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Non-operative Management for Appendicitis in Children

NCT02795793 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 226

Last updated 2018-09-18

No results posted yet for this study

Summary

This study is designed to determine the safety and efficacy of non-operative antibiotic management of clinically diagnosed acute uncomplicated appendicitis in children. Enrolled patients will be randomised and an allocation ratio of 1:1 will be made via weighted minimisation, where half of the patients will receive non-operative management with intravenous Piperacillin with Tazobactam, while the other half will have an appendicectomy.

Conditions

  • Acute Focal Appendicitis
  • Appendicitis

Interventions

DRUG

Non-operative management group (NOM)

With intravenous Piperacillin with Tazobactam (Tazocin)

PROCEDURE

Appendectomy group (Operative management, OM)

Sponsors & Collaborators

  • Sydney Children's Hospitals Network

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2019-05-31
Completion
2019-12-31

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02795793 on ClinicalTrials.gov