AppendicitisNCT01420367
Are Post-operative Antibiotics Indicated in Simple Appendicitis?
A study testing metronidazole and cephalzolin in people with Appendicitis, run by Monash University at 1 site in Australia.
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). Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Appendicitis
- What is being tested?
- metronidazole and cephalzolin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteAustralia
- Study dates
- Nov 2011to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Are Post-operative Antibiotics Indicated in Simple Appendicitis? a Prospective Randomized Trial
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;
Read more
- 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.
- Conditions
- Appendicitis
- Being tested
- metronidazole and cephalzolin
- Keywords
- Paediatric, Simple, Non-perforated
- Medical subject headings
- Appendicitis, Charcot-Marie-Tooth disease, Type 1C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metronidazole and cephalzolinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Single dose of antibiotics | Experimental | 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. Receives: Drug: metronidazole and cephalzolin |
| Three doses of antibiotics | Active comparator | 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. Receives: Drug: metronidazole and cephalzolin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of post-operative infection in the six weeks following appendectomy
Defined by wound infection, fever (>38.5) or evidence of sepsis.
Measured: 6 weeks
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.
Measured: 6 weeks
Secondary outcomes (2)
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
Measured: 1 week
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2011 (estimated)
- Study startNov 2011
- Primary completionNov 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AppendicitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Monash University
- Sponsor type
- University, hospital or other
- Collaborators
- Monash Medical Centre
- Responsible party
- Sponsor
- Investigators
- Nicole Mennie, MBBS, Principal investigator, Monash UniversityWei Cheng, MBBS, Study director, Monash Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01420367
- Sponsor's protocol ID
- U1111-1123-7877
- Status last verified
- Aug 2011
- First submitted
- 18 Aug 2011
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are Post-operative Antibiotics Indicated in Simple Appendicitis? a Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT01420367
- Acronym / sponsor ID
- U1111-1123-7877
- Conditions
- Appendicitis
- Keywords
- Paediatric, Simple, Non-perforated
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Monash UniversityUniversity, hospital or other
- Collaborators
- Monash Medical Centre
- Study start
- Nov 2011 (actual)
- Primary completion
- Nov 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 19 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single dose of antibiotics | Experimental | Drug: metronidazole and cephalzolinThis 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. |
| Three doses of antibiotics | Active comparator | Drug: metronidazole and cephalzolinThis 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. |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| metronidazole and cephalzolinIV 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. | Drug | Single dose of antibiotics, Three doses of antibiotics |
Primary outcome
Presence of post-operative infection in the six weeks following appendectomy
Time frame: 6 weeks
Defined by wound infection, fever (>38.5) or evidence of sepsis.
Requirement of further antibiotic therapy in the six weeks following appendectomy
Time frame: 6 weeks
Administration of antibiotics either by hospital or general practitioner in the 6 week post-operative period.
2 secondary outcomes
Time to discharge taken from the time of operation to the time the child first satisfied the discharge criteria
Time frame: 1 week
Re-admission in the six weeks following appendectomy
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
Related trials for Appendicitis
RecruitingObservational study
Prospective Comparison of Pro-Adrenomedullin, C-Reactive Protein, and Neutrophil-to-Lymphocyte Ratio for Diagnosing Acute Appendicitis
Acute Appendicitis
Active, not recruiting
PAINED: Project Addressing INequities in the Emergency Department
Pain, Appendicitis
Not yet recruiting
Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
Appendicitis, Perforated Appendicitis
Recruiting
Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Acute Appendicitis
RecruitingPhase 3
Laparoscopic Antibiotic Lavage to Prevent Intra-abdominal Abscess Formation in Complicated Appendicitis
Complicated Appendicitis, Intra-Abdominal Abscess
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole Mennie, MBBS principal investigator
Monash University
Wei Cheng, MBBS study director
Monash Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing metronidazole and cephalzolin in people with Appendicitis, run by Monash University at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of post-operative infection in the six weeks following appendectomy (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2024.