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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01420367




Registration number
NCT01420367
Ethics application status
Date submitted
18/08/2011
Date registered
19/08/2011
Date last updated
19/08/2011

Titles & IDs
Public title
Are Post-operative Antibiotics Indicated in Simple Appendicitis?
Scientific title
Are Post-operative Antibiotics Indicated in Simple Appendicitis? A Prospective Randomized Trial
Secondary ID [1] 0 0
U1111-1123-7877
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Appendicitis 0 0
Condition category
Condition code
Surgery 0 0 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - metronidazole and cephalzolin

Experimental: Single dose of antibiotics - This group will receive one dose of IV metronidazole (12.5mg/kg up to 500mg) and cefazolin (25mg/kg up to 1g) in the pre-operative period and two post-operative IV 'doses' of normal saline 8 and 16 hours after the pre-operative dose, which will act as a placebo and facilitate blinding.

Active comparator: Three doses of antibiotics - This group will receive one pre-operative dose of IV metronidazole (12.5mg/kg up to 500mg) and cefazolin (25mg/kg up to 1g) and two post-operative doses of IV metronidazole (12.5mg/kg up to 500mg) and cefazolin (25mg/kg up to 1g) 8 and 16 hours after the pre-operative dose.


Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Presence of post-operative infection in the six weeks following appendectomy
Timepoint [1] 0 0
6 weeks
Primary outcome [2] 0 0
Requirement of further antibiotic therapy in the six weeks following appendectomy
Timepoint [2] 0 0
6 weeks
Secondary outcome [1] 0 0
Time to discharge taken from the time of operation to the time the child first satisfied the discharge criteria
Timepoint [1] 0 0
1 week
Secondary outcome [2] 0 0
Re-admission in the six weeks following appendectomy
Timepoint [2] 0 0
6 weeks

Eligibility
Key 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.
Minimum age
4 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2013
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash Medical Centre - Clayton
Recruitment postcode(s) [1] 0 0
3168 - Clayton

Funding & Sponsors
Primary sponsor type
Other
Name
Monash University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Monash Medical Centre
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Nicole Mennie, MBBS
Address 0 0
Monash University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Nicole Mennie, MBBS
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01420367