A Randomized Trial Comparing Antibiotics with Appendectomy for Appendicitis.
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CODA Collaborative, Flum David R, Davidson Giana H, Monsell Sarah E, Shapiro Nathan I, Odom Stephen R, Sanchez Sabrina E, Drake F Thurston, Fischkoff Katherine, Johnson Jeffrey, Patton Joe H, Evans Heather, Cuschieri Joseph, Sabbatini Amber K, Faine Brett A, Skeete Dionne A, Liang Mike K, Sohn Vance, McGrane Karen, Kutcher Matthew E, Chung Bruce, Carter Damien W, Ayoung-Chee Patricia, Chiang William, Rushing Amy, Steinberg Steven, Foster Careen S, Schaetzel Shaina M, Price Thea P, Mandell Katherine A, Ferrigno Lisa, Salzberg Matthew, DeUgarte Daniel A, Kaji Amy H, Moran Gregory J, Saltzman Darin, Alam Hasan B, Park Pauline K, Kao Lillian S, Thompson Callie M, Self Wesley H, Yu Julianna T, Wiebusch Abigail, Winchell Robert J, Clark Sunday, Krishnadasan Anusha, Fannon Erin, Lavallee Danielle C, Comstock Bryan A, Bizzell Bonnie, Heagerty Patrick J, Kessler Larry G, Talan David A
Аннотация
METHODS: 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.
RESULTS: 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).
CONCLUSIONS: 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.).