Abstract
BackgroundBased on epidemiological and clinical data acute appendicitis can present either as uncomplicated (70–80%) or complicated (20–30%) disease. Recent studies have shown that antibiotic therapy is both safe and cost-effective for a CT-scan confirmed uncomplicated acute appendicitis. However, based on the study protocols to ensure patient safety, these randomised studies used mainly broad-spectrum intravenous antibiotics requiring additional hospital resources and prolonged hospital stay. As we now know that antibiotic therapy for uncomplicated acute appendicitis is feasible and safe, further studies evaluating optimisation of the antibiotic treatment regarding both antibiotic spectrum and shorter hospital stay are needed to evaluate antibiotics as the first-line treatment for uncomplicated acute appendicitis.MethodsAPPAC II trial is a multicentre, open-label, non-inferiority randomised controlled trial comparing per oral (p.o.) antibiotic monotherapy with intravenous (i.v.) antibiotic therapy followed by p.o. antibiotics in the treatment of CT-scan confirmed uncomplicated acute appendicitis. Adult patients with CT-scan diagnosed uncomplicated acute appendicitis will be enrolled in nine Finnish hospitals. The intended sample size is 552 patients.Primary endpoint is the success of the randomised treatment, defined as resolution of acute appendicitis resulting in discharge from the hospital without the need for surgical intervention and no recurrent appendicitis during one-year follow-up. Secondary endpoints include post-intervention complications, late recurrence of acute appendicitis after one year, duration of hospital stay, pain, quality of life, sick leave and treatment costs. Primary endpoint will be evaluated in two stages: point estimates with 95% confidence interval (CI) will be calculated for both groups and proportion difference between groups with 95% CI will be calculated and evaluated based on 6 percentage point non-inferiority margin.DiscussionTo our knowledge, APPAC II trial is the first randomised controlled trial comparing per oral antibiotic monotherapy with intravenous antibiotic therapy continued by per oral antibiotics in the treatment of uncomplicated acute appendicitis. The APPAC II trial aims to add clinical evidence on the debated role of antibiotics as the first-line treatment for a CT-confirmed uncomplicated acute appendicitis as well as to optimise the non-operative treatment for uncomplicated acute appendicitis.Trial registrationClinicaltrials.gov, NCT03236961, retrospectively registered on the 2nd of August 2017.
Highlights
Based on epidemiological and clinical data acute appendicitis can present either as uncomplicated (70–80%) or complicated (20–30%) disease
The APPAC trial reported that 73% of patients with uncomplicated acute appendicitis treated with antibiotics did not require appendectomy during a 1-year follow-up period, and those patients who required appendectomy did not experience major complications suggesting that computed tomography (CT)-proven uncomplicated acute appendicitis is not a surgical emergency and that antibiotic treatment is a safe first-line treatment for uncomplicated acute appendicitis [10]
As non-operative treatment for uncomplicated acute appendicitis has been shown to be safe [7,8,9,10,11,12] and cost-effective [13], the time has come to evaluate optimisation of the antibiotic therapy in the treatment of uncomplicated acute appendicitis focusing on both required antibiotic spectrum and the antibiotic therapy associated hospital stay
Summary
Based on epidemiological and clinical data acute appendicitis can present either as uncomplicated (70–80%) or complicated (20–30%) disease. The APPAC trial reported that 73% of patients with uncomplicated acute appendicitis treated with antibiotics did not require appendectomy during a 1-year follow-up period, and those patients who required appendectomy did not experience major complications suggesting that CT-proven uncomplicated acute appendicitis is not a surgical emergency and that antibiotic treatment is a safe first-line treatment for uncomplicated acute appendicitis [10]. This view has since been endorsed in recent meta-analyses [7,8,9, 12]. The economic evaluation from the APPAC trial at one-year follow-up showed substantial cost savings of 2245€ per patient favouring the antibiotic treatment over appendectomy [13]
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