Antibiotic Therapy vs Appendectomy for Treatment of Uncomplicated XXXX : The APPAC Randomized Clinical Trial.

@entity1 @entity697 @entity868 @entity698 @entity6177 @entity5553 @entity6543
IMPORTANCE: An increasing amount of evidence supports the use of antibiotics instead of surgery for treating @entity1 with uncomplicated @entity697 . OBJECTIVE: To compare antibiotic therapy with appendectomy in the treatment of uncomplicated @entity697 confirmed by computed tomography (CT). DESIGN, SETTING, AND @entity1 : The @entity698 Acuta (APPAC) multicenter, open-label, noninferiority randomized clinical trial was conducted from November 2009 until June 2012 in Finland. The trial enrolled 530 @entity1 aged 18 to 60 years with uncomplicated @entity697 confirmed by a CT scan. @entity1 were randomly assigned to early appendectomy or antibiotic treatment with a 1-year follow-up period. INTERVENTIONS: @entity1 randomized to antibiotic therapy received intravenous @entity6543 (1 g/d) for 3 days followed by 7 days of oral @entity5553 (500 mg once daily) and @entity868 (500 mg 3 times per day). @entity1 randomized to the surgical treatment group were assigned to undergo standard open appendectomy. MAIN OUTCOMES AND MEASURES: The primary end point for the surgical intervention was the successful completion of an appendectomy. The primary end point for antibiotic-treated @entity1 was discharge from the hospital without the need for surgery and no recurrent @entity698 during a 1-year follow-up period. RESULTS: There were 273 @entity1 in the surgical group and 257 in the antibiotic group. Of 273 @entity1 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 @entity1 (27.3%; 95% CI, 22.0% to 33.2%) underwent appendectomy within 1 year of initial presentation for @entity698 . Of the 256 @entity1 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 @entity1 randomized to antibiotic treatment who subsequently underwent appendectomy, 58 (82.9%; 95% CI, 72.0% to 90.8%) had @entity698 , 7 (10.0%; 95% CI, 4.1% to 19.5%) had complicated @entity697 , and 5 (7.1%; 95% CI, 2.4% to 15.9%) did not have @entity698 but received appendectomy for suspected recurrence. There were no @entity6177 or other major complications associated with delayed appendectomy in @entity1 randomized to antibiotic treatment. CONCLUSIONS AND RELEVANCE: Among @entity1 with CT-proven, @entity698 , antibiotic treatment did not meet the prespecified criterion for noninferiority compared with appendectomy. Most @entity1 randomized to antibiotic treatment for @entity698 did not require appendectomy during the 1-year follow-up period, and those who required appendectomy did not experience significant complications. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01022567.
