Are Post-operative Antibiotics Indicated in Simple Appendicitis?

NCT01420367 | Completed

• 1 other identifier: U1111-1123-7877
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Appendicitis

Keywords

Paediatric; Simple; Non-perforated

Outcome Measures

Primary Outcomes (2)

• Presence of post-operative infection in the six weeks following appendectomy

  Defined by wound infection, fever (\>38.5) or evidence of sepsis.

  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.

  6 weeks

Secondary Outcomes (2)

• Time to discharge taken from the time of operation to the time the child first satisfied the discharge criteria

  1 week

• Re-admission in the six weeks following appendectomy

  6 weeks

Study Arms (2)

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.

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.

Drug: metronidazole and cephalzolin

Interventions

metronidazole and cephalzolin DRUG

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.

Single dose of antibiotics; Three doses of antibiotics

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Monash University: lead
• Monash Medical Centre: collaborator

Study Sites (1)

Monash Medical Centre

Clayton, Victoria, 3168, Australia

Location

MeSH Terms

Conditions

Appendicitis; Charcot-Marie-Tooth disease, Type 1C

Interventions

Metronidazole

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Nicole Mennie, MBBS

  Monash University

  PRINCIPAL INVESTIGATOR

• Wei Cheng, MBBS

  Monash Medical Centre

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2011
• First Posted: August 19, 2011
• Study Start: November 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 2, 2024

Record last verified: 2011-08

Locations

AU (1)