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Antimicrobial Stewardship in Pediatric Surgery (AbxPS)

16. mars 2018 oppdatert av: Dr Anna Shawyer, Alberta Children's Hospital

An Antimicrobial Stewardship Intervention Program in Pediatric Surgery

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.

Studieoversikt

Status

Tilbaketrukket

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Ikke eldre enn 18 år (Barn, Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

The study population is the pediatric surgeons at our institution who will have their antibiotic prescribing audited.

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
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.
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.
Annen: Antimicrobial Stewardship Program
Twice weekly meeting with Infectious Disease and Pediatric Surgery team members to audit antibiotics prescribed and suggest role for discontinuation.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Compliance with American Pediatric Surgical Association recommendations for postoperative antibiotics for appendicitis
Tidsramme: 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
From date of admission until first follow-up visit, typically within 4-6 weeks of discharge

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Postoperative intravenous antibiotics for non-perforated appendicitis
Tidsramme: 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)
From date of admission until first follow-up visit, typically within 4-6 weeks of discharge
Postoperative oral antibiotics for non-perforated appendicitis
Tidsramme: 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)
From date of admission until first follow-up visit, typically within 4-6 weeks of discharge

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Postoperative fever
Tidsramme: Length of admission
Rectal temperature above 100.4ºF (38ºC), measured as yes/no and on what postoperative day Oral temperature above 100ºF (37.8ºC) Axillary (armpit) temperature above 99ºF (37.2ºC) Ear (tympanic membrane) temperature above 100.4ºF (38ºC) in rectal mode or 99.5ºF (37.5ºC) in oral mode Forehead (temporal artery) temperature above 100.4ºF (38ºC)
Length of admission
Readmission within 30 days
Tidsramme: Within 30 days of discharge
Need for readmission within 30 days of discharge, measured as yes/no
Within 30 days of discharge
Peripherally inserted intravenous catheter (PICC)
Tidsramme: From date of admission until first follow-up visit, typically within 4-6 weeks of discharge
Need for PICC insertion for long term antibiotics, intravenous fluids or parenteral nutrition, measured as yes/no
From date of admission until first follow-up visit, typically within 4-6 weeks of discharge
Drain insertion
Tidsramme: From date of admission until first follow-up visit, typically within 4-6 weeks of discharge
Need for a drain insertion (by interventional radiology) for postoperative abscess, measured as yes/no
From date of admission until first follow-up visit, typically within 4-6 weeks of discharge
Re-operation
Tidsramme: From date of admission until first follow-up visit, typically within 4-6 weeks of discharge
Need for re-operation on the same admission, measured as yes/no
From date of admission until first follow-up visit, typically within 4-6 weeks of discharge
Length of Stay
Tidsramme: Length of admission
Measured in days (from date of admission until date of discharge)
Length of admission
Adverse reaction to antibiotic
Tidsramme: From date of admission until first follow-up visit, typically within 4-6 weeks of discharge
Measured as yes/no in addition to description of reaction (eg hives, shortness of breath)
From date of admission until first follow-up visit, typically within 4-6 weeks of discharge
Wrong medication/Wrong dose
Tidsramme: From date of admission until date of first follow-up visit, typically within 4-6 weeks of discharge
Measured as yes/no in addition to description of problem (wrong dose, wrong medication)
From date of admission until date of first follow-up visit, typically within 4-6 weeks of discharge
C difficile infection
Tidsramme: From date of admission until first follow-up visit, typically within 4-6 weeks of discharge
Measured as yes/no based on stool assay
From date of admission until first follow-up visit, typically within 4-6 weeks of discharge

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Alberta Children's Hospital

Etterforskere

  • Hovedetterforsker: Anna Shawyer, MS, MSc, Alberta Children's Hospital

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. januar 2015

Primær fullføring (Forventet)

1. desember 2015

Studiet fullført (Forventet)

1. desember 2015

Datoer for studieregistrering

Først innsendt

8. oktober 2014

Først innsendt som oppfylte QC-kriteriene

21. oktober 2014

Først lagt ut (Anslag)

22. oktober 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

20. mars 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. mars 2018

Sist bekreftet

1. mars 2018

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • ACH PedSurg ACS 002

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