Antimicrobial Stewardship in Pediatric Surgery

NCT ID: NCT02270996

Last Updated: 2018-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-12-31

Brief Summary

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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

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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.

Conditions

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Appendicitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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NO Antimicrobial Stewardship Program

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

No interventions assigned to this group

WITH 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.

Antimicrobial Stewardship Program

Intervention Type OTHER

Twice weekly meeting with Infectious Disease and Pediatric Surgery team members to audit antibiotics prescribed and suggest role for discontinuation.

Interventions

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Antimicrobial Stewardship Program

Twice weekly meeting with Infectious Disease and Pediatric Surgery team members to audit antibiotics prescribed and suggest role for discontinuation.

Intervention Type OTHER

Eligibility Criteria

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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
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Alberta Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dr Anna Shawyer

Dr. Anna Shawyer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anna Shawyer, MS, MSc

Role: PRINCIPAL_INVESTIGATOR

Alberta Children's Hospital

References

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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.

Reference Type RESULT
PMID: 19040944 (View on PubMed)

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.

Reference Type RESULT
PMID: 21034941 (View on PubMed)

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.

Reference Type RESULT
PMID: 23932828 (View on PubMed)

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.

Reference Type RESULT
PMID: 21292089 (View on PubMed)

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.

Reference Type RESULT
PMID: 20133327 (View on PubMed)

Other Identifiers

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ACH PedSurg ACS 002

Identifier Type: -

Identifier Source: org_study_id

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