Antibiotics vs. Placebo in Acute Uncomplicated Appendicitis
Status:
Enrolling by invitation
Trial end date:
2029-08-30
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"
operation. At the same time other similar intra-abdominal infections, such as diverticulitis,
are treated with antibiotics. Several studies have proved promising results of the safety and
efficiency of antibiotics in the treatment of acute uncomplicated appendicitis. Our previous
APPAC study, published in 2015 in the Journal of American Medical Association, also proved
promising results with 73% of patients with CT-diagnosed uncomplicated appendicitis treated
successfully with antibiotics within one-year follow-up. 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.
Already in 1886 Fitz noted that 1/3 of patients in a large series of autopsies from the
pre-appendicectomy era had evidence of prior appendices inflammation suggesting spontaneous
resolution of acute appendicitis. Acute appendicitis is thought to be similar to acute
diverticulitis ("left-sided appendicitis") and this similarity has been shown in
epidemiological studies. Recent studies have shown no benefit of antibiotic treatment in the
treatment of uncomplicated diverticulitis with outpatient management without antibiotics
proving safe and well-functioning.
The aim of this randomised double-blinded study is to compare antibiotic therapy with placebo
to evaluate the role of antibiotic therapy in the resolution of CT-diagnosed uncomplicated
acute appendicitis.
The hypothesis is that antibiotic therapy is necessary in the treatment of acute
uncomplicated appendicitis and that antibiotic therapy is superior to spontaneous resolution
(placebo) with the primary endpoint evaluated at ten days after the intervention.
Phase:
N/A
Details
Lead Sponsor:
Turku University Hospital
Collaborators:
Helsinki University Central Hospital Kuopio University Hospital Oulu University Hospital Tampere University Hospital