Randomized clinical trial of antibiotic therapy versus appendicectomy as primary treatment of acute appendicitis in unselected patients

Abstract

Background: A trial in selected men suggested that antibiotic therapy could be an alternative to appendicectomy in appendicitis. This study aimed to evaluate antibiotic therapy in unselected men and women with acute appendicitis. Methods: Consecutive patients were allocated to study (antibiotics) or control (surgery) groups according to date of birth. Study patients received intravenous antibiotics for 24 h and continued at home with oral antibiotics for 10 days. Control patients had a standard appendicectomy. Follow-up at 1 and 12 months was carried out according to intention and per protocol. Results: Study and control patients were comparable at inclusion; 106 (52·5 per cent) of 202 patients allocated to antibiotics completed the treatment and 154 (92·2 per cent) of 167 patients allocated to appendicectomy had surgery. Treatment efficacy was 90·8 per cent for antibiotic therapy and 89·2 per cent for surgery. Recurrent appendicitis occurred in 15 patients (13·9 per cent) after a median of 1 year. A third of recurrences appeared within 10 days and two-thirds between 3 and 16 months after hospital discharge. Minor complications were similar between the groups. Major complications were threefold higher in patients who had an appendicectomy (P < 0·050). Conclusion: Antibiotic treatment appears to be a safe first-line therapy in unselected patients with acute appendicitis. Registration number: NCT00469430 (http://www.clinicaltrials.gov).