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International Journal of Colorectal Disease
Published in: International Journal of Colorectal Disease 11/2017

01-11-2017 | Clinical Study Protocol

A prospective non-randomized controlled, multicenter trial comparing Appendectomy and Conservative Treatment for Patients with Uncomplicated Acute Appendicitis (the ACTUAA study)

Authors: Mauro Podda, Fernando Serventi, Lorenzo Mortola, Stefano Marini, Danilo Sirigu, Michela Piga, Marcello Pisano, Massimiliano Coppola, Ferdinando Agresta, Francesco Virdis, Salomone Di Saverio, Nicola Cillara, The ACTUAA Study Collaborative Working Group

Published in: International Journal of Colorectal Disease | Issue 11/2017

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Abstract

Purpose

Acute appendicitis (AA) is among the most common causes of lower abdominal pain and admissions to the emergency department. Over the past 20 years, there has been a renewed interest in the conservative management of uncomplicated AA, and several studies demonstrated that an antibiotic-first strategy is a viable treatment option for uncomplicated AA. The aim of this prospective non-randomized controlled, multicenter trial is to compare antibiotic therapy and emergency appendectomy as treatment for patients with uncomplicated AA confirmed by US and/or CT or MRI scan.

Methods

All adult patients in the age range 18 to 65 years with suspected AA, consecutively admitted to the Surgical Department of the 13 participating Italian Hospitals, will be invited to take part in the study. A multicenter prospective collected registry developed by surgeons, radiologists, and pathologists with expertise in the diagnosis and treatment of uncomplicated acute appendicitis represents the best research method to assess the long-term role of antibiotics in the management of the disease. Comparison will be made between surgical and antibiotic-first approaches to uncomplicated AA through the analysis of the primary outcome measure of complication-free treatment success rate based on 1-year follow-up. Quality of life, length of hospital stay, pain evaluation, and time to return to normal activity will be evaluated as secondary outcome measures.

Trial registration

Clinicaltrials.​gov ID: NCT03080103
Appendix
Available only for authorised users
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Metadata
Title
A prospective non-randomized controlled, multicenter trial comparing Appendectomy and Conservative Treatment for Patients with Uncomplicated Acute Appendicitis (the ACTUAA study)
Authors
Mauro Podda
Fernando Serventi
Lorenzo Mortola
Stefano Marini
Danilo Sirigu
Michela Piga
Marcello Pisano
Massimiliano Coppola
Ferdinando Agresta
Francesco Virdis
Salomone Di Saverio
Nicola Cillara
The ACTUAA Study Collaborative Working Group
Publication date
01-11-2017
Publisher
Springer Berlin Heidelberg
Published in
International Journal of Colorectal Disease / Issue 11/2017
Print ISSN: 0179-1958
Electronic ISSN: 1432-1262
DOI
https://doi.org/10.1007/s00384-017-2878-5

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