Antimicrobial Stewardship in Pediatric Surgery (AbxPS)
16. marts 2018 opdateret af: 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.
Studieoversigt
Status
Trukket tilbage
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Observationel
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
Ikke ældre end 18 år (Barn, Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / 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.
|
Twice weekly meeting with Infectious Disease and Pediatric Surgery team members to audit antibiotics prescribed and suggest role for discontinuation.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Anna Shawyer, MS, MSc, Alberta Children's Hospital
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. januar 2015
Primær færdiggørelse (Forventet)
1. december 2015
Studieafslutning (Forventet)
1. december 2015
Datoer for studieregistrering
Først indsendt
8. oktober 2014
Først indsendt, der opfyldte QC-kriterier
21. oktober 2014
Først opslået (Skøn)
22. oktober 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
20. marts 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. marts 2018
Sidst verificeret
1. marts 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ACH PedSurg ACS 002
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .