Never put equipoise in appendix! Final results of ASAA (antibiotics vs. surgery for uncomplicated acute appendicitis in adults) randomized controlled trial

Abstract

Acute appendicitis is the most common surgical emergency; however, its etiology and diagnosis are still discussed with a considerable proportion of wrong diagnosis resulting in appendectomies for non inflamed appendix. Moreover, the biologic function of the appendix is still unclear. For uncomplicated acute appendicitis the conservative treatment with antibiotics has been proposed with interesting results. The aim of this study was to compare surgical treatment vs. antibiotics in uncomplicated acute appendicitis. This is a monocentric randomized controlled trial comparing surgery with antibiotic therapy in adults with uncomplicated acute appendicitis. The primary outcome was the success rate (resolution of symptoms within 2 weeks and no need for further treatments); secondary outcomes were complication rate; negative appendectomy rate (only in surgical arm); and long-term outcomes within a year as recurrence. The study was designed as a non-inferiority trial. From September 2011 to December 2014, 224 patients fulfilled the eligibility criteria and 45 patients were randomized. Twenty four patients (53.3%) were randomly assigned to surgery and 21 (46.6%) to antibiotic therapy. In surgical group primary outcome was reached for all the patients; secondary negative outcomes were recorded in five patients (22.7%): two cases of negative appendectomies, three wound infections. In antibiotics group treatment fails in 16.8% of cases; secondary negative outcomes were recorded in one patient who experienced relapse of AA at 30 days No further events or complications were observed at 1-year follow-up. Due to the poor patients' accrual the study had no enough statistical power to demonstrate the non-inferiority of conservative treatment and results were inconclusive. Due to the poor patient's accrual rate the study failed to demonstrate the non-inferiority of conservative treatment in uncomplicated acute appendicitis. On the other hand the study demonstrates the difficulty in performing randomized trials in emergency surgery and focus on the ethical aspects.

Keywords: Acute appendicitis; Antibiotics; Conservative treatment; Equipoise; Randomized trial; Uncomplicated acute appendicitis.