classification, no. (%)
 I
156/678 (23)
65/338 (19)
 II
386/678 (57)
211/338 (62)
 III
131/678 (19)
61/338 (18)
 IV
5/678 (<1)
1/338 (<1)
 Missing data
21/699 (3)
7/345 (2)
Body-mass index, mean (SD), kg/m2
26.1 (4.5)
26.5 (4.7)
Location of tumor (distance from anal verge), no. (%)
 Upper rectum (10–15 cm)
223/699 (32 %)
116/345 (34)
 Middle rectum (5–10 cm)
273/699 (39 %)
136/345 (39)
 Lower rectum (<5 cm)
203/699 (29 %)
93/345 (27)
Clinical stage, no. (%)
 I
201/667 (30)
96/329 (29)
 II
209/667 (31)
107/329 (33)
 III
257/667 (38)
126/329 (38)
 Missing data
32/699 (5)
16/345 (5)
Table 2
Clinical resource use
Type of resource
Laparoscopic surgery (n = 699)
Open surgery (n = 345)
Source
Basic laparoscopic equipment, no (%)
699 (100)
0 (0)
COLOR II
Surgical instruments, no (%)a
  
COLOR II
 TME
396/699 (57)
219/345 (63)
 
 Other (APR, PME)
294/699 (42)
126/345 (37)
 
 Missing
9/699 (1)
0/345 (0)
 
Skin-to-skin time, min
247 (83)
200 (69)
COLOR II
Time in anesthesia, minb
306 (104)
256 (89)
Subset of COLOR II-patients
Time in recovery room, minb,c
992 (N/A)
1054 (N/A)
Subset of COLOR II- patients
Length of hospital stay < 28 days, days
11.5 (6.5)
12.1 (6.0)
COLOR II
Length of hospital stay < 3 years, days
12.8 (11.5)
13.4 (11.0)
COLOR II
Days with ileostomy < 28 days, days
10.5 (13.5)
10.8 (13.6)
COLOR II
Days with ileostomy < 3 years, days
91 (182)
80 (139)
COLOR II
Days with colostomy < 28 days, days
9.7 (13.2)
8.1 (12.6)
COLOR II
Days with colostomy < 3 years, days
363 (502)
281 (461)
COLOR II
No. (%) of patients with reoperation < 28 days
  
COLOR II
No
588/697 (84)
299/345 (87)
 
Yes
109/697 (16)
46/345 (13)
 
No. (%) of patients with reoperation < 3 years
  
COLOR II
 No
459/697 (66)
240/345 (70)
 
 Yes
238/697 (34)
105/345 (30)
 
Reasons for reoperation (< 3 years)d
  
COLOR II
Recurrence
28
14
 
Complication
217
89
 
Stoma reversal
68
28
 
Complication and new stoma
48
21
 
Not related to rectal surgery
10
7
 
Sick leave < 28 days, dayse
6.2 (11.6)
6.4 (11.8)
Swedish Social Insurance Agency
Sick leave < 3 years, dayse
75 (137)
86 (157)
Swedish Social Insurance Agency
Values are mean (standard deviation) unless stated otherwise
aTME-Resection with total mesorectal excision, APR-Abdominoperineal resection, PME-Resection with partial mesorectal excision. Described in more detail in van der Pas et al. [2]. A set of surgical instruments used for open and laparoscopic TME and non-TME was determined in collaboration with senior surgeons. The number of TME and non-TME was collected from the COLOR II-trial
bCollected within the Swedish cohort of COLOR II operated at the Sahlgrenska University Hospital, Gothenburg
cThe mean value of time in recovery room in the Swedish cohort and in the global study population all patients were assigned these mean values, i.e., std. dev. not possible to calculate
dLong-term data (< 3 years) from RCT COLOR II previously not published. Several patients have had more than one reoperation collected within the Swedish cohort of COLOR II only
eCollected within the Swedish cohort of COLOR II only
Table 3
Unit costs
Resource use category
Unit cost (USD)
Unit
Source
Basic laparoscopic equipment
281
Per laparoscopic resection
Region Västra Götaland, Sweden
Surgical instrumentsa
  
