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Are Post-operative Antibiotics Indicated in Simple Appendicitis?

NCT01420367 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2024-12-02

No results posted yet for this study

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.

Conditions

  • Appendicitis

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Nicole Mennie, MBBS · Monash University

  • Wei Cheng, MBBS · Monash Medical Centre

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2013-11-30
Completion
2013-12-31

Countries

  • Australia

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01420367 on ClinicalTrials.gov