ORIGINAL ARTICLES

Robotic-assisted Versus Laparoscopic Cholecystectomy

Outcome and Cost Analyses of a Case-matched Control Study
Stefan Breitenstein, MD,* Antonio Nocito, MD,* Milo Puhan, MD, PhD, Ulrike Held, PhD, Markus Weber, MD,* and Pierre-Alain Clavien, MD, PhD, FACS, FRCS*

Objective: To compare safety and costs of robotic-assisted and laparoscopic cholecystectomy in patients with symptomatic cholecystolithiasis. Background: Technical benets of robotic-assisted surgery are well documented. However, pressure is currently applied to decrease costs, leading to restriction of development, and implementation of new technologies. So far, no convincing data are available comparing outcome or costs between computer assisted and conventional laparoscopic cholecystectomy. Methods: A prospective case-matched study was conducted on 50 consecutive patients, who underwent robotic-assisted cholecystectomy (Da Vinci Robot, Intuitive Surgical) between December 2004 and February 2006. These patients were matched 1:1 to 50 patients with conventional laparoscopic cholecystectomy, according to age, gender, American Society of Anesthesiologists score, histology, and surgical experience. Endpoints were complications after surgery (mean follow-up of 12.3 months SD 1.2), conversion rates, operative time, and hospital costs (ClinicalTrial.gov ID: NCT00562900). Results: No minor, but 1 major complication occurred in each group (2%). No conversion to open surgery was needed in either group. Operation time (skin-to-skin, 55 minutes vs. 50 minutes, P 0.85) and hospital stay (2.6 days vs. 2.8 days) were similar. Overall hospital costs were signicantly higher for robotic-assisted cholecystectomy $7985.4 (SD 1760.9) versus $6255.3 (SD 1956.4), P 0.001, with a raw difference of $1730.1(95% CI 991.4 2468.7) and a difference adjusted for confounders of $1606.4 (95% CI 1076.72136.2). This difference was mainly related to the amortization and consumables of the robotic system. Conclusions: Robotic-assisted cholecystectomy is safe and, therefore, a valuable approach. Costs of robots, however, are high and do not justify the use of this technology considering the lack of benets for patients. A reduction of acquisition and mainte-

nance costs for the robotic system is a prerequisite for large-scale adoption and implementation. (Ann Surg 2008;247: 987993)

From the Swiss HPB (Hepato-Pancreato-Biliary) Center, *Department of Surgery and Horton Center, University Hospital of Zurich, Zurich, Switzerland. Presented in part at the 47th SSAT Annual Meeting during DDW, May 20 24, 2006, Los Angeles, California. Reprints: Pierre-Alain Clavien, MD, PhD, FACS, FRACS, Department of Surgery, University Hospital Zurich, Ramistrasse 100, CH-8091 Zurich, Switzerland. E-mail: clavien@chir.uzh.ch. Copyright 2008 by Lippincott Williams & Wilkins ISSN: 0003-4932/08/24706-0987 DOI: 10.1097/SLA.0b013e318172501f

he recent introduction of robotic surgical systems has revolutionized the eld of minimally invasive surgery. Well-known advantages of the commonly used DaVinci Robot such as improved vision via 3-dimensional view, magnication, tremor suppression, and the exibility of the instruments13 have allowed precise operating techniques in a variety of procedures in general surgery.4 11 However, so far only a few studies involving small numbers of patients (between 6 and 25 robotic cases) have compared robotic surgery with conventional laparoscopy.10 16 At the current stage of development, the benets of robotic-assisted surgery in general surgery have not yet been dened. The main drawback of advanced robotic surgery is the associated cost. Few studies, which have analyzed the cost effectiveness of robotic technology in general surgical procedures including Nissen fundoplication, splenectomy, bariatric surgery, and colorectal surgery,11,12,15,16 urology,1719 and cardiac surgery.20 have been published so far. Although the patient collectives were consistently small and the methodology for cost evaluation varied between the trials, each study identied an increase of expenses for robotic surgery mainly due to the higher costs in the operating room caused by costs for the robotic equipment and instruments, and also due to the prolonged operating time. Cholecystectomy is used as a starting procedure for robotic-assisted technology in general surgery by most centers. Surprisingly, data are lacking regarding patient outcome or associated costs compared with the use of conventional laparoscopic surgery. Two studies comparing robotic-assisted versus laparoscopic procedures including 10 and 20 patients, respectively, are available.10,14 These early studies focused mostly on time requirements to perform the procedures, but failed to provide convincing information regarding patient outcome or costs. A few other noncomparative, usually small, case series on robotic-assisted cholecystectomy have been reported demonstrating the feasibility of the procedure.5,6,2126

