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Open Access Highly Accessed Study protocol

A prospective randomized controlled multicenter trial comparing antibiotic therapy with appendectomy in the treatment of uncomplicated acute appendicitis (APPAC trial)

Hannu Paajanen123, Juha M Grönroos45, Tero Rautio6, Pia Nordström7, Markku Aarnio8, Tuomo Rantanen9, Saija Hurme10, Kirsti Dean11, Airi Jartti12, Jukka-Pekka Mecklin38, Juhani Sand7 and Paulina Salminen45*

Author Affiliations

1 Department of Surgery, Kuopio University Hospital, Kuopio, Finland

2 Department of Surgery, Mikkeli Central Hospital and Institute of clinical medicine, Mikkeli, Finland

3 University of Eastern Finland, Kuopio, Finland

4 Department of Surgery, Turku University Hospital, Turku, Finland

5 University of Turku, Turku, Finland

6 Department of Surgery, Oulu University Hospital, Oulu, Finland

7 Division of Surgery, Gastroenterology and Oncology, Tampere University Hospital, Tampere, Finland

8 Department of Surgery, Jyväskylä Central Hospital, Jyväskylä, Finland

9 Department of Surgery, Seinäjoki Central Hospital, Seinäjoki, Finland

10 Department of Biostatistics, University of Turku, Turku, Finland

11 Department of Radiology, Turku University Hospital, Turku, Finland

12 Department of Radiology, Oulu University Hospital, Oulu, Finland

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BMC Surgery 2013, 13:3  doi:10.1186/1471-2482-13-3

Published: 8 February 2013

Abstract

Background

Although the standard treatment of acute appendicitis (AA) consists of an early appendectomy, there has recently been both an interest and an increase in the use of antibiotic therapy as the primary treatment for uncomplicated AA. However, the use of antibiotic therapy in the treatment of uncomplicated AA is still controversial.

Methods/design

The APPAC trial is a randomized prospective controlled, open label, non-inferiority multicenter trial designed to compare antibiotic therapy (ertapenem) with emergency appendectomy in the treatment of uncomplicated AA. The primary endpoint of the study is the success of the randomized treatment. In the antibiotic treatment arm successful treatment is defined as being discharged from the hospital without the need for surgical intervention and no recurrent appendicitis during a minimum follow-up of one-year (treatment efficacy). Treatment efficacy in the operative treatment arm is defined as successful appendectomy evaluated to be 100%. Secondary endpoints are post-intervention complications, overall morbidity and mortality, the length of hospital stay and sick leave, treatment costs and pain scores (VAS, visual analoque scale). A maximum of 610 adult patients (aged 18–60 years) with a CT scan confirmed uncomplicated AA will be enrolled from six hospitals and randomized by a closed envelope method in a 1:1 ratio either to undergo emergency appendectomy or to receive ertapenem (1 g per day) for three days continued by oral levofloxacin (500 mg per day) plus metronidazole (1.5 g per day) for seven days. Follow-up by a telephone interview will be at 1 week, 2 months and 1, 3, 5 and 10 years; the primary and secondary endpoints of the trial will be evaluated at each time point.

Discussion

The APPAC trial aims to provide level I evidence to support the hypothesis that approximately 75–85% of patients with uncomplicated AA can be treated with effective antibiotic therapy avoiding unnecessary appendectomies and the related operative morbidity, also resulting in major cost savings.

Trial registration

Clinicaltrials.gov http://NCT01022567 webcite

Keywords:
Acute appendicitis; Appendicitis; Uncomplicated appendicitis; Appendectomy; Appendicectomy; Antibiotic treatment; Conservative; Non-operative; Randomized