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Minneci PC, Hade EM, Lawrence AE, et al. Association of Nonoperative Management Using Antibiotic Therapy vs Laparoscopic Appendectomy With Treatment Success and Disability Days in Children With Uncomplicated Appendicitis. JAMA. Published online July 27, 2020. doi:10.1001/jama.2020.10888
Among children with uncomplicated appendicitis, what is the success rate of an initial nonoperative management strategy with antibiotic therapy alone and is this approach associated with fewer disability days compared with an initial strategy of urgent laparoscopic surgery?
In this nonrandomized controlled intervention study that used propensity score weighting and included 1068 children, 67.1% of the children who received initial nonoperative management with antibiotics alone did not require appendectomy by 1 year. Compared with a strategy of urgent surgery (≤12 hours of admission), initial management with antibiotics alone was significantly associated with fewer patient disability days at 1 year (6.6 days vs 10.9 days).
Among children with uncomplicated appendicitis, an initial nonoperative management strategy with antibiotics was successful for most children and, compared with urgent surgery, was associated with significantly fewer disability days at 1 year. However, the prespecified thresholds for success rate of nonoperative management and disability days were not met, and there were substantial missing data.
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.
Design, Setting, and Participants
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).
Main Outcomes and Measures
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.
Conclusion and Relevance
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
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