Acute uncomplicated appendicitis study: rationale and protocol for a multicentre, prospective randomised controlled non-inferiority study to evaluate the safety and effectiveness of non-operative management in children with acute uncomplicated appendicitis.

ABSTRACT:

Introduction

This article presents an overview of a prospective randomised controlled non-inferiority study designed to evaluate the safety and effectiveness of non-operative management (NOM) with operative management in children with acute uncomplicated appendicitis (AUA). Here, we present the study protocol for this APRES study, a multicentre Australian study. The rationale and details of future analysis, in particular, non-inferiority calculations, cost-effectiveness, feasibility and acceptability of each intervention.

Design

A multicentre, prospective randomised controlled clinical trial, conducted in 2 Australian tertiary paediatric hospitals.

Participants

Children who meet the inclusion criteria of an age between 5 and 15 years and a clinical diagnosis of AUA wi

SUBMITTER: Xu J 

PROVIDER: S-EPMC5223693 | biostudies-literature | 2016 Dec

REPOSITORIES: biostudies-literature