Clinical trial NCT02270996: Antimicrobial Stewardship in Pediatric Surgery
Official title: An Antimicrobial Stewardship Intervention Program in Pediatric Surgery
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Appendicitis
Keywords: antibiotic, antimicrobial, stewardship, child
Lead sponsor: Alberta Children's Hospital
Sponsor class: OTHER
First posted: 2014-10-22
Enrollment: 0
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population is the pediatric surgeons at our institution who will have their antibiotic prescribing audited.

Brief summary: Acute appendicitis is a common surgical emergency in children. Non-perforated appendicitis patients do not require antibiotics after appendectomy. Although guidelines and recommendations exist to decrease post-operative antibiotic mis-use after appendectomy, surgeons continue to prescribe unwarranted antibiotics.

The aim of this study is to determine if an Antimicrobial Stewardship Program in Pediatric Surgery will decrease the use of un-warranted antibiotics.

Detailed description: Many surgeons continue to treat non-perforated or "borderline perforated" appendicitis with postoperative antibiotics despite an evidence-based definition of perforation (in the pediatric surgical literature) and many guidelines and recommendations that specify that no postoperative antibiotics are required. Children with perforated appendicitis are also often treated with longer-than-necessary courses of antibiotics. Although surgeons may feel that they only prescribe additional doses on occasion, evidence suggests that this behavior occurs in over 50% of children with non-perforated appendicitis.

These additional doses contribute to a longer length of stay, excess costs to the health care system, and disrupt patient flow. Additionally, the patients are exposed to more antibiotics and their potential for adverse effects (such as incorrect dose, incorrect medication, allergic reaction, antimicrobial resistance or c difficile infection).

Antimicrobial stewardship programs have been successful in pediatrics and adult general surgery in curbing unwarranted antibiotic use, but have never been evaluated in pediatric general surgery.

Eligibility criteria: Inclusion Criteria:

* Participant (surgeon) is a pediatric surgeon at McMaster Children's Hospital and takes care of patients under the age of 18 who undergo appendectomy.
* Participant (surgeon) is able to read, write and understand English.
* Participant (surgeon) is able to provide informed consent.

Exclusion Criteria:

* Participant (surgeon) only has patients who undergo drain insertion, PICC line insertion or a secondary operation during the same admission
* Participant (surgeon) only has patients who do not undergo operation (i.e. "conservative management with interval appendectomy)
* Participant (surgeon) does not provide informed consent
* Participant (surgeon) does not understand written and spoken English diagnosis other than appendicitis at time of operation

Primary outcomes:
measure: Compliance with American Pediatric Surgical Association recommendations for postoperative antibiotics for appendicitis
timeFrame: From date of admission until first follow-up visit, typically within 4-6 weeks of discharge
Secondary outcomes:
measure: Postoperative intravenous antibiotics for non-perforated appendicitis
timeFrame: From date of admission until first follow-up visit, typically within 4-6 weeks of discharge
measure: Postoperative oral antibiotics for non-perforated appendicitis
timeFrame: From date of admission until first follow-up visit, typically within 4-6 weeks of discharge
Other outcomes:
measure: Postoperative fever
timeFrame: Length of admission
measure: Readmission within 30 days
timeFrame: Within 30 days of discharge
measure: Peripherally inserted intravenous catheter (PICC)
timeFrame: From date of admission until first follow-up visit, typically within 4-6 weeks of discharge
measure: Drain insertion
timeFrame: From date of admission until first follow-up visit, typically within 4-6 weeks of discharge
measure: Re-operation
timeFrame: From date of admission until first follow-up visit, typically within 4-6 weeks of discharge
measure: Length of Stay
timeFrame: Length of admission
measure: Adverse reaction to antibiotic
timeFrame: From date of admission until first follow-up visit, typically within 4-6 weeks of discharge
measure: Wrong medication/Wrong dose
timeFrame: From date of admission until date of first follow-up visit, typically within 4-6 weeks of discharge
measure: C difficile infection
timeFrame: From date of admission until first follow-up visit, typically within 4-6 weeks of discharge
Locations:
Study officials:
affiliation: Alberta Children's Hospital
name: Anna Shawyer, MS, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: St Peter SD, Sharp SW, Holcomb GW 3rd, Ostlie DJ. An evidence-based definition for perforated appendicitis derived from a prospective randomized trial. J Pediatr Surg. 2008 Dec;43(12):2242-5. doi: 10.1016/j.jpedsurg.2008.08.051.
citation: Lee SL, Islam S, Cassidy LD, Abdullah F, Arca MJ; 2010 American Pediatric Surgical Association Outcomes and Clinical Trials Committee. Antibiotics and appendicitis in the pediatric population: an American Pediatric Surgical Association Outcomes and Clinical Trials Committee systematic review. J Pediatr Surg. 2010 Nov;45(11):2181-5. doi: 10.1016/j.jpedsurg.2010.06.038.
citation: Srigley JA, Brooks A, Sung M, Yamamura D, Haider S, Mertz D. Inappropriate use of antibiotics and Clostridium difficile infection. Am J Infect Control. 2013 Nov;41(11):1116-8. doi: 10.1016/j.ajic.2013.04.017. Epub 2013 Aug 7.
citation: Rangel SJ, Fung M, Graham DA, Ma L, Nelson CP, Sandora TJ. Recent trends in the use of antibiotic prophylaxis in pediatric surgery. J Pediatr Surg. 2011 Feb;46(2):366-71. doi: 10.1016/j.jpedsurg.2010.11.016.
citation: Ghaleb MA, Barber N, Franklin BD, Wong IC. The incidence and nature of prescribing and medication administration errors in paediatric inpatients. Arch Dis Child. 2010 Feb;95(2):113-8. doi: 10.1136/adc.2009.158485. Epub 2010 Feb 4.