Back to Search
Start Over
Association of Nonoperative Management Using Antibiotic Therapy vs Laparoscopic Appendectomy With Treatment Success and Disability Days in Children With Uncomplicated Appendicitis.
- Source :
-
JAMA: Journal of the American Medical Association . 8/11/2020, Vol. 324 Issue 6, p581-593. 13p. - Publication Year :
- 2020
-
Abstract
- <bold>Importance: </bold>Nonoperative management with antibiotics alone has the potential to treat uncomplicated pediatric appendicitis with fewer disability days than surgery.<bold>Objective: </bold>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.<bold>Design, Setting, and Participants: </bold>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.<bold>Interventions: </bold>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).<bold>Main Outcomes and Measures: </bold>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.<bold>Results: </bold>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.<bold>Conclusion and Relevance: </bold>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.<bold>Trial Registration: </bold>ClinicalTrials.gov Identifier: NCT02271932. [ABSTRACT FROM AUTHOR]
- Subjects :
- *ANTIBIOTICS
*APPENDECTOMY
*LAPAROSCOPY
*ANTI-infective agents
*PEDIATRIC surgery
*RESEARCH
*ULTRASONIC imaging
*CLINICAL trials
*APPENDICITIS
*RESEARCH methodology
*EVALUATION research
*MEDICAL cooperation
*APPENDIX (Anatomy)
*TREATMENT effectiveness
*COMPARATIVE studies
*QUALITY of life
*RESEARCH funding
*RESEARCH bias
*COMPUTED tomography
*ACUTE diseases
*LONGITUDINAL method
*PROBABILITY theory
Subjects
Details
- Language :
- English
- ISSN :
- 00987484
- Volume :
- 324
- Issue :
- 6
- Database :
- Academic Search Index
- Journal :
- JAMA: Journal of the American Medical Association
- Publication Type :
- Academic Journal
- Accession number :
- 145136902
- Full Text :
- https://doi.org/10.1001/jama.2020.10888