Are Post-operative Antibiotics Indicated in Simple Appendicitis?
Status:
Unknown status
Trial end date:
2013-12-01
Target enrollment:
Participant gender:
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.