A randomized clinical trial conducted in the Netherlands shows that 2 days of postoperative intravenous (IV) antibiotics for complex appendicitis is non-inferior to 5 days, Dutch researchers reported yesterday in The Lancet.
In the open-label non-inferiority trial, patients with complex appendicitis at 15 Dutch hospitals were randomly assigned to receive 2 days or 5 days of IV antibiotics after appendectomy. The primary end point, based on electronic patient records and a telephone consultation 90 days after appendectomy, was a composite of infectious complications and mortality within 90 days. The non-inferiority margin for the absolute risk difference, adjusted for age and severity of appendicitis, was 7.5%.
A total of 1,066 patients were randomly assigned to the two treatment arms from Apr 12, 2017, to Jun 3, 2021, with 533 in each group. Appendectomy was done laparoscopically in 955 (95%) of 1,005 patients. The primary end point occurred in 51 (10%) of 502 patients in the 2-day group and 41 (8%) of 503 patients in the 5-day group, for an adjusted absolute risk difference of 2.0% (95% confidence interval [CI], -1.6% to 5.6%) in favor of the 5-day group. Fewer patients in the 2-day group had adverse effects from antibiotics than in the 5-day group (9% vs 22%; odds ratio [OR], 0.34; 95% CI, 0.24 to 0.50), while hospital re-admission was more frequent in the 2-day group than in the 5-day group (12% vs 6%; OR, 2.14; 95% CI, 1.43 to 3.37).
"This study supports the idea that extended antibiotic prophylaxis for intra-abdominal infections is not indicated after adequate source control," the investigators wrote.
In an accompanying commentary, researchers from the United Kingdom, Sweden, and Rwanda note that a shorter postoperative antibiotic course should be used cautiously in low- and middle income settings, where presentation to surgeons takes longer and laparoscopic surgery is less commonly available.
"A whole body of research is necessary for health systems in low-income and middle-income countries, including to understand challenges around access and diagnosis, implementing sustainable laparoscopic capacity, and identifying the optimum context-specific antibiotic strategies," they wrote.
A whole body of research is necessary for health systems in low-income and middle-income countries.