Related Experiment Video
Updated: Oct 27, 2025
Laparoscopic Common Bile Duct Exploration Followed by Primary Suture Using a Modified Bile Duct Incision
Published on: May 2, 2025
Budget Impact of Restrictive Strategy Versus Usual Care for Cholecystectomy (SECURE-Trial)
Carmen S S Latenstein1, Aafke H van Dijk2, Sarah Z Wennmacker1
1Department of Surgery, Radboud University Medical Centre, Nijmegen, the Netherlands.
Insights
Implementing a restrictive strategy for gallstone patients in specific subgroups can reduce hospital costs. This approach, focusing on selected patients, offers significant budget impact savings while managing care effectively.
Area of Science:
- Health Economics
- Surgical Outcomes
- Gastroenterology
Background:
- A cost-effectiveness analysis indicated that a restrictive strategy for gallstone patients did not universally compensate for fewer pain-free outcomes.
- However, specific subgroups identified in a randomized controlled trial (SECURE-trial) showed promise for restrictive management.
Purpose of the Study:
- To evaluate the hospital budget impact of implementing a restrictive strategy for cholecystectomy in identified subgroups of gallstone patients.
- To analyze cost-effectiveness from a hospital healthcare perspective.
Main Methods:
- Utilized data from the SECURE-trial for a four-year hospital budget impact analysis.
- Incorporated practice variation data (19% current restrictive strategy use) and performed scenario and sensitivity analyses.
- Examined budget impact across specific subgroups defined by sex, volume, and BMI.
Main Results:
- Budget impact analysis projected savings of €6.7-€15.6 million (2.2%-5.6%) between 2021-2024/2025 with the restrictive strategy in subgroups.
- Sensitivity analysis, assuming 30% initial restrictive strategy use, yielded savings between €5.4 million and €14.0 million (1.7%-5.0%).
Conclusions:
- A restrictive strategy for selecting cholecystectomy in specific gallstone patient subgroups, combined with usual care for others, reduces the overall hospital budget.
- This targeted approach optimizes resource allocation for treating gallstone-related abdominal pain.
Objectives:
A cost-effectiveness analysis of a multicenter randomized-controlled trial comparing restrictive strategy versus usual care in patients with gallstones showed that savings by restrictive strategy could not compensate for the lower proportion of pain-free patients. However, four subgroups based on combined stratification factors resulted in less cholecystectomies and more pain-free patients in restrictive strategy (female-low volume-BMI > 30, female-low volume-BMI25-30, female-high volume-BMI25-30, and male-low volume-BMI < 25). The aim of this study was to explore the budget impact from a hospital healthcare perspective of implementation of restrictive strategy in these subgroups.
Methods:
Data of the SECURE-trial were used to calculate the hospital budget impact with a time horizon of four years. Based on a study into practice variation, about 19% of hospitals treat patients according restrictive strategy. This represents the proportion of patients treated according restrictive strategy at the start of budget period. Three subanalyses were performed: a scenario analysis in which 30% of patients fall under a restrictive strategy in clinical practice, a sensitivity analysis in which we calculated the budget impact with the low and high 95% confidence limits of the expected future number of patients, a subgroup analysis in which restrictive strategy was also implemented in two additional subgroups (male-high volume-BMI < 25 and female-high volume-BMI >30).
Results:
Budget impact analysis showed savings of €6.7-€15.6 million (2.2%-5.6%) for the period 2021-2024/2025 by implementing the restrictive strategy in the four subgroups and provision of usual care in other patients. Sensitivity analysis with 30% of patients already in the restrictive strategy at the start of the budget period, resulted in savings between €5.4 million and €14.0 million (1.7%-5.0%).
Conclusion:
Performing a restrictive strategy for selection of cholecystectomy in subgroups of patients and provision of usual care in other patients will result in a lower overall hospital budget needed to treat patients with abdominal pain and gallstones.
Trial Registration:
The Netherlands National Trial Register NTR4022. Registered on June 5, 2013.