Region Västra Götaland, Sweden
 Open TME
931
Per open TME
 
 Laparoscopic TME
2101
Per laparoscopic TME
 
 Open non-TME
784
Per open non-TME
 
 Laparoscopic non-TME
1779
Per laparoscopic non-TME
 
Skin-to-skin time
11
Per minute
Janson et al. 2004
Duration of anesthesia
5
Per minute
Janson et al. 2004
Time in recovery room
1
Per minute
Janson et al. 2004
Length of hospital stay
531
Per day
Janson et al. 2004
Ileostomy
12
Per day
Pharmacy sales price
Colostomy
18
Per day
Pharmacy sales price
Reoperationb
N/A
Per type of reoperation
Swedish association of local authorities and regions
Sick leave
303
Per day
Statistics Sweden
aTME-Resection with total mesorectal excision, APR-Abdominoperineal resection and PME-Resection with partial mesorectal excision. Described in more detail in van der Pas et al. [2]
bThe type of reoperation was collected within the COLOR II-trial. The unit cost per type of reoperation was collected from a national database (Swedish association of local authorities and regions) containing the costs for approximately 70 % of the Swedish in-patient episodes of care
Table 4
Mean cost and difference in mean cost per resource use category
Resource use category
Mean cost per patient/laparoscopic surgery (USD)
Mean cost per patient/open surgery (USD)
Difference in mean costs (USD)
Basic laparoscopic equipment
281 (0)
N/A
281 (N/A)
Surgical instruments
1964 (159)
878 (71)
1087 (7)
Skin-to-skin time
2676 (898)
2161 (750)
514 (53)
Duration of anesthesia
1545 (526)
1293 (451)
252 (32)
Time in recovery room
1074 (N/A)
1141 (N/A)
−67 (N/A)
Length of hospital stay
 28 days
6129 (3427)
6431 (3210)
−302 (221)
 3 years
6796 (6129)
7117 (5844)
−321 (398)
Stoma
 Ileostomy 28 days
124 (158)
127 (160)
−3,6 (10)
 Ileostomy 3 years
1070 (2142)
941 (1630)
129 (120)
 Colostomy 28 days
174 (238)
146 (227)
27 (15)
 Colostomy 3 years
6519 (9022)
5038 (8288)
1481 (578)
Reoperation
 28 days
2397 (7280)
2199 (7591)
198 (486)
 3 years
5902 (11,867)
5323 (11,580)
578 (775)
Sick leave
 28 days
1888 (3447)
1945 (3575)
−58 (230)
 3 years
22,793 (41,618)
25,964 (47,712)
−3171 (3014)
Values are mean (standard deviation), except difference in mean costs (standard error)
Table 5
Mean total cost and difference in mean total cost per surgical technique
Perspective and time of analysis
Mean total cost laparoscopic resection (USD)
Mean total cost open resection (USD)
Difference in mean total cost (95 % CI)
p value
Health care costs 28 days
Parametric
16,226 (10,140)
14,316 (10,361)
1910 (677 to 3143)
<0.002
Nonparametric (bootstrap)
  
1910 (685 to 3123)
<0.003
Health care costs 3 years
 Parametric
27,686 (46,198)
23,831 (51,993)
3854 (1527 to 6182)
<0.001
 Nonparametric (bootstrap)
  
3854 (1491 to 6053)
<0.001
Societal costs 28 days
 Parametric
18,113 (9524)
16,261 (9591)
1852 (533 to 3171)
<0.006
 Nonparametric (bootstrap)
  
1852 (391 to 3110)
<0.006
 Societal costs 3 years
 Parametric
50,479 (18,162)
49,795 (17,719)
684 (−5799 to 7166)
0.84
 Nonparametric (bootstrap)
  
684 (−5698 to 7255)
0.84
Values are mean (standard deviation) unless stated otherwise. Bootstrap confidence intervals and p values are based on 2000 replications

Healthcare perspective

The mean healthcare cost per patient (Table 5) during the 28 days following surgery was significantly higher in the laparoscopic group $16226 (SEK, 105694) than in the open group $14316 (SEK, 93253), yielding a difference of $1910 (SEK, 12440) (CI95 % 677–3143). Three years after surgery, this difference had increased to $3854 (SEK 25107) (CI95 % 1527–6182).

Societal perspective

From the societal perspective, the mean cost per patient (Table 5) at 28 days following surgery was significantly higher in the laparoscopic group $18113 (SEK, 117990) than in the open group $16261 (SEK 105926), with a difference of $1852 (SEK, 12063) (95 % CI 533–3171). Three years after surgery, the difference was not significant and had decreased to $684 (SEK, 4453) (95 % CI −5799 to 7166).

