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World J Surg (2017) 41:1225–1233

DOI 10.1007/s00268-016-3851-0

ORIGINAL SCIENTIFIC REPORT

Laparoscopic Versus Open Cholecystectomy: A Cost–Effectiveness


Analysis at Rwanda Military Hospital
Allison Silverstein1,2 • Ainhoa Costas-Chavarri1,3 • Mussa R. Gakwaya3 •
Joseph Lule3 • Swagoto Mukhopadhyay1,4 • John G. Meara1,5 • Mark G. Shrime1,6

Published online: 30 November 2016


Ó Société Internationale de Chirurgie 2016

Abstract
Background Laparoscopic cholecystectomy is first-line treatment for uncomplicated gallstone disease in high-income
countries due to benefits such as shorter hospital stays, reduced morbidity, more rapid return to work, and lower mortality
as well-being considered cost-effective. However, there persists a lack of uptake in low- and middle-income countries.
Thus, there is a need to evaluate laparoscopic cholecystectomy in comparison with an open approach in these settings.
Methods A cost–effectiveness analysis was performed to evaluate laparoscopic and open cholecystectomies at
Rwanda Military Hospital (RMH), a tertiary care referral hospital in Rwanda. Sensitivity and threshold analyses were
performed to determine the robustness of the results.
Results The laparoscopic and open cholecystectomy costs and effectiveness values were $2664.47 with 0.87 quality-
adjusted life years (QALYs) and $2058.72 with 0.75 QALYs, respectively. The incremental cost–effectiveness ratio
for laparoscopic over open cholecystectomy was $4946.18. Results are sensitive to the initial laparoscopic equipment
investment and number of cases performed annually but robust to other parameters. The laparoscopic intervention is
more cost-effective with investment costs less than $91,979, greater than 65 cases annually, or at willingness-to-pay
(WTP) thresholds greater than $3975/QALY.
Conclusions At RMH, while laparoscopic cholecystectomy may be a more effective approach, it is also more
expensive given the low caseload and high investment costs. At commonly accepted WTP thresholds, it is not cost-
effective. However, as investment costs decrease and/or case volume increases, the laparoscopic approach may
become favorable. Countries and hospitals should aspire to develop innovative, low-cost options in high volume to
combat these barriers and provide laparoscopic surgery.

Introduction cholecystectomy is now the first-line treatment for uncom-


plicated gallstone disease in high-income countries and is
The 1980s welcomed the introduction of laparoscopic associated with shorter hospital stays, reduced morbidity,
cholecystectomy as an alternative to the traditionally open more rapid return to work, lower mortality, and significantly
approach to removing the gallbladder [1]. Laparoscopic

& Mark G. Shrime 3


Rwanda Military Hospital, Kigali, Rwanda
shrime@mail.harvard.edu 4
Department of Surgery, University of Connecticut,
1 Farmington, CT, USA
Program in Global Surgery and Social Change, Harvard
5
Medical School, 641 Huntington Ave #411, Boston, Department of Plastic and Oral Surgery, Boston Children’s
MA 02115, USA Hospital, Boston, MA, USA
2 6
University of Miami Miller School of Medicine, Miami, FL, Department of Otolaryngology and Office of Global Surgery,
USA Massachusetts Eye and Ear Infirmary, Boston, MA, USA

