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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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 - Defined by wound infection, fever (>38.5) or evidence of sepsis.
Timepoint [1] 0 0
6 weeks
Primary outcome [2] 0 0
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.
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 - Discharge criteria:
Pain adequately controlled with oral analgesia Tolerating full diet Afebrile
Timepoint [1] 0 0
1 week
Secondary outcome [2] 0 0
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.
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
Gender
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
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
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
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.
Trial website
https://clinicaltrials.gov/show/NCT01420367
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
nmmen4@student.monash.edu
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT01420367