CODA
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
63.0% male
N = 1552
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
0.92
0.91
0.9 points
0.7 points
0.5 points
0.2 points
0.0 points
Antibiotics
Appendectomy
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in mean improvement in health status at day 30 as measured by the european QoL-5 dimension questionnaire score (0.92 points vs. 0.91 points; 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 patients vs. 3.5 per 100 patients).
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 QoL-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.
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