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It's time to deconstruct treatment-failure: A randomized controlled trial of nonoperative management of uncomplicated pediatric appendicitis with antibiotics alone

Perez Otero, Sofia; Metzger, Julia W; Choi, Beatrix H; Ramaraj, Akila; Tashiro, Jun; Kuenzler, Keith A; Ginsburg, Howard B; Tomita, Sandra S; Fisher, Jason C
BACKGROUND:Published data demonstrate that management of uncomplicated pediatric appendicitis with antibiotics-alone is safe and frequently successful. Randomized controlled trials (RCT) comparing antibiotics-alone to appendectomy are lacking, alongside insight into drivers of failure. We sought to validate the antibiotics-alone approach and identify barriers to success using an RCT design. METHODS:Patients aged 6-17 years with uncomplicated appendicitis were randomized to appendectomy or intravenous piperacillin/tazobactam for 24-48 h followed by 10 days of oral ciprofloxacin/metronidazole. Enrollment required symptoms <48 h, WBC<18, appendiceal diameter <11 mm, and radiographic absence of perforation. Lack of clinical improvement or persistently elevated WBC resulted in appendectomy. Primary outcomes were 1-year success rate of antibiotics-alone and quality-of-life measures. RESULTS:Among 39 children enrolled over 31 months, 20 were randomized to antibiotics-alone and 19 to surgery. At 1 year, 6 nonoperative patients underwent appendectomy (70% success). Four cases were not true antibiotic failures but instead reflected "pragmatic" challenges to executing nonoperative algorithms. Only 2 cases represented recurrent/refractory appendicitis, suggesting a 90% adjusted 1-year success rate. Parental PedsQL™ scores were similar between treatment cohorts (91.3 vs 90.2, P = 0.32). Children treated with antibiotics-alone had faster return to activity (2.0 vs 12 days, P = 0.001) and fewer parental missed work days (0.0 vs 2.5, P = 0.03). CONCLUSIONS:These data corroborate findings from non-randomized studies suggesting 70-90% of uncomplicated pediatric appendicitis can be treated with antibiotics-alone, with fewer disability days. Failures appear multifactorial, often reflecting practical hurdles and not antibiotic limitations. As surgeons consider nonoperative protocols for uncomplicated appendicitis, these data further inform the variability of treatment success. LEVEL OF EVIDENCE/METHODS:1; randomized controlled trial.
PMID: 34674843
ISSN: 1531-5037
CID: 5064342

It's time to deconstruct treatment-failure: A randomized controlled trial of nonoperative management of uncomplicated pediatric appendicitis with antibiotics alone [Meeting Abstract]

Otero, Sofia Perez; Metzger, Julia W.; Choi, Beatrix H.; Ramaraj, Akila; Tashiro, Jun; Kuenzler, Keith A.; Ginsburg, Howard B.; Tomita, Sandra S.; Fisher, Jason C.
ISSN: 0022-3468
CID: 5242732

Response to Letter to Editor: Standardized Care and Oral Antibioics on Discharge for Pediatric Perforated Appendicitis [Letter]

Tomita, Sandra; Fisher, Jason; Ginsburg, Howard; Kuenzler, Keith; Choi, Jee-Hye; Gordon, Alex
PMID: 34274121
ISSN: 1095-8673
CID: 5066582

Increase in Pediatric Perforated Appendicitis in the New York City Metropolitan Region at the Epicenter of the COVID-19 Outbreak

Fisher, Jason C; Tomita, Sandra S; Ginsburg, Howard B; Gordon, Alex; Walker, David; Kuenzler, Keith A
OBJECTIVE:The aim of the study was to determine whether perforated appendicitis rates in children were influenced by the Coronavirus disease 2019 (COVID-19) surge. BACKGROUND:Disruption of care pathways during a public health crisis may prevent children from obtaining prompt assessment for surgical conditions. Progression of appendicitis to perforation is influenced by timeliness of presentation. In the context of state-mandated controls and public wariness of hospitals, we investigated the impact of the COVID-19 outbreak on perforated appendicitis in children. STUDY DESIGN/METHODS:We conducted an analysis of all children presenting to 3 hospital sites with acute appendicitis between March 1 and May 7, 2020, corresponding with the peak COVID-19 outbreak in the New York City region. Control variables were collected from the same institutions for the preceding 5 years. The primary outcome measure was appendiceal perforation. RESULTS:Fifty-five children presented with acute appendicitis over 10 weeks. Compared to a 5-year control cohort of 1291 patients, we observed a higher perforation rate (45% vs 27%, odds ratio 2.23, 95% confidence interval 1.29-3.85, P = 0.005) and longer mean duration of symptoms in children with perforations (71 ± 39 vs 47 ± 27 h, P = 0.001) during the COVID-19 period. There were no differences in perforation rates (55% vs 59%, P = 0.99) or median length of stay (1.0 vs 3.0 days, P = 0.58) among children screening positive or negative for SARS-CoV-2. CONCLUSIONS:Children in the epicenter of the COVID-19 outbreak demonstrated higher rates of perforated appendicitis compared to historical controls. Preoperative detection of SARS-CoV-2 was not associated with inferior outcomes. Although children likely avoid much of the morbidity directly linked to COVID-19, disruption to local healthcare delivery systems may negatively impact other aspects of pediatric surgical disease.
PMID: 32976285
ISSN: 1528-1140
CID: 4606112

