Not Yet RecruitingPhase 4ACTRN12611000919910

Are post-operative antibiotics indicated in simple appendicitis? A prospective randomized trial.

Is a single dose of prophylactic antibiotics as effective as a three dose regime in preventing post-operative infection in paediatric patients with simple appendicitis?


Sponsor

Nicole Mennie, BMedSci Student

Enrollment

300 participants

Start Date

Nov 1, 2011

Study Type

Interventional

Conditions

Summary

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.


Eligibility

Sex: Both males and femalesMin Age: 4 YearssMax Age: 16 Yearss

Plain Language Summary

Simplified for easier understanding

This trial investigates whether antibiotics are needed after surgery for simple (uncomplicated) appendicitis in children aged 4-16. Patients whose appendix was found to be inflamed but not gangrenous or perforated during surgery are randomly assigned to receive or not receive post-operative antibiotics. The study aims to determine if skipping post-operative antibiotics is safe for straightforward cases.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Single pre-operative dose of antibiotics (IV metronidazole 12.5mg/kg up to 500mg and IV cefazolin 25mg/kg up to 1g) administered at the time of induction. And Normal Saline (used as a placebo) IV 10

Single pre-operative dose of antibiotics (IV metronidazole 12.5mg/kg up to 500mg and IV cefazolin 25mg/kg up to 1g) administered at the time of induction. And Normal Saline (used as a placebo) IV 10mL given at 8 and 16 hours after the antibiotics.


Locations(1)

Australia

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ACTRN12611000919910