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reduced hospital costs [2–4]. The practice of laparoscopy in Fig. 1 Sequential decision tree. GB gallbladder, Lap chole laparo- c
low- and middle-income countries (LMICs) remains limited scopic cholecystectomy, Open chole open cholecystectomy, CBD
common bile duct, USG ultrasonography, CBDE common bile duct
[3]; economic and cost–effectiveness concerns are fre- exploration, MRCP magnetic resonance cholangiopancreatography,
quently cited as major barriers to widespread acceptance of Square decision node, Circle probability node, Left pointed triangle
laparoscopic surgery [5–10]. with square terminal node. Numerical values for all variables are
Despite such uncertainty regarding the value of laparo- defined in Table 1
scopy in LMICs, studies have repeatedly demonstrated that
minimally invasive surgery is safe, feasible, and beneficial in
low-resource settings [4, 7, 11–14]. Successful implemen-
Design of decision trees
tation of laparoscopy in low-resource settings has been
demonstrated in Mongolia, where laparoscopic procedures
The study evaluated two treatment options for biliary dis-
have been associated with decreases in surgical site infec-
ease at Rwanda Military Hospital—laparoscopic or open
tions, shorter hospital stays, and lower hospital expenditures
cholecystectomy. In this setting, where endoscopic retro-
in comparison with an open approach [14, 15]. While the
grade cholangiopancreatography (ERCP) is not available,
laparoscopy expansion project in Mongolia did not assess the
suspected cholelithiasis requires imaging for diagnostic
economics of laparoscopy, it made cost-minimizing adap-
confirmation as well as assessing for the presence of
tations, such as utilization of reusable ports, sterilization
common bile duct (CBD) stones. For each of the radio-
techniques for otherwise disposable materials, meticulous
logical studies—ultrasound, CT, and magnetic resonance
care of instruments to extend life, and use of surgical gloves
cholangiopancreatography (MRCP)—tree branches were
as extraction bags [14]. Other countries such as Nigeria have
constructed for true-positive, true-negative, false-positive,
demonstrated use of similar cost-saving methods in con-
and false-negative possibilities. In cases where CBD stones
junction with their integration of laparoscopy [4].
were suspected, a common bile duct exploration (CBDE)
In 2015, The Lancet Commission on Global Surgery esti-
was performed in addition to the general open approach.
mated that five billion people lack access to safe, affordable
Terminal nodes reflected common outcomes of cholecys-
surgical and anesthesia care when needed [16, 17]. Further,
tectomies—uncomplicated recovery, bile duct injury, sur-
essential surgical and anesthesia care was established as cost-
gical site infection (SSI), incisional hernia, or death. The
effective interventions in low-resource settings [18]. How-
tree is depicted in Fig. 1.
ever, 81 million individuals face catastrophic health expen-
ditures due to payment for both surgery and anesthesia, and the
non-medical costs associated with accessing surgical care Event probability estimation
[19]. Determining the most cost-effective option is key to
ensuring that limited resources are best used to combat the A literature review was conducted to determine the prob-
unmet need of surgical care. Given robust evidence supporting abilities of each event in the tree pathway. Due to the small
the safety and feasibility of laparoscopy in LMICs and the sample size of laparoscopic cholecystectomies at RMH,
continual lack of uptake of laparoscopic surgery, there is a other sources were consulted; outcomes at RMH are
need to determine the value of laparoscopic cholecystectomy compared to these estimates in Table 1. Sources were
in comparison with an open approach. evaluated and selected in the following order: (1) country
(Rwanda), (2) region (East Africa), (3) super-region (sub-
Saharan Africa), (4) development group (low-income
Methods countries), (5) high-income country data (preferably older),
and (6) assumptions [24].
Study design

This study looks at a single institution, Rwanda Military Effectiveness measure estimation
Hospital (RMH), a referral hospital that provides secondary
and tertiary level care as well as educational activities. Quality-adjusted life years (QALYs) were used as the
RMH is one of the four major referral hospitals in Rwanda. measure of effectiveness. Sources were evaluated in the
It provides health care services to both civilian (80%) and same order as those for probability estimations. The anal-
military (20%) patients and has a capacity of approxi- yses include a study for patients undergoing ventral hernia
mately 350 beds [20]. A cost–effectiveness analysis (CEA) repair to define the utility weights for surgical site infection
was performed following the recommendations published and incisional hernia because no study was identified
on behalf of the Panel on Cost-Effectiveness in Health and which assessed these utility weights in patients undergoing
Medicine in JAMA 1996 [21–23]. a cholecystectomy [25].

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Table 1 Point estimates for probabilities of epidemiological variables and utility values, and distributions used for probabilistic sensitivity
analysis as well as parameterization
Variables RMH Point Standard error a (success b (failure n Distr Author
estimates estimates [sq (pq) – 0.05] or lower or upper
(mean) bound) bound)

