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

BMC Surgery

Study Protocol

Saija Hurme¹  Airi Jartti²  Kirsti Dean³  Markku Aarnio⁴  Jukka-Pekka Mecklin⁵  Hannu Paajanen⁶  Tero Rautio⁷  Tuomo Rantanen⁸  Paulina Salminen⁹  Juha M Grönroos⁹  Juhani Sand^1,10  Pia Nordström^1,10 

[1] Department of Biostatistics, University of Turku, Turku, Finland;Department of Radiology, Oulu University Hospital, Oulu, Finland;Department of Radiology, Turku University Hospital, Turku, Finland;Department of Surgery, Jyväskylä Central Hospital, Jyväskylä, Finland;Department of Surgery, Jyväskylä Central Hospital, Jyväskylä, Finland;University of Eastern Finland, Kuopio, Finland;Department of Surgery, Kuopio University Hospital, Kuopio, Finland;Department of Surgery, Mikkeli Central Hospital and Institute of clinical medicine, Mikkeli, Finland;University of Eastern Finland, Kuopio, Finland;Department of Surgery, Oulu University Hospital, Oulu, Finland;Department of Surgery, Seinäjoki Central Hospital, Seinäjoki, Finland;Department of Surgery, Turku University Hospital, Turku, Finland;University of Turku, Turku, Finland;Division of Surgery, Gastroenterology and Oncology, Tampere University Hospital, Tampere, Finland;

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

DOI  :  10.1186/1471-2482-13-3

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

来源: Springer

【 摘 要 】

BackgroundAlthough 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/designThe 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.DiscussionThe 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 registrationClinicaltrials.govhttp://NCT01022567

【 授权许可】

Unknown   
© Paajanen et al; licensee BioMed Central Ltd. 2013. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.