Are Post-operative Antibiotics Indicated in Simple Appendicitis?
Information source: Monash University
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Appendicitis
Intervention: metronidazole and cephalzolin (Drug)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Monash University Official(s) and/or principal investigator(s): Nicole Mennie, MBBS, Principal Investigator, Affiliation: Monash University Wei Cheng, MBBS, Study Director, Affiliation: Monash Medical Centre
Overall contact: Nicole Mennie, MBBS, Email: nmmen4@student.monash.edu
Summary
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.
Clinical Details
Official title: Are Post-operative Antibiotics Indicated in Simple Appendicitis? A Prospective Randomized Trial
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Presence of post-operative infection in the six weeks following appendectomyRequirement of further antibiotic therapy in the six weeks following appendectomy
Secondary outcome: Time to discharge taken from the time of operation to the time the child first satisfied the discharge criteriaRe-admission in the six weeks following appendectomy
Eligibility
Minimum age: 4 Years.
Maximum age: 17 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Nicole Mennie, MBBS, Email: nmmen4@student.monash.edu
Monash Medical Centre, Clayton, Victoria 3168, Australia; Not yet recruiting Wei Cheng, MBBS, Phone: +61395945500 N Mennie, MBBS, Email: nmmen4@student.monash.edu Nicole M Mennie, MBBS, Principal Investigator Wei Cheng, MBBS, Principal Investigator Peter Ferguson, MBBS, Sub-Investigator
Additional Information
Starting date: November 2011
Last updated: August 18, 2011
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