Probabilities
Common bile duct stones 0.805 60 685 B Ersumo [31]
USG detecting CBD stones if 0.82 0.33 B Pickuth [32]
they exist
USG detecting CBD stones if 0.02 0.09 B Pickuth [32]
they do not exist
CT detecting CBD stones if 0.86 0.30 B Pickuth [32]
they exist
CT detecting CBD stones if 0.02 0.09 B Pickuth [32]
they exist
MRCP detecting CBD stones 0.96 0.15 B Pickuth [32]
if they exist
MRCP detecting CBD stones 0.02 0.09 B Pickuth [32]
if they exist
Open chole cure 1.0 0.9291 694 D Ersumo [31]
Open chole BDI 0.0 0.0027 2 D Ersumo [31]
Open chole SSI 0.0 0.0562 42 D Ersumo [31]
Open chole incisional hernia 0.0 0.0080 6 D Ersumo [31]
Open chole mortality 0.0 0.0040 3 D Ersumo [31]
Open chole ? CBDE cure 0.7741 45,099 D Vellacott and Powell [33]
Open chole ? CBDE BDI 0.0128 747 D Vellacott and Powell [33]
Open chole ? CBDE SSI 0.1795 10,458 D Ersumo [31]
Open chole ? CBDE 0.0080 468 D Vellacott and Powell [33]
incisional hernia
Open chole ? CBDE 0.0256 1,494 D Vellacott and Powell [33]
mortality
Lap chole cure 0.9412 0.9386 2,668 D Mohamed et al. [34]
Lap chole BDI 0.0 0.0031 9 D Mohamed et al. [34]
Lap chole SSI 0.0 0.0021 6 D Mohamed et al. [34]
Lap chole incisional hernia 0.0 0.0028 8 D Mohamed et al. [34]
Lap chole mortality 0.0 0.0021 6 D Mohamed et al. [34]
Lap conversion to open chole 0.0588 0.0513 145 D Mohamed et al. [34]
Utilities
Open/CBDE chole (cure) 0.77 0.54 1.0 U Bass et al. [35]
Lap chole (cure) 0.91 0.82 1.0 U Bass et al. [35]
Bile duct injury 0.61 0.22 1.0 U Moore et al. [36]
Surgical site infection 0.69 0.38 1.0 U Chatterjee et al. [25]
Incisional hernia 0.60 0.20 1.0 U Chatterjee et al. [25]
Mortality 0
Open chole open cholecystectomy Lap chole laparoscopic cholecystectomy CBDE common bile duct exploration USG ultrasonography CBD
common bile duct MRCP magnetic resonance cholangiopancreatography BDI bile duct injury SSI surgical site infection Distr distribution B beta
D Dirichlet U uniform

Cost estimation of surgery including transportation, lost salary during


hospital admission for both the patient and accompanying
For costing data, a societal perspective was taken. Cost family members, as well as time until return to work were
parameters were gathered primarily via RMH’s electronic also considered [26]. Terminal node costs were calculated
medical records which details exact costs. Ancillary costs in consideration of the procedure received—laparoscopic

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Table 2 Costs per patient in 2014 USDs related to open and versus open. For example, those patients who developed an
laparoscopic cholecystectomy incisional hernia following an open procedure incurred
Variable Cost ($) greater costs than those who had laparoscopic surgery due
to increased cost of supplies. Contrastingly, patients
Open chole 596.63
incurred the same cost following a bile duct infection no
Open chole ? CBDE 691.88 matter which intervention they received. Using Rwanda’s
Lap chole 1305.55 purchasing power parity, costs were converted to 2014
Lap conversion to open chole 1612.17 USD for analysis [27]. The initial investment for laparo-
Abdominal USG 33.00 scopic equipment was amortized over a period of five years
Abdominal CT 682.07 to reflect yearly investment.
MRCP 838.36
Post-op: cure 7.31 Cost–effectiveness and sensitivity analysis
Post-op: BDI 1445.33
Post-op: SSI 409.19 Analysis was performed to test alternative data and
Post-op: incisional hernia (lap chole) 904.59 assumptions to elucidate the stability of the findings. A
Post-op: incisional hernia (open chole) 930.47 tornado diagram was run to identify those variables whose
Post-op: mortality 0.0 uncertainty most greatly drive the results; probabilities
were standardized to avoid sums greater than 1.0. Subse-
quently, for all parameters that crossed the willingness-to-
Table 3 Cost–effectiveness for open and laparoscopic cholecystec- pay (WTP) threshold on the tornado diagram, one-way
tomy approaches sensitivity analyses were performed to assess for thresholds
Strategy Cost Effectiveness Incremental C/E (ICER) at which laparoscopic cholecystectomy became cost-ef-
fective. The WTP threshold was set at three times Rwan-
Open chole 2058.72 0.75 da’s gross domestic product (GDP) per capita or $2088
Lap chole 2664.47 0.87 4946.18 USD [28, 29]. Of note, this threshold was originally

Fig. 2 Net monetary benefit


one-way cost–effectiveness
sensitivity analysis.
Willingness-to-pay measured in
2014 USD

