Are Post-operative Antibiotics Indicated in Simple Appendicitis?

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Monash University.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Monash Medical Centre
Information provided by:
Monash University
ClinicalTrials.gov Identifier:
NCT01420367
First received: August 18, 2011
Last updated: NA
Last verified: August 2011
History: No changes posted

August 18, 2011
August 18, 2011
November 2011
November 2013   (final data collection date for primary outcome measure)
  • Presence of post-operative infection in the six weeks following appendectomy [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Defined by wound infection, fever (>38.5) or evidence of sepsis.
  • Requirement of further antibiotic therapy in the six weeks following appendectomy [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Administration of antibiotics either by hospital or general practitioner in the 6 week post-operative period.
Same as current
No Changes Posted
  • Time to discharge taken from the time of operation to the time the child first satisfied the discharge criteria [ Time Frame: 1 week ] [ Designated as safety issue: No ]

    Discharge criteria:

    Pain adequately controlled with oral analgesia Tolerating full diet Afebrile

  • Re-admission in the six weeks following appendectomy [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Re-admission to the treating hospital or any other hospital in the 6 weeks post-operative period.
Same as current
Not Provided
Not Provided
 
Are Post-operative Antibiotics Indicated in Simple Appendicitis?
Are Post-operative Antibiotics Indicated in Simple Appendicitis? A Prospective Randomized Trial

Hypothesis: A single dose of prophylactic antibiotics is as effective as a three dose regime in preventing post-operative complications in paediatric patients with simple appendicitis.

This project will compare patients 16 years and under with simple appendicitis (appendicitis that is not perforated or gangrenous). Patients will be randomly divided into two groups;

  • Group one will receive a single pre-operative dose of antibiotics (metronidazole 12.5mg/kg up to 500mg and cefazolin 25mg/kg up to 1g) and two 'doses' of normal saline (placebo) eight and sixteen hours after the initial dose, respectively.
  • Group two will receive one pre-operative dose of antibiotics (metronidazole 12.5mg/kg up to 500mg and cefazolin 25mg/kg up to 1g) and two post-operative doses, eight and sixteen hours after the first dose, respectively.

Group allocation will be concealed from the patient and their guardian, the treating surgical team and outcome assessors (triple blinded). A process to rapidly reveal group allocation if required will be in place.

The aim of the study is to determine if a single dose of antibiotics is as effective as three doses in preventing post-operative infection. This will be assessed by comparing:

  • Duration of hospital stay from operation until discharge, based on a standardised discharge criteria.
  • Development of wound infection or requirement of antibiotics in the six weeks post-operation
  • Need for re-admission.

Information will be collected prospectively from each patient's hospital notes and from a follow-up phone call six weeks after the operation.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Appendicitis
Drug: metronidazole and cephalzolin
IV doses of metronidazole (12.5mg/kg up to 500mg) and cefazolin (25mg/kg up to 1g). One dose for study arm, two for comparative arm.
  • Experimental: Single dose of antibiotics
    This group will receive one dose of IV metronidazole (12.5mg/kg up to 500mg) and cefazolin (25mg/kg up to 1g) in the pre-operative period and two post-operative IV 'doses' of normal saline 8 and 16 hours after the pre-operative dose, which will act as a placebo and facilitate blinding.
    Intervention: Drug: metronidazole and cephalzolin
  • Active Comparator: Three doses of antibiotics
    This group will receive one pre-operative dose of IV metronidazole (12.5mg/kg up to 500mg) and cefazolin (25mg/kg up to 1g) and two post-operative doses of IV metronidazole (12.5mg/kg up to 500mg) and cefazolin (25mg/kg up to 1g) 8 and 16 hours after the pre-operative dose.
    Intervention: Drug: metronidazole and cephalzolin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
300
December 2013
November 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • All patients who have their appendix removed and are found on operation to have 'simple appendicitis' as defined in the Cochrane review[7]. That is an appendix that is non-inflamed, acutely inflamed, phlegmonous, suppurative or mildly inflamed.

Exclusion Criteria:

  • Patients who on operation are found to have 'complicated appendicitis' defined as an appendix that is gangrenous or perforated.
  • Patients who pre-operatively appear to be acutely septic or for another reason require extended antibiotic therapy.
  • Patients who, at operation, are found to have other pathology e.g. Meckel's Diverticulum, Intussusception; requiring surgical or medical intervention.
  • Any patient whose guardian does not wish for them to participate in the study.
  • Patients who have additional co-morbidities, including diabetes, immuno-suppression, cardiac, renal or liver failure.
  • If the child continues to show sign of sepsis, in terms of fever, tachycardia, he/she will be discontinued from the study and be given additional doses of antibiotics, as clinically indicated.
Both
4 Years to 17 Years
No
Contact: Nicole Mennie, MBBS nmmen4@student.monash.edu
Contact: Wei Cheng, MBBS +61395945500
Australia
 
NCT01420367
U1111-1123-7877
No
Nicole Mennie, Monash University
Monash University
Monash Medical Centre
Principal Investigator: Nicole Mennie, MBBS Monash University
Study Director: Wei Cheng, MBBS Monash Medical Centre
Monash University
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP