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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01420367
• Other study ID #: U1111-1123-7877
• Status: Not yet recruiting
• Phase: N/A
• First received: August 18, 2011
• Last updated: August 18, 2011
• Start date: November 2011
• Est. completion date: December 2013

Study information

• Verified date: August 2011
• Source: Monash University
• Contact: Nicole Mennie, MBBS
• Email: nmmen4[@]student.monash.edu
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: December 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 17 Years

Eligibility

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.

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

Intervention

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.

Locations

Country	Name	City	State
Australia	Monash Medical Centre	Clayton	Victoria

Sponsors (2)

Lead Sponsor	Collaborator
Monash University	Monash Medical Centre

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of post-operative infection in the six weeks following appendectomy	Defined by wound infection, fever (>38.5) or evidence of sepsis.	6 weeks	No
Primary	Requirement of further antibiotic therapy in the six weeks following appendectomy	Administration of antibiotics either by hospital or general practitioner in the 6 week post-operative period.	6 weeks	No
Secondary	Time to discharge taken from the time of operation to the time the child first satisfied the discharge criteria	Discharge criteria: Pain adequately controlled with oral analgesia Tolerating full diet Afebrile	1 week	No
Secondary	Re-admission in the six weeks following appendectomy	Re-admission to the treating hospital or any other hospital in the 6 weeks post-operative period.	6 weeks	No