In uncomplicated acute appendicitis, 61% of patients initially treated with antibiotics had not had appendectomy at 5 years
- Kalligeros, Markos MD
- Mylonakis, Eleftherios MD, PhD, FIDSA
Question
In uncomplicated acute appendicitis (UAA), what is the long-term effectiveness of antibiotic therapy compared with appendectomy?
Methods
Design: Randomized controlled noninferiority trial (Appendicitis Acuta [APPAC] trial). ClinicalTrials.gov NCT01022567.
Allocation: Concealed.
Blinding: Unblinded.
Follow-up period: 5 years.
Setting: 6 hospitals in Finland.
Patients: 530 patients 18 to 60 years of age (median age 33 to 35 y, 62% men) who had UAA (appendiceal diameter > 6 mm with wall thickening and ≥ 1 of inflammatory edema, fluid around the appendix, or appendiceal wall abnormal contrast enhancement) confirmed by computed tomography (CT). Exclusion criteria included complicated acute appendicitis (appendicolith, perforation, abscess, or tumor suspicion), peritonitis, or serious systemic illness.
Intervention: Antibiotic therapy with IV ertapenem sodium, 1 g/d for 3 d, followed by oral levofloxacin, 500 mg/d, and metronidazole, 500 mg 3 times/d, for 7 days (n = 257), or open appendectomy (n = 273).
Outcomes: Late recurrence of appendicitis in the antibiotic group at ≥ 1 year and postintervention complications (surgical site infection, incisional hernia, abdominal or incisional pain, or obstructive symptoms), length of hospital stay, and duration of appendicitis-related sick leave in both groups. The primary trial outcome, treatment success (successful appendectomy in the appendectomy group and hospital discharge without surgery and no recurrent appendicitis at ≥ 1 y in the antibiotic therapy group) was previously reported at 1 year.
Patient follow-up: 93% for complications (intention-to-treat analysis); {> 99% in the antibiotic group for late recurrence}.
Main results
{At 1 year, antibiotic therapy was not as efficacious as appendectomy for treatment success (73% vs 99.6%; difference −27%, {95% CI −33% to −22%}), and the prespecified noninferiority margin of −24% was not shown (95% CI −32% to ∞)}. By 5 years, 100 patients (39%) in the antibiotic group had appendectomy, including 7 who did not have appendicitis and 15 who had surgery during the initial hospitalization; 70 patients (27%) had appendectomy at 1 year, and 30 (16% of those without surgery at 1 y) at > 1 to 5 years. Other outcomes are shown in the Table.
Conclusion
In uncomplicated acute appendicitis, 61% of patients initially treated with antibiotic therapy rather than immediate appendectomy had not had appendectomy at 5 years.
