6/28/23, 12:13 AM CODA Pathway Feedback Search Clinical Topics Home Studies CODA CODA Disease Acute appendicitis Trial question Is antibiotic therapy noninferior to appendectomy in patients with appendicitis? Study design Multi-center Open label RCT Population Characteristics of study participants 37.0% female N = 1552 63.0% male 1552 patients (576 female, 976 male) Inclusion criteria: adult patients with appendicitis Key exclusion criteria: septic shock; diffuse peritonitis; recurrent appendicitis; severe phlegmon on imaging; walled-off abscess; free air or more than minimal free fluid; evidence suggestive of neoplasm Interventions N=776 antibiotics (intravenous antibiotics for 24 hours followed by oral antibiotics for 10 days) N=776 appendectomy (use of laparoscopic and conventional surgical approaches) Primary outcome Mean improvement in health status at day 30 as measured by european quality of life-5 dimension questionnaire score 0.9 0.92 0.91 0 7 https://web.pathway.md/studies/recn9Bi4fqoM3JTKj 1/2 6/28/23, 12:13 AM CODA Pathway 0.7 0.5 Difference not exceeding nonferiority margin 0.2 0.0 Antibiotics Appendectomy Difference not exceeding nonferiority margin in mean improvement in health status at day 30 as measured by the european quality of life-5 dimension questionnaire score (0.92 vs. 0.91; MD 0.01, 95% CI 0 to 0.03) Secondary outcomes No significant difference in resolution of symptoms at day 30 (68% vs. 70%; RR 0.97, 95% CI 0.91 to 1.04) Borderline significant increase in the rate of emergency department or urgent care clinic visit after index treatment within 90 days (9% vs. 4%; RR 2.07, 95% CI 1.32 to 3.25) No significant difference in days from randomization to discharge for index treatment (1.33 vs. 1.3; RR 1, 95% CI 0.89 to 1.13) Safety outcomes No significant difference in serious adverse events. Significant difference in complications at day 90 (8.1 per 100 participants vs. 3.5 per 100 participants). Conclusion In adult patients with appendicitis, antibiotics were noninferior to appendectomy with respect to mean improvement in health status at day 30 as measured by the european quality of life-5 dimension questionnaire score. Reference CODA Collaborative, David R Flum, Giana H Davidson et al. A Randomized Trial Comparing Antibiotics with Appendectomy for Appendicitis. N Engl J Med. 2020 Nov 12;383(20):1907-1919. Open reference URL https://web.pathway.md/studies/recn9Bi4fqoM3JTKj 2/2