The major goal of the project is to demonstrate the feasibility of conducting a multi-center
randomized clinical trial of antibiotic therapy versus appendectomy for the treatment of
patients with acute uncomplicated appendicitis by conducting a single-site pilot study so as
to optimize the chance of a large multi-center clinical trial's future success.
This will be a single-site open clinical trial in which subjects with acute uncomplicated
appendicitis are randomized to one of two initial treatment strategies, surgery with
peri-operative antibiotics or antibiotics alone, with surgical rescue if necessary.
- Adult or child ages ≥5 years;
- Diagnosis of acute uncomplicated appendicitis, confirmed by CT, ultrasound and/or MRI
performed within 24 hours of consent, as read by an attending radiologist, and
confirmed by consultation of an attending surgeon;
- Ability to provide written informed consent (and for subjects ages 5-17, consent from
their parent/guardian and assent if applicable); and
- Negative pregnancy test for subjects who are women of childbearing potential.
- instability/severe sepsis, appendiceal perforation by imaging, serious co-morbidities
limiting randomization, pregnancy, and inability to complete the treatment protocol.