6/28/23, 12:43 AM APPAC Pathway Feedback Search Clinical Topics Home Studies APPAC APPAC Disease Acute appendicitis Trial question Is antibiotic therapy noninferior to appendectomy in patients with uncomplicated acute appendicitis? Study design Multi-center Open label RCT Population Characteristics of study participants 38.0% female N = 530 62.0% male 530 patients (201 female, 329 male) Inclusion criteria: patients with uncomplicated appendicitis confirmed by a CT scan Key exclusion criteria: complicated appendicitis, age < 18 years or > 60 years, contraindications for CT (eg, pregnancy or lactating, allergy to contrast media or iodine, renal insufficiency with serum creatinine level > 150 mol/L, actively taking metformin), peritonitis, unable to cooperate and provide informed consent, and the presence of serious systemic illness Interventions N=257 antibiotic treatment (ertapenem 1 g IV once daily for 3 days followed by 7 days of levofloxacin 500 mg PO once daily and metronidazole 500 mg TID) N=273 surgical appendectomy (standard open appendectomy) https://web.pathway.md/studies/recscxEzDvDAoYPFv 1/2 6/28/23, 12:43 AM APPAC Pathway Primary outcome Treatment success 99.6 % 99.6 74.7 % 72.7 49.8 % Difference exceeding nonferiority margin 24.9 % 0.0 % Antibiotic treatment Surgical appendectomy Difference exceeding nonferiority margin in treatment success (72.7% vs. 99.6%; ARD -27, 95% CI -31.6 to Infinity) Safety outcomes Significant differences in overall complication rate (2.8% vs. 20.5%, p < 0.001; difference, 17.7%, 95% CI 11.9% to 23.4%). Conclusion In patients with uncomplicated appendicitis confirmed by a CT scan, antibiotic treatment was not noninferior to surgical appendectomy with respect to treatment success. Reference Salminen P, Paajanen H, Rautio T et al. Antibiotic Therapy vs Appendectomy for Treatment of Uncomplicated Acute Appendicitis: The APPAC Randomized Clinical Trial. JAMA. 2015 Jun 16;313(23):2340-8. Open reference URL https://web.pathway.md/studies/recscxEzDvDAoYPFv 2/2