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Amoxicillin plus clavulanic acid versus appendicectomy for treatment of acute uncomplicated appendicitis: an open-label, non-inferiority, randomised controlled trial
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Prof Corinne VonsMD a Corresponding AuthorEmail Address, Caroline Barry PhD c ‡, Sophie Maitre MD b ‡, Karine Pautrat MD d, Mahaut Leconte MD e, Bruno Costaglioli MD f, Mehdi Karoui MD g, Prof Arnaud Alves MD d, ProfBertrand Dousset MD e, Prof Patrice Valleur MD d, Prof Bruno Falissard MD c, Prof Dominique Franco MD a
Researchers have suggested that antibiotics could cure acuteappendicitis. We assessed the efficacy of amoxicillin plus clavulanic acid by comparison with emergency appendicectomy for treatment of patients with uncomplicated acute appendicitis.
In thisopen-label, non-inferiority, randomised trial, adult patients (aged 18—68 years) with uncomplicated acute appendicitis, as assessed by CT scan, were enrolled at six university hospitals in France. Acomputer-generated randomisation sequence was used to allocate patients randomly in a 1:1 ratio to receive amoxicillin plus clavulanic acid (3 g per day) for 8—15 days or emergency appendicectomy. The primaryendpoint was occurrence of postintervention peritonitis within 30 days of treatment initiation. Non-inferiority was shown if the upper limit of the two-sided 95% CI for the difference in rates was lowerthan 10 percentage points. Both intention-to-treat and per-protocol analyses were done. This trial is registered with, number NCT00135603.
Of 243 patients randomised,123 were allocated to the antibiotic group and 120 to the appendicectomy group. Four were excluded from analysis because of early dropout before receiving the intervention, leaving 239 (antibioticgroup, 120; appendicectomy group, 119) patients for intention-to-treat analysis. 30-day postintervention peritonitis was significantly more frequent in the antibiotic group (8%, n=9) than in the...
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