Abstract
BackgroundAlthough the standard treatment of acute appendicitis (AA) consists of an early appendectomy, there has recently been both an interest and an increase in the use of antibiotic therapy as the primary treatment for uncomplicated AA. However, the use of antibiotic therapy in the treatment of uncomplicated AA is still controversial.Methods/designThe APPAC trial is a randomized prospective controlled, open label, non-inferiority multicenter trial designed to compare antibiotic therapy (ertapenem) with emergency appendectomy in the treatment of uncomplicated AA. The primary endpoint of the study is the success of the randomized treatment. In the antibiotic treatment arm successful treatment is defined as being discharged from the hospital without the need for surgical intervention and no recurrent appendicitis during a minimum follow-up of one-year (treatment efficacy). Treatment efficacy in the operative treatment arm is defined as successful appendectomy evaluated to be 100%. Secondary endpoints are post-intervention complications, overall morbidity and mortality, the length of hospital stay and sick leave, treatment costs and pain scores (VAS, visual analoque scale). A maximum of 610 adult patients (aged 18–60 years) with a CT scan confirmed uncomplicated AA will be enrolled from six hospitals and randomized by a closed envelope method in a 1:1 ratio either to undergo emergency appendectomy or to receive ertapenem (1 g per day) for three days continued by oral levofloxacin (500 mg per day) plus metronidazole (1.5 g per day) for seven days. Follow-up by a telephone interview will be at 1 week, 2 months and 1, 3, 5 and 10 years; the primary and secondary endpoints of the trial will be evaluated at each time point.DiscussionThe APPAC trial aims to provide level I evidence to support the hypothesis that approximately 75–85% of patients with uncomplicated AA can be treated with effective antibiotic therapy avoiding unnecessary appendectomies and the related operative morbidity, also resulting in major cost savings.Trial registrationClinicaltrials.gov http://NCT01022567
Highlights
The standard treatment of acute appendicitis (AA) consists of an early appendectomy, there has recently been both an interest and an increase in the use of antibiotic therapy as the primary treatment for uncomplicated AA
The APPAC trial aims to provide level I evidence to support the hypothesis that approximately 75–85% of patients with uncomplicated AA can be treated with effective antibiotic therapy avoiding unnecessary appendectomies and the related operative morbidity, resulting in major cost savings
For over a century it has been generally believed that AA progresses invariably from early inflammation to later gangrene and perforation, and that emergency appendectomy is always required for surgical source control [4]
Summary
The hypothesis of the APPAC trial is that the majority of patients with uncomplicated AA can be cured with wide-spectrum antibiotics avoiding a large number of unnecessary appendectomies and this hypothesis is supported by previous randomized studies [13,14,15,16,17,18]. If Vons et al had excluded the patients with an appendicolith from their analysis, no significant difference in the incidence of post-intervention peritonitis between the treatment groups would have been noticed in their study. 68% of the patients in their study did not require appendectomy supporting our study hypothesis, that the majority of patients (> 70%) with uncomplicated AA can be treated successfully with antibiotics and unnecessary appendectomies can be avoided resulting in reduced morbidity and mortality of surgical treatment of AA, enormous cost savings and allocation of surgical resources to other emergency operations. Since so far only a small number of RCTs (< 1000 patients) with somewhat impaired methodological quality are available, more well-designed RCTs are urgently needed to both conclusively define the role of antibiotic therapy in the management of uncomplicated AA and to assess the predictive markers for successful non-operative treatment of uncomplicated AA
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