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JAMA. 2015 Jun 16;313(23):2340-8. doi: 10.1001/jama.2015.6154.

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

Author information

1
Division of Digestive Surgery and Urology, Departments of Acute and Digestive Surgery, Turku University Hospital, Turku, Finland2Department of Surgery, Turku University, Turku, Finland.
2
Department of Surgery, Mikkeli Central Hospital, Mikkeli, Finland4Institute of Clinical Medicine, University of Eastern Finland, Joensuu, Finland.
3
Department of Surgery, Oulu University Hospital, Oulu, Finland.
4
Division of Surgery, Gastroenterology and Oncology, Tampere University Hospital, Tampere, Finland.
5
Department of Surgery, Jyväskylä Central Hospital, Jyväskylä, Finland.
6
Institute of Clinical Medicine, University of Eastern Finland, Joensuu, Finland8Department of Surgery, Kuopio University Hospital, Kuopio, Finland9Department of Surgery, Seinäjoki Central Hospital, Seinäjoki, Finland.
7
Department of Public Health, University of Turku, Turku, Finland11Primary Health Care Unit, Hospital District of Southwest Finland, Turku, Finland.
8
Department of Biostatistics, University of Turku, Turku, Finland.
9
Department of Radiology, Turku University Hospital, Turku, Finland.
10
Institute of Clinical Medicine, University of Eastern Finland, Joensuu, Finland7Department of Surgery, Jyväskylä Central Hospital, Jyväskylä, Finland.
11
Department of Radiology, Oulu University Hospital, Oulu, Finland.
12
Department of Radiology, Tampere University Hospital, Tampere, Finland.

Abstract

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 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:

Patients randomized 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 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 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:

Among patients with CT-proven, uncomplicated appendicitis, antibiotic treatment did not meet the prespecified criterion for noninferiority compared with appendectomy. Most patients randomized 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:

clinicaltrials.gov Identifier: NCT01022567.

Summary for patients in

PMID:
26080338
DOI:
10.1001/jama.2015.6154
[Indexed for MEDLINE]

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