Abstract
IntroductionResults of the first randomized trial comparing on-demand versus planned-relaparotomy strategy in patients with severe peritonitis (RELAP trial) indicated no clear differences in primary outcomes. We now report the full economic evaluation for this trial, including detailed methods, nonmedical costs, further differentiated cost calculations, and robustness of different assumptions in sensitivity analyses.MethodsAn economic evaluation was conducted from a societal perspective alongside a randomized controlled trial in 229 patients with severe secondary peritonitis and an acute physiology and chronic health evaluation (APACHE)-II score ≥11 from two academic and five regional teaching hospitals in the Netherlands. After the index laparotomy, patients were randomly allocated to an on-demand or a planned-relaparotomy strategy. Primary resource-utilization data were used to estimate mean total costs per patient during the index admission and after discharge until 1 year after the index operation. Overall differences in costs between the on-demand relaparotomy strategy and the planned strategy, as well as relative differences across several clinical subgroups, were evaluated.ResultsCosts were substantially lower in the on-demand group (mean, €65,768 versus €83,450 per patient in the planned group; mean absolute difference, €17,682; 95% CI, €5,062 to €29,004). Relative differences in mean total costs per patient (approximately 21%) were robust to various alternative assumptions. Planned relaparotomy consistently generated more costs across the whole range of different courses of disease (quick recovery and few resources used on one end of the spectrum; slow recovery and many resources used on the other end). This difference in costs between the two surgical strategies also did not vary significantly across several clinical subgroups.ConclusionsThe reduction in societal costs renders the on-demand strategy a more-efficient relaparotomy strategy in patients with severe peritonitis. These differences were found across the full range of healthcare resources as well as across patients with different courses of disease.Trial RegistrationISRCTN51729393
Highlights
Results of the first randomized trial comparing on-demand versus planned-relaparotomy strategy in patients with severe peritonitis (RELAP trial) indicated no clear differences in primary outcomes
Secondary peritonitis or abdominal sepsis is a serious condition with high in-hospital mortality and considerable major disease
We present an economic evaluation within a randomized clinical trial comparing two commonly used surgical strategies for patients with secondary peritonitis after their initial emergency laparotomy, on-demand relaparotomy and planned relaparotomy
Summary
Results of the first randomized trial comparing on-demand versus planned-relaparotomy strategy in patients with severe peritonitis (RELAP trial) indicated no clear differences in primary outcomes. A relaparotomy is performed every other day (24 to 36 h) until findings are negative for (ongoing) peritonitis. This strategy may incur the risk of potential surgery-related complications. The on-demand strategy uses ‘watchful waiting,’ in which a relaparotomy is performed only in those patients showing clinical deterioration or lack of improvement. Fewer relaparotomies are likely to be performed with this strategy [3], which may benefit the already critically ill patients, but may lead to a potentially harmful delay
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