Sensitivity analyses

Sensitivity analyses can be found in Table 6. From the short-term healthcare and societal perspectives length of hospital stay were the only variable demonstrating significant sensitivity (difference in mean cost became negative) to the variation of the base case value. Long-term societal costs were affected by the number of days on sick leave.
Table 6
Sensitivity analyses
Perspective and time of analysis
Variable
Change in cost
Difference in mean (USD)
95 % CI
Health care costs 28 days
 
Base case cost
N/A
1910
677
3143
 
Skin-to-skin time
Lap −30 %
1103
−125
2330
  
Lap +30 %
2671
1430
3912
  
Open −30 %
2524
1293
3755
  
Open +30 %
1250
13
2487
 
Length of hospital stay
Lap −30 %
79
−1097
1255
  
Lap +30 %
3740
2444
5037
  
Open −30 %
3839
2632
5046
  
Open +30 %
−19
−1282
1243
 
Colostomy
Lap −30 %
5970
2671
9269
  
Lap +30 %
1700
−1708
5108
  
Open −30 %
1853
−641
4348
  
Open +30 %
1927
−568
4422
 
Reoperation
Lap −30 %
1191
31
2350
  
Lap +30 %
2629
1299
3958
  
Open −30 %
2570
1505
3634
  
Open +30 %
1250
−180
2679
Health care costs 3 years
 
Base case cost
N/A
3854
1527
6182
 
Length of hospital stay
Lap −30 %
1824
−413
4061
  
Lap +30 %
5884
3455
8314
  
Open −30 %
5989
3706
8272
  
Open +30 %
1719
−658
4097
 
Reoperation
Lap −30 %
2084
−115
4283
  
Lap +30 %
5625
3181
8068
  
Open −30 %
5451
3365
7538
  
Open +30 %
2257
−308
4823
Societal costs 28 days
 
Base case cost
N/A
1852
533
3171
 
Surgical instruments
Lap −30 %
1269
−50
2588
  
Lap +30 %
2435
1115
3755
  
Open −30 %
2115
796
3434
  
Open +30 %
1589
269
2908
 
Skin-to-skin time
Lap −30 %
1124
−102
2351
  
Lap +30 %
2695
1455
3935
  
Open −30 %
2547
1316
3777
  
Open +30 %
1273
37
2509
 
Length of hospital stay
Lap −30 %
21
−1244
1286
  
Lap +30 %
3683
2302
5063
  
Open −30 %
3781
2486
5076
  
Open +30 %
−77
−1424
1270
 
Reoperation
Lap −30 %
1133
−126
2391
  
Lap +30 %
2571
1155
3987
  
Open −30 %
2512
1344
3679
  
Open +30 %
1192
−321
2705
 
Sick leave
Lap −30 %
1286
−7
2579
  
Lap +30 %
2418
1064
3772
  
Open −30 %
2436
1132
3740
  
Open +30 %
1268
−71
2607
Societal costs 3 years
 
 Base case cost
N/A
684
−5799
7166
 
 Skin-to-skin time
Lap −30 %
3069
749
5389
  
Lap +30 %
4640
2305
6974
  
Open −30 %
4491
2189
6794
  
Open +30 %
3217
887
5548
 
 Sick leave
Lap −30 %
−6154
−12,241
−67
  
Lap +30 %
7522
541
14,502
  
Open −30 %
8473
3121
13,825
  
Open +30 %
−7106
−14,852
641
Lap Laparoscopic resection, open open resection

Additional sensitivity analysis

The incidence of colostomy had considerable impact on the study result and so did the number of days on sick leave. A detailed analysis of the data showed that patients in the open surgery group were older, and therefore, fewer were eligible for sick leave compared with patients in the laparoscopic group. Numerically more patients on sick leave in the laparoscopic group died earlier compared to the open group which resulted in a lower cost of sick leave in the laparoscopic group. As survival did not significantly differ between the groups, this was most likely a random finding due to sick leave only having been examined in a small sub-group of the COLOR II-trial. The mean number of days with a colostomy was higher in the laparoscopic group, partly due to numerically more laparoscopic patients subject to abdominoperineal resection at the index operation and partly due to longer survival time in the sub-group of colostomy patients in the laparoscopic group. Additional sensitivity analyses were, therefore, performed and the results showed that excluding the costs of stoma material the difference in mean cost per patient to the health care sector ($1886, 95 % CI 657–3115) (SEK, 12286) was similar to the base case analysis at 28 days after the index surgery. At 3 years the difference in mean health care cost per patient ($2245, 95 % CI 270–4219) (SEK, 14621) was lower compared to the base case analysis ($3854). Laparoscopic surgery was numerically less costly per patient for society than open surgery −$926 (SEK, −6034) (95 % CI −7261 to 5409) at 3 years after primary operation. In the short time perspective, it made little difference ($1828, 95 % CI 513–3144) (SEK, 11909).

