Association of Nonoperative Management Using Antibiotic Therapy vs Laparoscopic Appendectomy With Treatment Success and Disability Days in Children With Uncomplicated Appendicitis

Abstract

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.

Conflict of interest statement

Conflict of Interest Disclosures: Dr Minneci reported grants from PCORI during the conduct of the study. Dr Hade reported grants from PCORI during the conduct of the study; grants from NIH, grants from Smart Columbus, and grants from PCORI/PCORnet outside the submitted work. Dr Saito reported grants from PCORI during the conduct of the study; grants from AHRQ outside the submitted work. Dr Mak reported grants from PCORI during the conduct of the study; grants from Thrasher outside the submitted work. Dr Gadepalli reported grants from PCORI during the conduct of the study. Dr Sato reported grants from PCORI during the conduct of the study. Dr Cooper reported grants from PCORI during the conduct of the study. Dr Deans reported grants from PCORI during the conduct of the study. No other disclosures were reported.

Figures

Figure.. Study Flow of Nonoperative Management and Surgery for Uncomplicated Appendicitis

aSample sizes for secondary patient-reported outcomes vary based on availability of completed surveys for each measure. bAlthough nonoperative management success rate can only be assessed in the nonoperative management group, the data from all 698 surgery group patients were used to perform the inverse probability of treatment weighting analysis for nonoperative management success rate.