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  • Association of Nonoperative...
    Minneci, Peter C; Hade, Erinn M; Lawrence, Amy E; Sebastião, Yuri V; Saito, Jacqueline M; Mak, Grace Z; Fox, Christa; Hirschl, Ronald B; Gadepalli, Samir; Helmrath, Michael A; Kohler, Jonathan E; Leys, Charles M; Sato, Thomas T; Lal, Dave R; Landman, Matthew P; Kabre, Rashmi; Fallat, Mary E; Cooper, Jennifer N; Deans, Katherine J

    JAMA : the journal of the American Medical Association, 08/2020, Letnik: 324, Številka: 6
    Journal Article

    IMPORTANCE: Nonoperative management with antibiotics alone has the potential to treat uncomplicated pediatric appendicitis with fewer disability days than surgery. OBJECTIVE: 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. INTERVENTIONS: 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. RESULTS: 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. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02271932