Association of Nonoperative Management Using Antibiotic Therapy vs Laparoscopic Appendectomy With Treatment Success and Disability Days in Children With Uncomplicated Appendicitis.
Acute Disease
Adolescent
Anti-Bacterial Agents
/ therapeutic use
Appendectomy
/ methods
Appendicitis
/ diagnostic imaging
Appendix
/ diagnostic imaging
Child
Female
Follow-Up Studies
Humans
Laparoscopy
Male
Propensity Score
Quality of Life
Selection Bias
Tomography, X-Ray Computed
Treatment Outcome
Ultrasonography
Journal
JAMA
ISSN: 1538-3598
Titre abrégé: JAMA
Pays: United States
ID NLM: 7501160
Informations de publication
Date de publication:
11 08 2020
11 08 2020
Historique:
pubmed:
31
7
2020
medline:
22
10
2020
entrez:
31
7
2020
Statut:
ppublish
Résumé
Nonoperative management with antibiotics alone has the potential to treat uncomplicated pediatric appendicitis with fewer disability days than surgery. To determine the success rate of nonoperative management and compare differences in treatment-related disability, satisfaction, health-related quality of life, and complications between nonoperative management and surgery in children with uncomplicated appendicitis. Multi-institutional nonrandomized controlled intervention study of 1068 children aged 7 through 17 years with uncomplicated appendicitis treated at 10 tertiary children's hospitals across 7 US states between May 2015 and October 2018 with 1-year follow-up through October 2019. Of the 1209 eligible patients approached, 1068 enrolled in the study. Patient and family selection of nonoperative management with antibiotics alone (nonoperative group, n = 370) or urgent (≤12 hours of admission) laparoscopic appendectomy (surgery group, n = 698). The 2 primary outcomes assessed at 1 year were disability days, defined as the total number of days the child was not able to participate in all of his/her normal activities secondary to appendicitis-related care (expected difference, 5 days), and success rate of nonoperative management, defined as the proportion of patients initially managed nonoperatively who did not undergo appendectomy by 1 year (lowest acceptable success rate, ≥70%). Inverse probability of treatment weighting (IPTW) was used to adjust for differences between treatment groups for all outcome assessments. Among 1068 patients who were enrolled (median age, 12.4 years; 38% girls), 370 (35%) chose nonoperative management and 698 (65%) chose surgery. A total of 806 (75%) had complete follow-up: 284 (77%) in the nonoperative group; 522 (75%) in the surgery group. Patients in the nonoperative group were more often younger (median age, 12.3 years vs 12.5 years), Black (9.6% vs 4.9%) or other race (14.6% vs 8.7%), had caregivers with a bachelor's degree (29.8% vs 23.5%), and underwent diagnostic ultrasound (79.7% vs 74.5%). After IPTW, the success rate of nonoperative management at 1 year was 67.1% (96% CI, 61.5%-72.31%; P = .86). Nonoperative management was associated with significantly fewer patient disability days at 1 year than did surgery (adjusted mean, 6.6 vs 10.9 days; mean difference, -4.3 days (99% CI, -6.17 to -2.43; P < .001). Of 16 other prespecified secondary end points, 10 showed no significant difference. Among children with uncomplicated appendicitis, an initial nonoperative management strategy with antibiotics alone had a success rate of 67.1% and, compared with urgent surgery, was associated with statistically significantly fewer disability days at 1 year. However, there was substantial loss to follow-up, the comparison with the prespecified threshold for an acceptable success rate of nonoperative management was not statistically significant, and the hypothesized difference in disability days was not met. ClinicalTrials.gov Identifier: NCT02271932.
Identifiants
pubmed: 32730561
pii: 2768929
doi: 10.1001/jama.2020.10888
pmc: PMC7385674
doi:
Substances chimiques
Anti-Bacterial Agents
0
Banques de données
ClinicalTrials.gov
['NCT02271932']
Types de publication
Comparative Study
Controlled Clinical Trial
Journal Article
Multicenter Study
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
581-593Subventions
Organisme : NCATS NIH HHS
ID : UL1 TR001070
Pays : United States
Commentaires et corrections
Type : CommentIn
Références
Biometrics. 1996 Mar;52(1):98-111
pubmed: 8934587
Ann Emerg Med. 2017 Jul;70(1):1-11.e9
pubmed: 27974169
J Pediatr Surg. 2017 Oct 9;:
pubmed: 29103784
Adv Data. 2001 Jun 25;(320):1-34
pubmed: 12666256
Stat Methods Med Res. 2016 Dec;25(6):3066-3068
pubmed: 27852808
Pediatrics. 2017 Mar;139(3):
pubmed: 28213607
BMJ Open. 2017 Nov 15;7(11):e016117
pubmed: 29146633
Stat Med. 2015 Dec 10;34(28):3661-79
pubmed: 26238958
Pediatr Clin North Am. 2009 Aug;56(4):843-63
pubmed: 19660631
Epidemiology. 2000 Sep;11(5):550-60
pubmed: 10955408
Epidemiology. 2000 Sep;11(5):561-70
pubmed: 10955409
Stat Methods Med Res. 2016 Feb;25(1):188-204
pubmed: 22687877
Ulus Travma Acil Cerrahi Derg. 2013 May;19(3):200-4
pubmed: 23720105
Med Decis Making. 1996 Jan-Mar;16(1):58-64
pubmed: 8717600
Ann Surg. 2015 Jan;261(1):67-71
pubmed: 25072441
JAMA. 2018 Sep 25;320(12):1259-1265
pubmed: 30264120
JAMA Netw Open. 2019 Jun 5;2(6):e195009
pubmed: 31173118
Med Care. 2005 Mar;43(3):256-65
pubmed: 15725982
Eur J Pediatr. 2020 May;179(5):735-742
pubmed: 31897841
J Am Coll Surg. 2012 Jul;215(1):101-5; discussion 105-6
pubmed: 22609030
J Pediatr Surg. 2015 Nov;50(11):1893-7
pubmed: 26259556
J Behav Med. 2002 Apr;25(2):175-93
pubmed: 11977437
Am J Epidemiol. 2008 Sep 15;168(6):656-64
pubmed: 18682488
Med Care. 1999 Feb;37(2):126-39
pubmed: 10024117
J Pediatr Surg. 2007 Aug;42(8):1439-42
pubmed: 17706511
Contemp Clin Trials. 2019 Aug;83:10-17
pubmed: 31254670
Ambul Pediatr. 2003 Nov-Dec;3(6):329-41
pubmed: 14616041
JAMA Surg. 2016 May 1;151(5):408-15
pubmed: 26676711
Health Expect. 2003 Jun;6(2):149-59
pubmed: 12752743
Health Qual Life Outcomes. 2004 Sep 27;2:55
pubmed: 15450120
Stat Methods Med Res. 2007 Jun;16(3):199-218
pubmed: 17621468
Can J Surg. 2011 Oct;54(5):307-14
pubmed: 21651835
Stat Med. 2004 Oct 15;23(19):2937-60
pubmed: 15351954
JAMA. 2015 Jun 16;313(23):2340-8
pubmed: 26080338