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Obviously, from the perspective of the cost requirements, an investment in this technology can only be justied if the costs are reasonable and a signicant benet is demonstrated regarding patient outcome. Although the ideal study design to identify the best procedure remains a randomized controlled trial, this approach is difcult in many centers for organizational reasons, as the robotic equipment needs to be used at maximum capacity. The system has to be shared with various departments, particularly urology. The next best strategy to compare these procedures is a matched pair study design including a large prospective collected database. As we initiated a large prospective database including laparoscopic cholecystectomy in 2002 and robotic-assisted procedures because its introduction in our department in 2004, we performed a prospective casematched controlled study of Robotic-assisted versus laparoscopic cholecystectomy in patients with symptomatic cholecystolithiasis.

tive Surgical). Similar to the laparoscopic technique, an additional fourth trocar was used to retract the gallbladder. The positioning (French) of the patients and the trocars were also comparable with the conventional laparoscopic cholecystectomy.

Outcome Measures
Database evaluation and charts were reviewed to extract data about outcome-parameters and hospital costs. Complications were graded according to a validated therapyorientated complication score on a 5-point scale.27 Severe complications were dened as an event requiring intervention in local or general anesthesia or treatment in the intensive care unit (complications grades 3 and 4). The assessment of intraoperative parameters included conversion rates, presence of concrements in the gallbladder, dissection of the gallbladder, (accidental perforation of the gallbladder or not) and operating and anesthesia time. The operating time was dened as the time from skin incision to wound closure. Time needed for draping either the robotic arms or the laparoscopic camera was also evaluated. Anesthesia time was dened as the time of total attendance of the anesthetists including the pre- and postoperative periods.

MATERIALS AND METHODS Study Design

We prospectively designed a study to assess the potential benets of robotic-assisted cholecystectomy. To achieve a high level of evidence, we chose a prospective case-matched controlled methodology. Three experienced and one junior (2nd year) surgeon were involved, and were fully trained with the robot before initiating the study including tasks in a training box on pig livers and 5 cholecytectomies performed on humans with this technology. Complications after surgery (mean follow-up of 12.3 months SD 1.2) were recorded for each patient using a standardized grading system for negative outcome,27 and the total hospital costs were prospectively calculated based on actual cost. Each patient operated with the robotic system was retrospectively matched one by one with patients who underwent a laparoscopic cholecystectomy (see matching criteria below) (ClinicalTrial.gov ID: NCT00562900).

Cost Analysis
The cost analysis was performed with the support of the departmental budget manager. Data were collected from the bottom up and divided into costs generated in the operating theater and costs accrued on the ward (Fig. 1). Costs generated in the operating theater were calculated as costs per minute. These included the surgeons and anesthesiologists salaries, the nursing personnel costs, and the costs for consumables for the procedures and the amortization of the equipment. Based on the purchase costs of $1,275,000 (CHF 1,500,000) and an additional annual maintenance fee of $127,500, the amortization for the robotic system per case was calculated to be $1275 (amortization period of 5 years, 300 cases per year). Expenses for the laparoscopic equipment included purchase costs of $72,250 and maintenance costs of $4250 per year. Amortization of the laparoscopic system was, therefore, calculated as $38.3 per case (amortization period of 5 years, 500 cases per year). On the ward, lump sums were separately assessed for the preoperative, operative, and postoperative days. Further costs for preoperative radiographs and electrocardiograms routinely performed for patients older than 50 years were additionally included (additional costs) (Fig. 1).

Population
Between December 2004 and February 2006, the rst 65 operations on patients with symptomatic cholecystolithiasis were performed with the Da Vinci robot system (Da Vinci Robot, Intuitive Surgical) in our department. From this database, the rst 15 patients with robotic-assisted cholecystectomy were excluded from the study to avoid a learning curve bias. The consecutive 50 elective computer-assisted procedures were matched one by one by handwork, scrutinizing consecutively backward from 2006 by an independent reviewer with 50 elective laparoscopic cholecystectomies. Matching criteria were age (2 years), gender, American society of Anesthesiologists (ASA)-score, histologic nding of inammation (acute, chronic, or both) and surgical experience (junior or experienced surgeon). Patients were routinely hospitalized 1 day before surgery.

Statistical Analysis
We rst assessed the distributions of variables for patient characteristics, patient outcomes, and costs using means (SD) for normally distributed data and medians (ranges) for non-normally distributed data. We then compared patient outcomes between the robotic and laparoscopic surgery group with and without adjustment for potential confounders such as age, gender, preoperative inammation status, (leukocyte counts) and comorbidities (Charlson index28) using linear regression (continuous outcomes) and logistic (binary outcomes) regression ana 2008 Lippincott Williams & Wilkins

Operative Technique
The robotic-assisted operations were performed with the 3-arm Da Vinci robot system (Da Vinci Robot, Intui-

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FIGURE 1. Principle of the cost analysis.

lysis. For comparison of costs between the robotic and laparoscopic surgery groups, we also used linear regression analysis with and without adjustment for potential confounders. We added the term (individual age minus
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mean age)2 to the multivariable regression equation to t a linear regression model with normally distributed residuals. We performed all analyses using SPSS 12.0.1 for Windows (SPSS Inc, Chicago, IL).

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TABLE 1. Patient Characteristics Preoperative Mean (SD)

Robotic-assisted Number Mean age(SD) (yrs) Inammation histologically: acute/chronic/both ASA: 1/2/3 Surgical experience (junior/experienced surgeon) Gender: male/female Mean BMI (m/kg2, SD) Median Charlson Index (range) Median CRP preop (range) Mean Leucocytes preop (SD) 50 53.2 (17.3) 2/41/7 13/31/6 15/35 12/38 28.2 (6.0) 0 (06) 3 (068) 6.5 (2.0) Laparoscopic 50 51.7 (15.9) 2/40/8 13/31/6 15/35 13/37 27.7 (8.4) 0 (04) 2.5 (097) 7.1 (2.8)

cases). The total hospital stay (including a 1 day preoperative examination) was similar in both groups. The subsequent clinical course, checked by a routine clinical control 1 year after robotic-assisted surgery, was uneventful in all cases. Operating time (skin to skin) was similar in both groups (mean 55, 22 minutes vs. 50 19 minutes, P 0.85) and the attendance time for anesthesia was also comparable (168 50 minutes vs. 167 36 minutes, P 0.88). The setup time for the robotic system before skin incision was 17 minutes (8) and 8 minutes (4) for the laparoscopic group.

How are the Costs of Robotic-Assisted Cholecystectomy Compared With Laparoscopic Cholecystectomy?
In the unadjusted analysis, total costs were signicantly higher in the robotic group with a difference of $1730.1 (95% CI 991.4.0 2468.7, P 0.001). Although in the analysis adjusted for age, gender, preoperative inammation status, and comorbidities the difference in costs was slightly lower, robotically performed interventions were still signicantly more expensive ($1628.2, 95% CI 854.6 2401.8, P 0.01, R2 0.32). The 2 patients with major complications caused much higher costs. When these outliers were excluded from the analysis, the adjusted difference between groups remained similar, but the condence interval was much narrower ($ 606.4, 95% CI 1076.72136.2, P 0.001), and the model explained a substantial amount of variability in costs (R2 0.47) (Tables 3 and 4). In the operating room, costs for surgery were comparable ($698.3 vs. $641.7). Although costs for anesthesiologist attendance were similar, the much higher costs generated by the computer-assisted system were due to consumables ($1126.1 vs. $495.0) and the amortization ($1275.0 vs. $38.3). Preoperative ward costs were almost identical in both groups whereas postoperative ward costs were slightly lower in the computer-assisted group ($2068.0 vs. $2276.3) because of a slightly shorter hospital stay (Table 3).

ASA indicates American Society of Anesthesiologist; BMI, body mass index.

RESULTS Are the 2 Populations Comparable?

As dened by the study protocol, all patients were well-matched for age, gender, ASA-score, and histologic nding of inammation. Moreover, additional parameters such as gender, body mass index, Charlson Index28 describing comorbidities preoperatively, and preoperative levels of CRP, and leukocytes were comparable. Furthermore, the same surgeons were involved in all cases (Table 1).

