The
Appendicitis Acuta (APPAC) multicenter, open-label, noninferiority randomized clinical trial was conducted from November 2009 until June 2012 in Finland. The trial enrolled 530 patients aged 18 to 60 years with uncomplicated acute
appendicitis confirmed by a CT scan. Patients were randomly assigned to early
appendectomy or
antibiotic treatment with a 1-year follow-up period.
INTERVENTIONS: The primary end point for the surgical intervention was the successful completion of an
appendectomy. The primary end point for
antibiotic-treated patients was discharge from the hospital without the need for surgery and no recurrent
appendicitis during a 1-year follow-up period.
RESULTS: There were 273 patients in the surgical group and 257 in the
antibiotic group. Of 273 patients in the surgical group, all but 1 underwent successful
appendectomy, resulting in a success rate of 99.6% (95% CI, 98.0% to 100.0%). In the
antibiotic group, 70 patients (27.3%; 95% CI, 22.0% to 33.2%) underwent
appendectomy within 1 year of initial presentation for
appendicitis. Of the 256 patients available for follow-up in the
antibiotic group, 186 (72.7%; 95% CI, 66.8% to 78.0%) did not require surgery. The intention-to-treat analysis yielded a difference in treatment efficacy between groups of -27.0% (95% CI, -31.6% to ∞) (P = .89). Given the prespecified noninferiority margin of 24%, we were unable to demonstrate noninferiority of
antibiotic treatment relative to surgery. Of the 70 patients randomized to
antibiotic treatment who subsequently underwent
appendectomy, 58 (82.9%; 95% CI, 72.0% to 90.8%) had uncomplicated
appendicitis, 7 (10.0%; 95% CI, 4.1% to 19.5%) had complicated acute
appendicitis, and 5 (7.1%; 95% CI, 2.4% to 15.9%) did not have
appendicitis but received
appendectomy for suspected recurrence. There were no
intra-abdominal abscesses or other major complications associated with delayed
appendectomy in patients randomized to
antibiotic treatment.
CONCLUSIONS AND RELEVANCE: TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01022567.