A Randomized Trial Comparing Antibiotics with Appendectomy for Appendicitis
Copyright © 2020 Massachusetts Medical Society..
BACKGROUND: Antibiotic therapy has been proposed as an alternative to surgery for the treatment of appendicitis.
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.).
| Errataetall: |
CommentIn: N Engl J Med. 2020 Nov 12;383(20):1985-1986. - PMID 33017105 |
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| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2020 |
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| Erschienen: |
2020 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:383 |
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| Enthalten in: |
The New England journal of medicine - 383(2020), 20 vom: 12. Nov., Seite 1907-1919 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
CODA Collaborative [VerfasserIn] |
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| Links: |
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| Themen: |
Anti-Bacterial Agents |
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| Anmerkungen: |
Date Completed 24.11.2020 Date Revised 30.04.2021 published: Print-Electronic ClinicalTrials.gov: NCT02800785 CommentIn: N Engl J Med. 2020 Nov 12;383(20):1985-1986. - PMID 33017105 Citation Status MEDLINE |
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| doi: |
10.1056/NEJMoa2014320 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| 245 | 1 | 2 | |a A Randomized Trial Comparing Antibiotics with Appendectomy for Appendicitis |
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| 500 | |a Date Completed 24.11.2020 | ||
| 500 | |a Date Revised 30.04.2021 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT02800785 | ||
| 500 | |a CommentIn: N Engl J Med. 2020 Nov 12;383(20):1985-1986. - PMID 33017105 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2020 Massachusetts Medical Society. | ||
| 520 | |a BACKGROUND: Antibiotic therapy has been proposed as an alternative to surgery for the treatment of appendicitis | ||
| 520 | |a 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 | ||
| 520 | |a 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) | ||
| 520 | |a 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.) | ||
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| 650 | 4 | |a Journal Article | |
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| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 7 | |a Anti-Bacterial Agents |2 NLM | |
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| 700 | 1 | |a Cuschieri, Joseph |e investigator |4 oth | |
| 700 | 1 | |a Sabbatini, Amber K |e investigator |4 oth | |
| 700 | 1 | |a Faine, Brett A |e investigator |4 oth | |
| 700 | 1 | |a Skeete, Dionne A |e investigator |4 oth | |
| 700 | 1 | |a Liang, Mike K |e investigator |4 oth | |
| 700 | 1 | |a Sohn, Vance |e investigator |4 oth | |
| 700 | 1 | |a McGrane, Karen |e investigator |4 oth | |
| 700 | 1 | |a Kutcher, Matthew E |e investigator |4 oth | |
| 700 | 1 | |a Chung, Bruce |e investigator |4 oth | |
| 700 | 1 | |a Carter, Damien W |e investigator |4 oth | |
| 700 | 1 | |a Ayoung-Chee, Patricia |e investigator |4 oth | |
| 700 | 1 | |a Chiang, William |e investigator |4 oth | |
| 700 | 1 | |a Rushing, Amy |e investigator |4 oth | |
| 700 | 1 | |a Steinberg, Steven |e investigator |4 oth | |
| 700 | 1 | |a Foster, Careen S |e investigator |4 oth | |
| 700 | 1 | |a Schaetzel, Shaina M |e investigator |4 oth | |
| 700 | 1 | |a Price, Thea P |e investigator |4 oth | |
| 700 | 1 | |a Mandell, Katherine A |e investigator |4 oth | |
| 700 | 1 | |a Ferrigno, Lisa |e investigator |4 oth | |
| 700 | 1 | |a Salzberg, Matthew |e investigator |4 oth | |
| 700 | 1 | |a DeUgarte, Daniel A |e investigator |4 oth | |
| 700 | 1 | |a Kaji, Amy H |e investigator |4 oth | |
| 700 | 1 | |a Moran, Gregory J |e investigator |4 oth | |
| 700 | 1 | |a Saltzman, Darin |e investigator |4 oth | |
| 700 | 1 | |a Alam, Hasan B |e investigator |4 oth | |
| 700 | 1 | |a Park, Pauline K |e investigator |4 oth | |
| 700 | 1 | |a Kao, Lillian S |e investigator |4 oth | |
| 700 | 1 | |a Thompson, Callie M |e investigator |4 oth | |
| 700 | 1 | |a Self, Wesley H |e investigator |4 oth | |
| 700 | 1 | |a Yu, Julianna T |e investigator |4 oth | |
| 700 | 1 | |a Wiebusch, Abigail |e investigator |4 oth | |
| 700 | 1 | |a Winchell, Robert J |e investigator |4 oth | |
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| 700 | 1 | |a Krishnadasan, Anusha |e investigator |4 oth | |
| 700 | 1 | |a Fannon, Erin |e investigator |4 oth | |
| 700 | 1 | |a Lavallee, Danielle C |e investigator |4 oth | |
| 700 | 1 | |a Comstock, Bryan A |e investigator |4 oth | |
| 700 | 1 | |a Bizzell, Bonnie |e investigator |4 oth | |
| 700 | 1 | |a Heagerty, Patrick J |e investigator |4 oth | |
| 700 | 1 | |a Kessler, Larry G |e investigator |4 oth | |
| 700 | 1 | |a Talan, David A |e investigator |4 oth | |
| 700 | 1 | |a Parson, Charles S |e investigator |4 oth | |
| 700 | 1 | |a Tichter, Aleksandr M |e investigator |4 oth | |
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| 700 | 1 | |a Dyamenahalli, Kiran |e investigator |4 oth | |
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