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A Randomized Trial Comparing Antibiotics with Appendectomy for Appendicitis
Journal article   Open access   Peer reviewed

A Randomized Trial Comparing Antibiotics with Appendectomy for Appendicitis

David R Flum, Giana H Davidson, Sarah E Monsell, Nathan I Shapiro, Stephen R Odom, Sabrina E Sanchez, F Thurston Drake, Katherine Fischkoff, Jeffrey Johnson, Joe H Patton, …
The New England journal of medicine, Vol.383(20), pp.1907-1919
11/12/2020
DOI: 10.1056/NEJMoa2014320
PMID: 33017106
url
https://doi.org/10.1056/NEJMoa2014320View
Published (Version of record) Open Access

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Abstract

Antibiotic therapy has been proposed as an alternative to surgery for the treatment of appendicitis. We conducted a pragmatic, nonblinded, noninferiority, randomized trial comparing antibiotic therapy (10-day course) with appendectomy in patients with appendicitis at 25 U.S. centers. The primary outcome was 30-day health status, as assessed with the European Quality of Life-5 Dimensions (EQ-5D) questionnaire (scores range from 0 to 1, with higher scores indicating better health status; noninferiority margin, 0.05 points). Secondary outcomes included appendectomy in the antibiotics group and complications through 90 days; analyses were prespecified in subgroups defined according to the presence or absence of an appendicolith. In total, 1552 adults (414 with an appendicolith) underwent randomization; 776 were assigned to receive antibiotics (47% of whom were not hospitalized for the index treatment) and 776 to undergo appendectomy (96% of whom underwent a laparoscopic procedure). Antibiotics were noninferior to appendectomy on the basis of 30-day EQ-5D scores (mean difference, 0.01 points; 95% confidence interval [CI], -0.001 to 0.03). In the antibiotics group, 29% had undergone appendectomy by 90 days, including 41% of those with an appendicolith and 25% of those without an appendicolith. Complications were more common in the antibiotics group than in the appendectomy group (8.1 vs. 3.5 per 100 participants; rate ratio, 2.28; 95% CI, 1.30 to 3.98); the higher rate in the antibiotics group could be attributed to those with an appendicolith (20.2 vs. 3.6 per 100 participants; rate ratio, 5.69; 95% CI, 2.11 to 15.38) and not to those without an appendicolith (3.7 vs. 3.5 per 100 participants; rate ratio, 1.05; 95% CI, 0.45 to 2.43). The rate of serious adverse events was 4.0 per 100 participants in the antibiotics group and 3.0 per 100 participants in the appendectomy group (rate ratio, 1.29; 95% CI, 0.67 to 2.50). For the treatment of appendicitis, antibiotics were noninferior to appendectomy on the basis of results of a standard health-status measure. In the antibiotics group, nearly 3 in 10 participants had undergone appendectomy by 90 days. Participants with an appendicolith were at a higher risk for appendectomy and for complications than those without an appendicolith. (Funded by the Patient-Centered Outcomes Research Institute; CODA ClinicalTrials.gov number, NCT02800785.).
 Quality of Life Absenteeism Administration, Intravenous Adult Anti-Bacterial Agents - adverse effects Anti-Bacterial Agents - therapeutic use Appendectomy - statistics & numerical data Appendicitis - complications Appendicitis - drug therapy Appendicitis - surgery Appendix - pathology Appendix - surgery Fecal Impaction Female Health Status Hospitalization - statistics & numerical data Humans Laparoscopy Male Middle Aged Postoperative Complications - epidemiology Surveys and Questionnaires Treatment Outcome

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