Discussion

This health economic evaluation of laparoscopic and open surgery for rectal cancer in the framework of the randomized trial COLOR II showed that laparoscopy was significantly more costly from the societal perspective at 28 days, but no statistical significance was detected at 3 years. From a healthcare perspective, laparoscopy was more costly than open surgery at both 28 days and 3 years.
The one-way sensitivity analyses showed that variations in sick leave and the incidence and days with colostomy had a large impact on the results. Data on sick leave were elicited for the Swedish sub-group only (n = 251), which increased the risk of random findings. This is a common problem for costly resource use items that may vary without relation to the studied interventions. In this study, the finding was a disadvantage to the results in the open surgery group. On the other hand, patients with a cancer in the lowest part of the rectum, who received a colostomy due to abdominoperineal resection, lived longer (n.s.) and were numerically more frequent in the laparoscopic group [3]. Since colostomies are costly and a longer follow-up time involves further costs, this was a disadvantage for the laparoscopic group. The additional sensitivity analyses confirmed that when stoma costs were deducted from the health care costs, the difference in mean cost per patient was reduced. For the long-term societal costs, the difference (laparoscopic minus open surgery) in mean cost per patient changed from $684 (base case) to -$926 (n.s.).
There are few findings about the cost of rectal cancer surgery and they are divergent. Franks et al. [6] reported on a randomized trial including the initial 3 months after index surgery and found no significant difference in societal costs between open and laparoscopic surgery, but the time chosen for their analysis differs from that of our analysis and the number of patients were fewer in their study. Son et al. [8] found statistically significant higher median costs for laparoscopic rectal resection compared to open, utilizing data for a cohort of a randomized trial. Using median costs makes it difficult to compare it to the results of the present study, since our results present mean costs. Their health economic evaluation covered the first three postoperative months and healthcare costs only, whereas our analysis covers 3 years and includes societal costs.
The results from the societal perspective in this trial correspond to those from the earlier trial of laparoscopic versus open surgery for colon cancer (COLOR) [18], although the time frame was shorter in that study. Three previous studies have reported the cost of sick leave after colorectal cancer. In Franks et al. [6], the average cost of sick leave after rectal cancer surgery was higher in the laparoscopic than in the open resection group (the difference in average cost was £103 95 % CI £−576 to £368). King et al. [7] reported the difference in average cost of productivity loss between laparoscopic and open resection of colorectal cancer within an enhanced recovery program to be £274 (bootstrap CI at 2.5 and 97.5 %, −386 to 983.2) less in the laparoscopic resection group. In a recent study by Crawshaw et al. [20], the difference in sick leave after colectomy was estimated to be on average 2.78 (95 % CI 1.93–3.59) days longer in the open resection group than in the laparoscopic resection group. That study was retrospective and based on national health insurance claims in USA. They evaluated health care utilization up to 1 year after primary operation and found the mean cost to be lower following laparoscopic surgery. Our study has a longer time perspective (3 years) and is based on a randomized controlled trial.
In the present study, the length of hospital stay was considerable in both groups, although 1 day shorter (median) in the laparoscopic group. The trial protocol prescribed that the same local principles for discharge should be applied for both groups and did not include the enhanced recovery after surgery (ERAS) concept [21]. The difference in hospital stay, however, between laparoscopic and open colorectal surgery is consistent with studies including enhanced recovery programs [22, 23]. The sensitivity analyses conducted in the present study indicated a potential for cost saving if length of hospital stay can be shortened. In one study, King et al. [7] evaluated the costs following laparoscopic and open surgery after colorectal cancer surgery within an enhanced recovery program and found a difference in mean cost of £354 (95 % CI −2 167 to 2 992) favoring laparoscopic surgery.
The strengths of our study include that it is based on clinical results from a large randomized trial with a multicenter design and that the principles for the health economic analysis were outlined before the start of the randomized trial. Thus, the clinical record forms included variables of importance for the economic analysis. The study also had a high rate of returned clinical record forms.
A limitation is that the present health economic analysis was a secondary objective within the randomized trial COLOR II and the sample size, thus, not calculated for the health economic outcomes. Further, some of the resource units are for a sub-group of patients of the COLOR II-trial, which adds to the uncertainty of these variables.
In conclusion, laparoscopic surgery for rectal cancer is more costly than open surgery from the health care perspective. It is important, however, that the cost of sick leave is taken into account to ensure inclusion of all costs arising as a consequence of the surgical method chosen. In the present study, sick leave was investigated in the Swedish cohort only which was too small to detect a true difference between the treatments. Future research is suggested to investigate the sick leave costs of rectal cancer surgery.

