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

BMC Surgery

Paulina Salminen⁹  Juhani Sand²  Jukka-Pekka Mecklin⁴  Airi Jartti⁶  Kirsti Dean¹  Saija Hurme³  Tuomo Rantanen⁷  Markku Aarnio⁴  Pia Nordström²  Tero Rautio⁵  Juha M Grönroos⁹  Hannu Paajanen⁸ 

[1]Department of Radiology, Turku University Hospital, Turku, Finland

[2]Division of Surgery, Gastroenterology and Oncology, Tampere University Hospital, Tampere, Finland

[3]Department of Biostatistics, University of Turku, Turku, Finland

[4]Department of Surgery, Jyväskylä Central Hospital, Jyväskylä, Finland

[5]Department of Surgery, Oulu University Hospital, Oulu, Finland

[6]Department of Radiology, Oulu University Hospital, Oulu, Finland

[7]Department of Surgery, Seinäjoki Central Hospital, Seinäjoki, Finland

[8]University of Eastern Finland, Kuopio, Finland

[9]University of Turku, Turku, Finland

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

Others  :  1123344
DOI  :  10.1186/1471-2482-13-3

 received in 2012-06-21, accepted in 2013-01-31,  发布年份 2013

【 摘 要 】

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.govhttp://NCT01022567 webcite

【 授权许可】

   
2013 Paajanen et al; licensee BioMed Central Ltd.

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