Antibiotic Prophylaxis for Pyloromyotomy in Children: An Opportunity for Better Stewardship
Kibileri Williams, MD MSa, Timothy Lautz, MDb,c, Richard J Hendrickson, MDd, Tolulope A Oyetunji, MD MPHd
a. Howard University Hospital
2041 Georgia Ave NW
Washington DC, 20001
b. Ann & Robert H. Lurie Children’s Hospital of Chicago
225 E. Chicago Ave, Box 63
Chicago IL, 60611
c. Northwestern University Feinberg School of Medicine
420 E. Superior St
Chicago IL, 60611
d. Children’s Mercy Kansas City
2401 Gillham Rd
Kansas City MO, 64108
Corresponding Author:
Tolulope Oyetunji
Children’s Mercy Kansas City
2401 Gillham Rd
Kansas City, MO 64108
Email: taoyetunji@cmh.edu
Tel: 816-234-3575
Author Contributions: KW assisted with data analysis and was the primary author of the manuscript. TL assisted with data analysis and provided editing of the manuscript. RJH provided final editing of the manuscript. TAO conceptualized the project, performed data analysis and supervised the preparation of the manuscript.
Acknowledgements: The authors express sincere gratitude to the members of the Pediatric Health Research Outcomes Group for Surgery at Ann & Robert H Lurie Children’s Hospital of Chicago for assistance in data analysis.
Disclosure: The abstract of this manuscript was presented at the International Pediatric Endosurgery Group’s 26th Annual Congress for Endosurgery in Children in London, England in July 2017. The authors report no proprietary or commercial interest in any product mentioned or concept discussed in this article.
Funding: This research did not receive any specific grant from funding agencies in the public, commercial or not-for-profit sectors.
Abstract
Introduction: Surgical site infection is very uncommon after pyloromyotomy in children and it is considered a “clean” procedure under the traditional wound classification system. This study aims to investigate prophylactic antibiotic administration for pyloromyotomy among children’s hospitals in the US.
Methods: The Pediatric Health Information System (PHIS) database was retrospectively reviewed from 2014-2015 including all patients less than 1 year old who had a principal diagnosis of pyloric stenosis and underwent pyloromyotomy. Patient demographics, hospital length of stay, and perioperative antibiotic administration were extracted.
Results: A total of 4206 patients met study criteria. Most patients were male (84%) and Caucasian (70%). The median age at admission was 32 days (IQR 24-44 days) and median length of stay was 2 days (IQR 1-2 days). Antibiotics were administered perioperatively in 2153 (51%) patients with marked variation among children’s hospitals. Antibiotics were given to more than 10% of patients in more than 90% of hospitals, and only 2 of 49 hospitals gave no antibiotic prophylaxis.
Conclusions: This study has shown that at several tertiary level children’s hospitals in the United States, antibiotic prophylaxis is administered for pyloromyotomy, a “clean” procedure. This highlights the need for standardization of care and more effective, antibiotic stewardship in pediatric surgery.
Introduction
Inappropriate antibiotic use often leads to the proliferation of multidrug resistant pathogens and is also associated with adverse antibiotic-related events, such as Clostridium difficile infection and allergic reactions, which result in patient morbidity and high healthcare costs.[1] The majority of hospitalized children receive antibiotics and, of these, more than 40% are for surgical indications with significant variation in administration among US children’s hospitals.[2] [3]
Consensus has not been achieved in the pediatric surgical community around antibiotic prophylaxis for common surgical procedures and there is marked interhospital variation in the rates of inappropriate antibiotic prophylaxis administration. Antibiotics are administered in more than 50% of surgical procedures performed at children’s hospitals but were only considered appropriate in 65% of cases, according to one study.[4] Moreover, the variation among children’s hospitals by procedure ranged from 11 to 100%, and antibiotics were given in 48% of cases in which they were not indicated.[4] In other pediatric subspecialties, the variation in practice is comparable. For example, the variation in antibiotic prophylaxis for clean outpatient pediatric urological procedures for which antibiotics are not indicated ranges from 35 to 98%.[5] For those procedures in which prophylaxis is indicated, there is similar variation in the choice, timing and duration of antibiotic administration.
Pyloromyotomy, for congenital hypertrophic pyloric stenosis, is one of the most common pediatric surgical procedures. According to the conventional wound classification system, pyloromyotomy is considered a “clean” procedure, given the absence of entry into a hollow viscus. There is a small risk of iatrogenic perforation, with an estimated incidence of 2%, for which antibiotics would theoretically reduce the risk of a subsequent surgical site infection (SSI). However, such a low incidence of perforation for this procedure would not seem to justify routine antibiotic prophylaxis in every case. For uneventful cases, studies have demonstrated a very low rate of SSI after this procedure of 1 to 2%, a rate that is not lowered by the administration of antibiotic prophylaxis.[6,7]
This study aims to investigate perioperative antibiotic administration for pyloromyotomy among children’s hospitals in the United States, with the hypothesis that despite the low SSI rate, antibiotic prophylaxis is being inappropriately administered, thus presenting a target for efforts at improving antibiotic stewardship in pediatric surgery.
Methods
Study Design, Data Source and Study Population
The Pediatric Health Information System (PHIS) is an administrative database comprising discharge and resource utilization data across multiple encounter types (emergency department, inpatient, observation, and ambulatory surgery) from more than 45 tertiary-level children’s hospitals in the United States affiliated with the Children’s Hospital Association. The data are de-identified and several validity and reliability checks are performed before inclusion in the database.
For this study, data from 45 hospitals were included from January 1, 2014 to December 31, 2015. The study was deemed exempt by the Institutional Review Board of Ann & Robert H. Lurie Children’s Hospital of Chicago (IRB 2017-799) and administrative approval was obtained from the PHIS before extraction.
This study included all patients aged less than 1 year who underwent pyloromyotomy, International Classification of Diseases, Ninth Revision (ICD-9) procedure code 43.3, for a principal diagnosis of congenital hypertrophic pyloric stenosis, ICD-9 diagnosis code 750.5. Those with length of stay greater than 10 days and those who were not discharged to home were excluded, under the assumption that these patients were likely to have had a complicated course and/or comorbidities.
Variables
Variables extracted included admission and disposition status, age (days), gender, ethnicity, race, and length of stay (LOS). Hospital city and identification number were also extracted as well as drug category, drug class, name of antibiotic, route and date of administration, dosage form, dosage strength, and unit of measure. Antibiotic administration was considered prophylactic if it was charted on the same calendar day as pyloromyotomy. Data were also extracted on in-hospital surgical complications and any 30-day readmissions for surgical site infection. The primary outcome was a binary indicator of antibiotic use on the day of the procedure.
Statistical Analysis
Descriptive analysis of demographic data were performed and reported as means, medians and proportions. Frequencies of antibiotic administration and number of cases are reported by hospital. Hospital identification number and city are not reported. Chi-square analysis was used for comparison of categorical variables and Student’s t test for continuous variables. STATA IC, version 10 (StataCorp, College Station, TX) was used for analysis and a p value less than 0.05 was considered statistically significant.
Results
Population characteristics
A total of 4206 patients from 49 hospitals were identified. The median age at admission was 32 days (IQR 24-44). Most patients were male, 3529 (83.9%), non-Hispanic, 2728 (64.9%) and White, 2954 (70.2%). (Table 1)
Antibiotic administration
Antibiotics were administered in 2153 (51.2%) patients. On univariate analysis, ethnicity and LOS were significantly associated with antibiotic use. (Table 1) Significant variation in antibiotic administration was demonstrated across the 49 hospitals included. Only 2 of 49 hospitals gave no antibiotic prophylaxis in all cases. More than 90% of hospitals gave antibiotic prophylaxis to more than 10% of their patients undergoing pyloromyotomy. (Figure 1)
Secondary outcomes
There were no 30-day infectious complications identified in the study population. The median total LOS was 2 days (IQR 1-2), with a median postoperative LOS of 1 day (IQR 1-2).
Discussion
Pyloromyotomy is the third most common pediatric surgical inpatient procedure in the United States.[8] This study has demonstrated that among tertiary-level pediatric institutions, antibiotic prophylaxis is being administered for this “clean” procedure for which such prophylaxis is not indicated, and that there is significant inter-hospital variation. Some studies have shown variation in the surgical site infection (SSI) rate and in the administration of antibiotic prophylaxis for pyloromyotomy based on the operative approach. Pyloromyotomy for congenital hypertrophic pyloric stenosis was first described using an open transverse right upper quadrant incision (Ramstedt pyloromyotomy). This was later modified to a periumbilical incision for improved cosmesis.[9] However, this latter approach is associated with a higher wound infection rate and some surgeons therefore advocate for antibiotic prophylaxis when using this technique.[10-12] In more recent years however, the laparoscopic approach has increasingly become the standard of care, particularly in the United States, and is associated with an SSI rate as low as 1%.[7,13] Indeed the laparoscopic approach has been demonstrated to be superior to open pyloromyotomy with shorter hospital length of stay and quicker return to full feeds postoperatively.[14,15,13] Irrespective of approach, however, pyloromyotomy is considered a clean procedure given the lack of entry into a hollow viscus.
Several single-institution studies have demonstrated SSI rates after pyloromyotomy less than 3%, which are not significantly lowered by the administration of antibiotic prophylaxis. Katz et al found no difference in wound infection rates in a 7-year review of 299 patients who had a laparoscopic pyloromyotomy between those who received antibiotic prophylaxis and those who did not.[6] Our study did not uncover any cases of readmission due to SSI postoperatively, but the administrative database used would not have captured patients who were seen in the outpatient office setting and likely treated with oral antibiotics and local wound care. However, given the popularity of the laparoscopic approach among children’s hospitals and the findings of other studies, it is unlikely that the incidence of SSI was higher than 1-3%.[16]
There has been increasing focus on antimicrobial stewardship particularly as it relates to inappropriate antibiotic use. Prolonged antibiotic therapy has been directly linked to the proliferation of antibiotic-resistant bacteria and the Centers for Disease Control and Prevention (CDC) has deemed antibiotic-resistant bacteria one of the world’s most serious public health threats, causing two million infections and at least 23,000 deaths each year in the United States.[17] Antibiotic-resistant bacteria are also associated with increases in patient morbidity, length of hospitalizations and the cost of healthcare. It is estimated that infections caused by antibiotic-resistant bacteria can cost up to $30,000 more per patient than those caused by antibiotic-susceptible organisms.[1]
Inappropriate antibiotic use is also responsible for adverse antibiotic-related events such as Clostridium difficile infections and allergic reactions. In 2011, it was estimated that 453,000 new Clostridium difficile infections occurred in the United States, of which two-thirds were healthcare-associated.[18] Not surprisingly, surgical antibiotic prophylaxis in children has been associated with higher odds of developing Clostridium difficile infection.[4,19] Surgical antibiotic prophylaxis has also been linked to greater odds of receiving treatment for an allergic reaction in both outpatient and inpatient pediatric surgical procedures.[19,20] Approximately 8% of all individuals using health care in the United States are allergic to penicillins and an estimated 1% are allergic to cephalosporins.[21] Since these are the classes of antibiotics most commonly used for antibiotic prophylaxis, it is evident that prophylaxis is not without inherent risk, which, although rare, must be weighed against the likelihood of surgical site infection for any given procedure.
In regard to surgical antibiotic prophylaxis for this procedure, we have shown significant variation across hospitals in antibiotic use. Other investigators have also demonstrated significant inter-hospital variation[4,19] and there is no consensus in the pediatric surgical community around prophylaxis for common procedures. There is also often lack of consensus in pediatric surgery around appropriate wound classification, particularly for neonatal operations. However this is not the case for pyloromyotomy, which was classified as “clean” by 97% of respondents to a web-based survey of pediatric surgeons in the United States.[22] Further, the role of the traditional wound classification system in directing antibiotic prophylaxis has been questioned for pediatric surgical procedures, which are often done using a minimally invasive approach and for which the SSI rates can be very low, in the range of 1 to 3%.[7,23] This study highlights the stark variation in care across some of the nation’s most advanced children’s hospitals for one of the field’s most common procedures. There is therefore a need for both standardization of antibiotic prophylaxis for commonly performed pediatric surgical procedures as well as a revision of the wound classification system to better reflect the unique physiology of pediatric surgical patients and the nature of the operations being performed.
The limitations of this study ought to be acknowledged. The use of an administrative database confers the potential for coding errors. Further, the ICD-9 classification system does not allow differentiation between the open and laparoscopic approaches for pyloromyotomy. However, this does not alter the designation of the procedure as “clean” requiring no antibiotic prophylaxis. As mentioned previously, in assessing postoperative SSI rates the database limited our ability to capture those patients who may have been seen and managed in the office setting. Again, given the findings of other studies in this population, the SSI rates are still very unlikely to exceed 3%. The paucity of clinical patient-level information in an administrative database means that it was not possible to deduce whether any intraoperative events, such as perforation, may have influenced the decision to administer antibiotics. However, given that the incidence of intraoperative complications of this nature is less than 2%, it does not explain the administration of antibiotics in more than 50% of patients.
Conclusion
This study has shown that at several tertiary level children’s hospitals in the United States, antibiotic prophylaxis is administered for pyloromyotomy, a “clean” procedure. This highlights the need for standardization of care and more effective, antibiotic stewardship in pediatric surgery.
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Reprint requests to be sent to:
Tolulope Oyetunji
Children’s Mercy Kansas City
2401 Gillham Rd
Kansas City, MO 64108
Email: taoyetunji@cmh.edu
Tel: 816-234-3575