A prospective randomized controlled multicenter trial comparing antibiotic therapy with appendectomy in the treatment of uncomplicated acute appendicitis (APPAC trial)
| Autor: | Pia Nordström, Saija Hurme, Kirsti Dean, Airi Jartti, Jukka-Pekka Mecklin, Juha Grönroos, Markku Aarnio, Tero Rautio, Tuomo Rantanen, Juhani Sand, Hannu Paajanen, Paulina Salminen |
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| Rok vydání: | 2013 |
| Předmět: |
Adult
Ertapenem medicine.medical_specialty Adolescent lcsh:Surgery Randomized beta-Lactams law.invention Study Protocol Young Adult chemistry.chemical_compound Anti-Infective Agents Randomized controlled trial law Multicenter trial Non-operative medicine Appendectomy Humans Conservative Prospective Studies Young adult Prospective cohort study Uncomplicated appendicitis Acute appendicitis business.industry Standard treatment lcsh:RD1-811 General Medicine Middle Aged Appendicitis medicine.disease Antibiotic treatment Anti-Bacterial Agents Surgery Treatment Outcome chemistry Acute Disease Appendicectomy business Follow-Up Studies |
| Zdroj: | BMC Surgery BMC Surgery, Vol 13, Iss 1, p 3 (2013) |
| ISSN: | 1471-2482 |
| Popis: | 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 |
| Databáze: | OpenAIRE |
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