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; Heather Evans; Joseph Cuschieri; Amber K. Sabbatini; Brett A. Faine; Dionne A. Skeete; Mike K. Liang; Vance Sohn; Karen McGrane; Matthew E. Kutcher; Bruce Chung; Damien W. Carter; Patricia Ayoung-Chee; William Chiang; Amy Rushing; Steven Steinberg; Careen S. Foster; Shaina M. Schaetzel; Thea P. Price; Katherine A. Mandell; Lisa Ferrigno; Matthew Salzberg; Daniel A. DeUgarte; Amy H. Kaji; Gregory J. Moran; Darin Saltzman; Hasan B. Alam; Pauline K. Park; Lillian S. Kao; Callie M. Thompson; Wesley H. Self; Julianna T. Yu; Abigail Wiebusch; Robert J. Winchell; Sunday Clark; Anusha Krishnadasan; Erin Fannon; Danielle C. Lavallee; Bryan A. Comstock; Bonnie Bizzell; Patrick J. Heagerty; Larry G. Kessler; David A. Talan

doi:10.1056/NEJMoa2014320

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, Heather Evans, Joseph Cuschieri, Amber K. Sabbatini, Brett A. Faine, Dionne A. Skeete, Mike K. Liang, Vance Sohn, Karen McGrane, Matthew E. Kutcher, Bruce ChungDamien W. Carter, Patricia Ayoung-Chee, William Chiang, Amy Rushing, Steven Steinberg, Careen S. Foster, Shaina M. Schaetzel, Thea P. Price, Katherine A. Mandell, Lisa Ferrigno, Matthew Salzberg, Daniel A. DeUgarte, Amy H. Kaji, Gregory J. Moran, Darin Saltzman, Hasan B. Alam, Pauline K. Park, Lillian S. Kao, Callie M. Thompson, Wesley H. Self, Julianna T. Yu, Abigail Wiebusch, Robert J. Winchell, Sunday Clark, Anusha Krishnadasan, Erin Fannon, Danielle C. Lavallee, Bryan A. Comstock, Bonnie Bizzell, Patrick J. Heagerty, Larry G. Kessler, David A. Talan

^*Corresponding author for this work

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Abstract

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.

Original language	English
Pages (from-to)	1907-1919
Number of pages	13
Journal	New England Journal of Medicine
Volume	383
Issue number	20
DOIs	https://doi.org/10.1056/NEJMoa2014320
State	Published - 12 Nov 2020
Externally published	Yes

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10.1056/NEJMoa2014320

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Flum, D. R., Davidson, G. H., Monsell, S. E., Shapiro, N. I., Odom, S. R., Sanchez, S. E., Drake, F. T., Fischkoff, K., Johnson, J., Patton, J. H., Evans, H., Cuschieri, J., Sabbatini, A. K., Faine, B. A., Skeete, D. A., Liang, M. K., Sohn, V., McGrane, K., Kutcher, M. E., ... Talan, D. A. (2020). A randomized trial comparing antibiotics with appendectomy for appendicitis. New England Journal of Medicine, 383(20), 1907-1919. https://doi.org/10.1056/NEJMoa2014320

@article{219a9652ec7244068c515df85687ab9f,

title = "A randomized trial comparing antibiotics with appendectomy for appendicitis",

abstract = "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.",

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

note = "Publisher Copyright: Copyright {\textcopyright} 2020 Massachusetts Medical Society.",

year = "2020",

month = nov,

day = "12",

doi = "10.1056/NEJMoa2014320",

language = "English",

volume = "383",

pages = "1907--1919",

journal = "New England Journal of Medicine",

issn = "0028-4793",

number = "20",

}

Flum, DR, Davidson, GH, Monsell, SE, Shapiro, NI, Odom, SR, Sanchez, SE, Drake, FT, Fischkoff, K, Johnson, J, Patton, JH, Evans, H, Cuschieri, J, Sabbatini, AK, Faine, BA, Skeete, DA, Liang, MK, Sohn, V, McGrane, K, Kutcher, ME, Chung, B, Carter, DW, Ayoung-Chee, P, Chiang, W, Rushing, A, Steinberg, S, Foster, CS, Schaetzel, SM, Price, TP, Mandell, KA, Ferrigno, L, Salzberg, M, DeUgarte, DA, Kaji, AH, Moran, GJ, Saltzman, D, Alam, HB, Park, PK, Kao, LS, Thompson, CM, Self, WH, Yu, JT, Wiebusch, A, Winchell, RJ, Clark, S, Krishnadasan, A, Fannon, E, Lavallee, DC, Comstock, BA, Bizzell, B, Heagerty, PJ, Kessler, LG & Talan, DA 2020, 'A randomized trial comparing antibiotics with appendectomy for appendicitis', New England Journal of Medicine, vol. 383, no. 20, pp. 1907-1919. https://doi.org/10.1056/NEJMoa2014320

TY - JOUR

T1 - A randomized trial comparing antibiotics with appendectomy for appendicitis

AU - Flum, David R.

AU - Davidson, Giana H.

AU - Monsell, Sarah E.

AU - Shapiro, Nathan I.

AU - Odom, Stephen R.

AU - Sanchez, Sabrina E.

AU - Drake, F. Thurston

AU - Fischkoff, Katherine

AU - Johnson, Jeffrey

AU - Patton, Joe H.

AU - Evans, Heather

AU - Cuschieri, Joseph

AU - Sabbatini, Amber K.

AU - Faine, Brett A.

AU - Skeete, Dionne A.

AU - Liang, Mike K.

AU - Sohn, Vance

AU - McGrane, Karen

AU - Kutcher, Matthew E.

AU - Chung, Bruce

AU - Carter, Damien W.

AU - Ayoung-Chee, Patricia

AU - Chiang, William

AU - Rushing, Amy

AU - Steinberg, Steven

AU - Foster, Careen S.

AU - Schaetzel, Shaina M.

AU - Price, Thea P.

AU - Mandell, Katherine A.

AU - Ferrigno, Lisa

AU - Salzberg, Matthew

AU - DeUgarte, Daniel A.

AU - Kaji, Amy H.

AU - Moran, Gregory J.

AU - Saltzman, Darin

AU - Alam, Hasan B.

AU - Park, Pauline K.

AU - Kao, Lillian S.

AU - Thompson, Callie M.

AU - Self, Wesley H.

AU - Yu, Julianna T.

AU - Wiebusch, Abigail

AU - Winchell, Robert J.

AU - Clark, Sunday

AU - Krishnadasan, Anusha

AU - Fannon, Erin

AU - Lavallee, Danielle C.

AU - Comstock, Bryan A.

AU - Bizzell, Bonnie

AU - Heagerty, Patrick J.

AU - Kessler, Larry G.

AU - Talan, David A.

PY - 2020/11/12

Y1 - 2020/11/12

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=85094877472&partnerID=8YFLogxK

U2 - 10.1056/NEJMoa2014320

DO - 10.1056/NEJMoa2014320

M3 - Article

C2 - 33017106

AN - SCOPUS:85094877472

SN - 0028-4793

VL - 383

SP - 1907

EP - 1919

JO - New England Journal of Medicine

JF - New England Journal of Medicine

IS - 20

ER -

A randomized trial comparing antibiotics with appendectomy for appendicitis

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