Is Robotic-Assisted Cholecystectomy Superior to Laparoscopic Cholecystectomy From a Medical Perspective?

One severe complication occurred in each group, while no minor complications were observed (Table 2). A postoperative bile leak from the cystic duct stump observed in the robotic group was treated by endoscopic stenting of the common bile duct (severity score 3a27). In the laparoscopic group one reoperation due to a jejunal perforation (severity score 3b) had to be performed. The conversion rate was zero in both the laparoscopic and in the computer-assisted groups. Iatrogenic perforation of the gallbladder during preparation was comparable in both groups (12 robotic vs. 9 laparoscopic

DISCUSSION
Many new, sophisticated, and expensive technologies are widely promoted before full evaluation, not only as a

TABLE 2. Intraoperative and Postoperative Outcome Parameters

Robotic-assisted Mortality Minor complications Major complications (%) Conversion rate (%) Gallbladder preparation: not opened/opened Concrements in bladder: no/yes Hospital stay (days): mean (SD) Anesthesia time (min): mean (SD) OP time skin to skin: mean (SD) 0 0 2 0 38/12 3/47 4.58 (1.9) 168.0 (49.9) 54.6 (31.6) Laparoscopic 0 0 2 0 41/9 2/48 4.84 (2.2) 166.9 (35.8) 50.2 (29.2) Adjusted P* Not estimable Not estimable 0.96 Not estimable 0.25 0.73 0.40 0.86 0.54

*Adjusted for age, (age-mean)2, gender, operator, leucocytes pre OP, and Charlson categories. Multiple logistic regression model. Multiple linear regression model.

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TABLE 3. Costs in US$: Mean (SD)

Robotic-assisted OR Surgery Anesthesiology Consumables (constant) Amortization (constant) Ward Preop lump sum (constant) Additional costs preop X-ray rate ( 118.0 SFR) ECG rate ( 74.3 SFR) Postop lump sum (day of operation, constant) Postop lump sum ( 942.97 SFR/d): mean (SD) Total cost: mean (SD) 698.3 (404.6) 1052.5 (328.1) 1126.1 1275.0 850.6 106.0 (74.2) 60% 72% 809.1 2068.0 (1493.7) 7985.4 (1760.9) Laparoscopic 641.7 (372.6) 1045.6 (224.2) 495.0 38.3 850.6 98.7 (74.5) 54% 70% 809.1 2276.3 (1754.2) 6255.3 (1956.4)

TABLE 4. Cost Difference (US$) Between Robotic-assisted and Laparoscopic Operation Method
Mean Cost Difference Unadjusted Adjusted* n 100 n 98 1730.1 1628.2 1606.4 95% CI 991.42468.7 854.62401.8 1076.72136.2

*Adjusted for age, (age-mean)2, gender, operator, leucocytes pre OP, and Charlson categories.

