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ABSTRACT
Objective: A novel preoperative procedure From Home To Operation (FHTO) seeks to combat increasing operation and infection rates. This is the first prospective randomized controlled trial (RCT) comparing the cost-effectiveness and cost-utility of FHTO and conventional ward procedures for standardized Laparoscopic Cholecystectomy (LC).
Research design and methods: During 12/2004–7/2005, 47 patients with symptomatic gallstones were randomized to receive LC in the FHTO (28 patients) or in a conventional manner (19 patients) in a Finnish hospital setting. The 15D quality of life tool was administered at the baseline and 1 month after.
Main outcome measures: A stochastic approach over a month interval for hospital costs, length of postoperative stay, infection rate and Quality-Adjusted Life Years (QALY) was employed.
Results: Baseline group characteristics were similar. The mean health care costs with FHTO (1695 EUR) were significantly lower ( p < 0.001) than in the conventional arm (2234 EUR). The number of patients discharged on the first postoperative day was 27 (96.4%) and 15 (78.9%) with two (7.1%) infections in the FHTO and four (21.1%) in the conventional arm. A difference in QALYs gained (0.0174; p = 0.030) favouring FHTO was observed. According to a cost-effectiveness acceptability curve, the probability of FHTO being cost-effective was 99%. The results were robust to probabilistic sensitivity analyses.
Conclusions: FHTO can introduce substantial cost savings and have a positive impact on both clinical measures and quality of life. Studies with larger numbers of patients are needed to assess whether conventional ward procedure can be a source of infections, which can be avoided with FHTO.
Clinical Trial Registry: ICJME-qualified registry of the Hospital District of Helsinki and Uusimaa (number 217849).