Peritoneal drainage as a safe alternative to laparotomy in children with abdominal compartment syndrome

Choi, Beatrix Hyemin; Shenoy, Rivfka; Levy-Lambert, Dina; Fisher, Jason C; Tomita, Sandra S
ISSN: 2543-0351
CID: 5181402

Oral Antibiotics and Abscess Formation After Appendectomy for Perforated Appendicitis in Children

Gordon, Alex J; Choi, Jee-Hye; Ginsburg, Howard; Kuenzler, Keith; Fisher, Jason; Tomita, Sandra
BACKGROUND:There is little consensus regarding the use of postoperative antibiotics in the management of perforated appendicitis in children. Patients are commonly discharged with oral antibiotics after a course of intravenous antibiotics; however, recent literature suggests that patients can be safely discharged without any oral antibiotics. To further evaluate this protocol, we conducted a multicenter retrospective preimplementation/postimplementation study comparing rates of abscess formation and rehospitalization between patients discharged with and without oral antibiotics. MATERIALS AND METHODS/METHODS:We reviewed the records of all pediatric patients who underwent appendectomies for perforated appendicitis at NYU Tisch Hospital, Bellevue Hospital, and Hackensack University Medical Center from January 2014 to June 2019. Data pertaining to patient demographics, hospital course, intraoperative appearance of the appendix, antibiotic treatment, abscess formation, and rehospitalization were collected. RESULTS:A total of 253 patients were included: 162 received oral antibiotics and 91 did not. The median length of antibiotic treatment (oral and intravenous) was 11 (10-14) d for patients on oral antibiotics and 5 (3-6) d for patients without oral antibiotics (P < 0.01). The median leukocyte count at discharge was 9.5 (7.4-10.9) and 8.1 (6.8-10.4) for these groups, respectively (P = 0.02). Postoperative abscesses occurred in 22% of patients receiving oral antibiotics and 15% of patients on no antibiotics (P = 0.25). Rates of rehospitalization for these groups were 10% and 11%, respectively (P = 0.99). CONCLUSIONS:Children who have undergone appendectomy for perforated appendicitis can be safely discharged without oral antibiotics on meeting clinical discharge criteria and white blood cell count normalization.
PMID: 32683057
ISSN: 1095-8673
CID: 4546092

Peritoneal Drainage as a Safe Alternative to Laparotomy in Children with Abdominal Compartment Syndrome [Meeting Abstract]

Choi, B H; Shenoy, R H; Kuenzler, K; Ginsburg, H; Fisher, J C; Tomita, S
Introduction: Abdominal compartment syndrome (ACS) in children carries a mortality rate of 40% to 60%. Definitive treatment for ACS traditionally involves decompressive laparotomy. Although percutaneous catheter drainage (PCD) is an accepted therapy for neonates with intestinal perforation, its adoption for ACS remains low, due to uncertainty concerning its efficacy and concerns about complications. We explored whether PCD safely and successfully reversed ACS physiology in a cohort of children with intra-abdominal fluid.
Method(s): We reviewed records of all children undergoing PCD for ACS from 2014 to 2018 at a single institution. Bedside sonogram-guided PCD was performed by the surgical service using the Seldinger technique, with catheters removed on resolution of ACS physiology and fluid output of <10 mL/d. Clinical variables were explored using descriptive statistics and reported as median with interquartile range (IQR). Physiologic improvements over 24 hours were compared using paired Wilcoxon signed-rank tests.
Result(s): A total of 11 infants with a median age of 11 days (IQR 4 to 273 days) and weight of 4.2 kg (IQR 2.3 to 9.2 kg) underwent PCD for ACS secondary to ascites (n = 6), hemoperitoneum (n = 4), and pneumoperitoneum with ascites (n = 1). Catheters remained in place for a median of 8 days (IQR 5 to 9 days), with a median of 359 mL of fluid (IQR 165 to 1,588 mL) drained in the first 24 hours. Percutaneous catheter drainage resulted in significant physiologic improvement across multiple variables (Table). No catheter-related complications occurred, with only 1 patient requiring subsequent laparotomy.
Conclusion(s): Percutaneous catheter drainage is efficacious in reversing ACS physiology in children with intra-abdominal fluid, and should be considered a safe intervention that can obviate decompressive laparotomy. [Figure presented]
ISSN: 1072-7515
CID: 4109092