result of biased marketing from the industry but also because of the medical community subjected to competitive innovation. To our knowledge, we report here the largest comparison between robotic surgery and conventional laparoscopy. Our focus on both clinical outcome and costs indicates comparable outcome in terms of complications and conversion to open surgery. Although operative time was similar in both groups, the current costs associated with the robotic technology were signicantly higher, and therefore the use of robotic assistance to perform cholecystectomy is not justied at this point. The quality of any study comparing 2 different surgical therapies relies on the similarity of the patient demographics between the groups including the level of experience of the surgeons in a high volume center.29 To meet these requirements we chose a matched-pair methodology in the setting of a single center study in an institution with more than 200 cholecystectomies per year. By matching for age, gender, ASA, histologic ndings, and also surgical experience, we established a homogenous patient population between the groups minimizing selection bias. Although computer-assisted operative technology is an attractive and likewise upcoming surgical technique, there is currently not much convincing data on its benets in general surgery. Nevertheless, there are well-known advantages of the robotic system for the surgeon, such as 3-dimensional view, magnication, the exibility of the instruments, tremor
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suppression, and improved economics.30 33 A reliable assessment of the efcacy of this technology needs to be based on veriable benets for patients, such as reduction of morbidity or mortality rates. So far, only a few studies have compared robotic with conventional laparoscopic surgical techniques in general surgery10 14,34,35 showing no patient-related advantages. Melvin et al13, however, suggested a unique benecial result concerning the use of antisecretory medication after robotic-assisted antireux surgery compared with laparoscopic procedures, evaluated by a survey of 20 patients in each group. The present study demonstrates that robotic-assisted cholecystectomy can be performed safely. Impressively none of the robotic-assisted procedures had to be converted to an open operation. These ndings are consistent with the experience of other groups that reported morbidity rates of 2% and conversion rates ranging between 0% and 3%6,24,25,36 for robotic-assisted cholecystectomy. Although the robotic technique shows no clinical advantages over the laparoscopic approach, all the involved surgeons considered the dissection in the triangle of Callot to be easier when performed with the robotic system (data not shown). This is in line with data reported from previously published uncontrolled series.9,3739 The operating time (skin to skin) for robotic-assisted cholecystectomies was similar to the laparoscopic operations. This does not entirely accord with previous studies, showing that time consumption is one of the main disadvantages of the robotic technology10 12,14 compared with the laparoscopic approach, not only for cholecystectomy,10,14 but mainly for more complex procedures in general surgery.11,12,15,16 However, comparisons of time consumption between different studies are difcult to interpret because of the lack of uniformity in reporting and documentation.36 The setup times (moving and draping the equipment) of the systems in the present study (17 8 minutes for the robotic equipment vs. 8 4 minutes for the laparoscopic) were not counted as operating time, but were included in the cost evaluation. Interestingly, although the surgical experience did not inuence the operating time in the robotic group (53 minutes (22) for junior surgeon, 56 minutes (23) for experienced surgeon, there was a difference in the laparoscopic group of 31 minutes (71 minutes (28) for junior surgeon, 40 minutes (15) for experienced surgeon). This suggests that the robotic technology particularly suits the younger generation of surgeons and may have a shorter learning curve. Although this study failed to identify any clinical benets for the patients after robotic-assisted cholecystectomy, based on the safety and ease of use, it conrms the potential important value of robotic cholecystectomy as an ideal starting procedure for robotic surgeons in abdominal surgery, as also described by Hanly and Talamini.7 However, the enthusiasm for robotic-assisted surgery must be tempered not only by the lack of data showing any convincing clinical benets, but also by the high costs related to this sophisticated technology. To our knowledge, this is the rst study presenting a detailed economic analysis including an adjustment for the majority of relevant parameters. We show signicantly higher expenses for the robotic system as

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a result of higher costs in the operating room, particularly generated by the amortization and consumables for the robotic system. Most of the articles analyzing cost, not only in general surgery11,12,15,16 but also in all other elds of roboticassisted surgery,18,20 differentiate between costs generated in the operating room, and on the ward. All are consistent with our ndings that the robotic equipment and instruments are the primary reasons for the signicant increase in costs whereas the prolonged operating time particularly in complex operations such as colorectal, bariatric, or antireux surgery is described as a secondary cause. Because of the similarity of the clinical outcome and the hospital stay, costs generated on the ward are not signicantly different, neither in the literature nor in the present study. The calculated costs for both laparoscopic and robotic-assisted cholecystectomy in the present study are relatively high compared with those of other centers. This is because of the relatively high costs in Switzerland and the longer hospital stay, which include a routine admission 1 day before the operation. Referring to the initial premise, the most compelling justication for higher costs would be the proof of clinically relevant benets for the patient such as lower complication rates, which is a prerequisite for the implementation of this technology in surgery. Unfortunately, the development of robotic surgery is monopolized by a single company creating the risk of keeping costs high and slowing down technological innovation due to the lack of competition. On the other hand, some surgeons may provide misleading information to their patients or the insurances about this approach because they might be primarily driven by marketing and the search for competitive advantages. There is no doubt that technology will continue to affect the way surgeons treat their patients. However, it is imperative that surgeons continue to evaluate new techniques in a professional and fair way. The ability of computers and robots to enhance surgical performance remains attractive, but clearly it is a goal that industry and surgeons should embrace in a common and objective effort to provide better outcomes for patients. In conclusion, robotic-assisted cholecystectomy shows no benets in clinical outcome over laparoscopic cholecystectomy. The costs for robotic-assisted cholecystectomy are signicantly higher than for laparoscopic operations because of extensive expenses for the robotic system itself and its consumables and is, therefore, not justiable. A reduction of these acquisition and maintenance costs is a prerequisite for a large-scale adoption and implementation of this technology in future surgery. REFERENCES
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