Acknowledgments

The authors are thankful to RN. Sofia Erestam (Sahlgrenska University Hospital/Östra, Gothenburg, Sweden) for help regarding collection of data.

Funding/Support

The study was supported by the Swedish Cancer Society (2013/497), Sahlgrenska University Hospital (ALF Grant 2014-4307771), Assar Gabrielsson Foundation, Alice Swenson Foundation, Gothenburg Medical Society, Anna-Lisa and Bror Björnsson Foundation and Axel Linders Foundation.

Compliance with ethical standards

Disclosures

Dr. Andersson reports grants from Assar Gabrielsson Foundation, Alice Swenson Foundation, Gothenburg Medical Society, Anna-Lisa and Bror Björnsson Foundation and Axel Linders Foundation, during the conduct of the study. Dr. Bonjer reports personal fees from Olympus, Stryker, Medtronic and Applied medical, outside the submitted work. Dr. Haglind reports grants from Swedish Cancer Society (2013/497) and Sahlgrenska University Hospital (ALF grant 2014-4307771) during the conduct of the study and grants from Swedish Research Council and Västra Götaland region outside the submitted work. Drs. Angenete, Björholt and Gehrman have no conflicts of interest or financial ties to disclose.
Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://​creativecommons.​org/​licenses/​by/​4.​0/​), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.

