a prospective randomized controlled multicenter trial comparing antibiotic therapy with appendectomy in the treatment of uncomplicated acute appendicitis (appac trial)前瞻性随机对照多中心试验比较简单的抗生素治疗阑尾切除术治疗急性阑尾炎(appac试验).pdfVIP

Paajanen et al. BMC Surgery 2013, 13:3 /1471-2482/13/3 STUDY PROTOCOL Open Access A prospective randomized controlled multicenter trial comparing antibiotic therapy with appendectomy in the treatment of uncomplicated acute appendicitis (APPAC trial) 1,2,3 4,5 6 7 8 9 Hannu Paajanen , Juha M Grönroos , Tero Rautio , Pia Nordström , Markku Aarnio , Tuomo Rantanen , Saija Hurme10, Kirsti Dean11, Airi Jartti12, Jukka-Pekka Mecklin8,3, Juhani Sand7 and Paulina Salminen4,5* 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 (age