Antimicrobial Stewardship in Pediatric Surgery

Appendicitis Clinical Trial

— AbxPS  

Official title:

An Antimicrobial Stewardship Intervention Program in Pediatric Surgery

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02270996
• Other study ID #: ACH PedSurg ACS 002
• Status: Withdrawn
• First received: October 8, 2014
• Last updated: March 16, 2018
• Start date: January 2015
• Est. completion date: December 2015

Study information

• Verified date: March 2018
• Source: Alberta Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Appendicitis

Intervention

Other:
• Antimicrobial Stewardship Program
Twice weekly meeting with Infectious Disease and Pediatric Surgery team members to audit antibiotics prescribed and suggest role for discontinuation.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alberta Children's Hospital

References & Publications (5)

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. — View Citation

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 Clinic — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Postoperative fever	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
Other	Readmission within 30 days	Need for readmission within 30 days of discharge, measured as yes/no	Within 30 days of discharge
Other	Peripherally inserted intravenous catheter (PICC)	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
Other	Drain insertion	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
Other	Re-operation	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
Other	Length of Stay	Measured in days (from date of admission until date of discharge)	Length of admission
Other	Adverse reaction to antibiotic	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
Other	Wrong medication/Wrong dose	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
Other	C difficile infection	Measured as yes/no based on stool assay	From date of admission until first follow-up visit, typically within 4-6 weeks of discharge
Primary	Compliance with American Pediatric Surgical Association recommendations for postoperative antibiotics for appendicitis	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
Secondary	Postoperative intravenous antibiotics for non-perforated appendicitis	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
Secondary	Postoperative oral antibiotics for non-perforated appendicitis	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