Antimicrobial Stewardship in Pediatric Surgery

Withdrawn

• Conditions: Appendicitis
• Interventions: Other: Antimicrobial Stewardship Program

• Registration Number: NCT02270996
• Lead Sponsor: Alberta Children's Hospital

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.

Study Timeline

• Study First Submitted: 2014-10-08
• Study First Submitted QC: 2014-10-21
• Study First Posted: 2014-10-22
• Study Start: 2015-01
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-16
• Last Update Posted: 2018-03-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
WITH Antimicrobial Stewardship Program	Antimicrobial Stewardship Program	Prospective cohort of children who undergo appendectomy for acute appendicitis (perforated and non-perforated) WITH the implementation of the Antimicrobial Stewardship Program.

Primary Outcome Measures

Name	Time	Method
Compliance with American Pediatric Surgical Association recommendations for postoperative antibiotics for appendicitis	From date of admission until first follow-up visit, typically within 4-6 weeks of discharge	Includes both intravenous and oral antibiotics prescribed, both during the time frame from admission until discharge, in addition to any prescription given for home, oral antibiotics. Measured as yes/no

Secondary Outcome Measures

Name	Time	Method
Postoperative intravenous antibiotics for non-perforated appendicitis	From date of admission until first follow-up visit, typically within 4-6 weeks of discharge	measured as number of days (ie number of doses divided by number of doses-per-day)
Postoperative oral antibiotics for non-perforated appendicitis	From date of admission until first follow-up visit, typically within 4-6 weeks of discharge	measured as number of days (ie number of doses divided by number of doses-per-day)