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Fig. 3 Cost–effectiveness
acceptability cure. Willingness-
to-pay measured in 2014 USD

defined by the WHO as per DALY averted, not per QALY Other point estimates for probabilities of epidemiolog-
gained. ical variables and utility values are found in Table 1. Cost
A probabilistic sensitivity analysis (PSA) was also per- estimates are summarized in Table 2.
formed. For this analysis, costs were defined as gamma
distributions, probabilities as beta or Dirichlet distribu- Cost–effectiveness analysis
tions, and utilities as uniform distributions. Lastly, a Monte
Carlo simulation with 1,000 total runs was conducted as Laparoscopic and open cholecystectomy cost and effec-
well as a two-way sensitivity analysis looking at the rela- tiveness values were $2664.47 with 0.87 QALYs and
tionship between investment cost and number of cases $2058.72 with 0.75 QALYs, respectively (Table 3). The
performed annually in determining cost–effectiveness incremental cost–effectiveness ratio (ICER) for laparo-
recommendations. scopic cholecystectomy, compared to open cholecystec-
tomy, was $4946.18/QALY.

Results Sensitivity analyses

Parameter estimation If the initial investment cost of the laparoscopic equipment


was not included in the total cost for the relevant pathways,
There were 17 total laparoscopic cholecystectomies con- the new laparoscopic approach cost and effectiveness val-
ducted at RMH prior to the study; during a time-matched ues were $1851.30 with 0.88 QALYs. The cost and
period, there were 12 documented open cholecystectomies. effectiveness values for the open approach remained the
Based on these numbers, terminal node event probabilities same. In this case, the laparoscopic approach strictly
are included in Table 1 for comparison with the outside dominated the open cholecystectomy approach.
sources utilized in calculations due to greater sample sizes. The one-way sensitivity analysis evaluating for the
Due to the small sample sizes, they were not included in threshold number of cases performed at RMH in order for
calculations. the laparoscopic cholecystectomy route to become more

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Fig. 4 Two-way sensitivity


analysis on investment cost and
number of cases. cInvestment
measured in 2014 USD; nCases
reflects annual volume

cost–effective at the WTP threshold was 65 laparoscopic recommended. Sensitivity analyses showed that above a
cholecystectomy cases annually (Fig. 2). Additionally, a WTP threshold of $3975, the laparoscopic approach is
one-way sensitivity analysis looking at investment cost more likely to be cost-effective. This suggests that
found that laparoscopic cholecystectomies were cost-ef- laparoscopic surgery may become more affordable in
fective at the WTP threshold for investment costs less than LMICs as GDP per capita grows.
$91,979. Results were robust to other sensitivity analyses. In sensitivity analyses performed without consideration
The Monte Carlo simulation demonstrated that at WTP of initial investment costs, the laparoscopic approach is
thresholds greater than $3975/QALY, a laparoscopic both less expensive and more effective, strictly dominating
cholecystectomy becomes more likely to be cost-effective. the open approach. This suggests that in settings where
For all WTP values below this value, the open cholecys- machinery can be donated, where machinery has already
tectomy was more likely to be cost-effective (Fig. 3). been donated, or where local/regional equipment can be
A graph generated from the two-way sensitivity analysis purchased, the implementation of a laparoscopic approach
on investment cost and number of cases performed annu- may be feasible and beneficial. At investments costs less
ally depicts the threshold considerations for both parame- than $91,979, the laparoscopic approach is also more
ters in combination; it models the values above or below favorable. Currently, opportunities exist to obtain laparo-
which laparoscopic surgery becomes more cost-effective scopic equipment for investment costs less than $7500
than an open approach for cholecystectomy (Fig. 4). from some sources such as Indian suppliers [30]. Thus, as
innovation leads to the availability of equipment at lower
investment costs, recommendations will shift to more
Discussion completely favor the laparoscopic approach.
Additionally, at an annual volume of 65 cases or more,
The results from RMH demonstrate that while a laparo- the laparoscopic cholecystectomy approach is more cost-
scopic cholecystectomy may be a more effective approach, effective at the WTP threshold even with the high initial
it is also more expensive. At a WTP threshold of 39 GDP capital cost paid in this specific case. RMH currently
per capita in Rwanda ($2088), the open approach is operates at a volume of 37 cholecystectomies annually. Not

