For new health technologies to replace existing ones, they must not only provide clinical benefits but also demonstrate cost-effectiveness. Our initial experience with the new ECPS supported the first criterion, showing a decrease in AL rates compared to conventional MCS (1.7% vs. 11.8%). [17] In the present study, we expanded the scope to include patients with anastomoses located less than 5 cm from the anal verge, those who underwent preoperative radiotherapy, and those with diverting ileostomy, a group excluded in our previous study. As anticipated, the AL rate was higher with the inclusion of higher-risk patients, although significant between-group differences remained (13.3% in the MCS group vs. 4.8% in the ECPS group). In addition to clinical benefits observed, this reduction in AL incidence has a substantial economic impact by lowering hospital costs. Despite the higher price of ECPS than MCS (a difference of €128), the average cost per patient was €3,469 lower in the ECPS than in the MCS group.
Other studies have also demonstrated clinical advantages associated with ECPS. In a prospective multicenter single-arm study involving 12 centers in Europe and the USA, which included 168 patients undergoing colorectal anastomosis using the new ECPS, the AL rate was 1.8%.[18] Subsequently, a retrospective, matching-adjusted indirect study compared this ECPS patient cohort with a control group that had undergone colorectal anastomosis with conventional MCS, obtained from a national database in the USA. The AL rate was significantly lower in the ECPS group than the conventional MCS group (1.8% vs. 6.9%, p < 0.001). [19] Using clinical data from this study, Pollak et al. assessed the economic impact of using ECPS compared to MCS. They developed a US hospital-based budget impact model analysing total costs, average length of stay, proportion of patients with non-home discharge, and reasons for readmission. The reduction in AL with ECPS resulted in estimated annual savings of $53,987 assuming 100 procedures per year with each type of circular device, despite the higher cost of this device compared to MCS. [24]
To our best knowledge, this is the first study to analyse the impact on colorectal AL reduction using the new ECPS on colorectal AL reduction compared to the results obtained with MCS, in the same centre, by the same group of surgeons, with no modification of perioperative protocols during the period, and with the type of circular stapler as the only change introduced. A further strength of our study is the analysis of economic impact considering the hospital resources actually used by each patient and their official cost in our setting.
The consequences of anastomotic leakage (AL) are undoubtedly of grave concern for patients, but it is equally crucial to consider the economic implications for the healthcare system. AL typically results in an increased burden on hospital resources, leading to a substantial economic impact. An Australian study examined hospital resources used for patients with AL after colorectal cancer resection in a cohort of 1228 patients. Treating the 41 patients who experienced leakage (AL rate of 3.8%) resulted in the following resource allocation: 92 days in intensive care, 129 days of total parenteral nutrition, 69 days of enteral feeding, 41 days on ventilation, and a median postoperative hospital stay of 28 days (range 11–104). These patients required 24 re-operations and 2273 separate medical consultations or additional services.[6] Although the cost of AL was not directly analysed in the study, this significant increase in hospital resource consumption would evidently have substantial economic repercussions.
The financial implications of AL can vary depending on each country's healthcare system. In many high-income countries, the diagnosis-related group (DRG) payment system is commonly used for hospital care reimbursement. Patients in the same DRG are expected to follow a similar clinical course, which should result in similar hospital costs. Surgical complications, including AL, are considered in DRG assignment and may contribute to higher reimbursement. However, AL often leads to substantially higher costs that may not be adequately covered by DRG reimbursement. [25] In a Swiss retrospective study, Regina et al. compared resource use and DRG reimbursement between patients undergoing uncomplicated colorectal resection and those with AL. The cost for uncomplicated cases was 17,647 euros, while patients with AL incurred costs of 71,978 euros (p < 0.01). The increase in costs was not fully compensated by the new complication-related DRG reimbursement, resulting in an average benefit per patient in the uncomplicated group of 542 euros, while the AL group incurred an average loss of 12,181 euros per patient. [11] Similarly, an Italian retrospective study found that the mean adjusted hospital cost was 108% higher for patients with AL after colorectal surgery (14,711 vs. 7,089 euros). The average DRG reimbursement for AL patients covered only 86% of hospitalization costs, resulting in an average loss per patient with AL of 2,041 euros. [7] In Spain, a recent study estimated the additional cost of diagnosing and treating AL following colorectal cancer surgery to be €38,819 for colon and €32,599 for rectal cancer patients. [26]
The economic impact of AL can be viewed from both the hospital's and the payer's perspective. Hospitals may not be fully compensated by payer reimbursements for the actual cost of resource consumption, and payers may also bear additional expenses, such as readmissions or stoma care. [27] Therefore, reducing AL incidence is essential not only for patient well-being but also to preserve the sustainability of the public healthcare system, especially in settings with fixed annual budgets such as our hospital.
Our study has several limitations that warrant consideration. Firstly, it is a retrospective observational study conducted at a single medical center, and patients in each group were treated at different time periods to allow for ECPS selection as the device under study. To mitigate potential bias, we carefully restricted the study period, ensuring uniformity in perioperative protocols and consistent surgical procedures performed by a cohesive team of colorectal surgeons, each boasting over a decade of experience. Moreover, we employed propensity score matching to create comparable patient groups.
Secondly, owing to characteristics of our healthcare system and the retrospective design of the study, detailed information on pharmaceutical expenses for individual patients was not accessible, thus ruling out the possibility of including these costs in our hospital resources analysis. While this omission may have resulted in slight underestimation of the actual costs, it is unlikely to significantly affect the differences observed between the two groups. Finally, other resource use-related factors not considered in our analysis could potentially have influenced the results.
Despite these limitations, our study highlights the positive impact of introducing ECPS into clinical practice, particularly in reducing AL rates. While a cost differential between ECPS and MCS exists, the hospital savings from the reduction in AL cases more than compensates for this difference.