Antibiotics vs. Placebo in Acute Uncomplicated Appendicitis

• Status: Enrolling by invitation
• Trial end date: 2029-08-30
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Turku University Hospital
• Collaborators: Helsinki University Central Hospital; Kuopio University Hospital; Oulu University Hospital; Tampere University Hospital
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Ertapenem; Levofloxacin; Metronidazole; Ofloxacin

Criteria

Inclusion Criteria:

• Age between 18-60 years

• CT confirmed uncomplicated acute appendicitis

• Ability to give informed consent

Exclusion Criteria:

• Age under 18 or over 60 years

• Pregnancy or lactation

• Allergy to contrast media or iodine

• Allergy or contraindication to antibiotic therapy

• Metformin medication

• Renal insufficiency

• Severe systemic illness (for example malignancy, medical condition requiring immunosuppressant medication)

• Complicated acute appendicitis confirmed by CT scan

• Inability to cooperate or give informed consent