Skip to main content
OpenTrials
Completed

NCT Number: NCT01420367

Are Post-operative Antibiotics Indicated in Simple Appendicitis?

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Appendicitis Cecal Diseases Charcot-Marie-Tooth disease, Type 1C Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Infections Intestinal Diseases Intraabdominal Infections

Age range

4 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Monash Medical Centre

Clayton, Victoria, 3168, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

metronidazole and cephalzolin

Drug

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.

Primary outcomes

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

    Time frame: 6 weeks

    Defined by wound infection, fever (>38.5) or evidence of sepsis.

  2. Requirement of further antibiotic therapy in the six weeks following appendectomy

    Time frame: 6 weeks

    Administration of antibiotics either by hospital or general practitioner in the 6 week post-operative period.

Secondary outcomes

  1. Time to discharge taken from the time of operation to the time the child first satisfied the discharge criteria

    Time frame: 1 week

    Discharge criteria:

    Pain adequately controlled with oral analgesia Tolerating full diet Afebrile

  2. Re-admission in the six weeks following appendectomy

    Time frame: 6 weeks

    Re-admission to the treating hospital or any other hospital in the 6 weeks post-operative period.

Sponsors and collaborators

Lead sponsor

Monash University

Other

Collaborators

  • Monash Medical Centre

Registry information

Official study title

Are Post-operative Antibiotics Indicated in Simple Appendicitis? a Prospective Randomized Trial

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Aug 19, 2011
Registry last updated
Dec 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.