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Antimicrobial Stewardship in Pediatric Surgery (AbxPS)

16 de marzo de 2018 actualizado por: 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.

Descripción general del estudio

Estado

Retirado

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

De observación

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

No mayor que 18 años (Niño, Adulto)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra de probabilidad

Población de estudio

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

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
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.
Otro: Antimicrobial Stewardship Program
Twice weekly meeting with Infectious Disease and Pediatric Surgery team members to audit antibiotics prescribed and suggest role for discontinuation.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Compliance with American Pediatric Surgical Association recommendations for postoperative antibiotics for appendicitis
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Postoperative intravenous antibiotics for non-perforated appendicitis
Periodo de tiempo: 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
Periodo de tiempo: 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

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Postoperative fever
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Length of admission
Measured in days (from date of admission until date of discharge)
Length of admission
Adverse reaction to antibiotic
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Alberta Children's Hospital

Investigadores

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

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de enero de 2015

Finalización primaria (Anticipado)

1 de diciembre de 2015

Finalización del estudio (Anticipado)

1 de diciembre de 2015

Fechas de registro del estudio

Enviado por primera vez

8 de octubre de 2014

Primero enviado que cumplió con los criterios de control de calidad

21 de octubre de 2014

Publicado por primera vez (Estimar)

22 de octubre de 2014

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

20 de marzo de 2018

Última actualización enviada que cumplió con los criterios de control de calidad

16 de marzo de 2018

Última verificación

1 de marzo de 2018

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • ACH PedSurg ACS 002

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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