BACKGROUND: Previous randomized studies of laparoscopic appendectomy produced conflicting recommendations, and the adequacy of sample sizes is generally unknown. We compared clinical and economic outcomes after laparoscopic and open appendectomy in a sample of predetermined statistical power. METHODS: A pre-study power analysis suggested that 200 randomized patients would yield 80% power to show a mean decrease of 1.3 days' hospitalization. One hundred ninety-eight patients with a preoperative diagnosis of acute appendicitis were randomized prospectively to laparoscopic or open appendectomy. Economic analysis included billed charges, total costs, direct costs, and indirect costs associated with treatment. RESULTS:Laparoscopic appendectomy took longer to perform than open appendectomy (median, 107 vs 91 minutes; P <.01) and was associated with fewer days to return to a general diet (mean, 1.6 versus 2.3 days; P <.01), a shorter duration of parenteral analgesia (mean, 1.6 versus 2.2 days; P <.01), fewer morphine-equivalent milligrams of parenteral narcotic (median, 14 mg versus 34 mg; P =.001), a shorter postoperative hospital stay (mean, 2.6 versus 3.4 days; P <.01), and earlier return to full activity (median, 14 versus 21 days; P <.02). However, operative morbidity and time to return to work were comparable. Billed charges and direct costs were not significantly different in the 2 groups ($7711 versus $7146 and $5357 versus $4945, respectively), but total costs (including indirect costs) of laparoscopic appendectomy were, on average, nearly $2400 less, given the shorter length of stay and abbreviated recuperative period ($11,577 versus $13,965). Subgroup analyses suggested the benefit of a laparoscopic approach for uncomplicated appendicitis and for patients with active lifestyles. CONCLUSIONS: While laparoscopic appendectomy is associated with statistically significant but clinically questionable advantages over open appendectomy, a laparoscopic approach is relatively less expensive. The estimated difference in total costs of treatment (direct and indirect costs) was at least $2000 in more than 60% of the bootstrapped iterations. The economic significance and implications favoring a laparoscopic approach cannot be ignored.
RCT Entities:
BACKGROUND: Previous randomized studies of laparoscopic appendectomy produced conflicting recommendations, and the adequacy of sample sizes is generally unknown. We compared clinical and economic outcomes after laparoscopic and open appendectomy in a sample of predetermined statistical power. METHODS: A pre-study power analysis suggested that 200 randomized patients would yield 80% power to show a mean decrease of 1.3 days' hospitalization. One hundred ninety-eight patients with a preoperative diagnosis of acute appendicitis were randomized prospectively to laparoscopic or open appendectomy. Economic analysis included billed charges, total costs, direct costs, and indirect costs associated with treatment. RESULTS: Laparoscopic appendectomy took longer to perform than open appendectomy (median, 107 vs 91 minutes; P <.01) and was associated with fewer days to return to a general diet (mean, 1.6 versus 2.3 days; P <.01), a shorter duration of parenteral analgesia (mean, 1.6 versus 2.2 days; P <.01), fewer morphine-equivalent milligrams of parenteral narcotic (median, 14 mg versus 34 mg; P =.001), a shorter postoperative hospital stay (mean, 2.6 versus 3.4 days; P <.01), and earlier return to full activity (median, 14 versus 21 days; P <.02). However, operative morbidity and time to return to work were comparable. Billed charges and direct costs were not significantly different in the 2 groups ($7711 versus $7146 and $5357 versus $4945, respectively), but total costs (including indirect costs) of laparoscopic appendectomy were, on average, nearly $2400 less, given the shorter length of stay and abbreviated recuperative period ($11,577 versus $13,965). Subgroup analyses suggested the benefit of a laparoscopic approach for uncomplicated appendicitis and for patients with active lifestyles. CONCLUSIONS: While laparoscopic appendectomy is associated with statistically significant but clinically questionable advantages over open appendectomy, a laparoscopic approach is relatively less expensive. The estimated difference in total costs of treatment (direct and indirect costs) was at least $2000 in more than 60% of the bootstrapped iterations. The economic significance and implications favoring a laparoscopic approach cannot be ignored.
Authors: Ulrich Guller; Sheleika Hervey; Harriett Purves; Lawrence H Muhlbaier; Eric D Peterson; Steve Eubanks; Ricardo Pietrobon Journal: Ann Surg Date: 2004-01 Impact factor: 12.969