Surgical Endoscopy

, Volume 31, Issue 3, pp 1225–1234 | Cite as

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

  • Jacob Gehrman
  • Ingela Björholt
  • Eva Angenete
  • John Andersson
  • Jaap Bonjer
  • Eva Haglind
Open Access
Article

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.

Keywords

Health economics Cost-minimization analysis Costs Rectal cancer surgery 

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 [6, 7, 8, 9] or have not included the cost of sick leave [8, 9, 10]; 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.
Fig. 1

Study flow chart and COLOR II

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.

Notes

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.

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Copyright information

© The Author(s) 2016

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.

Authors and Affiliations

  • Jacob Gehrman
    • 1
  • Ingela Björholt
    • 2
  • Eva Angenete
    • 1
  • John Andersson
    • 1
  • Jaap Bonjer
    • 3
  • Eva Haglind
    • 1
  1. 1.Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, SSORG—Scandinavian Surgical Outcomes Research GroupSahlgrenska University Hospital/ÖstraGothenburgSweden
  2. 2.Nordic Health EconomicsGothenburgSweden
  3. 3.Department of SurgeryVUmc University Medical CentreAmsterdamThe Netherlands

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