Reply to Letter to the Editor [Letter]

Tomita, Sandra; Fisher, Jason C; Fefferman, Nancy; Ginsburg, Howard B; Kuenzler, Keith A; Choi, Beatrix Hyemin
PMID: 30612745
ISSN: 1531-5037
CID: 3579772

Simple preoperative radiation safety interventions significantly lower radiation doses during central venous line placement in children

Choi, Beatrix Hyemin; Yaya, Kamalou; Prabhu, Vinay; Fefferman, Nancy; Mitchell, Beverly; Kuenzler, Keith A; Ginsburg, Howard B; Fisher, Jason C; Tomita, Sandra
PURPOSE/OBJECTIVE:The purpose of this study was to reduce radiation exposure during pediatric central venous line (CVL) placement by implementing a radiation safety process including a radiation safety briefing and a job-instruction model with a preradiation time-out. METHODS:We reviewed records of all patients under 21 who underwent CVL placement in the operating room covering 22 months before the intervention through 10 months after 2013-2016. The intervention consisted of a radiation safety briefing by the surgeon to the intraoperative staff before each case and a radiation safety time-out. We measured and analyzed the dose area product (DAP), total radiation time pre- and postintervention, and the use of postprocedural chest radiograph. RESULTS:, P < 0.001) and a 73% decrease in the median radiation time (28 vs 7.6 s, P < 0.001). Additionally, there was a significant reduction in use of confirmatory CXR (95% vs 15%, P < 0.01). CONCLUSION/CONCLUSIONS:A preoperative radiation safety briefing and a radiation safety time-out supported by a job-instruction model were effective in significantly lowering the absorbed doses of radiation in children undergoing CVL insertion. TYPE OF STUDY/METHODS:Case-control study. LEVEL OF EVIDENCE/METHODS:Level III.
PMID: 30415958
ISSN: 1531-5037
CID: 3456542

The epidemiology of inpatient pediatric trauma in United States hospitals 2000 to 2011

Oliver, Jamie; Avraham, Jacob; Frangos, Spiros; Tomita, Sandra; DiMaggio, Charles
BACKGROUND: This study provides important updates to the epidemiology of pediatric trauma in the United States. METHODS: Age-specific epidemiologic analysis of the Healthcare Cost and Utilization Project's Nationwide Inpatient Sample, representing 2.4 million pediatric traumatic injury discharges in the US from 2000 to 2011. We present yearly data with overlying loess smoothing lines, proportions of common injuries and surgical procedures, and survey-adjusted logistic regression analysis. RESULTS: From 2000 to 2011 there was a 21.7% decline in US pediatric trauma injury inpatient discharges from 273.2 to 213.7 admissions per 100,000. Inpatient case-fatality decreased 5.5% from 1.26% (95% CI 1.05-1.47) to 1.19% (95% CI 1.01-1.38). Severe injuries accounted for 26.5% (se=0.11) of all discharges in 2000 increasing to 31.3% (se=0.13) in 2011. The most common injury mechanism across all age groups was motor vehicle crashes (MVCs), followed by assaults (15-19years), sports (10-14), falls (5-9) and burns (<5). The total injury-related, inflation-adjusted cost was $21.7 billion, increasing 56% during the study period. CONCLUSIONS: The overall rate of inpatient pediatric injury discharges across the United States has been declining. While injury severity is increasing in hospitalized patients, case-fatality rates are decreasing. MVCs remain a common source of all pediatric trauma. LEVELS OF EVIDENCE: Level III.
PMID: 28506480
ISSN: 1531-5037
CID: 2562732