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Trial registered on ANZCTR


Registration number
ACTRN12611000919910
Ethics application status
Not yet submitted
Date submitted
17/08/2011
Date registered
29/08/2011
Date last updated
29/08/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Are post-operative antibiotics indicated in simple appendicitis? A prospective randomized trial.
Scientific title
Is a single dose of prophylactic antibiotics as effective as a three dose regime in preventing post-operative infection in paediatric patients with simple appendicitis?
Secondary ID [1] 262869 0
ClinicalTrials.gov: NCT01420367
Universal Trial Number (UTN)
U1111-1123-7877
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Simple Appendicitis 270584 0
Post-operative Infection 270588 0
Condition category
Condition code
Surgery 270755 270755 0 0
Other surgery
Oral and Gastrointestinal 270760 270760 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Infection 270761 270761 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single pre-operative dose of antibiotics (IV metronidazole 12.5mg/kg up to 500mg and IV cefazolin 25mg/kg up to 1g)
administered at the time of induction.
And Normal Saline (used as a placebo) IV 10mL given at 8 and 16 hours after the antibiotics.
Intervention code [1] 269216 0
Treatment: Drugs
Intervention code [2] 269224 0
Prevention
Comparator / control treatment
Three doses of antibiotics:
One pre-operative dose of IV metronidazole 12.5mg/kg up to 500mg and IV cefazolin 25mg/kg up to 1g
administered at the time of induction
Two post-operative dose at 8 and 16 hours after the first dose (IV metronidazole 12.5mg/kg up to 500mg and IV cefazolin 25mg/kg up to 1g)
Control group
Dose comparison

Outcomes
Primary outcome [1] 279448 0
Post-operative infection - defined as wound infection (red, swollen, hot around site of incision), fever (temperature >38.5 degrees celsius) or signs of sepsis (tachycardia, hypotension, raise white cell count and CRP). This is assessed in hospital whilst still an inpatient and at a 6 week follow-up phone call to see if they have been ill since, seen their GP or attended hospital.
Timepoint [1] 279448 0
6 weeks following surgery
Primary outcome [2] 279449 0
Requirement for further antibiotics - administered by the patients general practitioner or at a hospital due to suspected infection (as per primary outcome 1). Patients will be telephoned at 6 weeks post-operation to assess whether they have visited their GP or another hospital.
Timepoint [2] 279449 0
6 weeks following surgery
Secondary outcome [1] 287673 0
Time to discharge
Timepoint [1] 287673 0
From surgery til discharge home
Secondary outcome [2] 287674 0
Re-admission: Assessed with 6 week follow-up phone call to see if they have presented at hospital since the operation
Timepoint [2] 287674 0
6 weeks following surgery

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 (an appendix that is non-inflamed, acutely inflamed, phlegmonous, suppurative or mildly inflamed).
Minimum age
4 Years
Maximum age
16 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-Any patient whose guardian does not wish for them to participate in the study.
- 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.
-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)
Enrollment: All patients who are being taken to theatre for laparoscopic appendectomy will be consented with regard to the study pre-operatively. ). An information sheet will be provided to parents. In theatre the surgeon makes a decision as to whether patient meets the inclusion criteria (appears to have simple appendicitis) and at this point enrolment takes place.

Treatment Allocation: Randomisation will occur at the pharmacy department using a computerised random number generator to determine group allocation. The pharmacy will distribute individually labelled, identical appearing syringes containing whether antibiotics or placebo (normal saline).

Allocation Concealment: Allocation to single or three dose groups will be triple blinded, that is concealed from the patient, treating team and outcome assessors.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number generation using excel. Excel is used to randomly order numbers 1 to 300 with the first 150 numbers listed being allocated to group 1 (single dose + placebo) and the second 150 being allocated to group 2 (three doses).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
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)

Funding & Sponsors
Funding source category [1] 269684 0
Hospital
Name [1] 269684 0
Department of Paediatrics, Department of Surgery, Monash Medical Centre
Address [1] 269684 0
Southern Medical School, Faculty of Medicine, Nursing and Health Sciences, Level 5, Block E, Monash Medical Centre, 246 Clayton Rd, Clayton, VIC 3168
Country [1] 269684 0
Australia
Primary sponsor type
Individual
Name
Nicole Mennie, BMedSci Student
Address
Department of Paediatrics, Department of Surgery
Southern Medical School, Faculty of Medicine, Nursing and Health Sciences, Level 5, Block E, Monash Medical Centre, 246 Clayton Rd, Clayton, VIC 3168
Country
Australia
Secondary sponsor category [1] 268720 0
Individual
Name [1] 268720 0
Prof Wei Cheng
Address [1] 268720 0
Department of Paediatrics, Department of Surgery
Southern Medical School, Faculty of Medicine, Nursing and Health Sciences, Level 5, Block E, Monash Medical Centre, 246 Clayton Rd, Clayton, VIC 3168
Country [1] 268720 0
Australia
Secondary sponsor category [2] 268721 0
University
Name [2] 268721 0
Monash University
Address [2] 268721 0
BMedSci Course Administrator
Faculty of Medicine, Nursing and Health Sciences
Building 15 Reception, Monash University VIC 3800
Country [2] 268721 0
Australia
Other collaborator category [1] 252210 0
Individual
Name [1] 252210 0
Dr Peter Ferguson
Address [1] 252210 0
Department of Paediatrics, Department of Surgery
Southern Medical School, Faculty of Medicine, Nursing and Health Sciences, Level 5, Block E, Monash Medical Centre, 246 Clayton Rd, Clayton, VIC 3168
Country [1] 252210 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 271635 0
Southern Health HREC
Ethics committee address [1] 271635 0
Research Support Unit, Level 4 Main Block
Monash Medical Centre, 246 Clayton Rd, Clayton, VIC 3168
Ethics committee country [1] 271635 0
Australia
Date submitted for ethics approval [1] 271635 0
31/08/2011
Approval date [1] 271635 0
Ethics approval number [1] 271635 0

Summary
Brief summary
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
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33039 0
Address 33039 0
Country 33039 0
Phone 33039 0
Fax 33039 0
Email 33039 0
Contact person for public queries
Name 16286 0
Prof Wei Cheng
Address 16286 0
Department of Paediatrics, Department of Surgery,
Southern Medical School, Faculty of Medicine, Nursing and Health Sciences
Level 5 Block E, Monash Medical Centre,
246 Clayton Rd, Clayton
VIC 3168
Country 16286 0
Australia
Phone 16286 0
+61395945500
Fax 16286 0
Email 16286 0
wei.cheng@monash.edu
Contact person for scientific queries
Name 7214 0
Prof Wei Cheng
Address 7214 0
Department of Paediatrics, Department of Surgery,
Southern Medical School, Faculty of Medicine, Nursing and Health Sciences
Level 5 Block E, Monash Medical Centre,
246 Clayton Rd, Clayton
VIC 3168
Country 7214 0
Australia
Phone 7214 0
+61395945500
Fax 7214 0
Email 7214 0
wei.cheng@monash.edu

No information has been provided regarding IPD availability
Summary results
No Results