Optimizing the Antibiotic Treatment of Uncomplicated Acute Appendicitis
Status:
Active, not recruiting
Trial end date:
2029-04-01
Target enrollment:
Participant gender:
Summary
Appendicectomy has been the treatment of acute appendicitis for over a hundred years.
Appendicectomy, however, includes operative and postoperative risks despite being a routine
procedure. Several studies have proved promising results of the safety and efficiency of
antibiotics in the treatment of acute uncomplicated appendicitis. The APPAC study by the
investigators, published in 2015 in the Journal of American Medical Association, also proved
promising results with 73% of patients with uncomplicated appendicitis treated successfully
with antibiotics. None of the patients initially treated with antibiotics that later had
appendectomy had major complications. The results of the APPAC trial suggest that CT proven
uncomplicated acute appendicitis is not a surgical emergency and antibiotic therapy is a safe
first-line treatment option. Reducing unnecessary appendectomies has also been shown to lead
to significant economic savings.
The aim of this randomized prospective study is to optimize antibiotic therapy for
uncomplicated acute appendicitis by comparing different antibiotic regimens; intravenous
antibiotic (ertapenem) followed by per oral antibiotic (levofloxacin and metronidazole) with
only per oral antibiotics (moxifloxacin). Before randomization, the diagnosis of acute
uncomplicated appendicitis is confirmed with a CT scan.
The hypothesis is that broad-spectrum intravenous antibiotics requiring additional hospital
resources are not necessary for the treatment of uncomplicated acute appendicitis and that
per oral mono therapy is non-inferior to the combination of intravenous and per oral
antibiotic therapy.
Phase:
N/A
Details
Lead Sponsor:
Turku University Hospital
Collaborators:
Jyväskylä Central Hospital Kuopio University Hospital Lapland Central Hospital Mikkeli Central Hospital Oulu University Hospital Satakunta Central Hospital Seinajoki Central Hospital Tampere University Hospital