CompletedNot Applicable

Are Post-operative Antibiotics Indicated in Simple Appendicitis?

Australia300 participantsStarted 2011-11

Plain-language 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.

Who can participate

Age range

4 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Presence of post-operative infection in the six weeks following appendectomy

Timeframe: 6 weeks

Requirement of further antibiotic therapy in the six weeks following appendectomy

Timeframe: 6 weeks

Trial details

NCT IDNCT01420367

SponsorMonash University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-11

View on ClinicalTrials.gov More Appendicitis trials