Amoxicillin clavulanate vs appendectomy in the treatment of acute uncomplicated appendicitis: results of an open randomized controlled trial
There are a number of studies supporting the hypothesis that antibiotics can cure acute appendicitis. French researchers have evaluated the effectiveness of two methods of treating patients with uncomplicated acute appendicitis - the use of amoxicillin / clavulanate versus emergency appendectomy.
This randomized open-label controlled study conducted in 6 university hospitals in France included adult patients aged 18 to 68 years with uncomplicated acute appendicitis (the diagnosis was established by computed tomography). Patients were randomized into a 1: 1 ratio to receive amoxicillin / clavulanate (3 g per day) for 8 to 15 days or to perform an emergency appendectomy. The main endpoint evaluated during the study was the incidence of peritonitis after the intervention (conservative - antibiotic prescription - or surgical - appendectomy) within 30 days of the start of treatment. The non-inferiority criterion was valid if the upper limit of the 95% bilateral confidence interval for the differences in the incidence of peritonitis was less than 10%.
Of the 243 randomized patients, 123 were assigned to the antibiotic prescription group and 120 to the surgical treatment group. Four patients were excluded from the analysis due to an early withdrawal from the study before treatment (conservative or surgical), therefore 239 patients were included in the final analysis according to the prescribed intervention (ITT analysis) ( 120 in the amoxicillin / clavulanate group and 119 in the appendectomy group).
The incidence of peritonitis within 30 days of the intervention was statistically significantly higher in the amoxicillin / clavulanate group (8% vs 2%, difference 5.8%, 95% CI 3-12 1). In the appendectomy group, despite the CT scans, 21 patients (18%) unexpectedly developed complicated appendicitis with peritonitis during surgery. In the antibacterial therapy group, 14 patients out of 120 (12%) underwent appendectomy within the first 30 days after treatment and 30 patients out of 102 people (29%) underwent appendectomy between 1 month and 1 year after treatment, 26% of whom were diagnosed with acute appendicitis (i.e., the recurrence rate was 26%).
Thus, the administration of amoxicillin / clavulanate is less effective than emergency appendectomy in the treatment of acute appendicitis. Determining prognostic criteria based on CT data may be an opportunity to improve the targeted use of antibiotic therapy.