Status:
COMPLETED
Are Post-operative Antibiotics Indicated in Simple Appendicitis?
Lead Sponsor:
Monash University
Collaborating Sponsors:
Monash Medical Centre
Conditions:
Appendicitis
Eligibility:
All Genders
4-17 years
Phase:
NA
Brief 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 w...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT01420367
Start Date
November 1 2011
End Date
December 1 2013
Last Update
December 2 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Monash Medical Centre
Clayton, Victoria, Australia, 3168