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only would increasing the number of laparoscopic chole- of basic laparoscopic courses and have implemented them
cystectomies performed directly offset the investment cost at multiple referral centers [14]. Other countries such as
and consequently shift recommendations, but also would Yemen have relied on the support of high-income coun-
increasing the number of laparoscopic procedures in gen- tries [12]. However, even if finances shift and an LMIC
eral. Utilization of laparoscopic equipment for additional can afford to purchase the necessary equipment in a cost-
general surgery pathologies as well as other subspecialty or effective manner, lack of biomedical technicians in
OBGYN procedures would reduce the portion of initial LMICs hinders repair and maintenance of the equipment
investment costs each patient is responsible for with each [16].
laparoscopic procedure. This study has limitations. Due to the limited numbers
Such case threshold information can help guide recom- of laparoscopic cases performed at RMH and lack of
mendations regarding whether and when a program would studies about laparoscopy in Rwanda, event probabilities
benefit from starting to offer laparoscopic cholecystec- used in calculations were obtained from other LMICs.
tomies. The investment cost would actually need to decrease While a methodical approach was utilized to ensure the
approximately $70,000 (43% of initial investment) to a total most representative results possible, and while RMH
of $91,979 in order to be cost effective. Further, these probabilities were similar, the small sample size pre-
parameters must be considered in combination instead of in cludes direct applicability at RMH. Additionally, QALYs
exclusivity. Both the investment cost and case volume del- are derived from studies in HICs and sometimes involved
icately impact recommendations, and a decrease in invest- other procedures. In order to combat these limitations, a
ment cost in parallel to an increase in case volume can most sensitivity analysis was conducted and demonstrated that
effectively support introduction of laparoscopy in low-re- the results were not sensitive to any changes. Moreover,
source settings. As shown in Fig. 4, at each investment cost, the decision tree reflects current resources at RMH but
there is a specific case volume above which cost–effective- would be subject to change given the advent of new
ness shifts toward laparoscopic cholecystectomy. Similarly, resources. Such modifications to the decision pathway
at each case volume, there is a specific investment cost could alter which choice is most cost-effective. Lastly,
threshold. Such a model can enable healthcare leaders to the cost attributed to each case as a portion of the initial
predict whether at X cases per week or per year, they can equipment investment cost reflected only the number of
afford instruments at Y cost in a cost-effective manner. annual laparoscopic cholecystectomy cases; it did not
Healthcare leaders must consider this dichotomy when consider gynecologic or urologic laparoscopic cases
developing new laparoscopy programs. Furthermore, already currently performed at RMH.
beyond the measures directly considered in this cost–effec- Despite these limitations, our results are robust to
tiveness analysis lie the economies of scope—this includes uncertainty in all parameters except for the initial invest-
these different specialties that may conduct different pro- ment in laparoscopic equipment and the annual number of
cedures using the same equipment. Hospital administrators cases performed. This study contributes to the existing
and policymakers must not only utilize information from debate as it illustrates situations in which implementation
cost–effectiveness analyses, but also equally consider other of laparoscopic surgery may or may not be cost-effective.
critical players in the system to inform their decisions. It may serve as a model for future costing studies and also
Ultimately, given the widely accepted benefits of laparo- provides an evidence-based insight on the opportunities for
scopic surgery, efforts must be made toward developing laparoscopic surgery in LMICs.
programs and environments that can cost-effectively offer
laparoscopic care given the widely accepted benefits of such
minimally invasive surgery. Conclusion
Previous studies indicate mixed results regarding whe-
ther or not implementation of laparoscopy is cost-effective Though a laparoscopic cholecystectomy approach is a
in low-resource settings [6, 7, 10]. Some support laparo- more effective option for patients with biliary disease, it
scopic approaches at WTP thresholds of 39 GDP per may be too expensive to replace open cholecystectomy at
capita [10], while others suggest that economic benefit may current implementation costs and annual volume of cases.
only be for higher-income patients until future cost At willingness-to-pay thresholds of 39 GDP per capita in
reduction strategies can be employed [9]. Rwanda’s current setting, open cholecystectomy is more
Of note, non-financial barriers to the integration of cost-effective than laparoscopic cholecystectomy. How-
laparoscopic surgery exist. Such barriers include lack of ever, as investment costs decrease and/or case volume
training, lack of functioning equipment, and an unavail- increases, the laparoscopic approach may become cost-ef-
ability of qualified surgeons [12, 14]. Countries such as fective. Healthcare leaders must be aware of the complex
Mongolia have demonstrated the successful development variables involved in implementation of laparoscopic

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Acknowledgements MGS receives support from the GE Safe Sur- tematic review and analysis. Lancet Glob Health 2:e334–e345
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