Optimizing the Antibiotic Treatment of Uncomplicated Acute Appendicitis

• Status: Active, not recruiting
• Trial end date: 2029-04-01
• 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 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
• Accepts Healthy Volunteers?: No

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
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Ertapenem; Levofloxacin; Metronidazole; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination; Ofloxacin

Criteria

Inclusion Criteria:

• Age 18-60 years

• CT confirmed uncomplicated acute appendicitis

• Ability to give consent to participate in the study

Exclusion Criteria:

• Age under 18 years or over 60 years

• Pregnancy or lactation

• Allergy to contrast media or iodine

• Allergy or contraindication to antibiotic therapy

• Renal insufficiency

• Metformin medication

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

• CT confirmed complicated acute appendicitis

• Inability to co-operate and give informed consent