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Literatur
2.
Zurück zum Zitat van der Pas MH, Haglind E, Cuesta MA, Furst A, Lacy AM, Hop WC, Bonjer HJ, Group COcLoORIS (2013) Laparoscopic versus open surgery for rectal cancer (COLOR II): short-term outcomes of a randomised, phase 3 trial. Lancet Oncol 14:210–218CrossRefPubMed van der Pas MH, Haglind E, Cuesta MA, Furst A, Lacy AM, Hop WC, Bonjer HJ, Group COcLoORIS (2013) Laparoscopic versus open surgery for rectal cancer (COLOR II): short-term outcomes of a randomised, phase 3 trial. Lancet Oncol 14:210–218CrossRefPubMed
3.
Zurück zum Zitat Bonjer HJ, Deijen CL, Abis GA, Cuesta MA, van der Pas MH, de Lange-de Klerk ES, Lacy AM, Bemelman WA, Andersson J, Angenete E, Rosenberg J, Fuerst A, Haglind E, Group CIS (2015) A randomized trial of laparoscopic versus open surgery for rectal cancer. N Engl J Med 372:1324–1332CrossRefPubMed Bonjer HJ, Deijen CL, Abis GA, Cuesta MA, van der Pas MH, de Lange-de Klerk ES, Lacy AM, Bemelman WA, Andersson J, Angenete E, Rosenberg J, Fuerst A, Haglind E, Group CIS (2015) A randomized trial of laparoscopic versus open surgery for rectal cancer. N Engl J Med 372:1324–1332CrossRefPubMed
4.
Zurück zum Zitat Fleshman J, Branda M, Sargent DJ, Boller AM, George V, Abbas M, Peters WR Jr, Maun D, Chang G, Herline A, Fichera A, Mutch M, Wexner S, Whiteford M, Marks J, Birnbaum E, Margolin D, Larson D, Marcello P, Posner M, Read T, Monson J, Wren SM, Pisters PW, Nelson H (2015) Effect of laparoscopic-assisted resection vs open resection of stage II or III rectal cancer on pathologic outcomes: the ACOSOG Z6051 randomized clinical trial. JAMA 314:1346–1355CrossRefPubMedPubMedCentral Fleshman J, Branda M, Sargent DJ, Boller AM, George V, Abbas M, Peters WR Jr, Maun D, Chang G, Herline A, Fichera A, Mutch M, Wexner S, Whiteford M, Marks J, Birnbaum E, Margolin D, Larson D, Marcello P, Posner M, Read T, Monson J, Wren SM, Pisters PW, Nelson H (2015) Effect of laparoscopic-assisted resection vs open resection of stage II or III rectal cancer on pathologic outcomes: the ACOSOG Z6051 randomized clinical trial. JAMA 314:1346–1355CrossRefPubMedPubMedCentral
5.
Zurück zum Zitat Stevenson AR, Solomon MJ, Lumley JW, Hewett P, Clouston AD, Gebski VJ, Davies L, Wilson K, Hague W, Simes J (2015) Effect of laparoscopic-assisted resection vs open resection on pathological outcomes in rectal cancer: the ALaCaRT randomized clinical trial. JAMA 314:1356–1363CrossRefPubMed Stevenson AR, Solomon MJ, Lumley JW, Hewett P, Clouston AD, Gebski VJ, Davies L, Wilson K, Hague W, Simes J (2015) Effect of laparoscopic-assisted resection vs open resection on pathological outcomes in rectal cancer: the ALaCaRT randomized clinical trial. JAMA 314:1356–1363CrossRefPubMed
6.
Zurück zum Zitat Franks PJ, Bosanquet N, Thorpe H, Brown JM, Copeland J, Smith AM, Quirke P, Guillou PJ (2006) Short-term costs of conventional vs laparoscopic assisted surgery in patients with colorectal cancer (MRC CLASICC trial). Br J Cancer 95:6–12CrossRefPubMedPubMedCentral Franks PJ, Bosanquet N, Thorpe H, Brown JM, Copeland J, Smith AM, Quirke P, Guillou PJ (2006) Short-term costs of conventional vs laparoscopic assisted surgery in patients with colorectal cancer (MRC CLASICC trial). Br J Cancer 95:6–12CrossRefPubMedPubMedCentral
7.
Zurück zum Zitat King PM, Blazeby JM, Ewings P, Franks PJ, Longman RJ, Kendrick AH, Kipling RM, Kennedy RH (2006) Randomized clinical trial comparing laparoscopic and open surgery for colorectal cancer within an enhanced recovery programme. Br J Surg 93:300–308CrossRefPubMed King PM, Blazeby JM, Ewings P, Franks PJ, Longman RJ, Kendrick AH, Kipling RM, Kennedy RH (2006) Randomized clinical trial comparing laparoscopic and open surgery for colorectal cancer within an enhanced recovery programme. Br J Surg 93:300–308CrossRefPubMed
8.
Zurück zum Zitat Son HJ, Lee HY, Park JW, Choi HS, Jeong SY, Oh JH (2013) Cost-comparison of laparoscopic and open surgery for mid or low rectal cancer after preoperative chemoradiotherapy: data from a randomized controlled trial. World J Surg 37:214–219CrossRefPubMed Son HJ, Lee HY, Park JW, Choi HS, Jeong SY, Oh JH (2013) Cost-comparison of laparoscopic and open surgery for mid or low rectal cancer after preoperative chemoradiotherapy: data from a randomized controlled trial. World J Surg 37:214–219CrossRefPubMed
