Are Post-operative Antibiotics Indicated in Simple Appendicitis? - Full Text View

Purpose

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.

Condition	Intervention
Appendicitis	Drug: metronidazole and cephalzolin

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Are Post-operative Antibiotics Indicated in Simple Appendicitis? A Prospective Randomized Trial

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics Appendicitis

Drug Information available for: Metronidazole Metronidazole benzoate Metronidazole hydrochloride

U.S. FDA Resources

Further study details as provided by Monash University:

Primary Outcome Measures:

Presence of post-operative infection in the six weeks following appendectomy [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Administration of antibiotics either by hospital or general practitioner in the 6 week post-operative period.

Secondary Outcome Measures:

Time to discharge taken from the time of operation to the time the child first satisfied the discharge criteria [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Discharge criteria:

Pain adequately controlled with oral analgesia Tolerating full diet Afebrile
Re-admission in the six weeks following appendectomy [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Re-admission to the treating hospital or any other hospital in the 6 weeks post-operative period.

Estimated Enrollment:	300
Study Start Date:	November 2011
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	November 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	Drug: 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.
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.	Drug: 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.

Eligibility

Ages Eligible for Study:	4 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01420367

Contacts

Contact: Nicole Mennie, MBBS		nmmen4@student.monash.edu
Contact: Wei Cheng, MBBS	+61395945500

Locations

Australia, Victoria
Monash Medical Centre	Not yet recruiting
Clayton, Victoria, Australia, 3168
Contact: Wei Cheng, MBBS +61395945500
Contact: N Mennie, MBBS nmmen4@student.monash.edu
Principal Investigator: Nicole M Mennie, MBBS
Principal Investigator: Wei Cheng, MBBS
Sub-Investigator: Peter Ferguson, MBBS

Sponsors and Collaborators

Monash University

Monash Medical Centre

Investigators

Principal Investigator:	Nicole Mennie, MBBS	Monash University
Study Director:	Wei Cheng, MBBS	Monash Medical Centre

More Information

No publications provided

Responsible Party:	Nicole Mennie, Monash University
ClinicalTrials.gov Identifier:	NCT01420367 History of Changes
Other Study ID Numbers:	U1111-1123-7877
Study First Received:	August 18, 2011
Last Updated:	August 18, 2011
Health Authority:	Australia: Human Research Ethics Committee

Keywords provided by Monash University:

Paediatric
Simple
Non-perforated

Additional relevant MeSH terms:

Appendicitis
Acute Disease
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes

Anti-Bacterial Agents
Metronidazole
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on May 22, 2013