Are Post-operative Antibiotics Indicated in Simple Appendicitis?

Appendicitis Clinical Trial

Official title: Are Post-operative Antibiotics Indicated in Simple Appendicitis? A Prospective Randomized Trial

Status Not yet recruiting

Clinical Trial 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 Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Appendicitis

• NCT number: NCT01420367
• Study type: Interventional
• Source: Monash University
• Contact: Nicole Mennie, MBBS
• Email: nmmen4@student.monash.edu
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2011
• Completion date: December 2013