9.
Zurück zum Zitat Leung KL, Kwok SPY, Lam SCW, Lee JFY, Yiu RYC, Ng SSM, Lai PBS, Lau WY (2004) Laparoscopic resection of rectosigmoid carcinoma: Prospective randomised trial. Lancet 363:1187–1192CrossRefPubMed Leung KL, Kwok SPY, Lam SCW, Lee JFY, Yiu RYC, Ng SSM, Lai PBS, Lau WY (2004) Laparoscopic resection of rectosigmoid carcinoma: Prospective randomised trial. Lancet 363:1187–1192CrossRefPubMed
10.
Zurück zum Zitat Braga M, Frasson M, Vignali A, Zuliani W, Capretti G, Di Carlo V (2007) Laparoscopic resection in rectal cancer patients: outcome and cost-benefit analysis. Dis Colon Rectum 50:464–471CrossRefPubMed Braga M, Frasson M, Vignali A, Zuliani W, Capretti G, Di Carlo V (2007) Laparoscopic resection in rectal cancer patients: outcome and cost-benefit analysis. Dis Colon Rectum 50:464–471CrossRefPubMed
11.
Zurück zum Zitat Color IISG, Buunen M, Bonjer HJ, Hop WC, Haglind E, Kurlberg G, Rosenberg J, Lacy AM, Cuesta MA, D’Hoore A, Furst A, Lange JF, Jess P, Bulut O, Poornoroozy P, Jensen KJ, Christensen MM, Lundhus E, Ovesen H, Birch D, Iesalnieks I, Jager C, Kreis M, van Riet Y, van der Harst E, Gerhards MF, Bemelman WA, Hansson BM, Neijenhuis PA, Prins HA, Balague C, Targarona E, Lujan Mompean JA, Franco Osorio JD, Garcia Molina FJ, Skullman S, Lackberg Z, Kressner U, Matthiessen P, Kim SH, Poza AA (2009) COLOR II. A randomized clinical trial comparing laparoscopic and open surgery for rectal cancer. Dan Med Bull 56:89–91 Color IISG, Buunen M, Bonjer HJ, Hop WC, Haglind E, Kurlberg G, Rosenberg J, Lacy AM, Cuesta MA, D’Hoore A, Furst A, Lange JF, Jess P, Bulut O, Poornoroozy P, Jensen KJ, Christensen MM, Lundhus E, Ovesen H, Birch D, Iesalnieks I, Jager C, Kreis M, van Riet Y, van der Harst E, Gerhards MF, Bemelman WA, Hansson BM, Neijenhuis PA, Prins HA, Balague C, Targarona E, Lujan Mompean JA, Franco Osorio JD, Garcia Molina FJ, Skullman S, Lackberg Z, Kressner U, Matthiessen P, Kim SH, Poza AA (2009) COLOR II. A randomized clinical trial comparing laparoscopic and open surgery for rectal cancer. Dan Med Bull 56:89–91
12.
Zurück zum Zitat Drummond MF, Sculpher MJ, Torrance GW, O’Brien BJ, Stoddart GL (2005) Methods for the economic evaluation of health care programmes, 3rd edn. Oxford University Press, Oxford Drummond MF, Sculpher MJ, Torrance GW, O’Brien BJ, Stoddart GL (2005) Methods for the economic evaluation of health care programmes, 3rd edn. Oxford University Press, Oxford
13.
Zurück zum Zitat Andersson J, Abis G, Gellerstedt M, Angenete E, Angeras U, Cuesta MA, Jess P, Rosenberg J, Bonjer HJ, Haglind E (2014) Patient-reported genitourinary dysfunction after laparoscopic and open rectal cancer surgery in a randomized trial (COLOR II). Br J Surg 101:1272–1279CrossRefPubMedPubMedCentral Andersson J, Abis G, Gellerstedt M, Angenete E, Angeras U, Cuesta MA, Jess P, Rosenberg J, Bonjer HJ, Haglind E (2014) Patient-reported genitourinary dysfunction after laparoscopic and open rectal cancer surgery in a randomized trial (COLOR II). Br J Surg 101:1272–1279CrossRefPubMedPubMedCentral
14.
Zurück zum Zitat Andersson J, Angenete E, Gellerstedt M, Angeras U, Jess P, Rosenberg J, Furst A, Bonjer J, Haglind E (2013) Health-related quality of life after laparoscopic and open surgery for rectal cancer in a randomized trial. Br J Surg 100:941–949CrossRefPubMedPubMedCentral Andersson J, Angenete E, Gellerstedt M, Angeras U, Jess P, Rosenberg J, Furst A, Bonjer J, Haglind E (2013) Health-related quality of life after laparoscopic and open surgery for rectal cancer in a randomized trial. Br J Surg 100:941–949CrossRefPubMedPubMedCentral
15.
Zurück zum Zitat Briggs AH, O’Brien BJ (2001) The death of cost-minimization analysis? Health Econ 10:179–184CrossRefPubMed Briggs AH, O’Brien BJ (2001) The death of cost-minimization analysis? Health Econ 10:179–184CrossRefPubMed
16.
Zurück zum Zitat Bjorholt I, Janson M, Jonsson B, Haglind E (2006) Principles for the design of the economic evaluation of COLOR II: An international clinical trial in surgery comparing laparoscopic and open surgery in rectal cancer. Int J Technol Assess Health Care 22:130–135CrossRef Bjorholt I, Janson M, Jonsson B, Haglind E (2006) Principles for the design of the economic evaluation of COLOR II: An international clinical trial in surgery comparing laparoscopic and open surgery in rectal cancer. Int J Technol Assess Health Care 22:130–135CrossRef
17.
Zurück zum Zitat Glick H, Doshi JA, Sonnad SS, Polsky D (2014) Economic evaluation in clinical trials, 2nd edn. Oxford University Press, Oxford Glick H, Doshi JA, Sonnad SS, Polsky D (2014) Economic evaluation in clinical trials, 2nd edn. Oxford University Press, Oxford
18.
Zurück zum Zitat Janson M, Bjorholt I, Carlsson P, Haglind E, Henriksson M, Lindholm E, Anderberg B (2004) Randomized clinical trial of the costs of open and laparoscopic surgery for colonic cancer. Br J Surg 91:409–417CrossRefPubMed Janson M, Bjorholt I, Carlsson P, Haglind E, Henriksson M, Lindholm E, Anderberg B (2004) Randomized clinical trial of the costs of open and laparoscopic surgery for colonic cancer. Br J Surg 91:409–417CrossRefPubMed
19.
Zurück zum Zitat Barber JA, Thompson SG (2000) Analysis of cost data in randomized trials: an application of the non-parametric bootstrap. Stat Med 19:3219–3236CrossRefPubMed Barber JA, Thompson SG (2000) Analysis of cost data in randomized trials: an application of the non-parametric bootstrap. Stat Med 19:3219–3236CrossRefPubMed
20.
Zurück zum Zitat Crawshaw BP, Chien HL, Augestad KM, Delaney CP (2015) Effect of laparoscopic surgery on health care utilization and costs in patients who undergo colectomy. JAMA Surgery 150:410–415CrossRefPubMed Crawshaw BP, Chien HL, Augestad KM, Delaney CP (2015) Effect of laparoscopic surgery on health care utilization and costs in patients who undergo colectomy. JAMA Surgery 150:410–415CrossRefPubMed
21.
Zurück zum Zitat Nygren J, Thacker J, Carli F, Fearon KC, Norderval S, Lobo DN, Ljungqvist O, Soop M, Ramirez J, Enhanced Recovery After Surgery Society fPC, European Society for Clinical N, Metabolism, International Association for Surgical M, Nutrition (2013) Guidelines for perioperative care in elective rectal/pelvic surgery: Enhanced Recovery After Surgery (ERAS((R))) Society recommendations. World J Surg 37:285–305CrossRefPubMed Nygren J, Thacker J, Carli F, Fearon KC, Norderval S, Lobo DN, Ljungqvist O, Soop M, Ramirez J, Enhanced Recovery After Surgery Society fPC, European Society for Clinical N, Metabolism, International Association for Surgical M, Nutrition (2013) Guidelines for perioperative care in elective rectal/pelvic surgery: Enhanced Recovery After Surgery (ERAS((R))) Society recommendations. World J Surg 37:285–305CrossRefPubMed
22.
Zurück zum Zitat Kennedy RH, Francis A, Dutton S, Love S, Pearson S, Blazeby JM, Quirke P, Franks PJ, Kerr DJ (2012) EnROL: a multicentre randomised trial of conventional versus laparoscopic surgery for colorectal cancer within an enhanced recovery programme. BMC Cancer 12:1CrossRef Kennedy RH, Francis A, Dutton S, Love S, Pearson S, Blazeby JM, Quirke P, Franks PJ, Kerr DJ (2012) EnROL: a multicentre randomised trial of conventional versus laparoscopic surgery for colorectal cancer within an enhanced recovery programme. BMC Cancer 12:1CrossRef
23.
Zurück zum Zitat Vlug MS, Wind J, Hollmann MW, Ubbink DT, Cense HA, Engel AF, Gerhards MF, van Wagensveld BA, van der Zaag ES, van Geloven AA, Sprangers MA, Cuesta MA, Bemelman WA, Group Ls (2011) Laparoscopy in combination with fast track multimodal management is the best perioperative strategy in patients undergoing colonic surgery: a randomized clinical trial (LAFA-study). Ann Surg 254:868–875CrossRefPubMed Vlug MS, Wind J, Hollmann MW, Ubbink DT, Cense HA, Engel AF, Gerhards MF, van Wagensveld BA, van der Zaag ES, van Geloven AA, Sprangers MA, Cuesta MA, Bemelman WA, Group Ls (2011) Laparoscopy in combination with fast track multimodal management is the best perioperative strategy in patients undergoing colonic surgery: a randomized clinical trial (LAFA-study). Ann Surg 254:868–875CrossRefPubMed
Metadaten
Titel
Health economic analysis of costs of laparoscopic and open surgery for rectal cancer within a randomized trial (COLOR II)
verfasst von
Jacob Gehrman
Ingela Björholt
Eva Angenete
John Andersson
Jaap Bonjer
Eva Haglind
Publikationsdatum
15.07.2016
Verlag
Springer US
Erschienen in
Surgical Endoscopy / Ausgabe 3/2017
Print ISSN: 0930-2794
Elektronische ISSN: 1432-2218
DOI
https://doi.org/10.1007/s00464-016-5096-2

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