Although pain was a common criterion for nonresponse and appendectomy , analgesic regimens were poorly described .
BACKGROUND Meta-analyses and a recent guideline acknowledge that conservative management of uncomplicated appendicitis with antibiotics can be successful for patients who wish to avoid surgery .
However , guidance as to specific management does not exist .
Antibiotic Therapy vs Appendectomy for Treatment of Uncomplicated Acute Appendicitis: The APPAC Randomized Clinical Trial.
IMPORTANCE An increasing amount of evidence supports the use of antibiotics instead of surgery for treating patients with uncomplicated acute appendicitis . OBJECTIVE To compare antibiotic therapy with appendectomy in the treatment of uncomplicated acute appendicitis confirmed by computed tomography ( CT ) . DESIGN , SETTING , AND PARTICIPANTS The Appendicitis Acuta ( APPAC ) multicenter , open-label , noninferiority r and omized clinical trial was conducted from November 2009 until June 2012 in Finl and . The trial enrolled 530 patients aged 18 to 60 years with uncomplicated acute appendicitis confirmed by a CT scan . Patients were r and omly assigned to early appendectomy or antibiotic treatment with a 1-year follow-up period . INTERVENTIONS Patients r and omized to antibiotic therapy received intravenous ertapenem ( 1 g/d ) for 3 days followed by 7 days of oral levofloxacin ( 500 mg once daily ) and metronidazole ( 500 mg 3 times per day ) . Patients r and omized to the surgical treatment group were assigned to undergo st and ard 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 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 , result ing 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 r and omized 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 r and omized to antibiotic treatment . CONCLUSIONS AND RELEVANCE Among patients with CT-proven , uncomplicated appendicitis , antibiotic treatment did not meet the prespecified criterion for noninferiority compared with appendectomy . Most patients r and omized to antibiotic treatment for uncomplicated appendicitis did not require appendectomy during the 1-year follow-up period , and those who required appendectomy did not experience significant complications . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01022567
Although pain was a common criterion for nonresponse and appendectomy , analgesic regimens were poorly described .
BACKGROUND Meta-analyses and a recent guideline acknowledge that conservative management of uncomplicated appendicitis with antibiotics can be successful for patients who wish to avoid surgery .
However , guidance as to specific management does not exist .